MASSACHUSETTS GENERAL HOSPITAL

Department of Pharmacy

Department of Nursing

Adult General Care

GENERIC NAME

Bortezomib

TRADE NAME

Velcade

DESIGNATED CLINICAL AREAS

All

ACTION

Inhibits proteasomes, enzyme complexes which regulate protein homeostasis within the cell resulting in activation of signaling cascades, cell-cycle arrest, and apoptosis.

INDICATIONS

• Treatment of antibody mediated rejection

ADMINISTRATION GUIDELINES

Chemotherapeutic agents administered on low volume units must be administered by a chemo-certified nurse in collaboration with the nursing staff on the low-volume unit.

Administered via IV push over 3-5 seconds followed by standard saline flush

The amount (in mg) of drug to be administered will be determined based on body surface area.

If a patient experiences a notable change in weight (e.g., loss or gain of 5%) during treatment, the patient's dose will be recalculated at that time.

USUAL DOSE

1.3 mg/m 2 via IV push over 3-5 seconds on days 1, 4, 8, and 11

STANDARD CONCENTRATION:

Each single use vial of bortezomib contains 3.5 mg of bortezomib as a sterile lyophilized

powder

Reconstitute with 3.5 mL of 0.9% Sodium Chloride

Final concentration of 1 mg/mL of bortezomib

Dissolution is completed in approximately 10 seconds.  The reconstituted solution is clear and colorless, with a final pH of 5 to 6. 

The reconstituted product should be a clear and colorless solution

Reconstituted bortezomib should be administered within 8 hours of preparation and stored at 25ºC (77ºF).

CRITICAL ELEMENTS/SPECIAL CONSIDERATIONS

Consent should be obtained prior to the first dose.

Prior to each dose patients should be evaluated for possible toxicities that may have occurred after the previous dose(s).

Bortezomib is an antineoplastic agent. Handling and disposal guidelines should be followed according to cytotoxic drugs, including use of gloves and other protective clothing to prevent skin contact.

In case of skin contact, wash the affected area immediately and thoroughly with soap and water for at least 15 minutes.  If product contacts eye, immediately flush eye thoroughly with water for at least 15 minutes

CBC should be drawn prior to administration (baseline CBC to monitor for hematologic toxicity)

PRECAUTIONS AND SIDE EFFECTS

• Contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol
• Peripheral neuropathy (predominantly sensory), numbness, pain, burning in feet and hands
• Hypotension (postural, orthostatic, hypotension) 13%
• Acute development or exacerbation of congestive heart failure
• Acute diffuse infiltrative pulmonary disease, pneumonitis, interstitial pneumonia, lung infiltration, acute respiratory distress syndrome
• Gastrointestinal (nausea, diarrhea, constipation, vomiting)
• Hematologic toxicity (thrombocytopenia or neutropenia)
• Local inflammatory reaction if venous extravasation occurs

Revision Detail