Ritemvia - patient leaflet, side effects, dosage

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What you need to know before having

Ritemvia

• What the signs of an infection are
• What to do if you think you might

be getting an infection.

It also includes your name and doctor’s name and phone number on the back.

What should I do with this card?

• Keep this card with you all the time –

such as in your wallet or purse.

• Show this card to any doctor, nurse or

dentist you see – not just the specialist who prescribes your RitemviaKjk

Keep this card with you for^ years after your last dose of Ritemvia.

This is because side effects can develop several months after you have had treatment.

When should I not have Ritemvia?

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Do not have Ritemvia if you have an active infection or a serious problem with your immune system.

Tell your doctor or nurse if you are taking or have previously taken medicines which may affect your immune system this includes chemo-therapy.

What are the signs of getting an infection?

What else do I need to know?

Rarely Ritemvia can cause a serious brain infection, called “Progressive Multifocal Leukoencephalo­pathy” or PML. This can be fatal.

• Signs of PML include:

– Confusion, memory loss or probj emsr

thinking

– Loss of balance or a change in the

way you walk or talk

– Decreased strengtlhor^eakness on

one side of your body

– Blurred vision or loss of vision.

If you get any of these, tell a doctor or nurse straight away. You should also tell them qboutj 'our Ritemvia treatment.

^^Where can I get more information?

See the Ritemvia package leaflet for more information.

Treatment start date and contact details

Date of most recent infusion:

Date of first infusion:

Patient’s

Name:_________­_____________

Doctor’s

Name:_________­_____________

Doctor’s contact details:__________­__________

Make sure you have a list of all your medicines when you see a health care professional.

Please talk to your doctor or nurse if you have any questions about the information in this card.

Look out for the following possible signs of infection:

• Fever or cough all the time
• Weight loss
• Pain without injuring yourself
• Feeling generally unwell or listless.

If you get any of these, tell a doctor or nurse straight away.

You should also tell them about your Ritemvia treatment.

Package leaflet: Information for the patient

Ritemvia 100 mg concentrate for solution for infusion

Ritemvia 500 mg concentrate for solution for infusion

rituximab

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read 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, pharmacist or nurse.
• If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

• 2. What you need to know before you use Ritemvia

• 3. How to use Ritemvia

• 4. Possible side effects

• 5. How to store Ritemvia

• 6. Contents of the pack and other information

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1. What Ritemvia is and what it is used forWhat Ritemvia isRitemvia contains the active substance “rituximab”. This is a type of protein called a “monoclonal antibody”. It sticks to the surface of a type of white blood cell called “B-Lymphocyte”. When rituximab sticks to the surface of this cell, the cell dies.

What Ritemvia is used for

Ritemvia may be used for the treatment of several different conditions in adults and children. Your doctor may prescribe Ritemvia for the treatment of:

• a) Non-Hodgkin’s Lymphoma

This is a disease of the lymph tissue (part of the immune system) that affects a type of white blood cell called B-Lymphocytes.

In adults, Ritemvia can be given alone or with other medicines called “chemotherapy”.

In adult patients where the treatment is working, Ritemvia may be continued for 2 years after completing the initial treatment.

In children and adolescents, Ritemvia is given in combination with “chemotherapy”.

• b) Granulomatosis with polyangiitis or microscopic polyangiitis

Ritemvia is used for the treatment of adults and children 2 years of age and older with granulomatosis with polyangiitis (formerly called Wegener’s gra­nulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids. Granulomatosis with polyangiitis and microscopic polyangiitis are two forms of inflammation of the blood vessels which mainly affects the lungs and kidneys, but may affect other organs as well. B-lymphocytes are involved in the cause of these conditions.

• c) Pemphigus vulgaris

Ritemvia is used for the treatment of patients with moderate to severe pemphigus vulgaris.

Pemphigus vulgaris is an autoimmune condition that causes painful blisters on the skin and lining of the mouth, nose, throat and genitals.

2. What you need to know before you use RitemviaDo not take Ritemvia if: you are allergic to rituximab, other proteins which are like rituximab, or any of the other

ingredients of this medicine (listed in section 6)

• you have a severe active infection at the moment
• you have a weak immune system
• you have severe heart failure or severe uncontrolled heart disease and have granulomatosis with

polyangiitis, microscopic polyangiitis or pemphigus vulgaris.

Do not have Ritemvia if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before you are given Ritemvia.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Ritemvia if:

you have ever had or might now have a hepatitis infection. This is because in a few cases, Ritemvia could cause hepatitis B to become active again, which can be fatal in very rare cases. Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection.

you have ever had heart problems (such as angina, palpitations or heart failure) or breathing problems.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Ritemvia. Your doctor may need to take special care of you during your treatment with Ritemvia.

If you have granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris also tell your doctor

• if you think you may have an infection, even a mild one like a cold. The cells that are affected

by Ritemvia help to fight infection and you should wait until the infection has passed before you

tell your doctor if you had a lot of infections in the past or

if you think you may need any vaccinations in the near future, including vaccinations needed to travel to other countries. Some vaccines should not be given at the same time as Ritemvia or in the months after you receive Ritemvia. Your doctor will check if you should have any vaccines before you receive Ritemvia.

Children and adolescents

Non-Hodgkin’s lymphoma

Ritemvia can be used for the the treatment of children and adolescents, 6 months of age and older, with non-Hodgkin’s lymphoma, specifically CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL).

Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age.

Granulomatosis with polyangiitis or microscopic polyangiitis

Ritemvia can be used for treatment of children and adolescents, 2 years of age and older, with granulomatosis with polyangiitis (formerly called Wegener’s gra­nulomatosis) or microscopic polyangiitis. There is not much information about the use of Ritemvia in children and adolescents with other diseases.

Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age.

Other medicines and Ritemvia

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Ritemvia can affect the way some other medicines work. Also some other medicines can affect the way Ritemvia works.

In particular, tell your doctor:

• if you are taking medicines for high blood pressure. You may be asked not to take these other

medicines 12 hours before you are given Ritemvia. This is because some people have a fall in their blood pressure while they are being given Ritemvia.

• if you have ever taken medicines which affect your immune system – such as chemotherapy or

immune-suppressive medicines.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or n you are given Ritemvia.

Pregnancy and breast-feeding

You must tell your doctor or nurse if you are pregnant, think that you might be pregnant or are planning to become pregnant. This is because Ritemvia can across the placenta and may affect your baby.

If you can get pregnant, you and your partner must use an effective method of contraception while using Ritemvia. You must also do this for 12 months after your last treatment with Ritemvia.

Do not breast-feed while you are being treated with Ritemvia. Also do not breast-feed for 12 months after your last treatment with Ritemvia. This is because Ritemvia may pass into breast milk.

ven to you by a doctor or nurse who is experienced in the use of this treatment. u closely while you are being given this medicine. This is in case you get any

e given Ritemvia as a drip (intravenous infusion).

Medicines given before each Ritemvia administration

Before you are given Ritemvia, you will be given other medicines (pre-medication) to prevent or reduce possible side effects.

How much and how often you will receive your treatment

a) If you are being treated for non-Hodgkin’s Lymphoma

• If you are having Ritemvia alone

Ritemvia will be given to you once a week for 4 weeks. Repeated treatment courses with Ritemvia are possible.

• If you are having Ritemvia with chemotherapy

Ritemvia will be given to you on the same day as your chemotherapy. This is usually given

every 3 weeks up to 8 times.

If you respond well to treatment, you may be given Ritemvia every 2 or 3 months for two years. Your doctor may change this, depending on how you respond to the medicine.

If you are less than 18 years of age, you will be given Ritemvia with chemotherapy. You will receive Ritemvia up to 6 times over a 3.5 – 5.5 month period.

• b) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis

Treatment with Ritemvia uses four separate infusions given at weekly intervals. Corticosteroids will usually be given by injection before the start of Ritemvia treatment. Corticosteroids given by mouth may be started at any time by your doctor to treat your condition. If you are 18 years of age and older and respond well to treatment, you may be given Ritemvia as a maintenance treatment. This will be administered as 2 separate infusions which are given 2 weeks apart, followed by 1 infusion every 6 months for at least 2 years. Your doctor may decide to treat you longer with Ritemvia (up to 5 years), depending on how you respond to the medicine.

• c) If you are being treated for pemphigus vulgaris

Each course of treatment is made up of two separate infusions which are given 2 weeks apart. If you respond well to treatment, you may be given Ritemvia as a maintenance treatment. This will be administered 1 year and 18 months after the initial treatment and then every 6 months as needed or your doctor may change this, depending on how you respond to the medicine.

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

4.      Possible side effects

Like all medicines, this medicine can cause side effect

Most side effects are mild to moderate but some may be serious and require treatment. Rarely, some of these reactions have been fatal.

Infusion reactions

During or within the first 24 hours of the infusion you may develop fever, chills and shivering. Less frequently, some patients may experience pain at the infusion site, blisters, itching, sickness (nausea), tiredness, headache, breathing difficulties, blood pressure raised, wheezing, throat discomfort, tongue or throat ing, itchy or runny nose, vomiting, flushing or palpitations, heart. If you have heart disease or angina, these reactions might get

u the infusion immediately if you or your child develops any of

fusion may need to be slowed down or stopped. You may require as an antihistamine or paracetamol. When these symptoms go away, or

on can be continued. These reactions are less likely to happen after the second or may decide to stop your Ritemvia treatment if these reactions are serious.

doctor immediately if you or your child gets signs of an infection including:

• fever, cough, sore throat, burning pain when passing urine or feeling weak or generally unwell
• memory loss, trouble thinking, difficulty walking or sight loss – these may be due to a very rare,

serious brain infection, which has been fatal (progressive multifocal leukoencephalopathy or PML).

You might get infections more easily during your treatment with Ritemvia.

These are often colds, but there have been cases of pneumonia or urinary infections. These are

listed below under “Other side effects”.

If you are being treated for granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris, you will also find this information in the Patient Alert Card you have been given by your doctor. It is important that you keep this Alert Card and show it to your partner or caregiver.

Skin reactions

Very rarely, severe blistering skin conditions that can be life-threatening may occur. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present. Tell your doctor immediately if you have any of these symptoms.

Other side effects include:

a) If you or your child are being treated for non-Hodgkin’s Lymphoma

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

• bacterial or viral infections, bronchitis
• low number of white blood cells, with or without fever or blood cells called “platel
• feeling sick (nausea)
• bald spots on the scalp, chills, headache
• lower immunity – because of lower levels of anti-bodies called “immunoglobulins” (IgG) in the blood which help protect against infection

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

• infections of the blood (sepsis), pneumonia, shingles, cold, bronchial tube infections, fungal infections, infections of unknown origin, sinus inflammation, hepatitis B
• low number of red blood cells (anaemia), low number of all blood cells

allergic reactions (hypersensitivity)

high blood sugar level, weight loss, swelling in the enzyme “lactate dehydrogenase (LDH)” in the bloo unusual feelings of the skin – such as numbness, til skin feeling, reduced sense of touch feeling restless, problems falling asleep,

s of the skin as a consequence of dilation of blems, inflamed eye (conjunctivitis)

heart problems – such as heart attack, uneven or fast heart rate

high or low blood pressure (low blood pressure especially when standing upright) tightening of the muscles in the airways which causes wheezing (bronchospasm), inflammation, irritation in the lungs, throat or sinuses, being short of breath, runny

iting), diarrhoea, pain in the stomach, irritation or ulcers in the throat and mouth, problems swallowing, constipation, indigestion eating disorders, not eating enough, leading to weight loss hives, increased sweating, night sweats

muscle problems – such as tight muscles, joint or muscle pain, back and neck pain general discomfort or feeling uneasy or tired, shaking, signs of flu multiple-organ failure.

Uncommon side effects (may affect up to 1 in 100 people):

• blood clotting problems, decrease of red blood cell production and increase of red blood cell destruction (aplastic haemolytic anaemia), swollen or enlarged lymph nodes
• low mood and loss of interest or enjoyment in doing things, feeling nervous
• taste problems – such as changes in the way things taste
• heart problems – such as reduced heart rate or chest pain (angina)
• asthma, too little oxygen reaching the body organs
• swelling of the stomach.

Very rare side effects (may affect up to 1 in 10,000 people):

short term increase in the amount of some types of anti-bodies in the blood (called immunoglobulins – IgM), chemical disturbances in the blood caused by break-down of dying cancer cells

nerve damage in arms and legs, paralysed face

heart failure

inflammation of blood vessels including those leading to skin symptoms

respiratory failure

damage to the intestinal wall (perforation)

severe skin problems causing blisters that can be life-threatening. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present.

kidney failure

severe vision loss

Not known (it is not known how often these side effects happen):

• a reduction in white blood cells which does not happen straight away
• reduced platelets number just after the infusion – this can be reversed, but rare cases
• hearing loss, loss of other senses

Children and adolescents with non-Hodgkin’s lym­phoma:

In general, side effects in children and adolescents with non-Hodgkin’s lymphoma were similar to those in adults with non-Hodgkin’s lymphoma. The most common s ffects seen were fever associated with low levels of a type of white blood cell (neutrop inflammation or sores in the lining of the mouth, and allergic reactions (hypersensitivity).

• b) If you or your child are being treated for granulomatosis with polyangiitis or microscopic polyangiitis

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

• infections, such as chest infections, urinary tract infections (pain on passing water), colds and herpes infections
• allergic reactions that are most likely to occur during an infusion, but can occur up to 24-hours after infusion
• diarrhoea

nose bleeds

raised blood pressure painful joi r back muscle t feelin

tremo hakiness, often in the hands) difficulty sleeping (insomnia) swelling of the hands or ankles

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

• indigestion
• constipation
• skin rashes, including acne or spots
• flushing or redness of the skin
• fever

blocked or runny nose

tight or painful muscles

pain in the muscles or in the hands or feet

low number of red blood cells (anaemia)

low numbers of platelets in the blood

an increase in the amount of potassium in the blood

• changes in the rhythm of the heart, or the heart beating faster than normal

Very rare side effects (may affect up to 1 in 10,000 people):

• severe blistering skin conditions that can be life-threatening. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present.
• recurrence of a previous Hepatitis B infection

Children and adolescents with granulomatosis with polyangiitis or microscopic polyangiitis

In general, side effects in children and adolescents with granulomatosis with polyangiitis or microscopic polyangiitis were of a similar type to those in adults with granulomatosis with polyangiitis or microscopic polyangiitis. Most common side effects seen were infections, allergi reactions and feeling sick (nausea).

• c) If you are being treated for pemphigus vulgaris

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

iy side effects talk to your doctor, pharmacist or nurse. This includes any side effects not leaflet. You can also report side effects directly via the national reporting system listed in

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

5.     How to store Ritemvia

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 carton and the vial after EXP. The expiry date refers to the last day of that month.

6.     Contents of the pack and other information

What Ritemvia looks like and contents of the pack

Česká republika

EGIS Praha, spol. s r.o

Tel: +420 227 129 111

Magyarország

Egis Gyógyszergyár Zrt.

Tel.: + 36 1 803 5555

Danmark

Orion Pharma A/S

Tlf: + 45 86 14 00 00

Malta

Medical Logistics Ltd.

Tel: +356 2755 9990

Nederland

Mundipharma Pharmaceuticals B.V

Tel: + 31 33 450 8270

Eesti

Orion Pharma Eesti OÜ

Tel: + 372 6 644 550

Norge

Orion Pharma AS

Tlf: + 47 40 00 42 10

EMàôa

BLANES A.E.

Tql: +30 210 8009111 – 120

España

Kern Pharma, S.L.

Tel: +34 93 700 2525

France

Laboratoires Biogaran

Tél: +33 (0) 800 970 109

Polska

EGIS Polska Sp. z o.o.

Tel.: + 48 22 417 9200

Portugal

PharmaKERN Portugal –

Tel: +351 214 200 290

Hrvatska

Oktal Pharma d.o.o.

Tel: +385 1 6595 777

Ireland

Mundipharma Pharmaceuticals Limited

Tel: +353 1 2063800

România

Egis Pharmaceuticals PLC Romania

Tel: + 2 0017

PH Oktal Pharma d.o.o. el: +386 1 519 29 22

Ísland

Vistor hf.

Sími: +354 535 7000

Kùnpoç

C.A. Papaellinas

Tql: +357 22741

Suomi/Finland

Orion Pharma

Puh/Tel: + 358 10 4261

Sverige

Orion Pharma AB

Tel: + 46 8 623 64 40

United Kingdom

mticals PLC pärstävnieciba Latvijä NAPP Pharmaceutical­s Ltd.

Tel: +44 1223 424444

This leaflet was last revised in MM/YYYY.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

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