1. what lenalidomide is and what it is used for

The name of the product is Lenalidomide hard capsules (called lenalidomide throughout this leaflet). The capsules contain the active substance lenalidomide. This medicine belongs to a group of medicines which affect how your immune system works.

Lenalidomide is used in adults for:

• – Multiple myeloma.

• – Follicular lymphoma.

Multiple myeloma

Multiple myeloma is a type of cancer which affects a certain kind of white blood cell, called the plasma cell.

These cells collect in the bone marrow and divide, becoming out of control. This can damage the bones and kidneys.

Multiple myeloma generally cannot be cured. However, the signs and symptoms can be greatly reduced or disappear for a period of time. This is called a ‘response’.

Newly diagnosed multiple myeloma – in patients who have had a bone marrow transplant

Lenalidomide is used on its own as maintenance therapy after patients have recovered enough following a bone marrow transplant.

Newly diagnosed multiple myeloma – in patients who cannot have a bone marrow transplant

Lenalidomide is taken with other medicines. These may include:

• – A chemotherapy medicine called bortezomib.

• – An anti-inflammatory medicine called ‘dexamethasone’.

• – A chemotherapy medicine called ‘melphalan’.

• – An immunosuppressant medicine called ‘prednisone’.

You will take these other medicines at the start of treatment and then continue to take lenalidomide on its own.

If you are aged 75 years or older or have moderate to severe kidney problems – your doctor will check you carefully before starting treatment.

Multiple myeloma – in patients who have had treatment before Lenalidomide is taken together with an anti-inflammatory medicine called dexamethasone.

Lenalidomide can stop the signs and symptoms of multiple myeloma getting worse. It has also been shown to delay multiple myeloma from coming back following treatment.

Follicular lymphoma (FL)

FL is a slow growing cancer that affects the B-lymphocytes. These are a type of white blood cells that help your body fight infection. When you have FL, too many of these B-lymphocytes may collect in your blood, bone marrow, lymph nodes and spleen.

Lenalidomide is taken together with another medicine called rituximab for the treatment of adult patients with previously treated follicular lymphoma.

How lenalidomide works

Lenalidomide works by affecting the body’s immune system and directly attacking the cancer. It works in a number of different ways:

• – By stopping the cancer cells developing

• – By stopping blood vessels growing in the cancer

• – By stimulating part of the immune system to attack the cancer cells.

2. what you need to know before you take lenalidomide

You must read the package leaflet of all medicinal products to be taken in combination with lenalidomide before starting treatment with lenalidomide.

Do not take lenalidomide if you are:

• – pregnant, think you may be pregnant or are planning to become pregnant, as lenalidomide is expected to be harmful to an unborn child (see section 2, ‘Pregnancy, breastfeeding and contraception – information for women and men’).

• – able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant (see section 2, ‘Pregnancy, breast-feeding and contraception – information for women and men’). If you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and provide you with this confirmation.

• – allergic to lenalidomide or any of the other ingredients of this medicine listed in section 6. If you think you may be allergic, ask your doctor for advice.

If any of these apply to you, do not take lenalidomide. Talk to your doctor if you are not sure.

Warnings and precautions

Talk to your doctor or pharmacists before taking lenalidomide if you have:

• – had blood clots in the past – you have an increased risk of developing blood clots in the veins and arteries during treatment

• – any signs of an infection, such as a cough or fever

• – or have ever had previous viral infection, particularly hepatitis B infection, varicella zoster, HIV. If you are in doubt, talk to your doctor. Treatment with lenalidomide may cause the virus to become active again, in patients who carry the virus. This results in a recurrence of the infection. Your doctor should check whether you have ever had hepatitis B infection.

• – problems with your thyroid gland.

• – liver problems.

• – kidney problems – your doctor may adjust your dose of lenalidomide

• – had a heart attack, or if you smoke, have high blood pressure or high cholesterol levels.

• – had an allergic reaction whilst taking thalidomide (another medicine used to treat multiple myeloma) such as rash, itching, swelling, dizziness or trouble breathing

• – experienced in the past a combination of any of the following symptoms: Widespread rash, red skin, high body temperature, flu-like symptoms, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes these are signs of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms which is also known as DRESS, or drug hypersensitivity syndrome, see also section 4 “Possible side effects”).

If any of the above apply to you, tell your doctor or pharmacist before starting treatment.

At any time during or after your treatment, tell your doctor or nurse immediately if you experience:

• – blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion. These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leucoencephalopathy (PML). If you had these symptoms prior to treatment with lenalidomide, tell your doctor about any change in these symptoms.

• – shortness of breath, tiredness, dizziness, pain in the chest, a faster heartbeat, or welling in the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and checks

Before and during the treatment with lenalidomide you will have regular blood tests. This is because lenalidomide may cause a fall in the blood cells that help fight infection (white blood cells) and help the blood to clot (platelets). Your doctor will ask you to have a blood test:

• – Before treatment.

• – Every week for the first 8 weeks of treatment.

• – Then at least every month after that.

You may be evaluated for signs of cardiopulmonary problems before and during the treatment with lenalidomide.

For patients with FL taking lenalidomide

Your doctor will ask you to have a blood test:

• – Before treatment.

• – Every week for the first 3 weeks (1 cycle) of treatment.

• – Then every 2 weeks in cycles 2 to 4 (see section 3 “Treatment cycle” for more information).

• – After this it will happen at the start of each cycle.

• – At least every month.

Your doctor may check if you have a high total amount of tumour throughout the body, including your bone marrow. This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the blood which can lead to kidney failure (this condition is called ‘tumour lysis syndrome’).

Your doctor may check you for changes to your skin such as red spots or rashes.

Your doctor may adjust your dose of lenalidomide or stop your treatment based on the results of your blood tests and on your general condition. If you are newly diagnosed, your doctor may also assess your treatment based on your age and other conditions you already have.

Blood donation

You should not donate blood during treatment and for at least 7 days after the end of treatment.

Children and adolescents

Lenalidomide is not recommended for use in children and adolescents under 18 years.

Elderly and people with kidney problems

If you are aged 75 years or older or have moderate to severe kidney problems – your doctor will check you carefully before starting treatment.

Other medicines and lenalidomide

Tell your doctor or nurse if you are taking or have recently taken any other medicines. This is because lenalidomide can affect the way some other medicines work. Also, some other medicines can affect the way lenalidomide works.

In particular, tell your doctor or nurse if you are taking any of the following medicines:

• – Some medicines used to prevent pregnancy such as oral contraceptives, as they may stop working.

• – Some medicines used for heart problems – such as digoxin. – Some medicines used to thin the blood – such as warfarin.

• – Some medicines used to decrease high cholesterol level called statins.

Pregnancy, breast-feeding and contraception -information for women and men

Pregnancy

For women taking lenalidomide

• You must not take lenalidomide if you are pregnant, as it is expected to be harmful to an unborn baby.
• You must not become pregnant while taking lenalidomide. Therefore you must use effective methods of contraception if you are a woman of childbearing potential (see “Contraception”).
• If you do become pregnant during your treatment with lenalidomide, you must stop the treatment and inform your doctor immediately.

For men taking lenalidomide

• If your partner becomes pregnant whilst you are taking lenalidomide, you should inform your doctor immediately. It is recommended that your partner seeks medical advice.
• You must also use effective methods of contraception (see “Contraception”).

Breast-feeding

You must not breast-feed when taking lenalidomide, as it is not known if lenalidomide passes into breast milk.

Contraception

For women taking lenalidomide

Before starting the treatment, ask your doctor if you are able to become pregnant, even if you think this is unlikely.

If you are able to become pregnant

• – you will have pregnancy tests under the supervision of your doctor (before every treatment, at least every 4 weeks during treatment, and at least 4 weeks after the treatment has finished) except where it has been confirmed that the fallopian tubes have been severed and sealed, to stop eggs from reaching the uterus (tubal sterilisation)

AND

• – you must use effective methods of contraception for at least 4 weeks before starting treatment, during treatment, and until at least 4 weeks after stopping treatment. Your doctor will advise you on appropriate methods of contraception.

For men taking lenalidomide

Lenalidomide passes into human semen. If your female partner is pregnant or able to become pregnant, and she does not use effective methods of contraception, you must use condoms during treatment and for at least 7 days after the end of treatment, even if you have had a vasectomy.

Driving and using machines

Do not drive or operate machines if you feel dizzy, tired, sleepy, have vertigo or blurred vision after taking lenalidomide.

Lenalidomide contains lactose and sodium

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially “sodium-free”.

3. how to take lenalidomide

Lenalidomide must be given to you by healthcare professionals with experience in treating multiple myeloma, or FL.

• – When lenalidomide is used to treat multiple myeloma in patients who cannot have a bone marrow transplant or have had other treatments before, it is taken with other medicines (see section 1 “What lenalidomide is and what it is used for”).

• – When lenalidomide is used to treat multiple myeloma in patients who have had a bone marrow transplant, it is taken alone.

• – When lenalidomide is used to treat FL, it is taken with another medicine called rituximab.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

If you are taking lenalidomide in combination with other medicines, you should refer to the package leaflets for these medicines for further information on their use and effects.

Treatment cycle

Lenalidomide is taken on certain days over 3 weeks (21 days).

• – Every 21 days is called a ”treatment cycle”.

• – Depending on the day of the cycle, you will take 1 or more of the medicines. However, on some days you do not take any of the medicines.

• – After completing every 21-day cycle, you should start a new “cycle” over the next 21 days.

OR

• – Lenalidomide is taken on certain days over 4 weeks (28 days).

• – Every 28 days is called a “treatment cycle”.

• – Depending on the day of the cycle, you will take 1 or more of the medicines. However, on some days you do not take any of the medicines.

• – After completing each 28-day cycle, you should start a new “cycle” over the next 28 days.

How much lenalidomide to take

Before you start treatment, your doctor will tell you:

• – How much lenalidomide you should take.

• – How much of the other medicines you should take in combination with lenalidomide, if any.

• – On what days of your treatment cycle to take each medicine.

How and when to take lenalidomide

• – Swallow the capsules whole, preferably with water.

• – Do not break, open or chew the capsules. If powder from a broken lenalidomide capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water.

• – Healthcare professionals, caregivers and family members should wear disposable gloves when handling the blister or capsule. Gloves should then be removed carefully to prevent skin exposure, placed in a sealable plastic polyethylene bag and disposed of in accordance with local requirements. Hands should then be washed thoroughly with soap and water. Women who are pregnant or suspect they may be pregnant should not handle the blister or capsule.

• – The capsules can be taken either with or without food.

• – You should take lenalidomide at about the same time on the scheduled days.

Taking this medicine

To remove the capsule from the blister:

• – Press only one end of the capsule out to push it through the foil.

• – Do not put pressure on the centre of the capsule as this can cause it to break.

Duration of the treatment with lenalidomide

Lenalidomide is taken in treatment cycles, each cycle lasting 21 or 28 days (see above “Treatment cycle”). You should continue the cycles of treatment until your doctor tells you to stop.

If you take more lenalidomide than you should

If you take more lenalidomide than was prescribed, tell your doctor immediately.

If you forget to take lenalidomide

If you forget to take lenalidomide at your regular time and

• – less than 12 hours have passed – take your capsule immediately.

• – more than 12 hours have passed – do not take your capsule. Take your next capsule at the usual time the next day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking lenalidomide and see a doctor straight away if you notice any of the following serious side effects -you may need urgent medical treatment.

• – Hives, rashes, swelling of eyes, mouth or face, difficulty breathing, or itching, which may be symptoms of serious types of allergic reactions called angioedema and anaphylactic reaction.

1065026603_PIL COMON LENALIDOMID ZTV CAP BL3X7 GB.indd 1

• – A serious allergic reaction that may begin as a rash in

1 area but spread with extensive loss of skin over the whole body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).

• – Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (drug reaction with eosinophilia and systemic symptoms which is also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Also tell your doctor straight away if you notice any of the following serious side effects:

• – Fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection (including within the bloodstream (sepsis)

• – Bleeding or bruising in the absence of injury.

• – Leg pain, which could be a symptom of thrombosis.

• – Chest pain or shortness of breath, which may be a symptom of blood clots in the lungs, called pulmonary embolism.

• – Bone pain, muscle weakness, confusion or tiredness that might be due to high level of calcium in the blood.

Lenalidomide may reduce the number of white blood cells that fight infection, red blood cells which carry oxygen and also the blood cells which help the blood to clot (platelets) which may lead to bleeding disorders such as nosebleeds and bruising. Lenalidomide may also cause blood clots in the veins (thrombosis).

Other side effects

It is important to note that a small number of patients may develop additional types of cancer, and it is possible that this risk may be increased with lenalidomide treatment, therefore your doctor should carefully evaluate the benefit and risk when you are prescribed lenalidomide.

Very common (may affect more than 1 in 10 people):

• Infection of the lungs (with signs as wheezing, shortness of breath or a dry cough) or bronchi and the upper respiratory tract, shortness of breath
• Infections of all types
• Flu and flu like symptoms including fever
• Inflammation of stomach and bowels
• Infection of the sinuses that surround the nose
• Underactive thyroid
• Low levels of potassium, calcium or sodium in the blood
• Increase or decrease in your blood sugar level
• Dehydration
• Decreased appetite and weight
• Mood change
• Difficulty sleeping
• Numbness, tingling or burning sensation to the skin
• Pains in hands or feet
• Dizziness
• Tremor
• Changes in the way things taste
• Headache
• Clouding of your eye (cataract)
• Blurred vision
• Decreased blood pressure
• Cough
• Nosebleed
• Diarrhoea
• Constipation
• Stomach pain
• Feeling sick
• Vomiting
• Dry mouth
• Inflammation in the mouth
• Abnormal liver test results
• Rashes
• Itching
• Dry skin
• Muscle cramps or pain
• Back pain
• Joint pain
• Production of much more or much less urine than usual (which may be a symptom of kidney failure)
• Fatigue
• Weakness
• Fever
• Swelling including swelling of your arms and legs

Common (may affect up to 1 in 10 people):

• Urinary tract infection
• Lower respiratory tract infection
• Herpes zoster (viral infection also known as “shingles”, that causes a painful skin rash with blisters)
• Runny nose
• Skin infection
• Increase in pain, tumour size, redness around the tumour
• Certain types of skin tumour
• Overactive thyroid
• Low level of magnesium in the blood
• High levels of uric acid, bilirubin and calcium in the blood
• Diabetes
• Low levels of phosphates in the blood
• Gout
• An excess of iron in the body
• Lack of voluntary coordination of muscle movements
• Impaired balance
• Fainting
• Stroke
• Loss of vision acuity
• Deafness
• Ringing in the ears (tinnitus)
• Vertigo
• Fast, slow or irregular heart beat
• Chest pain spreading to the arms, neck, jaw, back

or stomach, feeling sweaty and breathless, feeling sick or vomiting, which may be symptoms of a heart attack (myocardial infarction)

• Shortness of breath especially when lying down (which may be a symptom of heart failure)
• Increased blood pressure
• Discoloration of your skin resulting from bleeding underneath, typically caused by bruising, swelling of skin filled with blood, bruise
• Changes to a protein in the blood that can cause swelling of the arteries (vasculitis)
• Voice disorder
• Sore throat
• Difficulty swallowing
• Heartburn
• Bowel obstruction
• Toothache
• Liver problems
• Darkening of your skin
• Hives
• Increased sweating including night sweats
• Skin eruptions, redness of skin
• Joint swelling
• Bone pain
• Neck pain
• Blood in the urine
• Problems with passing or involuntary loss of urine
• Difficulty getting an erection
• Lethargy
• Increased C-reactive protein (inflammation marker)
• Chills.

Uncommon (may affect up to 1 in 100 people)

• Destruction of blood cells
• Problems with blood coagulation
• Loss of sex drive (libido)
• Bleeding within the skull
• Circulatory problems also in the brain
• Loss of vision
• Increase in blood pressure within blood vessels that supply the lungs (pulmonary hypertension)
• Stomach pain, bloating, or diarrhoea, which may be symptoms of inflammation in the large intestine (called colitis or caecitis)
• Yellow pigmentation to the skin, mucus membrane or eyes (jaundice), pale coloured stools, dark coloured urine, skin itch, rash, pain or swelling of the stomach – these may be symptoms of liver failure
• Changes to the colour of your skin
• Sensitivity to sunlight
• Passing large amount of urine with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
• Passing much more or much less urine than usual, which may be a symptom of a type of kidney problem (renal tubular necrosis).

Rare side effects (may affect up to 1 in 1,000 people)

• Tumour lysis syndrome – metabolic complications that can occur during treatment of cancer and sometimes even without treatment. These complications are caused by the break-down products of dying cancer cells and may include the following: changes to blood chemistry; high potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney function, heartbeat, seizures, and sometimes death.

Not known (frequency cannot be estimated from the available data)

• Recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown-coloured urine, right-sided stomach pain, fever and feeling nauseous or being sick
• Rejection of solid organ transplant (such as kidney, heart)
• Sudden, or mild but worsening pain in the upper stomach and/or back, which remains for a few days, possibly accompanied by nausea, vomiting, fever and a rapid pulse. These symptoms may be due to inflammation of the pancreas
• Breakdown of the wall of the stomach or gut. This may lead to very serious infection. Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.
• A condition affecting the skin caused by inflammation of small blood vessels, along with pain in the joints and fever (leucocytoclastic vasculitis)
• Rare cases of muscle breakdown (muscle pain, weakness or swelling) which can lead to kidney problems (rhabdomyolysis) have been observed, some of them when lenalidomide is administered with a statin (a type of cholesterol lowering medicines).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the MHRA Yellow Card Scheme, Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store lenalidomide

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the blister and on the carton after “EXP”. The expiry date refers to the last day of that month.

This product does not require any special storage conditions.

Do not use this medicine if you notice any damage or signs of tampering to the pack.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to through away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What lenalidomide contains

The active substance is lenalidomide. Each capsule contains 5, 10, 15, or 25 mg of lenalidomide.

The other ingredients are:

• – Capsule contents: Lactose; cellulose, microcrystalline (E460 (i); croscarmellose sodium (E468); magnesium stearate (E470b).

• – Capsule shell: Gelatine, titanium dioxide (E171)

• – Only 10 mg and 15 mg: Indigotine (E132)

• – Only 10 mg: Yellow iron oxide (E172)

Printing ink: Shellac (E904); propylene glycol (E1502); black iron oxide (E172); potassium hydroxide.

What lenalidomide looks like and contents of the pack

1. what lenalidomide is and what it is used for

The name of the product is Lenalidomide hard capsules (called lenalidomide throughout this leaflet). The capsules contain the active substance lenalidomide. This medicine belongs to a group of medicines which affect how your immune system works.

Lenalidomide is used in adults for:

• – Multiple myeloma.

• – Follicular lymphoma.

Multiple myeloma

Multiple myeloma is a type of cancer which affects a certain kind of white blood cell, called the plasma cell.

These cells collect in the bone marrow and divide, becoming out of control. This can damage the bones and kidneys.

Multiple myeloma generally cannot be cured. However, the signs and symptoms can be greatly reduced or disappear for a period of time. This is called a ‘response’.

Newly diagnosed multiple myeloma – in patients who have had a bone marrow transplant

Lenalidomide is used on its own as maintenance therapy after patients have recovered enough following a bone marrow transplant.

Newly diagnosed multiple myeloma – in patients who cannot have a bone marrow transplant

Lenalidomide is taken with other medicines.

These may include:

• – A chemotherapy medicine called bortezomib.

• – An anti-inflammatory medicine called ‘dexamethasone’.

• – A chemotherapy medicine called ‘melphalan’.

• – An immunosuppressant medicine called ‘prednisone’.

You will take these other medicines at the start of treatment and then continue to take lenalidomide on its own.

If you are aged 75 years or older or have moderate to severe kidney problems – your doctor will check you carefully before starting treatment.

Multiple myeloma – in patients who have had treatment before Lenalidomide is taken together with an anti-inflammatory medicine called dexamethasone.

Lenalidomide can stop the signs and symptoms of multiple myeloma getting worse. It has also been shown to delay multiple myeloma from coming back following treatment.

Follicular lymphoma (FL)

FL is a slow growing cancer that affects the B-lymphocytes. These are a type of white blood cells that help your body fight infection. When you have FL, too many of these B-lymphocytes may collect in your blood, bone marrow, lymph nodes and spleen.

Lenalidomide is taken together with another medicine called rituximab for the treatment of adult patients with previously treated follicular lymphoma.

How lenalidomide works

Lenalidomide works by affecting the body’s immune system and directly attacking the cancer. It works in a number of different ways:

• – By stopping the cancer cells developing

• – By stopping blood vessels growing in the cancer

• – By stimulating part of the immune system to attack the cancer cells.

2. what you need to know before you take lenalidomide

You must read the package leaflet of all medicinal products to be taken in combination with lenalidomide before starting treatment with lenalidomide.

Do not take lenalidomide if you are:

• – pregnant, think you may be pregnant or are planning to become pregnant, as lenalidomide is expected to be harmful to an unborn child (see section 2, ‘Pregnancy, breast-feeding and contraception – information for women and men’).

• – able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant (see section 2, ‘Pregnancy, breast-feeding and contraception – information for women and men’). If you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and provide you with this confirmation.

• – allergic to lenalidomide or any of the other ingredients of this medicine listed in section 6. If you think you may be allergic, ask your doctor for advice.

If any of these apply to you, do not take lenalidomide. Talk to your doctor if you are not sure.

Warnings and precautions

Talk to your doctor or pharmacists before taking lenalidomide if you have:

• – had blood clots in the past – you have an increased risk of developing blood clots in the veins and arteries during treatment

• – any signs of an infection, such as a cough or fever

• – or have ever had previous viral infection, particularly hepatitis B infection, varicella zoster, HIV. If you are in doubt, talk to your doctor. Treatment with lenalidomide may cause the virus to become active again, in patients who carry the virus.

This results in a recurrence of the infection. Your doctor should check whether you have ever had hepatitis B infection.

• – problems with your thyroid gland.

• – liver problems.

• – kidney problems – your doctor may adjust your dose of lenalidomide

• – had a heart attack, or if you smoke, have high blood pressure or high cholesterol levels.

• – had an allergic reaction whilst taking thalidomide (another medicine used to treat multiple myeloma) such as rash, itching, swelling, dizziness or trouble breathing

• – experienced in the past a combination of any of the following symptoms: Widespread rash, red skin, high body temperature, flu-like symptoms, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes these are signs of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms which is also known as DRESS, or drug hypersensitivity syndrome, see also section 4 “Possible side effects”).

If any of the above apply to you, tell your doctor or pharmacist before starting treatment.

At any time during or after your treatment, tell your doctor or nurse immediately if you experience:

• – blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion. These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leucoencephalopathy (PML). If you had these symptoms prior to treatment with lenalidomide, tell your doctor about any change in these symptoms.

• – shortness of breath, tiredness, dizziness, pain in the chest, a faster heartbeat, or welling in the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and checks

Before and during the treatment with lenalidomide you will have regular blood tests. This is because lenalidomide may cause a fall in the blood cells that help fight infection (white blood cells) and help the blood to clot (platelets).

Your doctor will ask you to have a blood test: – Before treatment.

• – Every week for the first 8 weeks of treatment.

• – Then at least every month after that.

You may be evaluated for signs of cardiopulmonary problems before and during the treatment with lenalidomide.

For patients with FL taking lenalidomide

Your doctor will ask you to have a blood test: – Before treatment.

• – Every week for the first 3 weeks (1 cycle) of treatment.

• – Then every 2 weeks in cycles 2 to 4 (see section 3 “Treatment cycle” for more information).

• – After this it will happen at the start of each cycle.

• – At least every month.

Your doctor may check if you have a high total amount of tumour throughout the body, including your bone marrow. This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the blood which can lead to kidney failure (this condition is called ‘tumour lysis syndrome’).

Your doctor may check you for changes to your skin such as red spots or rashes.

Your doctor may adjust your dose of lenalidomide or stop your treatment based on the results of your blood tests and on your general condition. If you are newly diagnosed, your doctor may also assess your treatment based on your age and other conditions you already have.

Blood donation

You should not donate blood during treatment and for at least 7 days after the end of treatment.

Children and adolescents

Lenalidomide is not recommended for use in children and adolescents under 18 years.

Elderly and people with kidney problems

If you are aged 75 years or older or have moderate to severe kidney problems – your doctor will check you carefully before starting treatment.

Other medicines and lenalidomide

Tell your doctor or nurse if you are taking or have recently taken any other medicines. This is because lenalidomide can affect the way some other medicines work. Also, some other medicines can affect the way lenalidomide works.

In particular, tell your doctor or nurse if you are taking any of the following medicines:

• – Some medicines used to prevent pregnancy such as oral contraceptives, as they may stop working.

• – Some medicines used for heart problems – such as digoxin.

• – Some medicines used to thin the blood – such as warfarin.

• – Some medicines used to decrease high cholesterol level called statins.

Pregnancy, breast-feeding and contraception -information for women and men

Pregnancy

For women taking lenalidomide

• You must not take lenalidomide if you are pregnant, as it is expected to be harmful to an unborn baby.
• You must not become pregnant while taking lenalidomide. Therefore you must use effective methods of contraception if you are a woman of childbearing potential (see “Contraception”).
• If you do become pregnant during your treatment with lenalidomide, you must stop the treatment and inform your doctor immediately.

For men taking lenalidomide

• If your partner becomes pregnant whilst you are taking lenalidomide, you should inform your doctor immediately. It is recommended that your partner seeks medical advice.
• You must also use effective methods of contraception (see “Contraception”).

Breast-feeding

You must not breast-feed when taking lenalidomide, as it is not known if lenalidomide passes into breast milk.

Contraception

For women taking lenalidomide

Before starting the treatment, ask your doctor if you are able to become pregnant, even if you think this is unlikely.

If you are able to become pregnant

• – you will have pregnancy tests under the supervision of your doctor (before every treatment, at least every 4 weeks during treatment, and at least 4 weeks after the treatment has finished) except where it has been confirmed that the fallopian tubes have been severed and sealed, to stop eggs from reaching the uterus (tubal sterilisation)

AND

• – you must use effective methods of contraception for at least 4 weeks before starting treatment, during treatment, and until at least 4 weeks after stopping treatment.

Your doctor will advise you on appropriate methods of contraception.

For men taking lenalidomide

Lenalidomide passes into human semen. If your female partner is pregnant or able to become pregnant, and she does not use effective methods of contraception, you must use condoms during treatment and for at least 7 days after the end of treatment, even if you have had a vasectomy.

Driving and using machines

Do not drive or operate machines if you feel dizzy, tired, sleepy, have vertigo or blurred vision after taking lenalidomide.

Lenalidomide contains lactose and sodium

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially “sodium-free”.

3. how to take lenalidomide

Lenalidomide must be given to you by healthcare professionals with experience in treating multiple myeloma, or FL.

• – When lenalidomide is used to treat multiple myeloma in patients who cannot have a bone marrow transplant or have had other treatments before, it is taken with other medicines (see section 1 “What lenalidomide is and what it is used for”).

• – When lenalidomide is used to treat multiple myeloma in patients who have had a bone marrow transplant, it is taken alone.

• – When lenalidomide is used to treat FL, it is taken with another medicine called rituximab.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. If you are taking lenalidomide in combination with other medicines, you should refer to the package leaflets for these medicines for further information on their use and effects.

Treatment cycle

Lenalidomide is taken on certain days over 3 weeks (21 days). – Every 21 days is called a ”treatment cycle”.

• – Depending on the day of the cycle, you will take 1 or more of the medicines. However, on some days you do not take any of the medicines.

• – After completing every 21-day cycle, you should start a new “cycle” over the next 21 days.

OR

• – Lenalidomide is taken on certain days over 4 weeks (28 days). – Every 28 days is called a “treatment cycle”.

• – Depending on the day of the cycle, you will take 1 or more of the medicines. However, on some days you do not take any of the medicines.

• – After completing each 28-day cycle, you should start a new “cycle” over the next 28 days.

How much lenalidomide to take

Before you start treatment, your doctor will tell you:

• – How much lenalidomide you should take.

• – How much of the other medicines you should take in combination with lenalidomide, if any.

• – On what days of your treatment cycle to take each medicine.

How and when to take lenalidomide

• – Swallow the capsules whole, preferably with water.

• – Do not break, open or chew the capsules. If powder from a broken lenalidomide capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water.

• – Healthcare professionals, caregivers and family members should wear disposable gloves when handling the blister or capsule. Gloves should then be removed carefully to prevent skin exposure, placed in a sealable plastic polyethylene bag and disposed of in accordance with local requirements. Hands should then be washed thoroughly with soap and water. Women who are pregnant or suspect they may be pregnant should not handle the blister or capsule.

1065026596_PIL COMON LENALIDOMID ZT CAP BL3X7 SY GB.indd 1

• – The capsules can be taken either with or without food.

• – You should take lenalidomide at about the same time on the scheduled days.

Taking this medicine

To remove the capsule from the blister:

• – Press only one end of the capsule out to push it through the foil.

• – Do not put pressure on the centre of the capsule as this can cause it to break.

Duration of the treatment with lenalidomide

Lenalidomide is taken in treatment cycles, each cycle lasting 21 or 28 days (see above “Treatment cycle”). You should continue the cycles of treatment until your doctor tells you to stop.

If you take more lenalidomide than you should

If you take more lenalidomide than was prescribed, tell your doctor immediately.

If you forget to take lenalidomide

If you forget to take lenalidomide at your regular time and – less than 12 hours have passed – take your capsule immediately. – more than 12 hours have passed – do not take your capsule.

Take your next capsule at the usual time the next day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking lenalidomide and see a doctor straight away if you notice any of the following serious side effects -you may need urgent medical treatment.

• – Hives, rashes, swelling of eyes, mouth or face, difficulty breathing, or itching, which may be symptoms of serious types of allergic reactions called angioedema and anaphylactic reaction.

• – A serious allergic reaction that may begin as a rash in

1 area but spread with extensive loss of skin over the whole body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).

• – Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (drug reaction with eosinophilia and systemic symptoms which is also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Also tell your doctor straight away if you notice any of the following serious side effects:

• – Fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection (including within the bloodstream (sepsis)

• – Bleeding or bruising in the absence of injury.

• – Leg pain, which could be a symptom of thrombosis.

• – Chest pain or shortness of breath, which may be a symptom of blood clots in the lungs, called pulmonary embolism.

• – Bone pain, muscle weakness, confusion or tiredness that might be due to high level of calcium in the blood.

Lenalidomide may reduce the number of white blood cells that fight infection, red blood cells which carry oxygen and also the blood cells which help the blood to clot (platelets) which may lead to bleeding disorders such as nosebleeds and bruising. Lenalidomide may also cause blood clots in the veins (thrombosis).

Other side effects

It is important to note that a small number of patients may develop additional types of cancer, and it is possible that this risk may be increased with lenalidomide treatment, therefore your doctor should carefully evaluate the benefit and risk when you are prescribed lenalidomide.

Very common (may affect more than 1 in 10 people):

• Infection of the lungs (with signs as wheezing, shortness of breath or a dry cough) or bronchi and the upper respiratory tract, shortness of breath
• Infections of all types
• Flu and flu like symptoms including fever
• Inflammation of stomach and bowels
• Infection of the sinuses that surround the nose
• Underactive thyroid
• Low levels of potassium, calcium or sodium in the blood
• Increase or decrease in your blood sugar level
• Dehydration
• Decreased appetite and weight
• Mood change
• Difficulty sleeping
• Numbness, tingling or burning sensation to the skin
• Pains in hands or feet
• Dizziness
• Tremor
• Changes in the way things taste
• Headache
• Clouding of your eye (cataract)
• Blurred vision
• Decreased blood pressure
• Cough
• Nosebleed
• Diarrhoea
• Constipation
• Stomach pain
• Feeling sick
• Vomiting
• Dry mouth
• Inflammation in the mouth
• Abnormal liver test results
• Rashes
• Itching
• Dry skin
• Muscle cramps or pain
• Back pain
• Joint pain
• Production of much more or much less urine than usual (which may be a symptom of kidney failure)
• Fatigue
• Weakness
• Fever
• Swelling including swelling of your arms and legs

Common (may affect up to 1 in 10 people):

• Urinary tract infection
• Lower respiratory tract infection
• Herpes zoster (viral infection also known as “shingles”, that causes a painful skin rash with blisters)
• Runny nose
• Skin infection
• Increase in pain, tumour size, redness around the tumour
• Certain types of skin tumour
• Overactive thyroid
• Low level of magnesium in the blood
• High levels of uric acid, bilirubin and calcium in the blood
• Diabetes
• Low levels of phosphates in the blood
• Gout
• An excess of iron in the body
• Lack of voluntary coordination of muscle movements
• Impaired balance
• Fainting
• Stroke
• Loss of vision acuity
• Deafness
• Ringing in the ears (tinnitus)
• Vertigo
• Fast, slow or irregular heart beat
• Chest pain spreading to the arms, neck, jaw, back or stomach, feeling sweaty and breathless, feeling sick or vomiting, which may be symptoms of a heart attack (myocardial infarction)
• Shortness of breath especially when lying down (which may be a symptom of heart failure)
• Increased blood pressure
• Discoloration of your skin resulting from bleeding underneath, typically caused by bruising, swelling of skin filled with blood, bruise
• Changes to a protein in the blood that can cause swelling of the arteries (vasculitis)
• Voice disorder
• Sore throat
• Difficulty swallowing
• Heartburn
• Bowel obstruction
• Toothache
• Liver problems
• Darkening of your skin
• Hives
• Increased sweating including night sweats
• Skin eruptions, redness of skin
• Joint swelling
• Bone pain
• Neck pain
• Blood in the urine
• Problems with passing or involuntary loss of urine
• Difficulty getting an erection
• Lethargy
• Increased C-reactive protein (inflammation marker)
• Chills.

Uncommon (may affect up to 1 in 100 people)

• Destruction of blood cells
• Problems with blood coagulation
• Loss of sex drive (libido)
• Bleeding within the skull
• Circulatory problems also in the brain
• Loss of vision
• Increase in blood pressure within blood vessels that supply the lungs (pulmonary hypertension)
• Stomach pain, bloating, or diarrhoea, which may be symptoms of inflammation in the large intestine (called colitis or caecitis)
• Yellow pigmentation to the skin, mucus membrane or eyes (jaundice), pale coloured stools, dark coloured urine, skin itch, rash, pain or swelling of the stomach – these may be symptoms of liver failure
• Changes to the colour of your skin
• Sensitivity to sunlight
• Passing large amount of urine with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
• Passing much more or much less urine than usual, which may be a symptom of a type of kidney problem (renal tubular necrosis).

Rare side effects (may affect up to 1 in 1,000 people)

• Tumour lysis syndrome – metabolic complications that can occur during treatment of cancer and sometimes even without treatment. These complications are caused by the break-down products of dying cancer cells and may include the following: changes to blood chemistry; high potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney function, heartbeat, seizures, and sometimes death.

Not known (frequency cannot be estimated from the available data)

• Recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown-coloured urine, right-sided stomach pain, fever and feeling nauseous or being sick
• Rejection of solid organ transplant (such as kidney, heart)
• Sudden, or mild but worsening pain in the upper stomach and/or back, which remains for a few days, possibly accompanied by nausea, vomiting, fever and a rapid pulse. These symptoms may be due to inflammation of the pancreas
• Breakdown of the wall of the stomach or gut. This may lead to very serious infection. Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.
• A condition affecting the skin caused by inflammation of small blood vessels, along with pain in the joints and fever (leucocytoclastic vasculitis)
• Rare cases of muscle breakdown (muscle pain, weakness or swelling) which can lead to kidney problems (rhabdomyolysis) have been observed, some of them when lenalidomide is administered with a statin (a type of cholesterol lowering medicines).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the MHRA Yellow Card Scheme, Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store lenalidomide

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the blister and on the carton after “EXP”. The expiry date refers to the last day of that month.

This product does not require any special storage conditions.

Do not use this medicine if you notice any damage or signs of tampering to the pack.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to through away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What lenalidomide contains

The active substance is lenalidomide. Each capsule contains 5, 10, 15 or 25 mg of lenalidomide.

The other ingredients are:

• – Capsule contents: Lactose; cellulose, microcrystalline (E460 (i); croscarmellose sodium (E468); magnesium stearate (E470b).

• – Capsule shell: Gelatine, titanium dioxide (E171)

• – Only 10 mg and 15 mg: Indigotine (E132)

• – Only 10 mg: Yellow iron oxide (E172)

Printing ink: Shellac (E904); propylene glycol (E1502); black iron oxide (E172); potassium hydroxide.

What lenalidomide looks like and contents of the pack

Lenalidomide 5 mg hard capsules: Opaque white body and opaque white cap, with a length of approximately 18.0 mm, marked “L9NL” and “5”.

Lenalidomide 10 mg hard capsules: Opaque yellow body and opaque green to light green cap, with a length of approximately 21.7 mm, marked “L9NL” and “10”.

Lenalidomide 15 mg hard capsules: Opaque white body and opaque blue cap to light blue, with a length of approximately 21.7 mm, marked“L9NL” and “15”.

Lenalidomide 25 mg hard capsules: Opaque white body and opaque white cap, with a length of approximately 21.7 mm, marked “L9NL” and “25”.

Boxes contain 7, 21 hard capsules.

Not all pack sizes may be marketed.

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Package leaflet: Information for the patient

Lenalidomide 5 mg hard capsules

Lenalidomide 10 mg hard capsules

Lenalidomide 15 mg hard capsules

Lenalidomide 25 mg hard capsules

lenalidomide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What lenalidomide is and what it is used for

• 2. What you need to know before you take lenalidomide

• 3. How to take lenalidomide

• 4. Possible side effects

• 5. How to store lenalidomide

• 6. Contents of the pack and other information

1. what lenalidomide is and what it is used for

The name of the product is Lenalidomide hard capsules (called lenalidomide throughout this leaflet). The capsules contain the active substance lenalidomide. This medicine belongs to a group of medicines which affect how your immune system works.

Lenalidomide is used in adults for:

• – Multiple myeloma.

• – Follicular lymphoma.

Multiple myeloma

Multiple myeloma is a type of cancer which affects a certain kind of white blood cell, called the plasma cell.

These cells collect in the bone marrow and divide, becoming out of control. This can damage the bones and kidneys.

Multiple myeloma generally cannot be cured. However, the signs and symptoms can be greatly reduced or disappear for a period of time. This is called a ‘response’.

Newly diagnosed multiple myeloma – in patients who have had a bone marrow transplant

Lenalidomide is used on its own as maintenance therapy after patients have recovered enough following a bone marrow transplant.

Newly diagnosed multiple myeloma – in patients who cannot have a bone marrow transplant

Lenalidomide is taken with other medicines.

These may include:

• – A chemotherapy medicine called bortezomib.

• – An anti-inflammatory medicine called ‘dexamethasone’.

• – A chemotherapy medicine called ‘melphalan’.

• – An immunosuppressant medicine called ‘prednisone’.

You will take these other medicines at the start of treatment and then continue to take lenalidomide on its own.

If you are aged 75 years or older or have moderate to severe kidney problems – your doctor will check you carefully before starting treatment.

Multiple myeloma – in patients who have had treatment before Lenalidomide is taken together with an anti-inflammatory medicine called dexamethasone.

Lenalidomide can stop the signs and symptoms of multiple myeloma getting worse. It has also been shown to delay multiple myeloma from coming back following treatment.

Follicular lymphoma (FL)

FL is a slow growing cancer that affects the B-lymphocytes. These are a type of white blood cells that help your body fight infection. When you have FL, too many of these B-lymphocytes may collect in your blood, bone marrow, lymph nodes and spleen.

Lenalidomide is taken together with another medicine called rituximab for the treatment of adult patients with previously treated follicular lymphoma.

How lenalidomide works

Lenalidomide works by affecting the body’s immune system and directly attacking the cancer. It works in a number of different ways:

• – By stopping the cancer cells developing

• – By stopping blood vessels growing in the cancer

• – By stimulating part of the immune system to attack the cancer cells.

2. what you need to know before you take lenalidomide

You must read the package leaflet of all medicinal products to be taken in combination with lenalidomide before starting treatment with lenalidomide.

Do not take lenalidomide if you are:

• – pregnant, think you may be pregnant or are planning to become pregnant, as lenalidomide is expected to be harmful to an unborn child (see section 2, ‘Pregnancy, breast-feeding and contraception – information for women and men’).

• – able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant (see section 2, ‘Pregnancy, breast-feeding and contraception – information for women and men’). If you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and provide you with this confirmation.

• – allergic to lenalidomide or any of the other ingredients of this medicine listed in section 6. If you think you may be allergic, ask your doctor for advice.

If any of these apply to you, do not take lenalidomide. Talk to your doctor if you are not sure.

Warnings and precautions

Talk to your doctor or pharmacists before taking lenalidomide if you have:

• – had blood clots in the past – you have an increased risk of developing blood clots in the veins and arteries during treatment

• – any signs of an infection, such as a cough or fever

• – or have ever had previous viral infection, particularly hepatitis B infection, varicella zoster, HIV. If you are in doubt, talk to your doctor. Treatment with lenalidomide may cause the virus to become active again, in patients who carry the virus.

This results in a recurrence of the infection. Your doctor should check whether you have ever had hepatitis B infection.

• – problems with your thyroid gland.

• – liver problems.

• – kidney problems – your doctor may adjust your dose of lenalidomide

• – had a heart attack, or if you smoke, have high blood pressure or high cholesterol levels.

• – had an allergic reaction whilst taking thalidomide (another medicine used to treat multiple myeloma) such as rash, itching, swelling, dizziness or trouble breathing

• – experienced in the past a combination of any of the following symptoms: Widespread rash, red skin, high body temperature, flu-like symptoms, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes these are signs of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms which is also known as DRESS, or drug hypersensitivity syndrome, see also section 4 “Possible side effects”).

If any of the above apply to you, tell your doctor or pharmacist before starting treatment.

At any time during or after your treatment, tell your doctor or nurse immediately if you experience:

• – blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion. These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leucoencephalopathy (PML). If you had these symptoms prior to treatment with lenalidomide, tell your doctor about any change in these symptoms.

• – shortness of breath, tiredness, dizziness, pain in the chest, a faster heartbeat, or welling in the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and checks

Before and during the treatment with lenalidomide you will have regular blood tests. This is because lenalidomide may cause a fall in the blood cells that help fight infection (white blood cells) and help the blood to clot (platelets).

Your doctor will ask you to have a blood test: – Before treatment.

• – Every week for the first 8 weeks of treatment.

• – Then at least every month after that.

You may be evaluated for signs of cardiopulmonary problems before and during the treatment with lenalidomide.

For patients with FL taking lenalidomide

Your doctor will ask you to have a blood test: – Before treatment.

• – Every week for the first 3 weeks (1 cycle) of treatment.

• – Then every 2 weeks in cycles 2 to 4 (see section 3 “Treatment cycle” for more information).

• – After this it will happen at the start of each cycle.

• – At least every month.

Your doctor may check if you have a high total amount of tumour throughout the body, including your bone marrow. This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the blood which can lead to kidney failure (this condition is called ‘tumour lysis syndrome’).

Your doctor may check you for changes to your skin such as red spots or rashes.

Your doctor may adjust your dose of lenalidomide or stop your treatment based on the results of your blood tests and on your general condition. If you are newly diagnosed, your doctor may also assess your treatment based on your age and other conditions you already have.

Blood donation

You should not donate blood during treatment and for at least 7 days after the end of treatment.

Children and adolescents

Lenalidomide is not recommended for use in children and adolescents under 18 years.

Elderly and people with kidney problems

If you are aged 75 years or older or have moderate to severe kidney problems – your doctor will check you carefully before starting treatment.

Other medicines and lenalidomide

Tell your doctor or nurse if you are taking or have recently taken any other medicines. This is because lenalidomide can affect the way some other medicines work. Also, some other medicines can affect the way lenalidomide works.

In particular, tell your doctor or nurse if you are taking any of the following medicines:

• – Some medicines used to prevent pregnancy such as oral contraceptives, as they may stop working.

• – Some medicines used for heart problems – such as digoxin.

• – Some medicines used to thin the blood – such as warfarin.

• – Some medicines used to decrease high cholesterol level called statins.

Pregnancy, breast-feeding and contraception -information for women and men

Pregnancy

For women taking lenalidomide

• You must not take lenalidomide if you are pregnant, as it is expected to be harmful to an unborn baby.
• You must not become pregnant while taking lenalidomide. Therefore you must use effective methods of contraception if you are a woman of childbearing potential (see “Contraception”).
• If you do become pregnant during your treatment with lenalidomide, you must stop the treatment and inform your doctor immediately.

For men taking lenalidomide

• If your partner becomes pregnant whilst you are taking lenalidomide, you should inform your doctor immediately. It is recommended that your partner seeks medical advice.
• You must also use effective methods of contraception (see “Contraception”).

Breast-feeding

You must not breast-feed when taking lenalidomide, as it is not known if lenalidomide passes into breast milk.

Contraception

For women taking lenalidomide

Before starting the treatment, ask your doctor if you are able to become pregnant, even if you think this is unlikely.

If you are able to become pregnant

• – you will have pregnancy tests under the supervision of your doctor (before every treatment, at least every 4 weeks during treatment, and at least 4 weeks after the treatment has finished) except where it has been confirmed that the fallopian tubes have been severed and sealed, to stop eggs from reaching the uterus (tubal sterilisation)

AND

• – you must use effective methods of contraception for at least 4 weeks before starting treatment, during treatment, and until at least 4 weeks after stopping treatment.

Your doctor will advise you on appropriate methods of contraception.

For men taking lenalidomide

Lenalidomide passes into human semen. If your female partner is pregnant or able to become pregnant, and she does not use effective methods of contraception, you must use condoms during treatment and for at least 7 days after the end of treatment, even if you have had a vasectomy.

Driving and using machines

Do not drive or operate machines if you feel dizzy, tired, sleepy, have vertigo or blurred vision after taking lenalidomide.

Lenalidomide contains lactose and sodium

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially “sodium-free”.

3. how to take lenalidomide

Lenalidomide must be given to you by healthcare professionals with experience in treating multiple myeloma, or FL.

• – When lenalidomide is used to treat multiple myeloma in patients who cannot have a bone marrow transplant or have had other treatments before, it is taken with other medicines (see section 1 “What lenalidomide is and what it is used for”).

• – When lenalidomide is used to treat multiple myeloma in patients who have had a bone marrow transplant, it is taken alone.

• – When lenalidomide is used to treat FL, it is taken with another medicine called rituximab.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. If you are taking lenalidomide in combination with other medicines, you should refer to the package leaflets for these medicines for further information on their use and effects.

Treatment cycle

Lenalidomide is taken on certain days over 3 weeks (21 days). – Every 21 days is called a ”treatment cycle”.

• – Depending on the day of the cycle, you will take 1 or more of the medicines. However, on some days you do not take any of the medicines.

• – After completing every 21-day cycle, you should start a new “cycle” over the next 21 days.

OR

• – Lenalidomide is taken on certain days over 4 weeks (28 days). – Every 28 days is called a “treatment cycle”.

• – Depending on the day of the cycle, you will take 1 or more of the medicines. However, on some days you do not take any of the medicines.

• – After completing each 28-day cycle, you should start a new “cycle” over the next 28 days.

How much lenalidomide to take

Before you start treatment, your doctor will tell you:

• – How much lenalidomide you should take.

• – How much of the other medicines you should take in combination with lenalidomide, if any.

• – On what days of your treatment cycle to take each medicine.

How and when to take lenalidomide

• – Swallow the capsules whole, preferably with water.

• – Do not break, open or chew the capsules. If powder from a broken lenalidomide capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water.

• – Healthcare professionals, caregivers and family members should wear disposable gloves when handling the blister or capsule. Gloves should then be removed carefully to prevent skin exposure, placed in a sealable plastic polyethylene bag and disposed of in accordance with local requirements. Hands should then be washed thoroughly with soap and water. Women who are pregnant or suspect they may be pregnant should not handle the blister or capsule.

1065026596_PIL COMON LENALIDOMID ZT CAP BL3X7 SY GB.indd 1

• – The capsules can be taken either with or without food.

• – You should take lenalidomide at about the same time on the scheduled days.

Taking this medicine

To remove the capsule from the blister:

• – Press only one end of the capsule out to push it through the foil.

• – Do not put pressure on the centre of the capsule as this can cause it to break.

Duration of the treatment with lenalidomide

Lenalidomide is taken in treatment cycles, each cycle lasting 21 or 28 days (see above “Treatment cycle”). You should continue the cycles of treatment until your doctor tells you to stop.

If you take more lenalidomide than you should

If you take more lenalidomide than was prescribed, tell your doctor immediately.

If you forget to take lenalidomide

If you forget to take lenalidomide at your regular time and – less than 12 hours have passed – take your capsule immediately. – more than 12 hours have passed – do not take your capsule.

Take your next capsule at the usual time the next day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking lenalidomide and see a doctor straight away if you notice any of the following serious side effects -you may need urgent medical treatment.

• – Hives, rashes, swelling of eyes, mouth or face, difficulty breathing, or itching, which may be symptoms of serious types of allergic reactions called angioedema and anaphylactic reaction.

• – A serious allergic reaction that may begin as a rash in

1 area but spread with extensive loss of skin over the whole body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).

• – Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (drug reaction with eosinophilia and systemic symptoms which is also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Also tell your doctor straight away if you notice any of the following serious side effects:

• – Fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection (including within the bloodstream (sepsis)

• – Bleeding or bruising in the absence of injury.

• – Leg pain, which could be a symptom of thrombosis.

• – Chest pain or shortness of breath, which may be a symptom of blood clots in the lungs, called pulmonary embolism.

• – Bone pain, muscle weakness, confusion or tiredness that might be due to high level of calcium in the blood.

Lenalidomide may reduce the number of white blood cells that fight infection, red blood cells which carry oxygen and also the blood cells which help the blood to clot (platelets) which may lead to bleeding disorders such as nosebleeds and bruising. Lenalidomide may also cause blood clots in the veins (thrombosis).

Other side effects

It is important to note that a small number of patients may develop additional types of cancer, and it is possible that this risk may be increased with lenalidomide treatment, therefore your doctor should carefully evaluate the benefit and risk when you are prescribed lenalidomide.

Very common (may affect more than 1 in 10 people):

• Infection of the lungs (with signs as wheezing, shortness of breath or a dry cough) or bronchi and the upper respiratory tract, shortness of breath
• Infections of all types
• Flu and flu like symptoms including fever
• Inflammation of stomach and bowels
• Infection of the sinuses that surround the nose
• Underactive thyroid
• Low levels of potassium, calcium or sodium in the blood
• Increase or decrease in your blood sugar level
• Dehydration
• Decreased appetite and weight
• Mood change
• Difficulty sleeping
• Numbness, tingling or burning sensation to the skin
• Pains in hands or feet
• Dizziness
• Tremor
• Changes in the way things taste
• Headache
• Clouding of your eye (cataract)
• Blurred vision
• Decreased blood pressure
• Cough
• Nosebleed
• Diarrhoea
• Constipation
• Stomach pain
• Feeling sick
• Vomiting
• Dry mouth
• Inflammation in the mouth
• Abnormal liver test results
• Rashes
• Itching
• Dry skin
• Muscle cramps or pain
• Back pain
• Joint pain
• Production of much more or much less urine than usual (which may be a symptom of kidney failure)
• Fatigue
• Weakness
• Fever
• Swelling including swelling of your arms and legs

Common (may affect up to 1 in 10 people):

• Urinary tract infection
• Lower respiratory tract infection
• Herpes zoster (viral infection also known as “shingles”, that causes a painful skin rash with blisters)
• Runny nose
• Skin infection
• Increase in pain, tumour size, redness around the tumour
• Certain types of skin tumour
• Overactive thyroid
• Low level of magnesium in the blood
• High levels of uric acid, bilirubin and calcium in the blood
• Diabetes
• Low levels of phosphates in the blood
• Gout
• An excess of iron in the body
• Lack of voluntary coordination of muscle movements
• Impaired balance
• Fainting
• Stroke
• Loss of vision acuity
• Deafness
• Ringing in the ears (tinnitus)
• Vertigo
• Fast, slow or irregular heart beat
• Chest pain spreading to the arms, neck, jaw, back or stomach, feeling sweaty and breathless, feeling sick or vomiting, which may be symptoms of a heart attack (myocardial infarction)
• Shortness of breath especially when lying down (which may be a symptom of heart failure)
• Increased blood pressure
• Discoloration of your skin resulting from bleeding underneath, typically caused by bruising, swelling of skin filled with blood, bruise
• Changes to a protein in the blood that can cause swelling of the arteries (vasculitis)
• Voice disorder
• Sore throat
• Difficulty swallowing
• Heartburn
• Bowel obstruction
• Toothache
• Liver problems
• Darkening of your skin
• Hives
• Increased sweating including night sweats
• Skin eruptions, redness of skin
• Joint swelling
• Bone pain
• Neck pain
• Blood in the urine
• Problems with passing or involuntary loss of urine
• Difficulty getting an erection
• Lethargy
• Increased C-reactive protein (inflammation marker)
• Chills.

Uncommon (may affect up to 1 in 100 people)

• Destruction of blood cells
• Problems with blood coagulation
• Loss of sex drive (libido)
• Bleeding within the skull
• Circulatory problems also in the brain
• Loss of vision
• Increase in blood pressure within blood vessels that supply the lungs (pulmonary hypertension)
• Stomach pain, bloating, or diarrhoea, which may be symptoms of inflammation in the large intestine (called colitis or caecitis)
• Yellow pigmentation to the skin, mucus membrane or eyes (jaundice), pale coloured stools, dark coloured urine, skin itch, rash, pain or swelling of the stomach – these may be symptoms of liver failure
• Changes to the colour of your skin
• Sensitivity to sunlight
• Passing large amount of urine with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
• Passing much more or much less urine than usual, which may be a symptom of a type of kidney problem (renal tubular necrosis).

Rare side effects (may affect up to 1 in 1,000 people)

• Tumour lysis syndrome – metabolic complications that can occur during treatment of cancer and sometimes even without treatment. These complications are caused by the break-down products of dying cancer cells and may include the following: changes to blood chemistry; high potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney function, heartbeat, seizures, and sometimes death.

Not known (frequency cannot be estimated from the available data)

• Recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown-coloured urine, right-sided stomach pain, fever and feeling nauseous or being sick
• Rejection of solid organ transplant (such as kidney, heart)
• Sudden, or mild but worsening pain in the upper stomach and/or back, which remains for a few days, possibly accompanied by nausea, vomiting, fever and a rapid pulse. These symptoms may be due to inflammation of the pancreas
• Breakdown of the wall of the stomach or gut. This may lead to very serious infection. Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.
• A condition affecting the skin caused by inflammation of small blood vessels, along with pain in the joints and fever (leucocytoclastic vasculitis)
• Rare cases of muscle breakdown (muscle pain, weakness or swelling) which can lead to kidney problems (rhabdomyolysis) have been observed, some of them when lenalidomide is administered with a statin (a type of cholesterol lowering medicines).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the MHRA Yellow Card Scheme, Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store lenalidomide

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the blister and on the carton after “EXP”. The expiry date refers to the last day of that month.

This product does not require any special storage conditions.

Do not use this medicine if you notice any damage or signs of tampering to the pack.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to through away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What lenalidomide contains

The active substance is lenalidomide. Each capsule contains 5, 10, 15 or 25 mg of lenalidomide.

The other ingredients are:

• – Capsule contents: Lactose; cellulose, microcrystalline (E460 (i); croscarmellose sodium (E468); magnesium stearate (E470b).

• – Capsule shell: Gelatine, titanium dioxide (E171)

• – Only 10 mg and 15 mg: Indigotine (E132)

• – Only 10 mg: Yellow iron oxide (E172)

Printing ink: Shellac (E904); propylene glycol (E1502); black iron oxide (E172); potassium hydroxide.

What lenalidomide looks like and contents of the pack

Lenalidomide 5 mg hard capsules: Opaque white body and opaque white cap, with a length of approximately 18.0 mm, marked “L9NL” and “5”.

Lenalidomide 10 mg hard capsules: Opaque yellow body and opaque green to light green cap, with a length of approximately 21.7 mm, marked “L9NL” and “10”.

Lenalidomide 15 mg hard capsules: Opaque white body and opaque blue cap to light blue, with a length of approximately 21.7 mm, marked “L9NL” and “15”.

Lenalidomide 25 mg hard capsules: Opaque white body and opaque white cap, with a length of approximately 21.7 mm, marked “L9NL” and “25”.

Boxes contain 7, 21 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Zentiva Pharma UK Limited

• 12 New Fetter Lane