Parenteral Manual

Dinutuximab (SPECIAL ACCESS PROGRAM)

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): 
CHIMERIC 14.18 MONOCLONAL ANTIBODY, UNITUXIN
Classification: 
Monoclonal antibody
Original Date: 
August 2005
Revised Date: 
October 2015
Indications: 
  • Adjunctive immunotherapy for high-risk neuroblastoma
  • Investigational for relapsed, refractory or progressive neuroblastoma (COG protocol ANBL 1221)

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 a 3.5 mg/mL solution in 5 mL vials (17.5 mg) . Single dose vials. Refrigerate (2 - 8 C). Protect from light
  • Stability studies of intact vials are ongoing - verify retest date of investigational product for ANBL 1221
  • Solutions diluted in NS stable up to 24 hours at room temperature at concentrations between 0.044 mg/mL and 0.56 mg/mL
  • Mix by gentle inversion; do not shake
Compatibility: 

- Solutions Compatible: NS ONLY

- No other compatibility known.  Run in dedicated line.

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: 0.25 -0.5 mg/mL
Infusion rate: should not exceed 1.75 mg/m2/hr

Infusion time: Infusion is given over  approximately 10 hours (i.e. 0.88 - 1.75  mg/m2/hr).  Infusion may be extended  to a maximum of 20 hours for anticipated toxicities (pain, fever, tachycardia, tachypnea, hypotension) not responding to other supportive measures.

IV Continuous Infusion NO

 

 

Dosage: 

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

  • High-risk neuroblastoma: 17.5 mg/m2/day for 4 days every 4 weeks x 5 courses
  • For COG protocol ANBL 1221: 17.5 mg/m2/day for 4 days every 3 weeks, maximum 17 cycles

** Dosage may differ according to protocol

Potential hazards of parenteral administration: 

Common: pain, dysesthesia, mild fluctuation in blood pressure, tachycardia, urticaria, fever, nausea and vomiting, mild hyponatremia/hypokalemia, thrombocytopenia, increased ALT

Occasional: moderate hypo/hypertension, emesis, diarrhea, serum sickness, moderate hyponatremia/hypokalemia, somnolence, hypoalbuminemia, elevated creatinine, capillary leak syndrome, increased AST, maculopapular rash, anorexia, disseminated intravascular coagulation, peripheral sensory neuropathy, motor neuropathy

Rare: severe hypo/hypertension, bronchospasm, anaphylaxis, impaired accommodation of the eye, papilledema, acute urinary retention

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

Notes: 
  • Premedication with acetaminophen and diphenhydramine (Benadryl) will be given before MAB Ch. 14.18
  • Low dose morphine infusion will be given during infusion of MAB Ch. 14.18 and weaned off 2 hours following the completion of the infusion.
  • Additional supportive care measures include gabapentin (for pain) and meperidine  (for rigors)
  • Anaphylactic precautions (monitoring) must be followed as outlined in pre-printed orders and medication available at bedside
  • DO NOT administer steroids for any reason other than management of life-threatening toxicity.  Steroids interfere with anti-tumor activity of  dinutuximab.  DO NOT use steroids as antiemetics

The information contained on this website is provided for informational purposes only, as a guide to assist physicians, nurses and other healthcare providers in deciding on the appropriate care required for a particular patient. At all times, physicians, nurses and other healthcare providers must exercise their independent clinical judgment, based on their knowledge, training and experience, taking into account the specific facts and circumstances of each patient, when deciding on the appropriate course of investigation and/or treatment to recommend in a particular clinical situation.

CHEO has made every effort to ensure that the information contained on this website is as current and accurate as possible. However, changes can occur due to ongoing research and the constant influx of new information. Where possible, hospitals and healthcare practitioners should verify the information before acting on it.

Reliance on any information in this website is at the user's own risk. CHEO is not responsible or liable for any harm, loss or other consequences from the use or misuse of the information on this website.