Dinutuximab
Generic Name: dinutuximab
Brand Names:
Unituxin
11 DESCRIPTION Dinutuximab is a glycolipid disialoganglioside (GD2)-binding chimeric monoclonal antibody composed of murine variable heavy and light chain regions and the human constant region for the heavy chain IgG 1 and light chain kappa. Dinutuximab is produced in the murine myeloma cell line, SP2/0 and has an approximate molecular weight of 150 kDa.
Overview
11 DESCRIPTION Dinutuximab is a glycolipid disialoganglioside (GD2)-binding chimeric monoclonal antibody composed of murine variable heavy and light chain regions and the human constant region for the heavy chain IgG 1 and light chain kappa. Dinutuximab is produced in the murine myeloma cell line, SP2/0 and has an approximate molecular weight of 150 kDa.
Uses
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) ] . 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
2 DOSAGE AND ADMINISTRATION 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) ] . 17.5 mg/m 2 /day as a diluted intravenous infusion over 10 to 20 hours for 4 consecutive days for up to 5 cycles. ( 2.1 , 2.4 ) 2.1 Recommended Dose The recommended dose of Unituxin is 17.5 mg/m 2 /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) [see Dosage and Administration (2.4) and Clinical Studies (14) ] . Initiate at an infusion rate of 0.875 mg/m 2 /hour for 30 minutes.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infusion Reactions [see Boxed Warning and Warnings and Precautions (5.1) ] Neurotoxicity, including Pain, Peripheral Neuropathy, Neurological Disorders of the Eye, Prolonged Urinary Retention, Transverse Myelitis, and Reversible Posterior Leukoencephalopathy Syndrome [see Boxed Warning and Warnings and Precautions (5.2) ] Capillary Leak Syndrome [see Warnings and Precautions (5.3) ] Hypotension [see Warnings and Precautions (5.4) ] Infection [see Warnings and Precautions (5.5) ] Bone Marrow Suppression [see Warnings and Precautions (5.6) ] Electrolyte Abnormalities [see Warnings and Precautions (5.7) ] Atypical Hemolytic Uremic Syndrome [see Warnings and Precaution...
Interactions
7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted with dinutuximab.
Warnings
WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY See full prescribing information for complete boxed warning. 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) ] . 5 WARNINGS AND PRECAUTIONS Neurological Disorders of the Eye: Interrupt Unituxin for dilated pupil with sluggish light reflex or other visual disturbances and permanently discontinue Unituxin for recurrent eye disorders or loss of vision. ( 5.2 ) Prolonged Urinary Retention and Transverse Myelitis: Permanently discontinue Unituxin and institute supportive care. ( 5.2 ) Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Permanently discontinue Unituxin and institute supportive care for signs and symptoms of RPLS. ( 5.2 ) 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. 4 CONTRAINDICATIONS Unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab. History of anaphylaxis to dinutuximab. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Based on its mechanism of action, Unituxin may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no studies in pregnant women and no reproductive studies in animals to inform the drug-associated risk. Monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester. Advise pregnant women of the potential risk to a fetus.
Storage
Store Unituxin vials under refrigeration at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light until time of use. Do not freeze or shake the vial.
Frequently Asked Questions
What is Dinutuximab used for?▼
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) ] . 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 )
What are the side effects of Dinutuximab?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infusion Reactions [see Boxed Warning and Warnings and Precautions (5.1) ] Neurotoxicity, including Pain, Peripheral Neuropathy, Neurological Disorders of the Eye, Prolonged Urinary Retention, Transverse Myelitis, and Reversible Posterior Leukoencephalopathy Syndrome [see Boxed Warning and Warnings and Precautions (5.2) ] Capillary Leak Syndrome [see Warnings and Precautions (5.3) ] Hypotension [see Warnings and Precautions (5.4) ] Infection [see Warnings and Precautions (5.5) ] Bone Marrow Suppression [see Warnings and Precautions (5.6) ] Electrolyte Abnormalities [see Warnings and Precautions (5.7) ] Atypical Hemolytic Uremic Syndrome [see Warnings and Precaution...
Can I take Dinutuximab during pregnancy?▼
8.1 Pregnancy Risk Summary Based on its mechanism of action, Unituxin may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no studies in pregnant women and no reproductive studies in animals to inform the drug-associated risk. Monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester. Advise pregnant women of the potential risk to a fetus.
What are the important warnings for Dinutuximab?▼
WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY See full prescribing information for complete boxed warning. 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) ] . 5 WARNINGS AND PRECAUTIONS Neurological Disorders of the Eye: Interrupt Unituxin for dilated pupil with sluggish light reflex or other visual disturbances and permanently discontinue Unituxin for recurrent eye disorders or loss of vision. ( 5.2 ) Prolonged Urinary Retention and Transverse Myelitis: Permanently discontinue Unituxin and institute supportive care. ( 5.2 ) Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Permanently discontinue Unituxin and institute supportive care for signs and symptoms of RPLS. ( 5.2 ) 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. 4 CONTRAINDICATIONS Unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab. History of anaphylaxis to dinutuximab. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.