General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes

Exdensur

DEPEMOKIMAB

1 INDICATIONS AND USAGE EXDENSUR is indicated for the add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Limitations of Use EXDENSUR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions ( 5.2 )] . EXDENSUR is an interleukin‑5 (IL-5) antagonist, a monoclonal antibody (humanized immunoglobulin G [IgG]1 kappa) indicated for add-on maintenance treatment ...

Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians · May 2026

Brand names:Exdensur

Rx Only

ExdensurMedication

Quick Reference

Medicine ClassGeneral Medicine

FDA ApprovedYes

PregnancyCategory Not classified

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Quick Facts

Active ingredient: DEPEMOKIMAB
Medicine class: General Medicine
Brand names: Exdensur
Availability: Prescription only (Rx)
Pregnancy category: Not classified
Half-life: half‑life was 48 (4
FDA approved: Yes

Exdensur (DEPEMOKIMAB) medication overview

What Is Exdensur?

Exdensur (DEPEMOKIMAB) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.

Key Safety Information

•Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
•Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
•Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
•Avoid or limit alcohol while taking Exdensur. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
•Take Exdensur with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
•Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.

This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.

Uses & Indications

Exdensur is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.

Limitations of Use EXDENSUR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions ( 5.2 )] .

EXDENSUR is an interleukin‑5 (IL-5) antagonist, a monoclonal antibody (humanized immunoglobulin G [IgG]1 kappa) indicated for add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older.

( 1 ) Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus.

Dosage Guide

The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.

Adult Dosage

2 DOSAGE AND ADMINISTRATION The recommended dosage is 100 mg administered once every 6 months by subcutaneous (SC) injection into the upper arm, thigh, or abdomen. ( 2.1 ) • EXDENSUR should be administered by a healthcare provider. ( 2.2 ) • See full prescribing information for preparation and administration instructions. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage is 100 mg once every 6 months administered by subcutaneous (SC) injection into the upper arm, thigh, or abdomen avoiding 2 inches (5 cm) around the navel [see Dosage and Administration ( 2.2 )] . Missed Dose(s) If a dose is missed, administer the missed dose as soon as possible and resume the once every 6‑month injection schedule from the date of when the missed dose was given. 2.2 Preparation and Administration Instructions for EXDENSUR • EXDENSUR is for subcutaneous (SC) use only. • EXDENSUR should be administered by a healthcare provider. Do not use EXDENSUR prefilled pen or syringe if the security seal on the c

Available Forms

Available Strengths

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Side Effects

Common

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] .
The most common adverse reactions (incidence ≥4%) are upper respiratory tract infection, allergic rhinitis, influenza, arthralgia, and pharyngitis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of EXDENSUR was based on a pooled safety population from 2 replicate, randomized, double‑blind, parallel‑group, placebo‑controlled, multicenter clinical trials (SWIFT‑1 and SWIFT‑2) of 52 weeks duration.
The 2 trials included 762 adult and pediatric patients 12 years of age and older with asthma, who received either EXDENSUR 100 mg or placebo administered subcutaneously once every 6 months in addition to their existing background medications for asthma [see Clinical Studies ( 14 )] .
A total of 475 patients received 2 doses of EXDENSUR 100 mg in these trials.

Serious

5 WARNINGS AND PRECAUTIONS • Hypersensitivity reactions, including anaphylaxis, can occur after administration of EXDENSUR.
If a hypersensitivity reaction occurs, discontinue EXDENSUR and initiate appropriate therapy.
( 5.1 ) • Do not abruptly discontinue systemic or inhaled corticosteroids upon initiation of therapy with EXDENSUR.
Reduce corticosteroid dose gradually, if appropriate.
( 5.3 ) • Treat pre-existing helminth infections before initiating therapy with EXDENSUR.

Rare

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Medicine Interactions

Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.

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Warnings & Contraindications

5 WARNINGS AND PRECAUTIONS • Hypersensitivity reactions, including anaphylaxis, can occur after administration of EXDENSUR. If a hypersensitivity reaction occurs, discontinue EXDENSUR and initiate appropriate therapy. ( 5.1 ) • Do not abruptly discontinue systemic or inhaled corticosteroids upon initiation of therapy with EXDENSUR. Reduce corticosteroid dose gradually, if appropriate. ( 5.3 ) • Tr

How Exdensur Works

12.1 Mechanism of Action Depemokimab‑ulaa is an IL‑5 antagonist (humanized IgG1 kappa monoclonal antibody), which binds to IL‑5 with a dissociation constant of 10.5 pM, inhibiting the bioactivity of IL‑5 with in vitro IC50 value of 4 pM by blocking its binding to the alpha chain of the IL‑5 receptor complex expressed on the cell surface. Depemokimab‑ulaa contains a triple amino acid substitution (YTE) in the fragment crystallizable (Fc) region which increases binding to the neonatal Fc receptor and thereby extends the elimination half‑life. These properties support the dosing interval of every 6 months. IL‑5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Inflammation is an important component in the pathogenesis o

Pharmacokinetics

Absorption

Absorption Depemokimab‑ulaa median T max was approximately 14 days

Half-Life

half‑life was 48 (4

Metabolism

Metabolism: Depemokimab‑ulaa is a monoclonal antibody which is expected to be metabolized into small peptides and amino acids by catabolic pathways

Pregnancy & Breastfeeding Safety

Not classified

FDA Pregnancy Category Not classified

Consult your healthcare provider.

Full Pregnancy Information

Breastfeeding

Many medications pass into breast milk in varying amounts. Before using Exdensurwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.

Storage & Handling

Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.

Frequently Asked Questions

Sources & References

• FDA Prescribing Information — Official labeling and package insert for Exdensur
• U.S. National Library of Medicine — MedlinePlus drug information
• American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
• PubMed / MEDLINE — View clinical studies

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Medical Disclaimer

The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.