Unituxin Dosage
Generic name: DINUTUXIMAB 3.5mg in 1mL
Dosage form: injection
Drug class: Miscellaneous antineoplastics
Medically reviewed by Drugs.com. Last updated on Dec 13, 2024.
- Verify that patients have adequate hematologic, respiratory, hepatic, and renal function prior to initiating each course of Unituxin.
- Administer required premedication and hydration prior to initiation of each Unituxin infusion.
Recommended Dose
- The recommended dose of Unituxin is 17.5 mg/m2/day administered as an intravenous infusion over 10 to 20 hours for 4 consecutive days for a maximum of 5 cycles (Table 1 and Table 2).
- Initiate at an infusion rate of 0.875 mg/m2/hour for 30 minutes. The infusion rate can be gradually increased as tolerated to a maximum rate of 1.75 mg/m2/hour. Follow dose modification instructions for adverse reactions.
Cycle Day | 1 through 3 | 4 | 5 | 6 | 7 | 8 through 24* |
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Unituxin | X | X | X | X |
Cycle Day | 1 through 7 | 8 | 9 | 10 | 11 | 12 through 32* |
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Unituxin | X | X | X | X |
Required Pre-treatment Guidelines
Intravenous Hydration
- Administer 0.9% Sodium Chloride Injection, USP 10 mL/kg as an intravenous infusion over 1 hour just prior to initiating each Unituxin infusion.
Analgesics
- Administer morphine sulfate (50 mcg/kg) intravenously immediately prior to initiation of Unituxin and then continue as a morphine sulfate drip at an infusion rate of 20 to 50 mcg/kg/hour during and for 2 hours following completion of Unituxin.
- Administer additional 25 mcg/kg to 50 mcg/kg intravenous doses of morphine sulfate as needed for pain up to once every 2 hours followed by an increase in the morphine sulfate infusion rate in clinically stable patients.
- Consider using fentanyl or hydromorphone if morphine sulfate is not tolerated.
- If pain is inadequately managed with opioids, consider use of gabapentin or lidocaine in conjunction with intravenous morphine.
Antihistamines and Antipyretics
- Administer an antihistamine such as diphenhydramine (0.5 to 1 mg/kg; maximum dose 50 mg) intravenously over 10 to 15 minutes starting 20 minutes prior to initiation of Unituxin and as tolerated every 4 to 6 hours during the Unituxin infusion.
- Administer acetaminophen (10 to 15 mg/kg; maximum dose 650 mg) 20 minutes prior to each Unituxin 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.
Dosage Modifications
Manage adverse reactions by infusion interruption, infusion rate reduction, dose reduction, or permanent discontinuation of Unituxin (Table 3 and Table 4).
Grade 3 or 4 anaphylaxis |
Grade 3 or 4 serum sickness |
Grade 3 pain unresponsive to maximum supportive measures |
Grade 4 sensory neuropathy or Grade 3 sensory neuropathy that interferes with daily activities for more than 2 weeks |
Grade 2 or greater peripheral motor neuropathy |
Urinary retention that persists following discontinuation of opioids |
Transverse myelitis |
Reversible posterior leukoencephalopathy syndrome (RPLS) |
Subtotal or total vision loss |
Grade 4 hyponatremia despite appropriate fluid management |
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Infusion-related reactions | |
Mild to moderate adverse reactions, such as transient rash, fever, rigors, and localized urticaria, that respond promptly to symptomatic treatment | |
Onset of reaction: | Reduce Unituxin infusion rate to 50% of the previous rate and monitor closely. |
After resolution: | Gradually increase infusion rate up to a maximum rate of 1.75 mg/m2/hour. |
Prolonged or severe adverse reactions, such as mild bronchospasm without other symptoms, or angioedema that does not affect the airway | |
Onset of reaction: | Immediately interrupt Unituxin. |
After resolution: | If signs and symptoms resolve rapidly, resume Unituxin at 50% of the previous rate and observe closely. |
First recurrence: |
Discontinue Unituxin until the following day. If symptoms resolve and continued treatment is warranted, premedicate with hydrocortisone 1 mg/kg (maximum dose 50 mg) intravenously and administer Unituxin at a rate of 0.875 mg/m2/hour in an intensive care unit. |
Second recurrence: | Permanently discontinue Unituxin. |
Neurological disorders of the eye | |
Onset of reaction: | Discontinue Unituxin infusion until resolution. |
After resolution: | Reduce the Unituxin dose by 50%. |
First recurrence or if accompanied by visual impairment: | Permanently discontinue Unituxin. |
Capillary leak syndrome | |
Moderate to severe but not life-threatening capillary leak syndrome | |
Onset of reaction: | Immediately interrupt Unituxin. |
After resolution: | Resume Unituxin infusion at 50% of the previous rate. |
Life-threatening capillary leak syndrome | |
Onset of reaction: | Discontinue Unituxin for the current cycle. |
After resolution: | In subsequent cycles, administer Unituxin at 50% of the previous rate. |
First recurrence: | Permanently discontinue Unituxin. |
Hypotension* requiring medical intervention | |
Onset of reaction: | Interrupt Unituxin infusion. |
After resolution: |
Resume Unituxin infusion at 50% of the previous rate. If blood pressure remains stable for at least 2 hours, increase the infusion rate as tolerated up to a maximum rate of 1.75 mg/m2/hour. |
Severe systemic infection or sepsis | |
Onset of reaction: | Discontinue Unituxin until resolution of infection, and then proceed with subsequent cycles of therapy. |
Instructions for Preparation and Administration
Preparation
- Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light by storing in the outer carton. DO NOT FREEZE OR SHAKE vials.
- Inspect visually for particulate matter and discoloration prior to administration. Do not administer Unituxin and discard the single-dose vial if the solution is cloudy, has pronounced discoloration, or contains particulate matter.
- Aseptically withdraw the required volume of Unituxin from the single-dose vial and inject into a 100-mL bag of 0.9% Sodium Chloride Injection, USP. Mix by gentle inversion. Do not shake. Discard unused contents of the vial.
- Store the diluted Unituxin solution under refrigeration (2°C to 8°C). Initiate infusion within 4 hours of preparation.
- Discard diluted Unituxin solution 24 hours after preparation.
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