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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL17780/0812.
Bortezomib 3.5mg powder for solution for injection
Bortezomib 3.5 mg powder for solution for injection
1. What Bortezomib is and what it is used for
2. What you need to know before you use Bortezomib
3. How to use Bortezomib
4. Possible side effects
5. How to store Bortezomib
6. Contents of the pack and other information
Bortezomib 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 is used for the treatment of multiple myeloma (a cancer of the bone marrow) in patients older than 18 years:
Bortezomib 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.
Talk to your doctor or pharmacist before using Bortezomib, if you have any of the following:
You will have to take regular blood tests before and during your treatment with Bortezomib, to check your blood cell counts regularly.
If you have mantle cell lymphoma and are given the medicine rituximab with Bortezomib you should tell your doctor:
You must read the package leaflets of all medicinal products to be taken in combination with Bortezomib for information related to these medicines before starting treatment with Bortezomib.
When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see Pregnancy and breast-feeding in this section).
Bortezomib should not be used in children and adolescents because it is not known how the medicine will affect them.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor if you are using medicines containing any of the following active substances:
You should not use Bortezomib if you are pregnant, unless clearly necessary.
Both men and women receiving Bortezomib 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. 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 is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Bortezomib 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.
Your doctor will work out your dose of Bortezomib according to your height and weight (body surface area). The usual starting dose of Bortezomib 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 is given alone, you will receive 4 doses of Bortezomib 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 together with the medicines pegylated liposomal doxorubicin or dexamethasone.
When Bortezomib is given together with pegylated liposomal doxorubicin, you will receive Bortezomib intravenously or subcutaneously as a 21-day treatment cycle and pegylated liposomal doxorubicin 30 mg/m2 is given on day 4 of the Bortezomib 21-day treatment cycle as an intravenous infusion after the Bortezomib injection.
You might receive up to 8 cycles (24 weeks).
When Bortezomib is given together with dexamethasone, you will receive Bortezomib intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the Bortezomib, 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 intravenously 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).
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 intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.
When Bortezomib is given together with dexamethasone, you will receive Bortezomib intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib 21-day treatment cycle.
You will receive 4 cycles (12 weeks).
When Bortezomib 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 28- day treatment cycle and 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 intravenously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Bortezomib is given intravenously 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 21-day treatment cycle as intravenous infusions:
This medicine is for intravenous or subcutaneous use. Bortezomib will be administered by a health care professional experienced in the use of cytotoxic medicines.
Bortezomib 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.
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.
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 for multiple myeloma or mantle cell lymphoma, tell your doctor straight away if you notice any of the following symptoms:
Treatment with Bortezomib 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, to check your blood cell counts regularly. You may experience a reduction in the number of
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
If you are given Bortezomib 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)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
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 at: 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.
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.
Keep the vial in the outer carton in order to protect from the light.
This medicinal product does not require any special temperature storage conditions.
Reconstitution solution
From a microbiological point of view, the reconstituted solution should be used immediately after preparation. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. However, the chemical and physical in-use stability of the reconstituted solution has been demonstrated for 8 days at 25 °C / 60%RH and for 15 days at 5 ±3°C, in the dark, both in a vial and in a polypropylene syringe.
The active substance is Bortezomib. Each vial contains 3.5 mg 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
After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg Bortezomib.
Bortezomib powder for solution for injection is a white to off-white cake or powder.
Bortezomib is packed in a glass vial with rubber stopper and a blue flip-off cap.
Each pack contains 1 single-use vial.
This leaflet was last updated in February 2021
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