Bortetrust Injection
Bortezomib
Panacea Biotec Ltd.
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Indications
Bortetrust Injection is used for:
Multiple Myeloma, Mantle Cell Lymphoma
Adult Dose
Mantle Cell Lymphoma
Indicated for the 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)
Retreatment
Indicated for retreatment 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
Child Dose
Renal Dose
Administration
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
Contra Indications
Hypersensitivity. Child. Pregnancy and lactation.
Precautions
Hepatic or renal impairment; history of syncope, orthostatic hypotension; dehydration. Impairs ability to drive or operate machinery. Monitor for symptoms of peripheral neuropathy. Monitor closely the blood glucose levels in patients receiving oral antidiabetic agents.
Pregnancy-Lactation
Interactions
Concurrent use of amiodarone, antivirals, isoniazid, nitrofurantoin, statins may increase the chance of peripheral neuropathy. Concurrent use of antihypertensives increases the chance of hypotension.
Adverse Effects
Side effects of Bortezomib :
>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%)
Frequency Not Defined
Hypotension
Anxiety
Pain
Pruritis
Abdominal pain
Dyspepsia
Back pain
Bone pain
Myalgia
Muscle spasms
Herpes zoster
Pneumonia
Blurred vision
Potentially Fatal: Pneumonia, pyrexia, diarrhoea, vomiting, dehydration and nausea.
Mechanism of Action
Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26-S proteasome. It prevents targeted proteolysis that affects multiple signaling cascades responsible for normal homeostatic functions within the cell, leading to cell death.
Note
Bortetrust Injection manufactured by Panacea Biotec Ltd.. Its generic name is Bortezomib. Bortetrust is availble in Nepal.
Farmaco Nepal drug index information on Bortetrust Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.