Trade Name: Unituxin

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: United Therapeutics Corp.

Presentation: INJECTION, HUMAN PRESCRIPTION DRUG

Strength: 3.5 mg/mL

Storage and handling

DINUTUXIMAB Glycolipid Disialoganglioside-directed Antibody [EPC],Glycolipid Disialoganglioside-directed Antibody Interactions [MoA]

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  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • 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 n- [see , and ]n- .
  • Neurotoxicity: 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 peripheral motor neuropathy has also been reported. Discontinue for severe unresponsive pain, severe sensory neuropathy, and moderate to severe peripheral motor neuropathy n- [see , and ]n- .
  • 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 n
  • 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. ()
  • No data
  • 17.5 mg/m/day as a diluted intravenous infusion over 10 to 20 hours for 4 consecutive days for up to 5 cycles. (, )
  • Injection: 17.5 mg/5 mL (3.5 mg/mL) as a clear and colorless to slightly opalescent solution in a single-dose vial.
  • Injection: 17.5 mg/5 mL (3.5 mg/mL) in a single-dose vial. ()
  • Unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab.
  • History of anaphylaxis to dinutuximab. ()
  • No data
  • 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. ()
  • Prolonged Urinary Retention and Transverse Myelitis: Permanently discontinue Unituxin and institute supportive care. ()
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Permanently discontinue Unituxin and institute supportive care for signs and symptoms of RPLS. ()
  • 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. (, )
  • Infection: Interrupt until resolution of systemic infection. ()
  • Bone Marrow Suppression: Monitor peripheral blood counts during Unituxin therapy. ()
  • Electrolyte Abnormalities: Monitor serum electrolytes closely. ()
  • Atypical Hemolytic Uremic Syndrome: Permanently discontinue Unituxin and institute supportive management. ()
  • Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception. (, , )
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • The most common adverse drug reactions (u226525%) 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. (, )
  • The most common serious adverse reactions (u22655%) are infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome. (, )
  • 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.
  • No drug-drug interaction studies have been conducted with dinutuximab.
  • No data
  • 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 and light chain kappa. Dinutuximab is produced in the murine myeloma cell line, SP2/0 and has an approximate molecular weight of 150 kDa.
  • 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.
  • No data
  • No data
  • 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 <1.5u00d7 the upper limit of normal and ALT <5u00d7 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 with systemic infections or a requirement for concomitant systemic corticosteroids or immunosuppressant usage were not eligible for enrollment.
  • 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/day (equivalent to 25 mg/m/day of clinical trials material) on 4 consecutive days. Patients in both treatment arms received 6 cycles of RA at a dose of 160 mg/m/day orally (for patients weighing more than 12 kg) or 5.33 mg/kg/day (for patients weighing less than or equal to 12 kg) in 2 divided doses for 14 consecutive days.
  • 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
  • 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
  • Store Unituxin vials under refrigeration at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F) in the outer carton to protect from light until time of use. Do not freeze or shake the vial.
  • No data
  • Unituxin manufactured by:
  • United Therapeutics Corp.Research Triangle Park, NC 27709US License No. 1993
  • NDC 66302-014-01
  • Unituxinn (dinutuximab)Injection
  • 17.5 mg/5 mL(3.5 mg/mL)
  • For Intravenous Infusion OnlyDilute Prior to Administration
  • Single-Dose VialDiscard Unused PortionRx Only

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of DINUTUXIMAB (Unituxin) which is also known as Unituxin and Manufactured by United Therapeutics Corp.. It is available in strength of 3.5 mg/mL.

DINUTUXIMAB (Unituxin) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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