Parenteral Manual

Cixutumamab (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): 
IMC-A12
Classification: 
Recominant Human Monoclonal antibody
Original Date: 
February 2012
Indications: 
  •  Currently undergoing Phase 1 trials for the treatment of high-risk rhabomyosarcoma, refractory solid tumours and Ewing sarcoma in pediatrics

  • Currently undergoing Phase 2 trials for the treatment of metastatic colorectal cancer, hormone-refractory breast cancer, castration-refractory prostate cancer, cancer of the head and neck and soft tissue sarcoma

Reconstitution and Stability: 
  • Available as a 250 mg single-use vial in 5 mg/mL concentration

  • Store unopened vials in refrigerator (2° - 8ºC). Do not freeze.

  • Protect from light

  • For patients < 20 kg: solution can be administered undiluted if volume > 125 mL.  For doses with a volume < 125 mL, further dilute to 125 mL with 0.9% NaCl

  •    For patients > 20 kg: solution can be administered undiluted if volume > 250 mL. For doses with a volume < 250 mL, further dilute to 250 mL with 0.9% NaCl

  •          Do not mix lot numbers when preparing the solution for administration

  •         Stable 24 hours refrigerated or at room temperature once mixed in a minibag.

Compatibility: 
  •  Solutions compatible: Normal Saline

  • DO NOT mix with other medications    

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 - Infuse over 1 hour or at a rate not to exceed 25 mg/min
- Administer via PVC or non-PVC tubing with a 0.22 micron in-line low-protein binding filter
- Infusion sets should be flushed thoroughly with 0.9% NaCl prior to use
IV Continuous Infusion NO
Dosage: 

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

Pediatrics:

  •  Investigational use: Children’s Oncology Group protocol ARST08P1
  • 3 - 9 mg/kg IV once weekly

Adults:

  • 3 - 15 mg/kg IV once every 2 weeks to once weekly

 

 

 

 

Potential hazards of parenteral administration: 

Immediate (within a few minutes to hours):

  • Infusion-related reaction – transient flushing, rash, drug fever, urticaria, dyspnea, bronchospasm
  • Anaphylaxis
  • Fatigue
  • Nausea & vomiting, diarrhea

Delayed (within a few days or weeks):

  • Hyperglycemia (may require treatment)
  • Sensorineural hearing loss
  • Back pain
  • ·          Thrombocytopenia, lymphopenia
  • ·          Anorexia
  • ·          Arthralgia

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