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)].
- 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) and 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)].
|Cycle Day||1 through 3||4||5||6||7||8 through 24*|
|Cycle Day||1 through 7||8||9||10||11||12 through 32*|
Required Pre-treatment and Guidelines for Pain Management
- Administer 0.9% Sodium Chloride Injection, USP 10 mL/kg as an intravenous infusion over one hour just prior to initiating each Unituxin infusion.
- 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.
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), and Clinical Studies (14)].
|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|
|Reversible posterior leukoencephalopathy syndrome (RPLS)|
|Subtotal or total vision loss|
|Grade 4 hyponatremia despite appropriate fluid management|
|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.|
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 [see Warnings and Precautions (5.2)]|
|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 [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.|
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.|
Instructions for Preparation and Administration
- 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.
- 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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- Drug class: miscellaneous antineoplastics