Risks & Side Effects

Please review this safety information

Below, you can learn about the risks and side effects of EXDENSUR. However, this is not all of the safety information and does not replace talking to your doctor about your condition or treatment. Please see the full Prescribing Information and Patient Information for EXDENSUR for more information, or ask your healthcare provider.

Who should not use EXDENSUR?

EXDENSUR is not used to treat sudden breathing problems. Tell your healthcare provider if your asthma does not get better or if it gets worse after you start treatment with EXDENSUR.

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

Do not use EXDENSUR if you are allergic to depemokimab or any of the ingredients in EXDENSUR (see “What are the ingredients in EXDENSUR?” below).

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.
Father and two sons with their hands touching standing in front of a soccer goal

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
    • breathing problems
    • fainting, dizziness, feeling lightheaded (low blood pressure)
    • rash
    • hives

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.

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.

Sign up to stay up to date on EXDENSUR

Get the latest news sent straight to your inbox.

SIGN UP HERE

Talk to your doctor to see if EXDENSUR is right for you.

Approved Use & Safety Info

Approved Use

Important Safety Information

Approved Use

EXDENSUR is an add-on, prescription maintenance treatment for patients 12 years and older with severe asthma, eosinophilic type. EXDENSUR is not used to treat sudden breathing problems.

Important Safety Information

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
    • breathing problems
    • fainting, dizziness, feeling lightheaded (low blood pressure)
    • rash
    • hives

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 because this may cause other symptoms 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, call 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.
  • are taking prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not change or stop taking your other medicines unless instructed by your healthcare provider.

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, and sore throat (pharyngitis).

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report negative side effects to GSK at gsk.public.reportum.com or 1-888-825-5249.
GSK Help Center logo

Explore the GSK Help Center website to find customer service support and contact information.

Contact Us
Together with EXDENSUR logo

If you have questions about how to access or pay for your GSK medication, visit togetherwithexdensur.com or call 1-844-Call-TwGSK (1-844-225-5894). For cost information, visit gskforyou.com.