Bortezomib
Cytostatic · Proteasome inhibitor
Indications
Treatment of multiple myeloma: treatment of relapsed or refractory mantle cell lymphoma.
Dosage
IV: Adults: Multiple Myeloma (first line therapy; in combination with melphalan and prednisone): 1.3 mg/m2 1, 4, 8, 11, 22, 25, 29 and 32 of a 42-day treatment cycle for 4 cycles, followed, by 1.3 mg/m2 days1, 8, 22 and 29 of a 42-day treatment cycle for 5 cycles. Relapsed multiple myeloma and mantle cell lymphoma: 1.3 mg/m2 twice weekly for 2 wk on days 1, 4, 8 and 11 of a 21-day treatment cycle. Consecutive doses should be separated by at least 72 hr. Therapy extending beyond 8 cycles may be given once weekly for 4 wk (days 1, 8, 15 and 22), followed by a 13-day rest (days 23 through 35). Non-Hodgkin's Lymphoma, other than mantle cell (unlabeled use): 1.3-1.5 mg/ m2 twice weekly for 2 wk on days 1, 4, 8 and 11 of a 21-day treatment cycle. Children: Not recommended.
Administration
Administer via rapid IV push (3-5 seconds). Reconstitution: Reconstitute with 3.5 mL of 0.9% NaCl, resulting in a final concentration of 1 mg/mL of bortezomib. The reconstituted product should be a clear and colourless solution. Stability: Store unopened vials in the original package at 25°C (77°F); excursions permitted between 15°C-30°C (59°F-86°F). Protect from light. Reconstituted bortezomib may be stored at 25°C (77°F). Administer within 8 hours of preparation.
Adverse Effects
Edema, hypotension, fever, psychiatric disturbances, headache, dysaesthesia, insomnia, dizziness, rash, pruritus, dehydration, nausea, constipation, anorexia, vomiting, abdominal pain, abnormal taste, dyspepsia, thrombocytopenia, neutropenia, weakness, peripheral neuropathy, paresthesia, arthralgia, bone pain, back pain, myalgia, muscle cramps, blurred vision, dyspnoea, cough, lower respiratory infection, pneumonia, syncope.
Risk Factor (Pregnancy/Lactation)
Pregnancy: Positive evidence of risk: Use only when no safer alternative exists for a serious problem. Lactation: Contraindicated or not recommended. Precautions: May cause peripheral neuropathy (usually sensory but may be mixed sensorimotor): risk may be increased with previous use of neurotoxic agents or pre-existing peripheral neuropathy; adjustment of dose and schedule may be required. May cause hypotension; use caution with dehydration, history of syncope, or medications associated with hypotension. Has been associated with the development or exacerbation of congestive heart failure and decreased left ventricular ejection; use caution in patients with risk factors or existing heart disease. Has also been associated with QTc prolongation. May cause tumour lysis syndrome; risk is increased in patients with large tumour prior to treatment. Risk is increased in patients with…
Interactions
Clopidogrel, Dasatinib, Deferasirox, Peginterferon Alfa-2b. CYP2C19 inducers and inhibitors, CYP3A4 inducers and inhibitors.
Advice to Patient
This medication is administered intravenously. Inform prescriber immediately if there is difficulty in breathing, itching, rash, acute headache, chest pain, throat tightness, redness, pain, swelling at infusion site. Contact prescriber if there is constant muscle, back, bone pain, headache, cramps, loss of sensation, vision changes. Regular monitoring is required during and after treatment. Take sufficient amount of fluids (2-3 litres per day) to maintain hydration, unless restricted by the prescriber.
Pharmacokinetics
Metabolism: Hepatic. Half-life elimination: IV: Single dose: 9-15 hrs. Multiple dosing: 1 mg/m2: 40-193 hrs; 1.3 mg/m2: 76-108 hrs.
Brands with this active ingredient
Compiled by Healify Pharmacy from published drug references. How we compile it →
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