Bortezomib - Velcade®
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| The recommended dose of VELCADE is 1.3 mg/m2 administered as a 3 to 5 second bolus intravenous injection. Dose adjustment may be used to manage adverse events that occur during treatment.
The drug quantity contained in one vial (3.5 mg) may exceed the usual dose required. Caution should be used in calculating the dose to prevent overdose.
Reconstitute with 3.5 mL of 0.9% Sodium Chloride resulting in a final concentration of 1 mg/mL of bortezomib. The reconstituted product should be a clear and colorless solution.
Stability: Unopened vials of VELCADE are stable until the date indicated on the package when stored in the original package protected from light. VELCADE contains no antimicrobial preservative. Reconstituted VELCADE should be administered within 8 hours of preparation. When reconstituted as directed, VELCADE may be stored at 25°C (77°F). The reconstituted material may be stored in the original vial and/or the syringe prior to administration. The product may be stored for up to 8 hours in a syringe; however total storage time for the reconstituted material must not exceed 8 hours when exposed to normal indoor lighting.
|Stability / Miscellaneous|
1. INDICATIONS AND USAGE
1.1 Multiple Myeloma
1.2 Mantle Cell Lymphoma
2.1 Dosage in Previously Untreated Multiple Myeloma
Table 1-Dosage Regimen for Patients with Previously Untreated Multiple Myeloma
2.2 Dose Modification Guidelines for Combination Therapy with VELCADE, Melphalan and Prednisone
Prior to initiating any cycle of therapy with VELCADE in combination with melphalan and prednisone: Platelet count should be ≥70 x 109/L and the ANC should be ≥ 1.0 x 109/L Non-hematological toxicities should have resolved to Grade 1 or baseline Table 2-Dose Modifications During Cycles of Combination VELCADE, Melphalan and Prednisone Therapy
2.3 Dosage in Relapsed Multiple Myeloma and Mantle Cell Lymphoma
2.4 Dose Modification Guidelines for Relapsed Multiple Myeloma and Mantle Cell Lymphoma
For the management of patients who experience VELCADE related neuropathic pain and/or peripheral neuropathy see Table 3. Patients with preexisting severe neuropathy should be treated with VELCADE only after careful risk-benefit assessment.
Table 3: Recommended Dose Modification for VELCADE related Neuropathic Pain and/or Peripheral Sensory or Motor Neuropathy
2.5 Dosage in Patients with Hepatic Impairment
Table 4: Recommended Starting Dose Modification for VELCADE in Patients with Hepatic Impairment
2.6 Administration Precautions
VELCADE is an antineoplastic. Procedures for proper handling and disposal should be considered. [see How Supplied/Storage and Handling]
In clinical trials, local skin irritation was reported in 5% of patients, but extravasation of VELCADE was not associated with tissue damage.
2.7 Reconstitution/Preparation for Intravenous Administration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. If any discoloration or particulate matter is observed, the reconstituted product should not be used.
Stability: Unopened vials of VELCADE are stable until the date indicated on the package when stored in the original package protected from light.
VELCADE contains no antimicrobial preservative. Reconstituted VELCADE should be administered within 8 hours of preparation. When reconstituted as directed, VELCADE may be stored at 25°C (77°F). The reconstituted material may be stored in the original vial and/or the syringe prior to administration. The product may be stored for up to 8 hours in a syringe; however total storage time for the reconstituted material must not exceed 8 hours when exposed to normal indoor lighting.
3. DOSAGE FORMS AND STRENGTHS
HOW SUPPLIED/STORAGE AND HANDLING
Unopened vials may be stored at controlled room temperature 25°C (77°F); excursions permitted from 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Retain in original package to protect from light.
Consider handling and disposal of VELCADE according to guidelines issued for cytotoxic drugs, including the use of gloves and other protective clothing to prevent skin contact.
VELCADE, and MILLENNIUM are registered trademarks of Millennium Pharmaceuticals, Inc.
[PACKAGE INSERT DATA] : VELCADE (bortezomib) injection, powder, lyophilized, for solution. Millennium Pharmaceuticals, Inc. 40 Landsdowne Street. Cambridge, MA 02139. Revision Date 12/2009.
2. Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. Journal of Clinical Oncology 1999; 17 (4):1244.
3. Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 2004-165.
4. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999.
5. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006;63:1172-1193.
6. Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society