Parenteral Manual

Ganitumab (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): 
AMC479
Classification: 
Human recombinant monoclonal antibody against IGF-1R
Original Date: 
January 2016
Indications: 
  • Investigational for metastatic Ewing Sarcoma

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: 
  • Supplied as a 70 mg/mL clear and colourless liquid (210 mg/3mL).
  • The product contains no preservative and vials should be used only once.
  • Refrigerate vials (2-8C). Protect from light.
  • Gently invert bag to mix. Do NOT shake vial or solution.
  • Infusion must be completed within 8 hours from the time that the ganitumab is injected into the infusion bag.
  • Maximum time between removing ganitumab vials from the fridge and completion of infusion is 24 hours
Compatibility: 

- Solution Compatible: 0.9% NaCl only

- Incompatible:  Do not mix with other drugs or IV 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 - Flush line with 0.9% NaCl before and after administration
Usual dilution: Dilute to a final concentration of 3 - 20 mg/mL
Infusion time: Give first dose over 60 minutes; if well tolerated, subsequent doses may be given over 30 minutes. Maximum infusion time 120 minutes.
For doses greater than 2100 mg: give first dose over 120 minutes; if well tolerated, subsequent doses may be given over 60 minutes
IV Continuous Infusion NO

 

Dosage: 

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

Pediatric:

  • 18 mg/kg/dose every 2 - 3 weeks (day 1 of each cycle)
Potential hazards of parenteral administration: 
  • Common (> 20%): Infusion reaction (may include chills, fever, hypotension, dyspnea, arthralgia, joint swelling, headache, dizziness, cardiac arrhythmia); Hyperglycemia
  • Occasional (≤ 20%): Anemia, Nausea, vomiting, diarrhea, fatigue, neutropenia, thrombocytopenia, increased ALT/AST, anorexia, rash
  • Rare (< 3%): Severe allergic reaction, hearing loss

                                    For any infusion toxicities,

              refer to protocol for detailed information on management

Notes: 
  • Anaphylactic precautions at bedside
  • Vitals signs, including BP: immediately prior to infusion, q15 minutes during first hour, q 30 minutes during second hour and hourly during third hour and until completion of the infusion. Also monitor 30 and 60 minutes post infusion.
References: 

Ref: Children’s Oncology group protocol AEWS1221

Created by: J. Hilliard RPh May 2015, checked by D. Kennedy RPh December 2015

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