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Exdensur (Depemokimab): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
100 mg/mL
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Exdensur

What is EXDENSUR?

  • EXDENSUR is a prescription medicine:

    • for the add‑on maintenance treatment of severe asthma in people 12 years and older whose asthma is not controlled with their current medicines.

      • EXDENSUR helps prevent severe asthma attacks (exacerbations).
      • EXDENSUR is not used to treat sudden breathing problems that occur with asthma. Tell your healthcare provider if your asthma does not get better or if it gets worse after you start treatment with EXDENSUR.
  • EXDENSUR works by targeting inflammation that plays a major role in severe asthma. EXDENSUR reduces blood eosinophils. Eosinophils are a type of white blood cells that may contribute to your disease.

It is not known if EXDENSUR is safe and effective in children with asthma under 12 years of age.

Before using EXDENSUR, tell your healthcare provider about all of your medical conditions, including if you:

  • are taking systemic or inhaled corticosteroid medicines. Do not change or stop taking your corticosteroid medicines unless instructed by your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine to come back.
  • have a parasitic (helminth) infection.

  • are pregnant or plan to become pregnant. Babies exposed to EXDENSUR before birth may have higher and longer‑lasting levels of the medicine in their bodies. It is not known if EXDENSUR may harm your unborn baby. If you become pregnant while taking EXDENSUR contact GlaxoSmithKline at 1‑888‑825‑5249.

  • are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will use EXDENSUR and breastfeed. You should not do both without talking with your healthcare provider first.

  • Tell your healthcare provider about all the medicines you take, including prescription and over‑the‑counter medicines, vitamins, and herbal supplements.

  • Do not change or stop taking your other medicines unless instructed to do so by your healthcare provider.

How EXDENSUR is given:

A healthcare provider will inject EXDENSUR under your skin (subcutaneously) every 6 months. If you miss a dose of EXDENSUR, contact your healthcare provider to get your next dose as soon as you can.

What are the possible side effects of EXDENSUR?

EXDENSUR can cause serious side effects including:

  • allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen after you get your EXDENSUR injection. Contact your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction:
  • swelling of your face, mouth, and tongue
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • hives
  • breathing problems
  • rash

The most common side effects of EXDENSUR include:

  • upper respiratory tract infection (common cold, sinus infection)
  • sneezing, nasal congestion, runny nose, and nasal itching (allergic rhinitis)
  • flu or flu‑like symptoms
  • joint pain
  • sore throat (pharyngitis)

These are not all of the possible side effects of EXDENSUR.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

General information about the safe and effective use of EXDENSUR.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

You can ask your pharmacist or healthcare provider for information about EXDENSUR that is written for health professionals.

What are the ingredients in EXDENSUR?

Active ingredients: depemokimab‑ulaa

Inactive ingredients: arginine HCl, edetate disodium, histidine, L‑histidine HCl monohydrate, polysorbate 80, trehalose, Water for Injection.

For more information about EXDENSUR, call 1‑833‑EXDENSUR or visit our website at www.EXDENSUR.com.

Trademarks are owned by or licensed to the GSK group of companies.

Manufactured by:

GlaxoSmithKline LLC, Philadelphia, PA 19104, U.S. License No. 1727

Distributed by:

GlaxoSmithKline, Durham, NC 27701

©2026 GSK group of companies or its licensor.

EXD:2PIL

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: June 2026

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: BLA 761458 · View the label on DailyMed

Revision date stated in the text: June 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Exdensur

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Depemokimab 100 mg/mL
Dosage form Injection, solution
Route Subcutaneous
Marketing status listed in the FDA NDC Directory
Company (applicant) GLAXOSMITHKLINE LLC
FDA approval BLA 761458Biologics License Application (BLA) Approved December 16, 2025
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
100 mg/mL – 1 ml in 1 syringe / 1 in 1 carton NDC 0173-0927-42
100 mg/mL – 1 ml in 1 syringe / 1 in 1 carton NDC 0173-0927-61

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.