Skip to Content

Dupilumab

Pronunciation

(doo PIL ue mab)

Index Terms

  • Dupixent

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Dupixent: 300 mg/2 mL (2 mL) [contains polysorbate 80]

Brand Names: U.S.

  • Dupixent

Pharmacologic Category

  • Interleukin-4 Receptor Antagonist
  • Monoclonal Antibody

Pharmacology

Dupilumab is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by binding to the IL-4Rα subunit. Blocking IL-4Rα with dupilumab inhibits IL-4 and IL-13 cytokine-induced responses, including the release of proinflammatory cytokines, chemokines and IgE.

Distribution

Vd: ~4.8 ± 1.3 L

Metabolism

Monoclonal antibodies are primarily degraded into small peptides and amino acids by catabolism

Excretion

Clearance: The median time to non-detectable concentrations is 10 weeks (for 300 mg every 2 weeks) and 13 weeks (for 300 mg weekly).

Time to Peak

~1 week

Special Populations Note

Weight: Dupilumab trough concentrations were lower in subjects with higher body weight.

Use: Labeled Indications

Atopic dermatitis: Treatment of moderate to severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Contraindications

Known hypersensitivity to dupilumab or any component of the formulation

Dosing: Adult

Atopic dermatitis: SubQ:

Initial: 600 mg (given as two 300 mg injections)

Maintenance: 300 mg once every other week

Missed doses: If a dose is missed, administer within 7 days from the missed dose and then resume the original schedule. If the missed dose is not administered within 7 days, wait until the next dose on the original schedule.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Administration

Administer as a subcutaneous injection into the thigh or lower abdomen (avoiding areas within 2 inches of navel); caregiver may administer in upper arm. Rotate injection sites including initial 300 mg doses; do not administer into skin that is tender, damaged, bruised, or scarred. Patients may self-administer injection after proper training. Allow solution to reach room temperature for 45 minutes prior to use; do not remove needle cap while allowing product to reach room temperature. Do not shake. Do not use if solution is discolored or contains particulate matter. Prefilled syringe does not contain a preservative; discard unused portion.

Storage

Store at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not expose to direct heat. Protect from light; do not expose to direct sunlight. Do not shake. Prefilled syringes may be stored up to 25°C (77°F) for a maximum of 14 days; after removal from refrigerator, use within 14 days or discard.

Drug Interactions

Belimumab: Monoclonal Antibodies may enhance the adverse/toxic effect of Belimumab. Avoid combination

Vaccines (Live): Dupilumab may enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Adverse Reactions

1% to 10%:

Dermatologic: Herpes simplex infection (2%)

Gastrointestinal: Oral herpes (4%)

Immunologic: Antibody development (7%; neutralizing: 2%)

Local: Injection site reaction (10%)

Ophthalmic: Conjunctivitis (10%), eye pruritus (1%)

<1% (Limited to important or life-threatening): Eosinophilia (transient), hypersensitivity reaction, keratitis, serum sickness, serum sickness-like reaction, urticaria, xerophthalmia

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Urticaria and serum sickness or serum sickness-like reactions have been reported (rare); if signs/symptoms of a serious hypersensitivity reaction develop discontinue immediately and initiate appropriate treatment.

• Ocular effects: Conjunctivitis and keratitis have been reported; report new-onset or worsening eye symptoms to health care provider.

Disease-related concerns:

• Asthma: Safety and efficacy have not been established in the treatment of asthma. Discontinuation or adjustment of asthma medications in patients with comorbid asthma should not be done without consulting health care provider.

• Helminth infections: It is unknown if administration of dupilumab will influence a patient's response against parasitic infections; patients with known helminth infections were not studied.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Other warnings/precautions:

• Appropriate use: Dupilumab may be used in combination with or without topical corticosteroids. Topical calcineurin inhibitors may be used, but should be reserved for problem areas only (eg, face, neck intertriginous and genital areas).

• Immunogenicity: Dupilumab antibodies, including neutralizing antibodies, may develop; may be associated with lower serum dupilumab concentrations.

• Vaccines: Avoid the use of live vaccines in patients treated with dupilumab.

Monitoring Parameters

Monitor for signs/symptoms of hypersensitivity reactions and ocular adverse effects.

Pregnancy Considerations

Dupilumab is a monoclonal IgG antibody; IgG molecules are known to cross the placenta therefore exposure to the fetus during pregnancy may occur.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience injection site irritation. Have patient report immediately to prescriber vision changes, eye pain, or severe eye irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Hide