Bortezomib IV/SC Injection
Bortezomib
3.5 mg/vial
ZAS Corporation
| Pack size | 3.5 mg vial |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 14000.00 AED |
Indications
Bortezomib IV/SC Injection is used for:
Mantle Cell Lymphoma, Multiple Myeloma,
Adult Dose
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 the 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)
Child Dose
Renal Dose
Renal Impairment
No starting dosage adjustment of Bortezomib Injection is recommended for patients with renal impairment. In patients requiring dialysis, Bortezomib Injection should be administered after the dialysis procedure
Administration
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
Contra Indications
Patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions.
Contraindicated for intrathecal administration.
Precautions
Peripheral Neuropathy: Manage with dose modification or discontinuation. Patients with preexisting severe neuropathy should be treated with Bortezomib Injection only after careful risk-benefit assessment.
Hypotension: Use caution when treating patients taking antihypertensives, with a history of syncope, or with dehydration.
Cardiac Toxicity: Worsening of and development of cardiac failure has occurred. Closely monitor patients with existing heart disease or risk factors for heart disease.
Pulmonary Toxicity: Acute respiratory syndromes have occurred. Monitor closely for new or worsening symptoms and consider interrupting Bortezomib Injection therapy.
Posterior Reversible Encephalopathy Syndrome: Consider MRI imaging for onset of visual or neurological symptoms; discontinue Bortezomib Injection if suspected.
Gastrointestinal Toxicity: Nausea, diarrhea, constipation, and vomiting may require use of antiemetic and antidiarrheal medications or fluid replacement.
Thrombocytopenia and Neutropenia: Monitor complete blood counts regularly throughout treatment.
Tumor Lysis Syndrome: Closely monitor patients with high tumor burden.
Hepatic Toxicity: Monitor hepatic enzymes during treatment. Interrupt Bortezomib Injection therapy to assess reversibility.
Thrombotic Microangiopathy: Monitor for signs and symptoms.
Discontinue Bortezomib Injection if suspected.
Embryo-fetal Toxicity: Bortezomib Injection can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception.
Monitoring Parameters
Monitor for symptoms of peripheral neuropathy.
Monitor closely the blood glucose levels in patients receiving oral antidiabetic agents.
Closely monitor patients with existing heart disease or risk factors for heart disease.
Monitor closely for new or worsening symptoms and consider interrupting Bortezomib Injection therapy.
Monitor hepatic enzymes during treatment.
Closely monitor patients with high tumor burden.
Monitor complete blood counts regularly throughout treatment.
Pregnancy-Lactation
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
Contraception
Females: Use effective contraception during treatment and for 7 months after last dose
Males: Males with female partners of reproductive potential should use effective contraception during treatment and for 4 months after last dose
Infertility
Based on mechanism of action and findings in animals, drug may have an effect on either male or female fertility
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
Interactions
Strong CYP3A4 Inhibitors: Closely monitor patients with concomitant use.
Strong CYP3A4 Inducers: Avoid concomitant use.
Concurrent use of amiodarone, antivirals, isoniazid, nitrofurantoin, statins may increase the chance of peripheral neuropathy. Concurrent use of antihypertensives increases the chance of hypotension.
Contraindicated (3)
eliglustat
green tea
mavacamten
Serious (13)
apalutamide
enzalutamide
etrasimod
fedratinib
fexinidazole
idelalisib
ivosidenib
lonafarnib
mefloquine
palifermin
ropeginterferon alfa 2b
selinexor
tucatinib
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%)
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
Bortezomib 3.5 mg/vial IV/SC Injection manufactured by ZAS Corporation. Its generic name is Bortezomib. Bortezomib is availble in Bangladesh.
Farmaco BD drug index information on Bortezomib IV/SC Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.