- 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.
- 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
- Solutions Compatible: NS ONLY
- No other compatibility known. Run in dedicated line.
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
|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|
(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
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
- 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