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Dupixent
Overview
What is Dupixent?
Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and inhibits IL-4 and IL-13 signaling. Dupilumab has an approximate molecular weight of 147 kDa.
Dupilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture.
DUPIXENT (dupilumab) Injection is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous injection. DUPIXENT is provided as a single-dose pre-filled syringe with needle shield in a 2.25 mL siliconized Type-1 clear glass syringe. The needle cap is not made with natural rubber latex. Each pre-filled syringe delivers 300 mg dupilumab in 2 mL which also contains L-arginine hydrochloride (10.5 mg), L-histidine (6.2 mg), polysorbate 80 (4 mg), sodium acetate (2 mg), sucrose (100 mg), and water for injection, pH 5.9.
What does Dupixent look like?
What are the available doses of Dupixent?
DUPIXENT is a clear to slightly opalescent, colorless to pale yellow solution available as:
What should I talk to my health care provider before I take Dupixent?
How should I use Dupixent?
DUPIXENT is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.
DUPIXENT is administered by subcutaneous injection.
The recommended dose of DUPIXENT for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week.
DUPIXENT can be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas.
If a dose is missed, instruct the patient to administer the injection within 7 days from the missed dose and then resume the patient's original schedule. If the missed dose is not administered within 7 days, instruct the patient to wait until the next dose on the original schedule.
What interacts with Dupixent?
Sorry No Records found
What are the warnings of Dupixent?
Sorry No Records found
What are the precautions of Dupixent?
Sorry No Records found
What are the side effects of Dupixent?
Sorry No records found
What should I look out for while using Dupixent?
DUPIXENT is contraindicated in patients who have known hypersensitivity to dupilumab or any of its excipients.
What might happen if I take too much Dupixent?
There is no specific treatment for DUPIXENT overdose. In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.
How should I store and handle Dupixent?
DUPIXENT is sterile and preservative-free. Discard any unused portion.Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.If necessary, pre-filled syringes may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days. Do not store above 77°F (25°C). After removal from the refrigerator, DUPIXENT must be used within 14 days or discarded. Do not expose the syringe to heat or direct sunlight. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.Do NOT freeze. Do NOT expose to heat. Do NOT shake.DUPIXENT is sterile and preservative-free. Discard any unused portion.Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.If necessary, pre-filled syringes may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days. Do not store above 77°F (25°C). After removal from the refrigerator, DUPIXENT must be used within 14 days or discarded. Do not expose the syringe to heat or direct sunlight. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.Do NOT freeze. Do NOT expose to heat. Do NOT shake.DUPIXENT is sterile and preservative-free. Discard any unused portion.Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.If necessary, pre-filled syringes may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days. Do not store above 77°F (25°C). After removal from the refrigerator, DUPIXENT must be used within 14 days or discarded. Do not expose the syringe to heat or direct sunlight. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.Do NOT freeze. Do NOT expose to heat. Do NOT shake.DUPIXENT is sterile and preservative-free. Discard any unused portion.Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.If necessary, pre-filled syringes may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days. Do not store above 77°F (25°C). After removal from the refrigerator, DUPIXENT must be used within 14 days or discarded. Do not expose the syringe to heat or direct sunlight. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.Do NOT freeze. Do NOT expose to heat. Do NOT shake.DUPIXENT is sterile and preservative-free. Discard any unused portion.Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.If necessary, pre-filled syringes may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days. Do not store above 77°F (25°C). After removal from the refrigerator, DUPIXENT must be used within 14 days or discarded. Do not expose the syringe to heat or direct sunlight. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.Do NOT freeze. Do NOT expose to heat. Do NOT shake.DUPIXENT is sterile and preservative-free. Discard any unused portion.Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.If necessary, pre-filled syringes may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days. Do not store above 77°F (25°C). After removal from the refrigerator, DUPIXENT must be used within 14 days or discarded. Do not expose the syringe to heat or direct sunlight. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.Do NOT freeze. Do NOT expose to heat. Do NOT shake.Phenobarbital Tablets, USP 16.2 mg are white, round, biconvex, scored tablets, debossed “5011” and “V” on one side and plain on the reverse side, and supplied as follows:Phenobarbital Tablets, USP 32.4 mg are white, round, biconvex, scored tablets, debossed “5012” and “V” on one side and plain on the reverse side, and supplied as follows:Phenobarbital Tablets, USP 64.8 mg are white, round, biconvex, scored tablets, debossed “5013” and “V” on one side and plain on the reverse side, and supplied as follows:Phenobarbital Tablets, USP 97.2 mg are white, round, biconvex, scored tablets, debossed “5014” and “V” on one side and plain on the reverse side, and supplied as follows:Phenobarbital Tablets, USP 16.2 mg are white, round, biconvex, scored tablets, debossed “5011” and “V” on one side and plain on the reverse side, and supplied as follows:Phenobarbital Tablets, USP 32.4 mg are white, round, biconvex, scored tablets, debossed “5012” and “V” on one side and plain on the reverse side, and supplied as follows:Phenobarbital Tablets, USP 64.8 mg are white, round, biconvex, scored tablets, debossed “5013” and “V” on one side and plain on the reverse side, and supplied as follows:Phenobarbital Tablets, USP 97.2 mg are white, round, biconvex, scored tablets, debossed “5014” and “V” on one side and plain on the reverse side, and supplied as follows:Phenobarbital Tablets, USP 16.2 mg are white, round, biconvex, scored tablets, debossed “5011” and “V” on one side and plain on the reverse side, and supplied as follows:Phenobarbital Tablets, USP 32.4 mg are white, round, biconvex, scored tablets, debossed “5012” and “V” on one side and plain on the reverse side, and supplied as follows:Phenobarbital Tablets, USP 64.8 mg are white, round, biconvex, scored tablets, debossed “5013” and “V” on one side and plain on the reverse side, and supplied as follows:Phenobarbital Tablets, USP 97.2 mg are white, round, biconvex, scored tablets, debossed “5014” and “V” on one side and plain on the reverse side, and supplied as follows:Phenobarbital Tablets, USP 16.2 mg are white, round, biconvex, scored tablets, debossed “5011” and “V” on one side and plain on the reverse side, and supplied as follows:Phenobarbital Tablets, USP 32.4 mg are white, round, biconvex, scored tablets, debossed “5012” and “V” on one side and plain on the reverse side, and supplied as follows:Phenobarbital Tablets, USP 64.8 mg are white, round, biconvex, scored tablets, debossed “5013” and “V” on one side and plain on the reverse side, and supplied as follows:Phenobarbital Tablets, USP 97.2 mg are white, round, biconvex, scored tablets, debossed “5014” and “V” on one side and plain on the reverse side, and supplied as follows:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Dupilumab is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor.
Blocking IL-4Rα with dupilumab inhibits IL-4 and IL-13 cytokine-induced responses, including the release of proinflammatory cytokines, chemokines and IgE.
Non-Clinical Toxicology
DUPIXENT is contraindicated in patients who have known hypersensitivity to dupilumab or any of its excipients.Most reports of clinically significant drug interactions occurring with the barbiturates have involved phenobarbital. However, the application of these data to other barbiturates appears valid and warrants serial blood level determinations of the relevant drugs when there are multiple therapies.
Hypersensitivity reactions, including generalized urticaria and serum sickness or serum sickness-like reactions, were reported in less than 1% of subjects who received DUPIXENT in clinical trials. Two subjects experienced serum sickness or serum sickness-like reactions that were associated with high titers of antibodies to dupilumab . If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.
The following adverse reactions are discussed in greater detail elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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