VIAL: 1. Dosage:
The recommended starting dose is 1.3 mg/m2 body surface area 2 x weekly for 2 weeks (days 1, 4, 8 and 11), followed by a 10 day rest period (days 12-21). This 3 week period is considered a treatment cycle. At least 72 hours should elapse between consecutive doses. It is recommended that patients with a confirmed complete response receive 2 additional cycles beyond a confirmation. It is also recommended that responding patients, who do not achieve complete remission, receive a total of 8 cycles of therapy. Currently there is limited data concerning retreatment.
Recommended dosage adjustment during treatment and re-initiation of treatment: Treatment must be withheld at the onset of any Grade 3 non-hematological or any Grade 4 hematological toxicities, excluding neuropathy. Once the symptoms of the toxicity have resolved, treatment may be re-initiated at a 25% reduced dose (1.3 mg/m2 reduced to 1.0 mg/m2; 1.0 mg/m2 reduced to 0.7 mg/m2). If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation must be considered unless the benefit of treatment clearly outweighs the risk. Prescribing Restrictions:
For the treatment of patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Contra-Indications:
Hypersensitivity to bortezomib, boron or to any of the excipients. Sever hepatic impairment. Pregnancy and lactation. See prescribing information for full details. Special Precautions:
Patients with pre-existing symptoms of peripheral neuropathy (numbness, pain or a burning feeling in the feet or hands) may experience worsening during treatment. Patients with a history of syncope, patients receiving medications known to be associated with hypotensions and patients who are dehydrated. Patients with risk factors for or existing heart disease. Patients with renal impairment: No clinical information is available on patients with creatinine clearance values less than 13 ml/minute and patients on hemodialysis. The safety and effectiveness in children have not been established. See prescribing information for full details. Side Effects:
Asthenic conditions (including fatigue, malaise and weakness), nausea, diarrhea, decreased appetite, constipation, thrombocytopenia, peripheral neuropathy (including peripheral sensory neuropathy and aggravated peripheral neuropathy), pyrexia, vomiting and anemia. See prescribing information for full details. Drug Interactions:
No formal drug interaction studies have been conducted.