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UNITUXIN(dinutuximab) injection, for intravenous
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use UNITUXIN safely and effectively. See Full Prescribing Information for UNITUXIN.
UNITUXIN™ (dinutuximab) injection, for intravenous use
Initial U.S. Approval: 2015
WARNING: SERIOUS INFUSION REACTIONS AND NEUROPATHY
See full prescribing information for complete boxed warning.
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Infusion Reactions: Life-threatening infusion adverse reactions occur with Unituxin. Administer required prehydration and premedication. Immediately interrupt for severe infusion reactions and permanently discontinue for anaphylaxis [see Dosage and Administration (2.2, 2.3) and Warnings and Precautions (5.1)].
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Neuropathy: Unituxin causes severe neuropathic pain. Administer intravenous opioid prior to, during, and for 2 hours following completion of the Unituxin infusion. Severe peripheral sensory neuropathy ranged from 2% to 9% in patients with neuroblastoma. Severe motor neuropathy was observed in adults. Discontinue for severe unresponsive pain, severe sensory neuropathy, or moderate to severe peripheral motor neuropathy [see Dosage and Administration (2.2, 2.3) and Warnings and Precautions (5.2)].
INDICATIONS AND USAGE
Unituxin is a GD2-binding monoclonal antibody indicated, 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. (1)
DOSAGE AND ADMINISTRATION
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17.5 mg/m2/day as a diluted intravenous infusion over 10 to 20 hours for 4 consecutive days for up to 5 cycles. (2.1, 2.4)
DOSAGE FORMS AND STRENGTHS
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Injection: 17.5 mg/5 mL (3.5 mg/mL) in a single-use vial. (3)
CONTRAINDICATIONS
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History of anaphylaxis to dinutuximab. (4)
WARNINGS AND PRECAUTIONS
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Capillary leak syndrome and hypotension: Administer required prehydration and monitor patients closely during treatment. Depending upon severity, manage by interruption, infusion rate reduction, or permanent discontinuation. (5.3, 5.4)
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Infection: Interrupt until resolution of systemic infection. (5.5)
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Neurological Disorders of the Eye: Interrupt for dilated pupil with sluggish light reflex or other visual disturbances and permanently discontinue for recurrent eye disorders or loss of vision. (5.6)
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Bone marrow suppression: Monitor peripheral blood counts during Unituxin therapy. (5.7)
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Electrolyte abnormalities: Monitor serum electrolytes closely. (5.8)
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Atypical hemolytic uremic syndrome: Permanently discontinue Unituxin and institute supportive management. (5.9)
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Embryo-Fetal toxicity: May cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception. (5.10, 8.1, 8.3)
ADVERSE REACTIONS
The most common adverse drug reactions (≥ 25%) are pain, pyrexia, thrombocytopenia, lymphopenia, infusion reactions, hypotension, hyponatremia, increased alanine aminotransferase, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia, urticaria, hypoalbuminemia, increased aspartate aminotransferase, and hypocalcemia. (5, 6.1)
The most common serious adverse reactions (≥ 5%) are infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome. (5, 6.1)
To report SUSPECTED ADVERSE REACTIONS, contact United Therapeutics Corp. at 1-866-458-6479 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 3/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
Unituxin (dinutuximab) is indicated, 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 [see Clinical Studies (14)].
2 DOSAGE AND ADMINISTRATION
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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)].
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Administer required premedication and hydration prior to initiation of each Unituxin infusion [see Dosage and Administration (2.2)].
2.1 Recommended Dose
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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)].
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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)].
2.2 Required Pre-treatment and Guidelines for Pain Management
Intravenous Hydration
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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
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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.
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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
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