Parenteral Manual

Bortezomib (NON-FORMULARY or INVESTIGATIONAL)

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
VELCADE
Classification: 
Antineoplastic, proteasome inhihibitor - CYTOTOXIC
Original Date: 
March 2010
Revised Date: 
November 2015
Indications: 
  •  Treatment of multiple myeloma and relapsed or refractory mantle cell lymphoma

  • Investigational -Treatment of  relapse acute lymphocytic leukemia and acute myeloid leukemia

THIS MEDICATION IS TO BE ADMINISTERED BY A CHEMO-TRAINED NURSE. IF THE NURSE IS NOT CHEMO-TRAINED, THEY ARE TO CONTACT THE UNIT NURSE EDUCATOR OR ADVANCED PRACTICE NURSE.

Reconstitution and Stability: 
  •   Available as sterile lyophilized powder containing 3.5 mg/vial (and 35 mg of mannitol/vial). Preservative free.
  • Store vials at room temperature [15 -30C]. Protect from light.
  • Dilute with 3.5 mL of normal saline for 1 mg/mL clear and colorless solution [pH of approximately 5-6]. Store at room temperature. Stable for 8 hours in syringe or original vial exposed at normal indoor lighting.
Compatibility: 

- Solutions Compatible:  NS

 

- DO NOT mix with any other  drugs

Administration: 

(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

SC YES
IM NO
IV Direct YES: administer over 3-5 seconds; do not further dilute
IV Intermittent Infusion NO
IV Continuous Infusion NO
INTRATHECAL NO  - FATAL

 

Dosage: 

(For neonatal dosages, refer to Neonatal IV Drug Manual.)

Pediatrics:  

Use Investigational supply from NCI

·          1.3 mg/m2/dose on Days 1, 4 and 8. Doses must be separated by at least 72 hours.

Adults:  

Usual dose:  1 - 1.3 mg/m2/day days 1,4,8 and 11

 

Potential hazards of parenteral administration: 

Immediate (hours to days):

-Fever (~ 35%), rigors (~10%), rash/urticaria (~25%), pruritus (~12%)

-Hypersensitivity reactions (< 1%), hypotension, diarrhea (common), nausea, constipation,

-Anorexia, vomiting, abdominal pain, abnormal taste, dyspepsia, dizziness, headache

Other (days to weeks)

-Neutropenia, thrombocytopenia, anemia

-Peripheral neuropathy (>20%), musculoskeletal pain,
sensory neuropathy (>20%)

-Cough, dyspnea, respiratory failure (rare)

-Blurred vision, mood changes, anxiety, insomnia

-Herpes virus infections reactivation

·          Patients must meet specific criteria for hepatic and pulmonary function and neurologic status to receive each dose of Bortezomib

·          Treatment for unusual side effects is available through the study chair identified on the front page of the protocol and/or pharmacy.   

Extravasation Hazard:   Irritant

Notes: 

·          Monitor for pulmonary toxicity and neuropathies prior to each dose

·          Monitor  hepatic function

·          Multiple drug-drug, drug-food and drug-supplement interactions (including green tea and dietary vitamin C). Consult pharmacy and/or protocol appendix prior to start of new concomitant agent.

·          Avoid the following enzyme-inducing anticonvulsants: carbamazepine, felbamate, phenobarbital, phenytoin, primidone, oxcarbazepine

.          Fevers and chills may occur 2 to 6 hours after IV administration.  If this occurs, premedication with acetaminophen, H1 antihistamine, and hydrocortisone may decrease the severity of fever and chills.

References: 
  • COG Chemotherapy Administration Guidelines Volume 7 September 2015

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