Brand Name
Unituxin
Generic Name
Dinutuximab
View Brand Information FDA approval date: March 10, 2015
Classification: Glycolipid Disialoganglioside-directed Antibody
Form: Injection
What is Unituxin (Dinutuximab)?
Unituxin is indicated, in combination with granulocyte-macrophage colony-stimulating factor , interleukin-2 , and 13-cis-retinoic acid , for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor , interleukin-2 , and 13-cis-retinoic acid , for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.
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Brand Information
Unituxin (DINUTUXIMAB)
1INDICATIONS 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
2DOSAGE AND ADMINISTRATION
- 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
2.1Recommended Dose
- The recommended dose of Unituxin is 17.5 mg/m
- Initiate at an infusion rate of 0.875 mg/m
2.2Dosage Modifications
Manage adverse reactions by infusion interruption, infusion rate reduction, dose reduction, or permanent discontinuation of Unituxin (Table 3 and Table 4)
3DOSAGE FORMS AND STRENGTHS
Injection: 17.5 mg/5 mL (3.5 mg/mL) as a clear and colorless to slightly opalescent solution in a single-dose vial.
4CONTRAINDICATIONS
Unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab.
5ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Serious Infusion Reactions
- Neurotoxicity, including Pain, Peripheral Neuropathy, Neurological Disorders of the Eye, Prolonged Urinary Retention, Transverse Myelitis, and Reversible Posterior Leukoencephalopathy Syndrome
- Capillary Leak Syndrome
- Hypotension
- Infection
- Bone Marrow Suppression
- Electrolyte Abnormalities
- Atypical Hemolytic Uremic Syndrome
- Embryo-Fetal Toxicity
5.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in clinical practice.
The data described below reflect exposure to Unituxin at the recommended dose and schedule in 1021 patients with high-risk neuroblastoma enrolled in an open-label, randomized (Study 1), or single-arm clinical trials (Study 2 and Study 3). Prior to enrollment, patients received therapy consisting of induction combination chemotherapy, maximum feasible surgical resection, myeloablative consolidation chemotherapy followed by autologous stem cell transplant, and radiation therapy to residual soft tissue disease. Patients received Unituxin in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA). Treatment commenced within 95 days post autologous stem cell transplant in Study 1, within 210 days of autologous stem cell transplant in Study 2, and within 110 days of autologous stem cell transplant in Study 3.
5.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Unituxin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Neurotoxicity: prolonged urinary retention, transverse myelitis, and reversible posterior leukoencephalopathy syndrome (RPLS)
6DRUG INTERACTIONS
No drug-drug interaction studies have been conducted with dinutuximab.
7DESCRIPTION
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
Unituxin (dinutuximab) injection is a sterile, preservative-free, clear and colorless to slightly opalescent solution for intravenous infusion. Unituxin is supplied in single-dose vials of 17.5 mg/5 mL. Each mL of solution contains 3.5 mg of dinutuximab, and histidine (3.10 mg), polysorbate 20 (0.55 mg), sodium chloride (8.77 mg), and Water for Injection, USP; hydrochloric acid is added to adjust pH to 6.8.
8CLINICAL STUDIES
The safety and effectiveness of Unituxin was evaluated in a randomized, open-label, multicenter trial conducted in pediatric patients with high-risk neuroblastoma (Study 1). All patients had received prior therapy consisting of induction combination chemotherapy, maximum feasible surgical resection, myeloablative consolidation chemotherapy followed by autologous stem cell transplant, and radiation therapy to residual soft tissue disease. Patients were randomized between Day 50 and Day 77 post-autologous stem cell transplantation.
Patients were required to have achieved at least a partial response prior to autologous stem cell transplantation, have no evidence of disease progression following completion of front-line multi-modality therapy, have adequate pulmonary function (no dyspnea at rest and peripheral arterial oxygen saturation of at least 94% on room air), adequate hepatic function (total bilirubin <1.5× the upper limit of normal and ALT <5× the upper limit of normal), adequate cardiac function (shortening fraction of >30% by echocardiogram, or if shortening fraction abnormal, ejection fraction of 55% by gated radionuclide study), and adequate renal function (glomerular filtration rate at least 70 mL/min/1.73 m
Patients randomized to the Unituxin/RA arm received up to 5 cycles of Unituxin (clinical trials material) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) (Table 8) or interleukin-2 (IL-2) (Table 9) plus 13-cis-retinoic acid (RA), followed by 1 cycle of RA alone. Patients randomized to the RA arm received 6 cycles of RA. Unituxin was administered at a dose of 17.5 mg/m
A total of 226 patients were randomized, 113 patients to each arm. In general, demographic and baseline tumor characteristics were similar across study arms. Across the study population, 60% were male, the median age was 3.8 years and 3% of patients were less than 1.5 years, 82% were White and 7% were Black. The majority (80%) of patients had International Neuroblastoma Staging System Stage 4 disease. Thirty-five percent of patients had a complete response, 43% had a very good partial response, and 23% had a partial response to therapy received prior to autologous stem cell transplant. Forty-six percent of patients had neuroblastoma that was not MYCN-amplified, 36% had tumors with known MYCN-amplification, and MYCN status was unknown or missing in 19% of patients. Forty-three percent of patients had hyperdiploid tumors, 36% had diploid tumors, and DNA ploidy status was unknown or missing in 21% of patients.
The major efficacy outcome measure was investigator-assessed event-free survival (EFS), defined as the time from randomization to the first occurrence of relapse, progressive disease, secondary malignancy, or death. Overall survival (OS) was also evaluated. After observing a numerical improvement in EFS based on the seventh interim analysis, the Data Monitoring Committee recommended termination of accrual. Efficacy results are shown in Table 10.
The Kaplan-Meier curve of EFS is shown in Figure 1.
Figure 1: Kaplan-Meier Curve of Event-Free Survival
9HOW SUPPLIED/STORAGE AND HANDLING
Unituxin (dinutuximab) injection as a clear and colorless to slightly opalescent solution is supplied in a carton containing one 17.5 mg/5 mL (3.5 mg/mL) single-dose vial.
NDC 66302-014-01
10PATIENT COUNSELING INFORMATION
- Serious Infusion Reactions
Inform patients and caregivers of the risk of serious infusion reactions and anaphylaxis and to immediately report any signs or symptoms, such as facial or lip swelling, urticaria, difficulty breathing, lightheadedness, or dizziness that occur during or within 24 hours following the infusion [see . - Pain, Peripheral Neuropathy, Prolonged Urinary Retention, and Transverse Myelitis
Inform patients and caregivers of the risk of severe pain, sensory and motor neuropathy, prolonged urinary retention, and transverse myelitis, and to promptly report severe or worsening pain and signs and symptoms, such as numbness, tingling, burning, weakness, or inability to urinate [see . - Neurological Disorders of the Eye
Inform patients and caregivers of the risk of neurological disorders of the eye and to promptly report signs or symptoms, such as blurred vision, photophobia, ptosis, diplopia, or unequal pupil size [see . - Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
Inform patients and caregivers of the risk of RPLS and to immediately report signs or symptoms, such as severe headache, hypertension, visual changes, lethargy, or seizures [see . - Capillary Leak Syndrome
Inform patients and caregivers of the risk of capillary leak syndrome and to immediately report any signs or symptoms [see . - Hypotension
Inform patients and caregivers of the risk of hypotension during the infusion and to immediately report any signs or symptoms [see . - Infection
Inform patients and caregivers of the risk of infection following treatment and to immediately report any signs or symptoms [see . - Bone Marrow Suppression
Inform patients and caregivers of the risk of bone marrow suppression, and to promptly report signs or symptoms of anemia, thrombocytopenia, or infection [see . - Electrolyte Abnormalities
Inform patients and caregivers of the risk of electrolyte abnormalities, including hypokalemia, hyponatremia, and hypocalcemia, and to report any signs or symptoms, such as seizures, heart palpitations, and muscle cramping [see . - Atypical Hemolytic Uremic Syndrome
Inform patients and caregivers of the risk of hemolytic uremic syndrome and to report any signs or symptoms, such as fatigue, dizziness, fainting, pallor, edema, decreased urine output, or hematuria [see . - Embryo-Fetal Toxicity
Advise women of reproductive potential of the potential risk to the fetus if administered during pregnancy and the need for use of effective contraception during and for at least 2 months after completing therapy [see .
11PRINCIPAL DISPLAY PANEL - 5 mL Vial Box
NDC 66302-014-01
Unituxin
17.5 mg/5 mL
For Intravenous Infusion Only
Single-Dose Vial
