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Unituxin Dosage

Generic name: DINUTUXIMAB 3.5mg in 1mL
Dosage form: injection

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  • Verify that patients have adequate hematologic, respiratory, hepatic, and renal function prior to initiating each course of Unituxin [see Clinical Studies (14)].
  • Administer required premedication and hydration prior to initiation of each Unituxin infusion [see Dosage and Administration (2.2)].

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 (Tables 1 and 2 ) [see Dosage and Administration (2.4), Clinical Studies (14)].
  • 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 [see Dosage and Administration (2.3)].
Table 1: Schedule of Unituxin Administration for Cycles 1, 3, and 5
Cycle Day 1 through 3 4 5 6 7 8 through 24*
*
Cycles 1, 3, and 5 are 24 days in duration.
Unituxin X X X X
Table 2: Schedule of Unituxin Administration for Cycles 2 and 4
Cycle Day 1 through 7 8 9 10 11 12 through 32*
*
Cycles 2 and 4 are 32 days in duration.
Unituxin X X X X

Required Pre-treatment and Guidelines for Pain Management

Intravenous Hydration

  • Administer 0.9% Sodium Chloride Injection, USP 10 mL/kg as an intravenous infusion over one 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 two 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) [see Warnings and Precautions (5), Adverse Reactions (6), Clinical Studies (14)].

Table 3: Adverse Reactions Requiring Permanent Discontinuation of Unituxin
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 peripheral motor neuropathy
Subtotal or total vision loss
Grade 4 hyponatremia despite appropriate fluid management
Table 4: Dose Modification for Selected Unituxin Adverse Reactions
*
Symptomatic hypotension, systolic blood pressure (SBP) less than lower limit of normal for age, or SBP decreased by more than 15% compared to baseline.
Infusion-related reactions [see Warnings and Precautions (5.1)]
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, 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.
Capillary leak syndrome [see Warnings and Precautions (5.3)]
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 [see Warnings and Precautions (5.4)]
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 [see Warnings and Precautions (5.5)]
Onset of reaction: Discontinue Unituxin until resolution of infection, and then proceed with subsequent cycles of therapy.
Neurological Disorders of the Eye [see Warnings and Precautions (5.6)]
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.

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-use vial if the solution is cloudy, has pronounced discoloration, or contains particulate matter.
  • Aseptically withdraw the required volume of Unituxin from the single-use 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.

Administration

  • Administer Unituxin as a diluted intravenous infusion only [see Dosage and Administration (2.1)]. Do not administer Unituxin as an intravenous push or bolus.
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