Medicine Overview of Bortez 1mg/vial Injection
Bortez 1 is used in the treatment of multiple myeloma and mantle-cell lymphoma. It shows its working by stopping or slowing down the growth of cancer cells.
Bortez 1 is given as an injection by a qualified medical professional. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to.
Fatigue, nausea, vomiting, and loss of appetite are some common side effects of this medicine. You may be advised to drink plenty of fluids every day during the treatment. You should not drive or operate machinery as medicine may cause tiredness and dizziness. This medicine may reduce the number of blood cells (decrease red blood and white blood cells) in your blood, thereby, increasing the susceptibility to infections. Regular blood tests are required to check your blood cells along with heart, liver, and blood uric acid levels.
Before taking Bortez 1, consult with your doctor if you have any liver, kidney, heart disease or bleeding problem. It is important to consult a doctor if you develop symptoms like memory loss or trouble in thinking. Many other medicines can affect, or be affected by, this medicine so let your healthcare team know all medications you are using. This medicine is not recommended during pregnancy or while breastfeeding. The use of effective contraception by both males and females during treatment is important to avoid pregnancy.
- Multiple myeloma
- Mantle-cell lymphoma
- Low blood platelets
- Fatigue
- Peripheral neuropathy (tingling and numbness of feet and hand)
- Psychiatric disturbances
- Nausea
- Vomiting
- Loss of appetite
- Fever
- Anemia (low number of red blood cells)
- Diarrhea
- Decreased appetite
- Decreased white blood cell count (neutrophils)
- Constipation
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Before taking bortezomib, consult your doctor if you have any of the following disease conditions: disease of liver, kidney, heart or infections like fever with rash or genital sores, diabetes, low number of red or white blood cells or bleeding problems.
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Drink plenty of fluids every day during your treatment with bortezomib.
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Tell your doctor if you are or planning to become pregnant or are breastfeeding.
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Consult your doctor if you have signs of serious brain infection such as memory loss, trouble in thinking, difficulty with walking or loss of vision.
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Do not drive or operate machinery after taking bortezomib as it may cause tiredness, dizziness, fainting or blurred vision.
IV or SC Preparation
Reconstitute vial with 0.9% NaCl
IV administration: Add 3.5 mL to vial for final concentration of 1 mg/mL
SC administration: 2.5 mg/mL: Add 1.4 mL to vial for final concentration of 2.5 mg/mL
If local injection site reactions occur following SC administration, a less concentrated solution (1 mg/mL) may be administered subcutaneously
IV or SC Administration
Not for intrathecal (IT) use; inadvertent IT has resulted in death and is contraindicated
Separate consecutive doses by at least 72 hr
Give IV as a bolus over 3-5 seconds or as SC injection
Give SC injection in thigh or abdomen; rotate injection site with each dose
Monitor hydration status
Use cytotoxic handling procedures for preparation, administration, and disposal
Mantle Cell Lymphoma
Indicated for treatment of patients with mantle cell lymphoma as first-line in previously untreated patients or those who have relapsed
Previously untreated MCL
1.3 mg/m²/dose IV twice weekly for 2 weeks (days 1, 4, 8, 11) followed by a 10-day rest period (days 12 to 21) for six 3-week cycles; may continue for 8 cycles if response is first seen at cycle 6
Give with rituximab 375 mg/m² IV, cyclophosphamide 750 mg/m² IV, and doxorubicin 50 mg/m² IV on day 1, plus prednisone 100 mg/m² IV on days 1-5
Relapsed MCL
1.3 mg/m²/dose IV/SC twice weekly for 2 weeks (days 1, 4, 8, 11) followed by a 10-day rest period (days 12 to 21)
Therapy extending beyond 8 cycles: Give standard schedule
Multiple Myeloma
Previously untreated multiple myeloma
Administer in combination with prednisone and melphalan as part of 6-wk treatment cycles for 9 cycles
Cycles 1-4 (twice weekly): 1.3 mg/m² IV/SC on Days 1, 4, 8, 11, 22, 25, 29, and 32
Cycles 5-9 (once weekly): 1.3 mg/m² IV/SC on Days 1, 8, 22, and 29
Relapsed multiple myeloma
1.3 mg/m²/dose IV/SC twice weekly for 2 weeks (Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12-21)
Therapy extending beyond 8 cycles: Standard schedule or maintenance schedule of once weekly for 4 weeks (Days 1, 8, 15, and 22) followed by a 13-day rest period (Days 23 to 35)
Re-treatment
Indicated for re-treatment of adults with multiple myeloma who had previously responded to bortezomib and relapsed at least 6 months following completion of prior bortezomib treatment
Treatment may be started at the last tolerated dose
Administer twice weekly for 2 weeks (days 1, 4, 8, 11) followed by a 10-day rest period (days 12 to 21)
Hepatic impairment
Moderate-to-severe (bilirubin >1.5x ULN): Reduce to 0.7 mg/m² in the first cycle; consider dose escalation to 1 mg/m² or further dose reduction to 0.5 mg/m² in subsequent cycles based on tolerability
>10%
Asthenia (61-65%)
Nausea (61-65%)
Diarrhea (51-55%)
Anorexia (41-45%)
Constipation (41-45%)
Thrombocytopenia (41-45%)
Peripheral neuropathy (IV: 16-41%; SC: 6-24%)
Pyrexia (36-40%)
Vomiting (36-40%)
Anemia (31-35%)
Arthralgia (26-30%)
Headache (26-30%)
Insomnia (26-30%)
Limb pain (26-30%)
Dizziness (21-25%)
Dyspnea (21-25%)
Edema (21-25%)
Neutropenia (21-25%)
Paresthesia (21-25%)
Rash (21-25%)
Cough (15-20%)
Dehydration (15-20%)
URI (15-20%)
Rigors, grade 4 toxicity (10-15%)
Pregnancy
Based on mechanism of action and findings in animals, therapy can cause fetal harm when administered to a pregnant woman; there are no studies in pregnant women to inform drug-associated risks; therapy caused embryo-fetal lethality in rabbits at doses lower than the clinical dose; advise pregnant women of potential risk to fetus
Verify pregnancy status of females of reproductive potential prior to initiating treatment
Advise patients of reproductive potential to use effective contraception during treatment with therapy and for at least 2 months after treatment
Lactation
There are no data on presence of bortezomib or metabolites in human milk, the effects of the drug on the breast fed infant or on milk production
Many drugs are excreted in human milk and potential for serious adverse reactions in breastfed infants from therapy is unknown
Advise nursing women not to breastfeed during treatment and for 2 months after treatment
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