UNITUXIN Solution for injection (2020)

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United Therapeutics Corporation

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BOXED WARNING SECTION

WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY Infusion Reactions Serious and potentially life-threatening infusion reactions occurred in 26% of patients treated with Unituxin. ...

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 ...

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 ...

3. Dosage 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.

4. Contraindications

Unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab.

5. Warnings and Precautions

5.1 Serious Infusion Reactions Serious infusion reactions requiring urgent intervention, including blood pressure support, bronchodilator therapy, corticosteroids, infusion rate reduction, infusion interruption, ...

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, ...

6.1. Clinical 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 ...

6.2. Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed ...

6.3. Postmarketing 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 ...

7. Drug Interactions

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

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 ...

8.2. 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 ...

8.3. Females and Males of Reproductive Potential

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 2 ...

8.4. Pediatric Use

The safety and effectiveness of Unituxin 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 ...

8.5. Geriatric Use

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

8.6. Renal Impairment

Unituxin has not been studied in patients with renal impairment.

8.7. Hepatic Impairment

Unituxin has not been studied in patients with hepatic impairment.

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 ...

12.1. 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 ...

12.3. Pharmacokinetics

The pharmacokinetics of dinutuximab was evaluated by a population pharmacokinetic analysis in a clinical study of Unituxin in combination with GM-CSF, IL-2, and RA. In this study, 27 children with high-risk ...

13.1. 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. ...

13.2. Animal Toxicology and/or Pharmacology

Nonclinical studies suggest that dinutuximab-induced neuropathic pain and neurotoxicity are mediated by binding of the antibody to the GD2 antigen located on the surface of nerve fibers and myelin and ...

14. Clinical 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 ...

16.1. How Supplied

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

16.2. Storage and Handling

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.

17. 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, ...