Millennium | Clinicians | Oncology | VELCADE | Handling and Administration

	MANTLE CELL LYMPHOMA



	MECHANISM
	DISEASE BACKGROUND
	PINNACLE TRIAL DESIGN AND RESULTS
	SAFETY PROFILE
	DOSING SCHEDULE
	DOSE MODIFICATION GUIDLINES
	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

Recommended Preadministration Procedures to Be Performed with Each Cycle of VELCADE Treatment.

Procedure/Test

Day 1

Day 4

Day 8

Day 11

Assess for symptom management
(e.g., diarrhea, vomiting, fever)

•

Monitor for symptoms of peripheral neuropathy such as burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, or pain

•

Monitor vital signs (blood pressure, respiration rate, temperature, pulse)

•

Conduct clinical laboratory tests

Hematology
(CBC, including platelet count)

•

Clinical chemistries

•

Calculate body surface area (recalculate dose if weight change 8% or greater)

•

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).