Dinutuximab

Dinutuximab
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vishal Devarkonda

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Black Box Warning

WARNING: SERIOUS INFUSION REACTIONS AND NEUROPATHY See full prescribing information for complete Boxed Warning. Infusion Reactions Serious and potentially life-threatening infusion reactions occurred in 26% of patients treated withDinutuximab. Administer required prehydration and premedication including antihistamines prior to eachDinutuximab infusion. Monitor patients closely for signs and symptoms of an infusion reaction during and for at least four hours following completion of eachDinutuximab infusion. Immediately interruptDinutuximab for severe infusion reactions and permanently discontinueDinutuximab for anaphylaxis (2.2, 2.3, 5.1). Neuropathy Unituxin causes severe neuropathic pain in the majority of patients. Administer intravenous opioid prior to, during, and for 2 hours following completion of theDinutuximab infusion. In clinical studies of patients with high-risk neuroblastoma, Grade 3 peripheral sensory neuropathy occurred in 2% to 9% of patients. In clinical studies ofDinutuximab and related GD2-binding antibodies, severe motor neuropathy was observed in adults. Resolution of motor neuropathy was not documented in all cases. DiscontinueDinutuximab for severe unresponsive pain, severe sensory neuropathy, or moderate to severe peripheral motor neuropathy (2.2, 2.3, 5.2).

Overview

Dinutuximab is a GD2-binding monoclonal antibody that is FDA approved for the treatment of 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. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Serious infusion reactions, pain and peripheral neuropathy, capillary leak syndrome, hypotension, infection, neurological disorders of the eye, bone marrow suppression, electrolyte abnormalities, atypical hemolytic uremic syndrome, and embryo-fetal toxicity.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Dinutuximab FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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.

Verify that patients have adequate hematologic, respiratory, hepatic, and renal function prior to initiating each course ofDinutuximab [see CLINICAL STUDIES (14)]. Administer required premedication and hydration prior to initiation of eachDinutuximab infusion [see DOSAGE AND ADMINISTRATION (2.2)]. 2.1 Recommended Dose The recommended dose ofDinutuximab 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)]. 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)].

Required Pre-treatment and Guidelines for Pain Management

Intravenous Hydration

Administer 0.9% Sodium Chloride Injection, USP 10 mL/kg as an intravenous infusion over one hour just prior to initiating eachDinutuximab infusion. Analgesics

Administer morphine sulfate (50 mcg/kg) intravenously immediately prior to initiation ofDinutuximab 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 ofDinutuximab. 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 ofDinutuximab and as tolerated every 4 to 6 hours during theDinutuximab infusion. Administer acetaminophen (10 to 15 mg/kg; maximum dose 650 mg) 20 minutes prior to eachDinutuximab 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. 2.3 Dosage Modifications Manage adverse reactions by infusion interruption, infusion rate reduction, dose reduction, or permanent discontinuation ofDinutuximab (Table 3 and Table 4)

Off-Label Use and Dosage (Pediatric)

Contraindications

History of anaphylaxis to dinutuximab.

Warnings

WARNING: SERIOUS INFUSION REACTIONS AND NEUROPATHY See full prescribing information for complete Boxed Warning. Infusion Reactions Serious and potentially life-threatening infusion reactions occurred in 26% of patients treated withDinutuximab. Administer required prehydration and premedication including antihistamines prior to eachDinutuximab infusion. Monitor patients closely for signs and symptoms of an infusion reaction during and for at least four hours following completion of eachDinutuximab infusion. Immediately interruptDinutuximab for severe infusion reactions and permanently discontinueDinutuximab for anaphylaxis (2.2, 2.3, 5.1). Neuropathy Unituxin causes severe neuropathic pain in the majority of patients. Administer intravenous opioid prior to, during, and for 2 hours following completion of theDinutuximab infusion. In clinical studies of patients with high-risk neuroblastoma, Grade 3 peripheral sensory neuropathy occurred in 2% to 9% of patients. In clinical studies ofDinutuximab and related GD2-binding antibodies, severe motor neuropathy was observed in adults. Resolution of motor neuropathy was not documented in all cases. DiscontinueDinutuximab for severe unresponsive pain, severe sensory neuropathy, or moderate to severe peripheral motor neuropathy (2.2, 2.3, 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. (5.3, 5.4) Infection: Interrupt until resolution of systemic infection. (5.5) 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) Bone marrow suppression: Monitor peripheral blood counts duringDinutuximab therapy. (5.7) Electrolyte abnormalities: Monitor serum electrolytes closely. (5.8) Atypical hemolytic uremic syndrome: Permanently discontinueDinutuximab and institute supportive management. (5.9) Embryo-Fetal toxicity: May cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception.

Adverse Reactions

Clinical Trials Experience

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.

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 toDinutuximab 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 receivedDinutuximab 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.

Study 1

In a randomized, open label, multi-center study (Study 1), 134 patients received dinutuximab in combination with GM-CSF, IL-2 and RA (Unituxin/RA group), including 109 randomized patients and 25 patients with biopsy-proven residual disease who were non-randomly assigned to receive dinutuximab. A total of 106 randomized patients received RA alone (RA group) [see DOSAGE AND ADMINISTRATION (2) and CLINICAL STUDIES (14)]. Patients had a median age at enrollment of 3.8 years (range: 0.94 to 15.3 years), and were predominantly male (60%) and White (82%). In Study 1, adverse reactions of Grade 3 or greater severity were comprehensively collected, but adverse reactions of Grade 1 or 2 severity were collected sporadically and laboratory data were not comprehensively collected.

Approximately 71% of patients in theDinutuximab/RA group and 77% of patients in the RA group completed planned treatment. The most common reason for premature discontinuation of study therapy was adverse reactions in theDinutuximab/RA group (19%) and progressive disease (17%) in the RA group.

The most common adverse drug reactions (≥ 25%) in theDinutuximab/RA group were 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 (≥ 5%) in theDinutuximab/RA group were infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome.

Table 5 lists the adverse reactions reported in at least 10% of patients in theDinutuximab/RA group for which there was a between group difference of at least 5% (all grades) or 2% (Grade 3 or greater severity).

6.2 Immunogenicity As with all therapeutic proteins, patients treated withDinutuximab may develop anti-drug antibodies. In clinical studies, 52 of 284 (18%) patients from Study 2 and 13 of 103 (13%) patients from Study 3 tested positive for anti-dinutuximab binding antibodies. Neutralizing antibodies were detected in 3.6% of patients who were tested for anti-dinutuximab binding antibodies in Study 2 and Study 3. However, due to the limitations of the assay, the incidence of neutralizing antibodies may not have been reliably determined.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies toDinutuximab with the incidences of antibodies to other products may be misleading.

Postmarketing Experience

There is limited information regarding Dinutuximab Postmarketing Experience in the drug label.

Drug Interactions

No drug-drug interaction studies have been conducted with dinutuximab.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Risk Summary

Based on its mechanism of action,Dinutuximab 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. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dinutuximab in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Dinutuximab during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Dinutuximab in women who are nursing.

Pediatric Use

8.4 Pediatric Use The safety and effectiveness ofDinutuximab as part of multi-agent, multimodality therapy have been established in pediatric patients with high-risk neuroblastoma based on results of an open-label, randomized (1:1) trial conducted in 226 patients aged 11 months to 15 years (median age 3.8 years) (Study 1). Prior to enrollment, patients achieved at least a partial response to prior first-line therapy for high-risk neuroblastoma consisting of induction combination chemotherapy, maximum feasible surgical resection, myeloablative consolidation chemotherapy followed by autologous stem cell transplant, and received radiation therapy to residual soft tissue disease. Patients randomized to theDinutuximab/13-cis-retinoic acid (RA) arm (Unituxin/RA) received up to five cycles ofDinutuximab in combination with alternating cycles of granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2) plus RA, followed by one cycle of RA alone. Patients randomized to the RA arm received up to six cycles of RA monotherapy. Study 1 demonstrated an improvement in event-free survival and overall survival in patients in theDinutuximab/RA arm compared to those in the RA arm [see ADVERSE REACTIONS (6), CLINICAL PHARMACOLOGY (12), CLINICAL STUDIES (14)].

Geriatic Use

The safety and effectiveness ofDinutuximab in geriatric patients have not been established.

Gender

There is no FDA guidance on the use of Dinutuximab with respect to specific gender populations.

Race

There is no FDA guidance on the use of Dinutuximab with respect to specific racial populations.

Renal Impairment

Unituxin has not been studied in patients with renal impairment.

Hepatic Impairment

Unituxin has not been studied in patients with hepatic impairment.

Females of Reproductive Potential and Males

Contraception

Females

Unituxin may cause fetal harm [see USE IN SPECIFIC POPULATIONS (8.1)]. Advise females of reproductive potential to use effective contraception during treatment and for two months after the last dose ofDinutuximab.

Immunocompromised Patients

There is no FDA guidance one the use of Dinutuximab in patients who are immunocompromised.

Lactation

Risk Summary

There is no information available on the presence of dinutuximab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. However, human IgG is present in human milk. Because of the potential for serious adverse reactions in a breastfed infant, advise a nursing woman to discontinue breastfeeding during treatment withDinutuximab.

Administration and Monitoring

Administration

Instructions for Preparation and Administration Preparation

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 administerDinutuximab and discard the single-use vial if the solution is cloudy, has pronounced discoloration, or contains particulate matter. Aseptically withdraw the required volume ofDinutuximab 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 dilutedDinutuximab solution under refrigeration (2°C to 8° C). Initiate infusion within 4 hours of preparation. Discard dilutedDinutuximab solution 24 hours after preparation. Administration

AdministerDinutuximab as a diluted intravenous infusion only [see DOSAGE AND ADMINISTRATION (2.1)]. Do not administerDinutuximab as an intravenous push or bolus.

Monitoring

There is limited information regarding Dinutuximab Monitoring in the drug label.

IV Compatibility

Injection: 17.5 mg/5 mL (3.5 mg/mL) in a single-use vial. (3)

Overdosage

There is limited information regarding Dinutuximab overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Mechanism of Action

Mechanism of Action Dinutuximab binds to the glycolipid GD2. This glycolipid is expressed on neuroblastoma cells and on normal cells of neuroectodermal origin, including the central nervous system and peripheral nerves. Dinutuximab binds to cell surface GD2 and induces cell lysis of GD2-expressing cells through antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).

Structure

There is limited information regarding Dinutuximab Structure in the drug label.

Pharmacodynamics

There is limited information regarding Dinutuximab Pharmacodynamics in the drug label.

Pharmacokinetics

The pharmacokinetics of dinutuximab was evaluated by a population pharmacokinetic analysis in a clinical study ofDinutuximab in combination with GM-CSF, IL-2, and RA. In this study, 27 children with high-risk neuroblastoma (age: 3.9±1.9 years) received up to 5 cycles ofDinutuximab at 17.5 mg/m2/day as an intravenous infusion over 10 to 20 hours for 4 consecutive days every 28 days. The observed maximum plasma dinutuximab concentration (Cmax) was 11.5 mcg/mL [20%, coefficient of variation (CV)]. The mean volume of distribution at steady state (Vdss) was 5.4 L (28%). The clearance was 0.21 L/day (62%) and increased with body size. The terminal half-life was 10 days (56%).

No formal pharmacokinetic studies were conducted in patients with renal or hepatic impairment.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility No animal studies have been conducted to evaluate the carcinogenic or mutagenic potential of dinutuximab.

Dedicated studies examining the effects of dinutuximab on fertility in animals have not been conducted. No clear effects on reproductive organs were observed in general toxicology studies conducted in rats.

13.2 Animal Toxicology and/or Pharmacology Non-clinical studies suggest that dinutuximab-induced neuropathic pain is mediated by binding of the antibody to the GD2 antigen located on the surface of peripheral nerve fibers and myelin and subsequent induction of CDC and ADCC activity.

Clinical Studies

The safety and effectiveness ofDinutuximab 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 m2). Patients with systemic infections or a requirement for concomitant systemic corticosteroids or immunosuppressant usage were not eligible for enrollment.

Patients randomized to theDinutuximab/RA arm received up to five cycles of dinutuximab (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 one cycle of RA alone. Patients randomized to the RA arm received six cycles of RA. Dinutuximab was administered at a dose of 17.5 mg/m2/day (equivalent to 25/mg/m2/day of clinical trials material) on four consecutive days. Patients in both treatment arms received six cycles of RA at a dose of 160 mg/m2/day orally (for patients weighing more than 12 kg) or 5.33 mg/kg/day

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How Supplied

Unituxin is supplied in a carton containing one 17.5 mg/5 mL (3.5 mg/mL) single-use vial.

NDC 66302-014-01

StoreDinutuximab vials under refrigeration at 2°C to 8°C until time of use. Do not freeze or shake the vial. Keep the vial in the outer carton in order to protect from light.

Storage

StoreDinutuximab vials under refrigeration at 2°C to 8°C until time of use. Do not freeze or shake the vial. Keep the vial in the outer carton in order to protect from light.

Images

Drug Images

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Package and Label Display Panel

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Patient 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 WARNINGS AND PRECAUTIONS (5.1)].

Pain and Peripheral Neuropathy Inform patients and caregivers of the risk of severe pain and peripheral sensory and motor neuropathy and to promptly report severe or worsening pain and signs and symptoms of neuropathy such as numbness, tingling, burning, or weakness [see WARNINGS AND PRECAUTIONS (5.2)].

Capillary Leak Syndrome Inform patients and caregivers of the risk of capillary leak syndrome and to immediately report any signs or symptoms [see WARNINGS AND PRECAUTIONS (5.3)].

Hypotension Inform patients and caregivers of the risk of hypotension during the infusion and to immediately report any signs or symptoms [see WARNINGS AND PRECAUTIONS (5.4)].

Infection Inform patients and caregivers of the risk of infection following treatment and to immediately report any signs or symptoms [see WARNINGS AND PRECAUTIONS (5.5)].

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 WARNINGS AND PRECAUTIONS (5.6)].

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 WARNINGS AND PRECAUTIONS (5.7)].

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 WARNINGS AND PRECAUTIONS (5.8)].

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 WARNINGS AND PRECAUTIONS (5.9)].

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 two months after completing therapy [see WARNINGS AND PRECAUTIONS (5.10)].

Precautions with Alcohol

Alcohol-Dinutuximab interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

Unituxin

Look-Alike Drug Names

There is limited information regarding Dinutuximab Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [2]

Overview

Dinutuximab (tradenameDinutuximab) is a drug developed by United Therapeutics for the treatment of high-risk neuroblastoma in pediatric patients. It was approved for use by the United States Food and Drug Administration for use on March 10, 2015.