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Bortezomib SUN 3.5 mg powder for solution for injection
Package Leaflet: Information for the patient
Bortezomib SUN 3.5 mg powder for solution for injection
bortezomib
Read all of this leaflet carefully before you start using 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.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Bortezomib SUN is and what it is used for 2. What you need to know before you are given Bortezomib SUN 3. How to use Bortezomib SUN 4. Possible side effects 5. How to store Bortezomib SUN 6. Contents of the pack and other information
1. What Bortezomib SUN is and what it is used for
Bortezomib SUN 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 SUN 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).
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 are given Bortezomib SUN
You should NOT be given Bortezomib SUN
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 SUN, to check your blood cell counts regularly.
If you have mantle cell lymphoma and are given the medicine rituximab with Bortezomib SUN you should tell your doctor:
if you think you have 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 medicinal products to be taken in combination with Bortezomib SUN for information related to these medicines before starting treatment with Bortezomib SUN. 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 SUN should not be used in children and adolescents because it is not known how the medicine will affect them.
Other medicines and Bortezomib SUN
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 SUN if you are pregnant, unless clearly necessary.
You should not breast-feed while using Bortezomib SUN. 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 SUN is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Contraception
Both men and women receiving Bortezomib SUN must use effective contraception during and for up to 3 months after treatment. If, despite these measures, pregnancy occurs, tell your doctor immediately.
Driving and using machines
Bortezomib SUN may 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 SUN
Your doctor will work out your dose of Bortezomib SUN according to your height and weight (body surface area). The usual starting dose of Bortezomib SUN is 1.3 mg/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).
Progressive multiple myeloma
When Bortezomib SUN is given alone, you will receive 4 doses of Bortezomib SUN intravenously or 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 SUN together with the medicines pegylated liposomal doxorubicin or dexamethasone:
When Bortezomib SUN is given together with pegylated liposomal doxorubicin, you will receive Bortezomib SUN intravenously or subcutaneously as a 21-day treatment cycle. Pegylated liposomal doxorubicin 30 mg/m2 is given on day 4 of the Bortezomib SUN 21-day treatment cycle as an intravenous infusion after the Bortezomib SUN injection. You might receive up to 8 cycles (24 weeks).
When Bortezomib SUN is given together with dexamethasone, you will receive Bortezomib SUN intravenously or subcutaneously as a 21-day treatment cycle. Dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the Bortezomib SUN 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 SUN 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 SUN is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
In cycles 5 to 9, Bortezomib SUN is administered once weekly on days 1, 8, 22 and 29.
Melphalan (9 mg/m2) and prednisone (60 mg/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 SUN intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment:
When Bortezomib SUN is given together with dexamethasone, you will receive Bortezomib SUN intravenously or subcutaneously as a 21-day treatment cycle. Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib SUN 21-day treatment cycle. You will receive 4 cycles (12 weeks).
When Bortezomib SUN is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks). Dexamethasone 40 mg is given orally on days-1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib SUN 28-day treatment cycle. Thalidomide is given orally daily at 50 mg up to day 14 of the first cycle, and if tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be further increased to 200 mg 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 SUN intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Bortezomib SUN is given intravenously or 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 medicinal products are given on day 1 of each Bortezomib SUN 21-day treatment cycle as intravenous infusions:
Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
Prednisone is given orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of the Bortezomib SUN treatment cycle.
How Bortezomib SUN is given
This medicine is for intravenous or subcutaneous use. Bortezomib SUN will be administered by a health care professional experienced in the use of cytotoxic medicines.
Bortezomib SUN powder has to be dissolved before administration. This will be done by a healthcare professional. The resulting solution is then either injected into a vein or under the skin. Injection into a vein is rapid, taking 3 to 5 seconds. Injection under the skin is in either the thighs or the abdomen.
If you are given too much Bortezomib SUN
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
In the unlikely event of an overdose, your doctor will monitor you for side effects.
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.
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 heart beat, high blood pressure, tiredness, fainting
coughing and breathing difficulties or tightness in the chest.
Treatment with Bortezomib SUN 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 SUN, 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.
Multiple myeloma
If you are given Bortezomib SUN 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 of 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)
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, problem 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
discoloration 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 fibers 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.
Mantle cell lymphoma
If you are given Bortezomib SUN 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 (localized 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
sudden fall of 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 discoloration 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 or pharmacist. 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 SUN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and the carton after EXP.
Do not store above 25°C. Keep the vial in the outer carton in order to protect from light.
From a microbiological point of view, the reconstituted solution should be used immediately after preparation. If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. However, the reconstituted solution is stable for 8 hours at 25°C stored in the original vial and/or a syringe, with a total storage time for the reconstituted medicine not exceeding 8 hours prior to administration.
Bortezomib SUN 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 SUN contains
The active substance is bortezomib. Each vial contains 3.5 mg of bortezomib (as a mannitol boronic ester).
The other ingredient is mannitol (E421).
Intravenous reconstitution:
After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib.
Subcutaneous reconstitution:
After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.
What Bortezomib SUN looks like and contents of the pack
Bortezomib SUN 3.5 mg powder for solution for injection is a white to off-white powder or cake.
Each carton of Bortezomib SUN contains a clear glass 10 ml vial closed with a light green aluminium cap, in a transparent blister pack.
Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 2132 JH Hoofddorp The Netherlands
This leaflet was last revised in August 2021.
V003
Ranbaxy (UK) Limited a Sun Pharmaceutical Company
Address
6-9 The Square, Stockley Park, Uxbridge, UB11 1FW, UK