Bortezomib 2.25 mg solution for injection in Pre-filled syringe – patient leaflet, side effects, dosage

1. What Bortezomib pre-filled syringe is and what it is used for

Bortezomib pre-filled syringe contains the active substance bortezomib, a so-called ‘proteasome inhibitor’. Proteasomes play an important role in controlling cell function and growth. By interfering with their function, bortezomib can kill cancer cells.

Bortezomib pre-filled syringe is used for the treatment of multiple myeloma (a cancer of the bone marrow) in patients older than 18 years:

• alone or together with the medicines pegylated liposomal doxorubicin or dexamethasone, for patients whose disease is worsening (progressive) after receiving at least one prior treatment and for whom blood stem cell transplantation was not successful or is unsuitable
• in combination with the medicines melphalan and prednisone, for patients whose disease has not been previously treated and are unsuitable for high-dose chemotherapy with blood stem cell transplantation
• in combination with the medicines dexamethasone or dexamethasone together with thalidomide, for patients whose disease has not been previously treated and before receiving high-dose chemotherapy with blood stem cell transplantation (induction treatment).

Bortezomib pre-filled syringe is used for the treatment of mantle cell lymphoma (a type of cancer affecting the lymph nodes) in patients 18 years or older in combination with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone, for patients whose disease has not been previously treated and for whom blood stem cell transplantation is unsuitable.

2. What you need to know before you use Bortezomib pre-filled syringe

Do not use Bortezomib pre-filled syringe

• if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6)
• if you have certain severe lung or heart problems.

Warnings and precautions

You should tell your doctor if you have any of the following:

• low numbers of red or white blood cells
• bleeding problems and/or low number of platelets in your blood
• diarrhoea, constipation, nausea or vomiting
• fainting, dizziness or light-headedness in the past
• kidney problems
• moderate to severe liver problems
• numbness, tingling, or pain in the hands or feet (neuropathy) in the past
• heart or blood pressure problems

• shortness of breath or cough

  • seizures
  • shingles (localised including around the eyes or spread across the body)
  • symptoms of tumour lysis syndrome such as muscle cramping, muscle weakness, confusion, visual loss or disturbances and shortness of breath
  • memory loss, trouble thinking, difficulty with walking or loss of vision. These may be signs of a serious brain infection and your doctor may suggest further testing and follow-up.

You will have to take regular blood tests before and during your treatment with Bortezomib pre-filled syringe to check your blood cell counts regularly.

If you have mantle cell lymphoma and are given the medicine rituximab with Bortezomib pre-filled syringe you should tell your doctor:

• if you think you have a hepatitis infection now or have had it in the past. In a few cases, patients who have had hepatitis B might have a repeated attack of hepatitis, which can be fatal. If you have a history of hepatitis B infection you will be carefully checked by your doctor for signs of active hepatitis B.

You must read the package leaflets of all medicines to be taken in combination with Bortezomib pre-filled syringe for information related to these medicines before starting treatment with Bortezomib pre-filled syringe. When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see Pregnancy and breast-feeding in this section).

Children and adolescents

Bortezomib pre-filled syringe should not be used in children and adolescents because it is not known how the medicine will affect them.

Other medicines and Bortezomib pre-filled syringe

Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are using medicines containing any of the following active substances:

• ketoconazole, used to treat fungal infections
• ritonavir, used to treat HIV infection
• rifampicin, an antibiotic used to treat bacterial infections
• carbamazepine, phenytoin or phenobarbital used to treat epilepsy
• St. John’s Wort (Hypericum perforatum), used for depression or other conditions
• oral antidiabetics.

Pregnancy and breast-feeding

You should not use Bortezomib pre-filled syringe if you are pregnant, unless clearly necessary.

Both men and women receiving Bortezomib pre-filled syringe must use effective contraception during and for up to 3 months after treatment. If, despite these measures, pregnancy occurs, tell your doctor immediately.

You should not breast-feed while using Bortezomib pre-filled syringe. Discuss with your doctor when it is safe to restart breast-feeding after finishing your treatment.

Thalidomide causes birth defects and foetal death. When Bortezomib pre-filled syringe is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).

Driving and using machines

Bortezomib pre-filled syringe might cause tiredness, dizziness, fainting, or blurred vision. Do not drive or operate tools or machines if you experience such side effects; even if you do not, you should still be cautious.

3. How to use Bortezomib pre-filled syringe

Your doctor will work out your dose of Bortezomib pre-filled syringe according to your height and weight (body surface area). The usual starting dose of Bortezomib pre-filled syringe is 1.3mg/m² body surface area twice a week.

Your doctor may change the dose and total number of treatment cycles, depending on your response to the treatment on the occurrence of certain side effects and on your underlying conditions (e.g. liver problems).

Bortezomib pre-filled syringe is not recommended where total dose to be administered is less than 2.0mg; in such instances bortezomib vials

are recommended.

Progressive multiple myeloma

When Bortezomib pre-filled syringe is given alone, you will receive 4 doses subcutaneously on days 1, 4, 8 and 11, followed by a 10-day ‘rest period’ without treatment. This 21-day period (3 weeks) corresponds to one treatment cycle. You might receive up to 8 cycles (24 weeks).

You may also be given Bortezomib pre-filled syringe together with the medicines pegylated liposomal doxorubicin or dexamethasone.

When Bortezomib pre-filled syringe is given together with pegylated liposomal doxorubicin, you will receive Bortezomib pre-filled syringe subcutaneously as a 21-day treatment cycle and pegylated liposomal doxorubicin 30mg/m² is given on day 4 of the Bortezomib pre-filled syringe 21-day treatment cycle as an intravenous infusion after the Bortezomib pre-filled syringe injection.

You might receive up to 8 cycles (24 weeks).

When Bortezomib pre-filled syringe is given together with dexamethasone, you will receive Bortezomib pre-filled syringe subcutaneously as a 21-day treatment cycle and dexamethasone 20mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12 of the Bortezomib pre-filled syringe 21-day treatment cycle.

You might receive up to 8 cycles (24 weeks).

Previously untreated multiple myeloma

If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive Bortezomib pre-filled syringe together with two other medicines; melphalan and prednisone.

In this case, the duration of a treatment cycle is 42 days (6 weeks). You will receive 9 cycles (54 weeks).

• In cycles 1 to 4, Bortezomib pre-filled syringe is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
• In cycles 5 to 9, Bortezomib pre-filled syringe is administered once weekly on days 1, 8, 22 and 29.

Melphalan (9mg/m²) and prednisone (60mg/m²) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.

If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive Bortezomib pre-filled syringe subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.

When Bortezomib pre-filled syringe is given together with dexamethasone, you will receive Bortezomib pre-filled syringe subcutaneously as a 21-day treatment cycle and dexamethasone 40mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib pre-filled syringe 21-day treatment cycle.

You will receive 4 cycles (12 weeks).

When Bortezomib pre-filled syringe is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).

Dexamethasone 40mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib pre-filled syringe 28-day treatment cycle and thalidomide is given orally daily at 50mg up to day 14 of the first cycle, and if tolerated the thalidomide dose is increased to 100mg on days 15-28 and may be further increased to 200mg daily from the second cycle onwards.

You might receive up to 6 cycles (24 weeks).

Previously untreated mantle cell lymphoma

If you have not been treated before for mantle cell lymphoma, you will receive Bortezomib pre-filled syringe subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.

Bortezomib pre-filled syringe is given subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period’ without treatment. The duration of a treatment cycle is 21 days (3 weeks). You might receive up to 8 cycles (24 weeks).

The following medicines are given on day 1 of each Bortezomib pre-filled syringe 21-day treatment cycle as intravenous infusions: Rituximab at 375mg/m², cyclophosphamide at 750mg/m² and doxorubicin at 50mg/m².

Prednisone is given orally at 100mg/m² on days 1, 2, 3, 4 and 5 of the Bortezomib pre-filled syringe treatment cycle.

How Bortezomib pre-filled syringe is given

Bortezomib pre-filled syringe will be administered either by a healthcare professional experienced in the use of cytotoxic medicines or may be self-administered by the patient.

This medicine is for subcutaneous use (injected under the skin) in either the thighs or the abdomen.

Injecting Bortezomib pre-filled syringe yourself

Your doctor may decide that it would be more convenient for you to inject Bortezomib pre-filled syringe yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself unless you have received special training from your doctor or nurse.

The instructions on how to inject yourself are given below, but proper treatment of your disease requires close and constant co-operation with your doctor. If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.

How do I inject Bortezomib pre-filled syringe myself?

You will need to give yourself the injection into the tissue just under the skin. This is known as a subcutaneous injection.

Equipment that you need

To give yourself a subcutaneous injection you will need:

• a pre-filled syringe of Bortezomib

• an alcohol swab.

What should I do before I give myself a subcutaneous injection of Bortezomib pre-filled syringe?

1. 1. Take the pre-filled syringe out of the refrigerator.
2. 2. Do not remove the needle cover from the syringe until just before you are ready to inject.
3. 3. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the month shown or if it has been kept outside of the refrigerator for more than 72 hours or has otherwise expired.
4. 4. Check the appearance of the solution in the Bortezomib pre-filled syringe. It must be a clear and colourless liquid. If there are particles in it, you must not use it.
5. 5. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm Bortezomib pre-filled syringe in any other way (for example, do not warm it in a microwave or in hot water).
6. 6. Wash your hands thoroughly.
7. 7. Find a comfortable, well-lit place and put everything you need where you can reach them (the pre-filled syringe and alcohol swab).

How do I prepare my Bortezomib pre-filled syringe injection?

Before you inject Bortezomib pre-filled syringe you must do the following:

1. 1. Check that the syringe is undamaged.
2. 2.

   Hold the syringe and gently pull the cap from the needle without twisting. Pull the cap in a straight line as shown in the picture below. Do not touch the needle or push the plunger.

   1. 3. You can now use the pre-filled syringe. The most suitable places to inject yourself are:
   2. - the top of your thighs; and
   3. - the abdomen, except for the area around the navel.

It is better to change the injection site every time to avoid the risk of soreness at any one site.

1. 4. How do I give my injection?

Disinfect the injection site by wiping the skin surface with an alcohol swab and pinch the skin between your thumb and forefinger, without squeezing it too tightly.

1. 5. Push the needle fully into the skin as shown by your nurse or doctor.
2. - Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.
3. -

   While keeping your skin pinched, press the plunger slowly and evenly while grasping the finger flange until the entire dose has been given and the plunger cannot be pressed down any further. Do not release the pressure on the plunger.

   1. 6. After injecting the liquid, while keeping the syringe at the same angle and maintaining pressure on the plunger, remove the needle and then let go of your skin. The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation. The needle guard will not activate unless the entire dose has been given.
   2. 7. Dispose of the syringe in a sharps container as instructed by your doctor, pharmacist or nurse.

Remember

If you have any problems, please ask your doctor or nurse for help and advice.

If you use more Bortezomib pre-filled syringe than you should

If you use more Bortezomib pre-filled syringe than you should contact your doctor, pharmacist or nurse.

If you forget to inject Bortezomib pre-filled syringe

If you are injecting yourself and have forgotten your dose of Bortezomib pre-filled syringe, you should contact your doctor to discuss when you should inject the next dose.

If you stop using Bortezomib pre-filled syringe

Your doctor will tell you when to stop using Bortezomib pre-filled syringe. It is quite normal to have a number of courses of treatment with Bortezomib pre-filled syringe. 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. Some of these effects may be serious.

If you are given Bortezomib pre-filled syringe for multiple myeloma or mantle cell lymphoma, tell your doctor straight away if you notice any of the following symptoms:

• muscle cramping, muscle weakness
• confusion, visual loss or disturbances, blindness, seizures, headaches
• shortness of breath, swelling of your feet or changes in your heartbeat, high blood pressure, tiredness, fainting
• coughing and breathing difficulties or tightness in the chest.

Treatment with Bortezomib pre-filled syringe can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood. Therefore, you will have to take regular blood tests before and during your treatment with Bortezomib pre-filled syringe, to check your blood cell counts regularly. You may experience a reduction in the number of:

• platelets, which may make you be more prone to bruising, or to bleeding without obvious injury (e.g., bleeding from your bowels, stomach, mouth and gum or bleeding in the brain or bleeding from the liver)
• red blood cells, which can cause anaemia, with symptoms such as tiredness and paleness
• white blood cells may make you more prone to infections or flu-like symptoms.

The following information is intended for healthcare professionals only:

Note: Bortezomib pre-filled syringe is a cytotoxic agent. Therefore, caution should be used during handling and preparation. Use of gloves and other protective clothing to prevent skin contact is recommended. Pregnant personnel should not handle this medicine.

ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF BORTEZOMIB SINCE NO PRESERVATIVE IS PRESENT.

Bortezomib pre-filled syringe IS FOR SUBCUTANEOUS USE. Do not give by other routes. Intrathecal administration has resulted in death.

1. 1. PREPARATION FOR SUBCUTANEOUS INJECTION

1.1 Bortezomib pre-filled syringe is intended for subcutaneous

administration only. Each ml solution contains 2.5mg bortezomib. The solution is clear and colourless with a pH of 4.0 to 7.0.

1.2 Bortezomib pre-filled syringe must be inspected visually for

particulate matter and discolouration prior to administration. If any discolouration or particulate matter is observed, the solution must be discarded. Be sure that the correct strength is being selected for the subcutaneous route of administration.

1.3 The product is preservative free and should be used immediately

after opening of the pre-filled syringe.

1.4 During preparation for administration keep the syringe in the

outer carton in order to protect from light.

1. 2. ADMINISTRATION FOR SUBCUTANEOUS INJECTION

2.1 Select the appropriate strength of the solution according to

calculated dose based upon the patient’s body surface area.

2.2 Confirm the dose and concentration in the syringe prior to use

(check that the syringe is marked as subcutaneous administration).

2.3 Disinfect the injection site by using an alcohol swab and pinch

the skin between your thumb and forefinger, without squeezing it.

2.4 Put the needle fully into the skin at a 45°-90° angle, as shown by

your nurse or doctor.

2.5 Pull slightly on the plunger to check that a blood vessel has not

been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.

2.6 Always keeping your skin pinched, depress the plunger slowly

and evenly while grasping the finger flange until the entire dose has been given and the plunger cannot be depressed any further. Do not release the pressure on the plunger.

2.7 After injecting the liquid, while keeping the syringe at the same

angle and maintaining pressure on the plunger, remove the

needle and then let go of your skin. The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation. The needle guard will not activate unless the entire dose has been given.

2.8 Injection sites should be rotated for successive injections.

2.9 If local injection site reactions occur following bortezomib

subcutaneous injection, a less concentrated solution (bortezomib vials reconstituted to 1mg/ml instead of 2.5mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.

2.10 Bortezomib pre-filled syringe is not recommended where the total dose is less than 2.0mg, in such instances bortezomib vials are recommended.

1. 3. DISPOSAL

Bortezomib pre-filled syringe is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

80 mm

10 0000 0 000000

Bortezomib 2.0mg, 2.25mg,

2.5mg and 2.75mg

10 0000 0 000000

Bortezomib 2.0mg, 2.25mg,

2.5mg and 2.75mg

If you are given Bortezomib pre-filled syringe for the treatment of multiple myeloma the side effects you may get are listed below:

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

• Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage
• Reduction in the number of red blood cells and or white blood cells (see above)
• Fever
• Feeling sick (nausea) or vomiting, loss of appetite
• Constipation with or without bloating (can be severe)
• Diarrhoea: if this happens, it is important that you drink more water than usual. Your doctor may give you another medicine to control diarrhoea
• Tiredness (fatigue), feeling weak
• Muscle pain, bone pain.

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

• Low blood pressure, sudden fall in blood pressure on standing which may lead to fainting
• High blood pressure
• Reduced functioning of your kidneys
• Headache
• General ill feeling, pain, vertigo, light-headedness, a feeling of weakness or loss of consciousness
• Shivering
• Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, coughing with phlegm, flu-like illness
• Shingles (localised including around the eyes or spread across the body)
• Chest pains or shortness of breath with exercise
• Different types of rash
• Itching of the skin, lumps on the skin or dry skin
• Facial blushing or tiny broken capillaries
• Redness of the skin
• Dehydration
• Heartburn, bloating, belching, wind, stomach pain, bleeding from your bowels or stomach
• Alteration of liver functioning
• A sore mouth or lip, dry mouth, mouth ulcers or throat pain
• Weight loss, loss of taste
• Muscle cramps, muscle spasms, muscle weakness, pain in your limbs
• Blurred vision
• Infection of the outermost layer of the eye and the inner surface of the eyelids (conjunctivitis)
• Nose bleeds
• Difficulty or problems in sleeping, sweating, anxiety, mood swings, depressed mood, restlessness or agitation, changes in your mental status, disorientation
• Swelling of body, to include around eyes and other parts of the body.

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

• Heart failure, heart attack, chest pain, chest discomfort, increased or reduced heart rate
• Failing of your kidneys
• Inflammation of a vein, blood clots in your veins and lungs
• Problems with blood clotting
• Insufficient circulation
• Inflammation of the lining around your heart or fluid around your heart
• Infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis
• Bloody stools, or bleeding from mucosal membranes, e.g., mouth, vagina
• Cerebrovascular disorders
• Paralysis, seizures, falling, movement disorders, abnormal or change in, or reduced sensation (feeling, hearing, tasting, smelling), attention disturbance, trembling, twitching
• Arthritis, including inflammation of the joints in the fingers, toes, and the jaw
• Disorders that affect your lungs, preventing your body from getting enough oxygen. Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise, breathing that becomes shallow, difficult or stops, wheezing
• Hiccups, speech disorders
• Increased or decreased urine production (due to kidney damage), painful passing of urine or blood/proteins in the urine, fluid retention
• Altered levels of consciousness, confusion, memory impairment or loss
• Hypersensitivity
• Hearing loss, deafness or ringing in the ears, ear discomfort

• Hormone abnormality which may affect salt and water absorption

  • Overactive thyroid gland
  • Inability to produce enough insulin or resistance to normal levels of insulin
  • Irritated or inflamed eyes, excessively wet eyes, painful eyes, dry eyes, eye infections, lump in the eyelid (chalazion), red and swollen eyelids, discharge from the eyes, abnormal vision, bleeding of the eye
  • Swelling of your lymph glands
  • Joint or muscle stiffness, sense of heaviness, pain in your groin
  • Hair loss and abnormal hair texture
  • Allergic reactions
  • Redness or pain at the injection site
  • Mouth pain
  • Infections or inflammation of the mouth, mouth ulcers, oesophagus, stomach and intestines, sometimes associated with pain or bleeding, poor movement of the intestines (including blockage), abdominal or oesophageal discomfort, difficulty swallowing, vomiting of blood
  • Skin infections
  • Bacterial and viral infections
  • Tooth infection
  • Inflammation of the pancreas, obstruction of the bile duct
  • Genital pain, problems having an erection
  • Weight increase
  • Thirst
  • Hepatitis
  • Injection site or injection device related disorders
  • Skin reactions and disorders (which may be severe and life-threatening), skin ulcers
  • Bruises, falls and injuries
  • Inflammation or haemorrhage of the blood vessels that can appear as small red or purple dots (usually on the legs) to large bruise-like patches under the skin or tissue
  • Benign cysts
  • A severe reversible brain condition which includes seizures, high blood pressure, headaches, tiredness, confusion, blindness or other vision problems.

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

• Heart problems to include heart attack, angina
• Serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barré syndrome)
• Flushing
• Discolouration of the veins
• Inflammation of the spinal nerve
• Problems with your ear, bleeding from your ear
• Underactivity of your thyroid gland
• Budd–Chiari syndrome (the clinical symptoms caused by blockage of the hepatic veins)
• Changes in or abnormal bowel function
• Bleeding in the brain
• Yellow discolouration of eyes and skin (jaundice)
• Serious allergic reaction (anaphylactic shock) signs of which may include difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing, collapse
• Breast disorders
• Vaginal tears
• Genital swelling
• Inability to tolerate alcohol consumption
• Wasting, or loss of body mass
• Increased appetite
• Fistula
• Joint effusion
• Cysts in the lining of joints (synovial cysts)
• Fracture
• Breakdown of muscle fibres leading to other complications
• Swelling of the liver, bleeding from the liver
• Cancer of the kidney
• Psoriasis like skin condition
• Cancer of the skin
• Paleness of the skin
• Increase of platelets or plasma cells (a type of white cell) in the blood
• Blood clot in small blood vessels (thrombotic microangiopathy)
• Abnormal reaction to blood transfusions
• Partial or total loss of vision
• Decreased sex drive
• Drooling
• Bulging eyes
• Sensitivity to light
• Rapid breathing

• Rectal pain

  • Gallstones
  • Hernia
  • Injuries
  • Brittle or weak nails
  • Abnormal protein deposits in your vital organs
  • Coma
  • Intestinal ulcers
  • Multi-organ failure
  • Death.

If you are given Bortezomib pre-filled injection together with other medicines for the treatment of mantle cell lymphoma the side effects you may get are listed below:

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

• Pneumonia
• Loss of appetite
• Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage
• Nausea and vomiting
• Diarrhoea
• Mouth ulcers
• Constipation
• Muscle pain, bone pain
• Hair loss and abnormal hair texture
• Tiredness, feeling weak
• Fever.

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

• Shingles (localised including around the eyes or spread across the body)
• Herpes virus infections
• Bacterial and viral infections
• Respiratory infections, bronchitis, coughing with phlegm, flu-like illness
• Fungal infections
• Hypersensitivity (allergic reaction)
• Inability to produce enough insulin or resistance to normal levels of insulin
• Fluid retention
• Difficulty or problems in sleeping
• Loss of consciousness
• Altered level of consciousness, confusion
• Feeling dizzy
• Increased heartbeat, high blood pressure, sweating
• Abnormal vision, blurred vision
• Heart failure, heart attack, chest pain, chest discomfort, increased or reduced heart rate
• High or low blood pressure
• Sudden fall in blood pressure upon standing which may lead to fainting
• Shortness of breath with exercise
• Cough
• Hiccups
• Ringing in the ears, ear discomfort
• Bleeding from your bowels or stomach
• Heartburn
• Stomach pain, bloating
• Difficulty swallowing
• Infection or inflammation of the stomach and intestines
• Stomach pain
• Sore mouth or lip, throat pain
• Alteration of liver function
• Itching of skin
• Redness of skin
• Rash
• Muscle spasms
• Infection of the urinary tract
• Pain in limbs
• Swelling of body, to include eyes and other parts of the body
• Shivering
• Redness and pain at injection site
• General ill feeling
• Weight loss
• Weight increase.

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

• Hepatitis

• Severe allergic reaction (anaphylactic reaction) signs of which may include difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing, collapse

  • Movement disorders, paralysis, twitching
  • Vertigo
  • Hearing loss, deafness
  • Disorders that affect your lungs, preventing your body from getting enough oxygen. Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise, breathing that becomes shallow, difficult or stops, wheezing
  • Blood clots in your lungs
  • Yellow discolouration of the eyes and skin (jaundice)
  • Lump in the eyelid (chalazion), red and swollen eyelids.

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

• Blood clot in small blood vessels (thrombotic microangiopathy)
• Serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barré syndrome).

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard 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 Bortezomib pre-filled syringe

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

Do not use this medicine after the expiry date stated on the pre-filled syringe and the carton after EXP.

Store in a refrigerator (2°C to 8°C), do not freeze.

Keep the syringe in the outer carton in order to protect from light.

Bortezomib pre-filled syringe is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

6. Contents of the pack and other information

What Bortezomib pre-filled syringe contains

• the active substance is bortezomib. Each pre-filled syringe contains 0.8ml, 0.9ml, 1.0ml or 1.1ml solution for injection which contains 2.0mg, 2.25mg, 2.5mg or 2.75mg of bortezomib (as a mannitol boronic ester) respectively
• the other ingredients are mannitol (E421) and water for injections.

What Bortezomib pre-filled syringe looks like and contents of the pack

Pre-filled syringes of clear, colourless glass (type I) of 1ml capacity with fixed needle covered with rigid needle shield. The pre-filled syringes are intended to administer the entire dose and do not have graduation marks.

Pack sizes

1 x 0.8ml pre-filled syringe

1 x 0.9ml pre-filled syringe

1 x 1.0ml pre-filled syringe

1 x 1.1ml pre-filled syringe

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex

HA1 4HF

United Kingdom

Manufacturers

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex

HA1 4HF, United Kingdom

Accord Healthcare Polska Sp.z o.o.

ul. Lutomierska 50,

95-200 Pabianice

Poland

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind.

Zona Franca, Barcelona, 08040, Spain

This leaflet was last revised in November 2023

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01271 385257