Overview
VELCADE
®
Research and Development
Clinical Trials
Resources for Patients
MULTIPLE MYELOMA
MECHANISM
LANDMARK PHASE 3 APEX TRIAL
SURVIVAL
TREATMENT TIMING
RENAL IMPAIRMENT
LENGTH OF THERAPY
RETREATMENT
SAFETY PROFILE
-
Peripheral Neuropathy
-
Transient Thrombocytopenia
DOSE MODIFICATION GUIDELINES
HANDLING AND ADMINISTRATION
IMPORTANT SAFETY INFORMATION
REIMBURSEMENT
ADDITIONAL INFORMATION
REFERENCES
HANDLING AND ADMINISTRATION GUIDELINES
VELCADE
®
(bortezomib) for Injection: How Supplied
10-mL single-dose vials containing 3.5 mg VELCADE as a lyophilized, white to off-white cake or powder without preservative
Each single-dose vial is intended for administration to 1 patient
Unopened vials may be stored at controlled room temperature 25°C/77°F; excursions permitted from 15° to 30°C/59° to 86°F
Store in original package, protected from light
VELCADE: Reconstitution
Reconstitute with 3.5 mL of normal (0.9%) saline, sodium chloride injection, USP
–
Concentration of reconstituted solution is 1 mg/mL
–
Reconstituted VELCADE should be administered within 8 hours of preparation; this
includes
time stored in the syringe
–
Reconstituted VELCADE does not need to be protected from indoor light
VELCADE Administration Precautions
VELCADE is an antineoplastic agent; caution should be used during handling and preparation.
VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy.
Proper aseptic technique is essential.
Use of gloves and other protective clothing is important to prevent contact with skin; VELCADE should be reconstituted under a fume hood.
VELCADE Administration
Direct injection into a peripheral line
Injection into an infusion port
VELCADE is injected by 3-5 second bolus intravenous injection into a peripheral line or into an infusion port.
Normal saline flush should follow injection to ensure full dose.
Infusion reactions and infusion-site reactions are uncommon.
–
In clinical trials, local skin irritation was reported in 5% of patients; no tissue damage was associated with extravasation
Please
click here
to view additional important safety information.
For full Prescribing Information
click here
. (pdf) (74KB)
For further information about VELCADE
®
(bortezomib) for Injection, call
1-866-VELCADE
(
U.S. clinicians only
).
© 2008 Millennium Pharmaceuticals, Inc.
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