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Dinutuximab Dosage

Applies to the following strength(s): 17.5 mg/5 mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Pediatric Dose for:

Additional dosage information:

Usual Pediatric Dose for Neuroblastoma

17.5 mg/m2/day IV over 10 to 20 hours for 4 consecutive days for a maximum of 5 cycles (in combination with GM-CSF [sargramostim], IL-2 [aldesleukin] and 13-cis-retinoic acid [isotretinoin]):
-Infuse on days 4, 5, 6, and 7 during cycles 1, 3, and 5 (cycles 1, 3, and 5 are 24 days in duration)
-Infuse on days 8, 9, 10, and 11 during cycles 2 and 4 (cycles 2 and 4 are 32 days in duration)

Comments:
REQUIRED PRE-TREATMENT AND GUIDELINES FOR PAIN MANAGEMENT IV HYDRATION:
1) Hydration:
-Administer 0.9% sodium chloride 10 mL/kg IV over one hour just prior to initiating each infusion.
2) Analgesics:
-Administer morphine 50 mcg/kg IV immediately prior to infusion and then continue as a morphine drip at an infusion rate of 20 to 50 mcg/kg/hour during and for two hours following completion of therapy.
-Administer additional 25 mcg/kg to 50 mcg/kg IV doses of morphine as needed for pain up to once every 2 hours followed by an increase in the morphine infusion rate in stable patients.
-Consider using fentanyl or hydromorphone if morphine is not tolerated.
-If pain is inadequately managed with opioids, consider use of gabapentin or lidocaine in conjunction with IV morphine.
3) Antihistamines and Antipyretics:
-Administer an antihistamine such as diphenhydramine (0.5 to 1 mg/kg; maximum dose 50 mg) IV over 10 to 15 minutes starting 20 minutes prior to initiation of therapy and as tolerated every 4 to 6 hours during therapy.
-Administer acetaminophen (10 to 15 mg/kg; maximum dose 650 mg) 20 minutes prior to each infusion and every 4 to 6 hours as needed for fever or pain. -Administer ibuprofen (5 to 10 mg/kg) every 6 hours as needed for control of persistent fever or pain.

Use: In combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Anaphylaxis, grade 3 or 4:
-Permanently discontinue therapy.

Capillary leak syndrome:
-Moderate to severe, but not life-threatening: Immediately interrupt infusion; upon resolution, resume infusion at 50% of the previous rate.
-Life-threatening: Discontinue infusion for the current cycle; in subsequent cycles, infuse at 50% of the previous rate. If life-threatening capillary leak syndrome recurs, permanently discontinue therapy.

Hemolytic uremic syndrome:
-Permanently discontinue therapy and administer supportive management.

Hyponatremia, grade 4 (despite appropriate fluid management):
-Permanently discontinue therapy.

Hypotension (symptomatic hypotension, systolic blood pressure (SBP) less than lower limit of normal for age, or SBP decreased by more than 15% compared to baseline):
-Interrupt infusion; upon resolution, resume infusion at 50% of the previous rate. If blood pressure remains stable for 2 hours or more, increase infusion rate as tolerated up to a maximum rate of 1.75 mg/m2/hour.

Infection (systemic)/sepsis, severe:
-Discontinue therapy until infection resolves; may resume therapy with subsequent cycles.

Infusion-related reaction:
-Mild to moderate reaction (e.g., transient rash, fever, rigors, and localized urticaria that respond promptly to symptomatic treatment): Reduce infusion rate by 50%; monitor closely. Upon resolution, gradually increase infusion rate up to a maximum of 1.75 mg/m2/hour.
-Severe or prolonged reaction (e.g., mild bronchospasm without other symptoms, angioedema that does not affect the airway): Immediately interrupt infusion; if symptoms resolve rapidly, resume infusion at 50% of the previous rate and monitor closely. If reaction recurs, discontinue therapy until the following day. If symptoms resolve and further treatment is warranted, premedicate with IV hydrocortisone 1 mg/kg (maximum 50 mg) and infuse at a rate of 0.875 mg/m2/hour in an intensive care unit. If reaction recurs again, permanently discontinue therapy.
-Life-threatening reaction: Permanently discontinue therapy and administer supportive management.

Neuropathy:
-Grade 4 sensory neuropathy or grade 3 sensory neuropathy that interferes with daily activities for more than 2 weeks: Permanently discontinue therapy.
-Grade 2 peripheral motor neuropathy: Permanently discontinue therapy.

Ocular neurological disorders (e.g., blurred vision, photophobia, mydriasis, fixed or unequal pupils, optic nerve disorder, eyelid ptosis, and/or papilledema):
-Discontinue infusion until symptom resolution; upon resolution, reduce dose by 50%. If reaction recurs, or if reaction is accompanied by visual impairment (e.g., subtotal or total vision loss), permanently discontinue therapy.

Pain, severe (grade 3):
-Decrease the infusion rate to 0.875 mg/m2/hour. If pain is not adequately controlled despite rate reduction and use of maximum supportive measures, permanently discontinue therapy.

Serum sickness, grade 3 or 4:
-Permanently discontinue therapy.

Precautions

US BLACK BOX WARNINGS:
-Infusion Reactions: Serious and potentially life-threatening infusion reactions occurred in 26% of patients treated with this drug. The required prehydration and premedication including antihistamines should be administered prior to each infusion. Patients should be monitored closely for signs of an infusion reaction during and for at least four hours following completion of each infusion. The infusion should be interrupted immediately for severe infusion reactions and permanently discontinued for anaphylaxis.
Neuropathy
-Neuropathic pain: This drug causes severe neuropathic pain in the majority of patients. The IV opioid should be administered prior to, during, and for 2 hours following completion of the infusion. In studies of patients with high-risk neuroblastoma, Grade 3 peripheral sensory neuropathy occurred in 2% to 9% of patients. In studies of this drug and related GD2-binding antibodies, severe motor neuropathy was observed in adults. Resolution of motor neuropathy was not documented in all cases. Discontinue therapy for severe unresponsive pain, severe sensory neuropathy, or moderate to severe peripheral motor neuropathy.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Verify that patients have adequate hematologic, respiratory, hepatic, and renal function prior to initiating each course of therapy.
-Administer required premedication and hydration prior to initiation of each course of therapy.

Storage requirements:
-Store vials under refrigeration at 2°C to 8°C until time of use. Do not freeze.
-Do not shake the vial.
-Keep the vial in the outer carton in order to protect from light.

Reconstitution/preparation/techniques:
-Refer to manufacturer product information.

Patient advice:
Patients and caregivers should be informed of these risks:
-The risk of serious infusion reactions and anaphylaxis and to immediately report any signs, such as facial or lip swelling, urticaria, difficulty breathing, lightheadedness, or dizziness that occur during or within 24 hours following the infusion.
-The risk of severe pain and peripheral sensory and motor neuropathy and to promptly report severe or worsening pain and signs of neuropathy such as numbness, tingling, burning, or weakness.
-The risk of capillary leak syndrome and to immediately report any signs or symptoms.
-The risk of hypotension during the infusion and to immediately report any signs or symptoms.
-The risk of infection following treatment and to immediately report any signs or symptoms.
-The risk of neurological disorders of the eye and to promptly report signs or symptoms such as blurred vision, photophobia, ptosis, diplopia, or unequal pupil size.
-The risk of bone marrow suppression, and to promptly report signs or symptoms of anemia, thrombocytopenia, or infection.
-The risk of electrolyte abnormalities including hypokalemia, hyponatremia, and hypocalcemia, and to report any signs or symptoms such as seizures, heart palpitations, and muscle cramping.
-The risk of hemolytic uremic syndrome and to report any signs or symptoms such as fatigue, dizziness, fainting, pallor, edema, decreased urine output, or hematuria.
-The potential risk to the fetus if administered during pregnancy (for women of reproductive potential) and the need for use of effective contraception during and for at least two months after completing therapy.

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