1 mg, 2.5 mg, 3 mg, 3.5 mg powder for injection , solution
, bortezomib
What Bortezomib Hospira is and what it is used for
Bortezomib Hospira contains the active substance bortezomib, a so-called “proteasome inhibitor”. The proteasome plays an important role in controlling the function and growth of cells. By interfering with their function, bortezomib can kill cancer cells.
Bortezomib is used to treat multiple myeloma (a type of bone marrow cancer) in patients over 18 years of age:
- as a single drug or together with the drugs pegylated liposomal doxorubicin or dexamethasone to patients whose disease worsens (is progressive ) after receiving at least one previous treatment and where blood stem cell transplantation has not been successful or inappropriate.
- in combination with the drugs melphalan and prednisone, for patients whose disease has not been previously treated and where high-dose chemotherapy with blood stem cell transplantation is not appropriate.
- in combination with the drugs 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 therapy).
Bortezomib is used to treat mantle cell lymphoma (a type of cancer that affects the lymph nodes) in patients 18 years of age and older in combination with rituximab, cyclophosphamide, doxorubicin and prednisone, for patients whose disease has not been previously treated and for whom blood stem cell transplantation is inappropriate.
What you need to know before you use Bortezomib Hospira
Do not use Bortezomib Hospira
- if you are allergic to bortezomib, boron, or any of the other ingredients of this medicine (listed in section 6).
- if you have some serious lung or heart problems.
Warnings and cautions
Talk to your doctor if you have any of the following:
- the low number of red or white blood cells
- bleeding problems and/or low platelet count
- diarrhea, constipation, nausea or vomiting
- if you have previously suffered from fainting, dizziness, or fainting
- kidney problems
- moderate to severe liver problems
- previous problems with numbness, tingling, or pain in the hands or feet ( neuropathy )
- heart problems or blood pressure et
- shortness of breath or cough
- seizures
- shingles (which can occur locally, even around the eyes, or be spread over the body)
- symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, vision loss or visual disturbances, and shortness of breath
- memory loss, difficulty thinking, difficulty walking, or loss of vision. These may be signs of serious brain infection and your doctor may suggest further examinations and follow-up.
You must take regular blood tests before and during treatment with Bortezomib Hospira to check the number of blood cells.
Tell your doctor if you have mantle cell lymphoma and are taking rituximab with bortezomib:
- if you think you have a liver infection ( hepatitis ) now or if you have had it before. In a few cases, patients who have had hepatitis B have had hepatitis again, which can be fatal. If you have had hepatitis B before, you will be closely monitored by your doctor for signs of active hepatitis B.
You must read the package leaflets of all medicines taken with Bortezomib Hospira for information on these medicines before starting treatment with Bortezomib Hospira. When thalidomide is used, special attention should be paid to pregnancy testing and contraception (see Pregnancy and breast-feeding in this section).
Children and young people
Bortezomib should not be used in children and adolescents because it is not known how the medicine will affect them.
Other medicines and Bortezomib Hospira
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 taking medicines that contain any of the following active substances:
- ketoconazole, which is 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 mild depression or mild anxiety
- oral diabetes medicine.
Pregnancy, breastfeeding, and fertility
You should only use bortezomib during pregnancy if absolutely necessary.
Both men and women should use effective contraception during and for three months after treatment with bortezomib. If pregnancy still occurs, consult a doctor immediately.
You should not breast-feed during treatment with bortezomib. Ask your doctor when it is safe to start breast-feeding again after stopping treatment.
Thalidomide causes birth defects and fetal death. When bortezomib is taken with thalidomide, you must follow the thalidomide prevention program to prevent pregnancy (see the thalidomide package leaflet).
Driving and using machines
Bortezomib may cause fatigue, dizziness, fainting, and blurred vision. Do not drive or use any tools or machines if you experience any of these symptoms and even if you do not feel any symptoms, caution should be exercised.
How to use Bortezomib Hospira
Your doctor will calculate the appropriate dose of bortezomib using your height and weight (body surface area). The usual starting dose of bortezomib is 1.3 mg / m 2body surface area twice a week.
Your doctor may change the dose and the number of rounds of treatment depending on how you respond to the treatment if you get certain side effects, and your underlying illnesses (eg liver problems).
Progressive multiple myeloma
When you receive bortezomib alone as a medicine, you will receive 4 doses of bortezomib intravenously or subcutaneously on days 1, 4, 8, and 11, followed by a 10-day treatment break. This 21-day period (3 weeks) corresponds to one round of treatment. You can receive up to 8 rounds of treatment (24 weeks).
You can also get bortezomib with the medicines pegylated liposomal doxorubicin or dexamethasone.
When bortezomib with pegylated liposomal doxorubicin get bortezomib intravenously or subcutaneously in a treatment cycle of 21 days, and pegylated liposomal doxorubicin 30 mg / m 2 given on day 4 of the treatment course of 21 days, bortezomib, as an intravenous infusion after injection a with bortezomib.
You can receive up to 8 rounds of treatment (24 weeks).
When bortezomib is co-administered with dexamethasone, you will receive bortezomib intravenously or subcutaneously over a 21-day course of treatment, and dexamethasone 20 mg will be given orally on days 1, 2, 4, 5, 8, 9, 11, and 12 of the 21-day course of bortezomib.
You can receive up to 8 rounds of treatment (24 weeks).
Previously untreated multiple myeloma
If you have not previously been treated for multiple myeloma, and you are not suitable for blood stem cell transplantation, you will receive bortezomib intravenously or subcutaneously with two other medicines: melphalan and prednisone.
In this case, a course of treatment lasts for 42 days (6 weeks). You will receive a total of 9 rounds of treatment (54 weeks).
- During cycles 1 to 4, bortezomib is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29, and 32.
- During cycles 5 to 9, bortezomib is administered once weekly on days 1, 8, 22, and 29.
Both melphalan (9 mg / m 2 ) and prednisone (60 mg / m 2 ) are taken orally on days 1, 2, 3 and 4 during the first week of each treatment cycle.
If you have not previously been treated for multiple myeloma, and if you are suitable for a blood stem cell transplant, you will receive bortezomib intravenously or subcutaneously with the medicines dexamethasone or dexamethasone and thalidomide, as induction therapy.
When bortezomib is co-administered with dexamethasone, you will receive bortezomib intravenously or subcutaneously over a 21-day course of treatment, and dexamethasone 40 mg will be given orally on days 1, 2, 3, 4, 8, 9, 10, and 11 of the 21-day course of treatment with bortezomib.
You will receive 4 rounds of treatment (12 weeks).
When bortezomib is co-administered with thalidomide and dexamethasone, the duration of treatment is 28 days (4 weeks).
Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10, and 11 of 28 days of treatment with bortezomib, and thalidomide is given orally daily with 50 mg until day 14 of the first cycle of treatment, and if you can tolerate the thalidomide dose, increase the dose one to 100 mg on days 15-28 and then increase it to 200 mg daily from the second round of treatment.
You can receive up to 6 rounds of treatment (24 weeks).
Previously untreated mantle cell lymphoma
If you have not been previously treated for mantle cell lymphoma, you will receive bortezomib intravenously or subcutaneously with the medicines rituximab, cyclophosphamide, doxorubicin, and prednisone.
Bortezomib is given intravenously or subcutaneously on days 1, 4, 8, and 11, followed by a “rest period” without treatment. The treatment cycle lasts 21 days (3 weeks). You can receive up to 8 rounds of treatment (24 weeks).
The following medicines are given as an intravenous infusion on day 1 of each 21-day course of bortezomib treatment:
Rituximab 375 mg / m 2 , cyclophosphamide 750 mg / m 2 and doxorubicin 50 mg / m 2 . Prednisone 100 mg / m 2 is given orally (orally) on days 1, 2, 3, 4 and 5 of the course of treatment with bortezomib.
How to take Bortezomib Hospira
This medicine should only be given intravenously or subcutaneously. Bortezomib will be given by healthcare professionals experienced in the use of cytotoxic drugs.
Bortezomib powder must be reconstituted before administration, which is done by healthcare professionals. The reconstituted solution is then injected either into a vein or under the skin. Injection into a vein is rapid, 3-5 seconds. Injection under the skin is given either in the thigh or abdomen.
If you take more Bortezomib Hospira than you should
Because you are receiving this medicine from a doctor or nurse, it is unlikely that you will receive too much. If you are unlikely to get an overdose, your doctor will monitor you for side effects.
If you take more Bortezomib Hospira than you should
Because you are receiving this medicine from a doctor or nurse, it is unlikely that you will receive too much. If you are unlikely to get 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 side effects can be serious.
If you get bortezomib for multiple myeloma or mantle cell lymphoma, tell your doctor straight away if you notice any of the following symptoms:
- muscle cramps, muscle weakness
- confusion, loss of vision or visual disturbances, blindness, seizures, headache
- shortness of breath, swollen feet or changes in your heartbeat, high blood pressure, fatigue, fainting
- coughing and difficulty breathing or that the chest feels tight.
It is very common that treatment with bortezomib causes a reduction in the number of red and white blood cells and platelets. Therefore, you must take regular blood tests before and during treatment with bortezomib to check the number of blood cells. You can get a reduced number:
- platelets, which may make you more likely to get bruises, or bleeding for no apparent reason (eg bleeding from the intestines, stomach, mouth, or gums or bleeding in the brain or bleeding from the liver)
- red blood cells, which can cause anemia with symptoms such as fatigue and pallor
- white blood cells, which may make you more likely to get an infection or flu-like symptoms.
If you are getting Bortezomib Hospira for multiple myeloma, you may experience the side effects listed below:
Very common side effects (may affect more than 1 user in 10)
- Sensitivity, numbness, tingling or burning in 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
- Nausea or vomiting, loss of appetite
- Constipation with or without bloating (can be severe)
- Diarrhea: If this happens, it is important that you drink more water than usual. Your doctor may give you another medicine for diarrhea
- Fatigue, a feeling of weakness
- Muscle pain, skeletal pain.
Common side effects (may affect up to 1 in 10 people)
- Low blood pressure, the sudden drop in blood pressure when you get up which can cause you to faint
- High blood pressure
- Impaired renal function
- Headache
- General malaise, pain, dizziness, fainting, lethargy, or loss of consciousness
- Shaking
- Infections include pneumonia, respiratory infections, bronchitis, fungal infections, coughing up mucus, flu-like conditions
- Shingles (which can occur locally, even around the eyes, or be spread over the body)
- Chest pain or shortness of breath during physical exertion
- Different types of rash
- Itchy skin, lumps of the skin, or dry skin
- Reddening of the face or small ruptured capillaries
- Reddening of the skin
- Dehydration
- Heartburn, bloating, belching, gas, abdominal pain, bleeding from the intestines or stomach
- Altered liver function
- Soreness in the mouth or lips, dry mouth, cold sores or sore throat
- Weight loss, loss of taste
- Muscle cramps, muscle spasms, muscle weakness, pain in arms/legs
- Dimsyn
- Infection is in the outer membrane of the eye and in the inner surface of the eyelids (conjunctivitis)
- Nasal blood
- Difficulty sleeping, sweating, anxiety, mood swings, depression, restlessness or anxiety, changes in mental health, disorientation
- Swelling of the body including swelling around the 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 decreased heart rate
- Kidney failure
- Inflammation of a blood vessel, blood clots in blood vessels or lungs
- Problems with blood clotting ability
- Insufficient circulation
- Inflammation of the pericardium or fluid around the heart
- Infections include urinary tract infections, flu, herpes infections, ear infections, and inflammation of the subcutaneous tissue ( cellulite )
- Bloody stools or bleeding in the mucous membranes of, for example, the mouth, abdomen
- Diseases of the blood vessels of the brain
- Paralysis, seizures, falls, movement disorders, abnormalities or changes in or decreased sensations (feeling, hearing, taste, smell), attention deficit disorder, tremors, muscle twitching
- Arthritis, including inflammation of the joints of the fingers, toes, and jaw
- Disorders that affect your lungs prevent your body from getting enough oxygen. Some of these are difficulty breathing, shortness of breath, shortness of breath without physical exertion, breathing that becomes shallow, strenuous or paused breathing, wheezing
- Hiccups, speech disorders
- Increased or decreased urine output (due to kidney damage), pain when urinating or blood/protein in the urine, fluid retention
- Altered degree of consciousness, confusion, impaired memory, or memory loss
- Hypersensitivity
- Hearing loss, deafness or wheezing in the ears, discomfort in the ears
- Disorders in the hormonal balance that can affect the uptake of salt and water
- Overactive thyroid gland
- Inability to produce enough insulin or resistance to normal insulin levels
- Irritated or inflamed eyes, excessively moist eyes, eye pain, dry eyes, eye infections, lump on the eyelid ( chalazion ), red and swollen eyelids, discharge from the eyes, blurred vision, bleeding from the eyes
- Swollen lymph nodes
- Stiffness in joints or muscles, the feeling of heaviness, pain in the groin
- Hair loss and abnormal hair structure
- Allergic reactions
- Redness or pain at the injection site
- Pain in the mouth
- Infection or inflammation of the mouth, cold sores, infection of the esophagus, stomach, and intestines sometimes associated with pain and bleeding, weak bowel movements (including total stop), discomfort in the stomach or esophagus, difficulty swallowing, vomiting of blood
- Skin infections
- Bacterial and viral infections
- Dental infections
- Inflammation of the pancreas, stasis in the bile duct
- Genital pain, difficulty getting an erection
- Weight gain
- Thirst
- Hepatitis
- Complications related to the injection site or intravenous entry
- Skin reactions and skin diseases (which can be serious and life-threatening), skin ulcers
- Bruises, falls, and injuries
- Inflammation or bleeding in blood vessels that can appear as everything from small red or purple dots (usually on the legs) to bruise-sized spots under the skin or tissue a
- Benign cysts
- A severely reversible condition of the brain that includes seizures, high blood pressure, headaches, fatigue, confusion, blindness, or other visual disturbances.
Rare side effects (may affect up to 1 in 1,000 people)
- Heart problems including heart attack, angina
- Redness
- Discoloration of the veins
- Inflammation of the spinal nerves
- Problems with the ears, bleeding in the ears
- Decreased activity of the thyroid gland
- Budd-Chiaris syndrome (the clinical symptoms are caused by a blockage of the hepatic veins)
- Changes in or abnormal bowel functions
- Cerebral hemorrhage
- Yellowing of the eyes and skin (jaundice)
- Signs of a severe allergic reaction (anaphylactic shock ) such as difficulty breathing, chest pain or pressure over the chest and/or feeling dizzy/fainting, severe skin itching or swelling of the skin, swelling of the face, lips, tongue, and/or throat, which may cause swallowing difficulties, collapse
- Breast disorders
- Vaginal ulcers
- Swollen genitals
- Inability to tolerate alcohol
- Weight loss
- Increased appetite
- Fistula
- Articulation
- Cysts in the synovium (synovial cyst)
- Fracture is
- Degradation of muscle fibers leading to other complications
- Swelling of the liver, bleeding from the liver
- Kidney cancer
- Psoriasis-like skin problems
- Skin cancer
- Pale skin
- Increase in platelets or plasma cells (a type of white blood cell ) in the blood
- Blood clots in small blood vessels (thrombotic microangiopathy)
- Abnormal reaction to blood transfusion is
- Partial or total vision loss
- Decreased sex drive
- Dreiling
- Protruding eyes
- Hypersensitivity to light
- Rapid breathing
- Rectal pain
- Gallstone ar
- Hernia
- Injuries
- Fragile or weak nails
- Abnormal precipitation of protein is in your vital organs
- Coma
- Intestinal ulcers
- Failure of several organs simultaneously
- Death.
If you are taking bortezomib with other medicines to treat mantle cell lymphoma, you may experience the side effects listed below:
Very common side effects (may affect more than 1 user in 10 )
- Pneumonia
- Reduced appetite
- Sensitivity, numbness, tingling or burning in the skin, or pain in the hands or feet due to nerve damage
- Nausea and vomiting
- Diarrhea
- Cold sores
- Constipation
- Muscle pain, skeletal pain
- Hair loss and abnormal hair structure
- Fatigue, the feeling of weakness
- Fever.
Common side effects (may affect up to 1 in 10 people )
- Shingles (which can occur locally, even around the eyes, or be spread over the body)
- Herpes infections
- Bacterial and viral infections
- Respiratory tract infections, bronchitis, cough with mucus, flu-like illness
- Fungal infections
- Hypersensitivity ( allergic reaction )
- Inability to produce enough insulin or resistance to normal insulin levels
- Fluid accumulation
- Sleeping problems
- Unconsciousness
- Altered level of consciousness, confusion
- Dizziness
- Faster heartbeat, high blood pressure, sweating
- Abnormal, dimsyn
- Heart failure, heart attack, chest pain, chest discomfort, increased or decreased heart rate
- High or low blood pressure
- The sudden drop in blood pressure when you get up, which can cause you to faint
- Shortness of breath on exertion
- Cough
- Hiccup
- Ringing in the ears, discomfort in the ears
- Bleeding from the intestines or stomach
- Heartburn
- Stomach pain, bloating
- Difficulty swallowing
- Infection or inflammation of the stomach or intestines
- Stomach pain
- Soreness in the mouth or lips, sore throat
- Altered liver function
- Skin itching
- Reddening of the skin
- Rash
- Muscle spasms
- Urinary tract infections
- Pain in arms and legs
- Swelling in the body, which also includes the eyes and other parts of the body
- Overindulge
- Redness and pain at the injection site
- General malaise
- Weight loss
- Weight gain.
Uncommon side effects (may affect up to 1 in 100 people )
- Hepatitis
- Signs of a severe allergic reaction (anaphylactic shock ) such as difficulty breathing, chest pain or pressure over the chest and/or feeling dizzy/fainting, severe skin itching or swelling of the skin, swelling of the face, lips, tongue, and/or throat, which may cause swallowing difficulties, collapse
- Movement disorders, paralysis, muscle twitching
- Dizziness
- Hearing loss, deafness
- Disorders that affect your lungs prevent your body from getting enough oxygen. Some of these are difficulty breathing, shortness of breath, shortness of breath without physical exertion, breathing that becomes shallow, strenuous or paused breathing, wheezing
- Blood clots in the lungs
- Yellowing of the eyes and skin (jaundice)
- Lump on the eyelid ( chalazion ), red and swollen eyelids
Rare side effects (may affect up to 1 in 1,000 people)
- Blood clots in small blood vessels (thrombotic microangiopathy)
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Bortezomib Hospira
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 vial and carton after EXP.
No special temperature instructions.
Keep the vial in the outer carton. Sensitive to light.
The reconstituted solution should be used immediately. 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 5-25 ° C when stored in the original vial and/or syringe, with a total storage time of the reconstituted solution up to 8 hours before administration.
Bortezomib Hospira is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.
6. Contents of the packaging and other information
Content declaration
The active substance is bortezomib.
Bortezomib Hospira 1 mg powder for injection solution
Each vial contains 1 mg bortezomib (as a mannitol boronic acid ester).
Bortezomib Concentrate 2.5 mg powder for injection solution
Each vial contains 2.5 mg bortezomib (as a mannitol boronic acid ester).
Bortezomib Hospira 3 mg powder for injection solution
Each vial contains 3 mg bortezomib (as a mannitol boronic acid ester).
Bortezomib Concentrate 3.5 mg powder for injection solution
Each vial contains 3.5 mg bortezomib (as a mannitol boronic acid ester).
Intravenous preparation:
After preparation, 1 ml injection solution for intravenous injection 1 mg bortezomib.
Subcutaneous preparation:
After preparation, 1 ml injection solution for subcutaneous injection 2.5 mg bortezomib.
The other ingredient is mannitol (E421).
What the medicine looks like and contents of the pack
Bortezomib Hospira powder for solution for injection is a white to whitish cake or powder.
Each pack of 1 mg Bortezomib Hospira contains a silicone-coated 5 ml glass vial with a rubber stopper with an aluminum seal.
Each pack of 2.5 mg, 3 mg, or 3.5 mg Bortezomib Hospira contains one 10 ml glass vial with a rubber stopper with an aluminum seal.
Marketing Authorization Holder and Manufacturer
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Hospira UK Ltd.
Horizon, Honey Lane
Hurley, SL6 6RJ
UK
Pfizer Service Company BVBA,
Hoge Wei 10,
1930 Zaventem,
Belgium
Contact the representative of the marketing authorization holder to find out more about this medicine:
| ATPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0 | LVPfizer Luxembourg SARL subsidiary LatvijāTel .: + 371 670 35 775 |
| ASKPfizer SA / NVTel: +32 2 554 62 11 | LTPfizer Luxembourg SARL branches in LithuaniaTel. + 370 52 51 4000 |
| BGPfizer of Luxembourg, Clone of Bulgaria Tel: +359 2 970 4333 | LUPfizer SA / NV Tel: +32 2 554 62 11 |
| CYPharmaceutical Trading Co. LtdFile: 24656165 | HUPfizer Kft.Tel: + 36 1 488 37 00 |
| CZPfizer, spol. s roTel: + 420-283-004-11 | MTDrugsales LtdPhone: +356 21 419 070/1/2 |
| DKPfizer ApSTel: + 45 44 20 11 00 | NLPfizer bvTel: +31 (0) 10 406 43 01 |
| THEPfizer Pharma PFE GmbHTel: + 49 (0) 800 8535555 | NOPfizer ASTel: +47 67 52 61 00 |
| EEPfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500 | PLPfizer Polska Sp. z ooTel: +48 22 335 61 00 |
| ELPfizer ΕΛΛΑΣ AE.:Ηλ .: +30 210 6785 800 | PTPfizer Laboratories, Lda.Tel: +351 21 423 55 00 |
| ES Pfizer, SLTel: +34 91 490 99 00 | ROPfizer România SRLTel: +40 (0) 21 207 28 00 |
| FRPfizerTel: + 33 (0) 1 58 07 34 40 | SIPfizer Luxembourg SARLPfizer, a company in the field of pharmaceuticals, LjubljanaTel: +386 (0) 1 52 11 400 |
| HRPfizer Croatia dooTel: +385 1 3908 777 | SKPfizer Luxembourg SARL, organizerTel: + 421–2–3355 5500 |
| IEPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161 | FIPfizer PFE Finland OyPuh / Tel: +358 (0) 9 430 040 |
| ISIcepharma hf.Phone: +354 540 8000 | SEEPfizer ABTel: +46 (0) 8 550 520 00 |
| ITPfizer SrlTel: +39 06 33 18 21 | UKHospira UK LimitedTel: + 44 (0) 1628 515500 |