Treatment of adult patients with multiple myeloma.
Treatment of adult patients with mantle cell lymphoma.
Dosage/Direction for Use
For subcutaneous or intravenous use only. Each route of administration has a different reconstituted concentration. Exercise caution when calculating the volume to be administered.
The recommended starting dose of BORTESUN is 1.3 mg/m2 administered either as a 3 to 5 second bolus intravenous injection or subcutaneous injection.
Retreatment for Multiple Myeloma: May retreat starting at the last tolerated dose.
Hepatic Impairment: Use a lower starting dose for patients with moderate or severe hepatic impairment.
Dose must be individualized to prevent overdose.
Contraindications
Patients with hypersensitivity (not including local reactions) to bortezomib or mannitol.
Contraindicated for intrathecal administration.
Special Precautions
Peripheral Neuropathy: Manage with dose modification or discontinuation. Patients with pre-existing severe neuropathy should be treated with BORTESUN only after careful risk-benefit assessment. Hypotension: Use caution when treating patients taking anti-hypertensives, with a history of syncope, or with dehydration.
Adverse Reactions
Most commonly reported adverse reactions (incidence ≥20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia.
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