Parenteral Manual

Gemtuzumab Ozogamicin (NON FORMULARY)

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): 
MYLOTARG®
Classification: 
Monoclonal antibody - CYTOTOXIC
Original Date: 
August 2005
Revised Date: 
March 2023
Indications: 
  • Treatment of relapsed CD33 positive Acute Myeloid Leukemia (AML) who are not candidates for other chemotherapy
  • Treatment of newly diagnosed Acute Myeloid Leukemia (AML) (protocol specific)
Reconstitution and Stability: 
  • Available as 4.5 mg single use vial of lyophilized powder.  White to off-white. 
  • Refrigerate vials. Protect from light.
  • Bring vials to room temperature (approximately 5 minutes) and reconstitute with 5 mL sterile water for injection to make a 1 mg/mL solution; gently swirl to mix. Do not shake
  • Reconstituted solution may contain small to off-white, opaque to translucent, and amorphous to fiber-like particles.
  • Dilute only with 0.9% Sodium Chloride
  • Should be infused immediately following dilution.  If not used immediately, it may be stored up to 6 hours at room temperature or up to 18 hours refrigerated, including the preparation and infusion time. 
  • Protect from light. The infusion line does not need to be protected from light.
  • Do not shake diluted solution.
Compatibility: 

- Solutions Compatible: 0.9% Sodium Chloride

- No other compatibility information available - DO NOT run with dextrose-containing solutions

Administration: 

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

SC NO
IM

NO
IV Direct

NO
IV Intermittent Infusion YES
Usual dilution: in 0.9% Sodium Chloride, IV bag or syringe

Doses must be mixed to a final concentration between 0.075 - 0.234 mg/mL:

  • Doses less than 3.9 mg: syringe
  • Doses greater than or equal to 3.9 mg: IV bag

Infusion time: 2 hours via dedicated line; central or peripheral line
IV bag:  use an in-line, low protein binding 0.2 micron polyethersulfone (PES) filter
Syringe: use micro-bore tubing with an in-line, low protein-binding 0.2 micron polyethersulfone (PES) filter
IV Continuous Infusion NO
Dosage: 

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

Pediatric: 

  • 2-3 mg/m2 IV over 2 hours every 2-4 weeks

** Dosage may differ according to protocol

Potential hazards of parenteral administration: 
  • Anaphylaxis (rare) - monitor vital signs every 15 minutes x 4, then Q1H until 4 hours post-infusion
  • Fever, chills, headache (common) - pre-medicate with diphenhydramine and acetaminophen 30 minutes pre-infusion and Q4H x 2 post-infusion
  • Hypotension or hypertension, tachycardia
  • Nausea, vomiting, abdominal pain, mucositis, stomatitis
  • Hyperglycemia (rare), hypokalemia
  • Hypoxia, dyspnea (rare), wheezing
  • Tumour lysis syndrome - prehydration ± allopurinol (in children with high white counts >30 x 109/L)
  • Severe myelosuppression can occur - neutropenia and thrombocytopenia occur in most patients

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

Notes: 
  • Anaphylaxis kit should be available at bedside
  • Liver failure, hepatotoxicity, including veno-occlusive disease have been reported - monitor liver function (bilirubin, ALT, AST), watch for abdominal pain, ascites, weight gain
  • Acute Respiratory Distress Syndrome (rare) - hypoxemia, pulmonary infiltrates, non-cardiogenic pulmonary edema
References: 

Mylotarg Product Monograph: Pfizer Canada ULC. Version: Nov 28, 2019. Accessed: 8July2020

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