Is it time for Niktimvo™ (axatilimab-csfr)?

Not everyone sees improvement in symptoms with initial treatments for chronic graft-versus-host disease (GVHD).

If your chronic GVHD symptoms haven't improved after taking more than one treatment, ask your doctor about other options.

When should I talk to my doctor about a new treatment?

New or worsening symptoms may be a sign that chronic GVHD is progressing. If left unaddressed, this may lead to an increased risk of irreversible damage.

Share any symptoms you experience with your doctor so they can create a treatment plan that's right for you.

Potential signs and symptoms of chronic GVHD you may experience:

icon of intestines

Digestive Tract

  • You experience more frequent nausea, vomiting, diarrhea, or abdominal cramping
  • You lose your appetite or interest in food, even for meals you used to enjoy
icon of a bent knee with bones illustrated

Joints/Muscles

  • Your joints feel stiff and you have trouble doing daily tasks like laundry or dishes
  • You notice unusual muscle aches or pains, cramps, or weakness
  • You have trouble lifting things you used to carry easily
icon of a side profile with esophagus outlined

Esophagus

  • Your mouth feels drier than usual
  • You have difficulty eating and swallowing food
  • Your mouth still feels dry after drinking water
icon of lungs

Lungs

  • You experience unusual shortness of breath after walking a short distance
  • You feel winded after climbing a flight of stairs or while doing household chores
icon of a liver

Liver

  • You notice your eyes and skin looking yellower than usual
icon of an eye

Eyes

  • Your eyes feel dry or irritated
  • You are sensitive to light or experience intermittent blurry vision
  • Your eyes are difficult to open when waking up
icon of a hand with spots on it

Skin

  • You see changes in your skin texture, like skin thickening, or you develop a rash or itchy skin
  • You start wearing looser fitting layers to avoid irritating your skin

If your chronic GVHD symptoms are impacting your daily routine, talk to your doctor

Discover how Niktimvo may help

Explore Study Results

Niktimvo works differently

How Niktimvo Works

Indications and Usage

NiktimvoTM (axatilimab-csfr) is a prescription medicine used to treat adults and children who weigh at least 88.2 pounds (40 kg) with chronic graft-versus-host disease (cGVHD) after receiving at least 2 prior treatments (systemic therapy) and they did not work.

It is not known if Niktimvo is safe and effective in adults and children weighing less than 88.2 pounds (40 kg).

IMPORTANT SAFETY INFORMATION

What are the possible side effects of Niktimvo?

Niktimvo may cause serious side effects, including:

Infusion-related reactions. Infusion-related reactions are common with Niktimvo and can be serious. Your healthcare provider will monitor you for infusion-related reactions during your treatment. If you have a reaction, your healthcare provider may temporarily or completely stop your treatment with Niktimvo. Tell your healthcare provider right away if you have fever, chills, rash, flushing, shortness of breath, trouble breathing, nausea, vomiting, or symptoms of high blood pressure such as chest pain, headaches, or blurred vision during an infusion of Niktimvo.

The most common side effects of Niktimvo include:

  • infections
  • increased blood level of liver enzymes
  • decreased blood level of phosphate
  • low red blood cell count (anemia)
  • muscle, bone, or joint pain
  • increased blood level of pancreatic enzymes
  • low energy
  • increased blood level of calcium
  • increased blood level of a muscle enzyme
  • increased blood level of a bone enzyme
  • nausea
  • headache
  • diarrhea
  • cough
  • fever
  • shortness of breath

These are not all the possible side effects of Niktimvo. Call your doctor for medical advice about side effects.

Before receiving Niktimvo, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had liver problems.
  • are pregnant or plan to become pregnant. Niktimvo may harm your unborn baby.

    Females who are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with Niktimvo.
    • You should use an effective method of birth control during your treatment and for 30 days after your last dose of Niktimvo. Talk to your healthcare provider about birth control methods that you can use during this time.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Niktimvo.
  • are breastfeeding or plan to breastfeed. It is not known if Niktimvo passes into your breast milk. Do not breastfeed during treatment and for 30 days after your last dose of Niktimvo.

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

Please see the Full Prescribing Information, which includes a more complete discussion of the risks associated with Niktimvo.

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 side effects to Incyte Medical Information at 1-855-463-3463.

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Indications and Usage

NiktimvoTM (axatilimab-csfr) is a prescription medicine used to treat adults and children who weigh at least 88.2 pounds (40 kg) with chronic graft-versus-host disease (cGVHD) after receiving at least 2 prior treatments (systemic therapy) and they did not work.

It is not known if Niktimvo is safe and effective in adults and children weighing less than 88.2 pounds (40 kg).

IMPORTANT SAFETY INFORMATION

What are the possible side effects of Niktimvo?

Niktimvo may cause serious side effects, including:

Infusion-related reactions. Infusion-related reactions are common with Niktimvo and can be serious. Your healthcare provider will monitor you for infusion-related reactions during your treatment. If you have a reaction, your healthcare provider may temporarily or completely stop your treatment with Niktimvo. Tell your healthcare provider right away if you have fever, chills, rash, flushing, shortness of breath, trouble breathing, nausea, vomiting, or symptoms of high blood pressure such as chest pain, headaches, or blurred vision during an infusion of Niktimvo.

The most common side effects of Niktimvo include:

  • infections
  • increased blood level of liver enzymes
  • decreased blood level of phosphate
  • low red blood cell count (anemia)
  • muscle, bone, or joint pain
  • increased blood level of pancreatic enzymes
  • low energy
  • increased blood level of calcium
  • increased blood level of a muscle enzyme
  • increased blood level of a bone enzyme
  • nausea
  • headache
  • diarrhea
  • cough
  • fever
  • shortness of breath

These are not all the possible side effects of Niktimvo. Call your doctor for medical advice about side effects.

Before receiving Niktimvo, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had liver problems.
  • are pregnant or plan to become pregnant. Niktimvo may harm your unborn baby.

    Females who are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with Niktimvo.
    • You should use an effective method of birth control during your treatment and for 30 days after your last dose of Niktimvo. Talk to your healthcare provider about birth control methods that you can use during this time.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Niktimvo.
  • are breastfeeding or plan to breastfeed. It is not known if Niktimvo passes into your breast milk. Do not breastfeed during treatment and for 30 days after your last dose of Niktimvo.

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

Please see the Full Prescribing Information, which includes a more complete discussion of the risks associated with Niktimvo.

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 side effects to Incyte Medical Information at 1-855-463-3463.

Niktimvo and the Niktimvo logo are trademarks of Incyte.

Incyte and the Incyte logo are registered trademarks of Incyte.

Niktimvo (axatilimab) is licensed to Incyte from Syndax.

© 2025, Incyte. MAT-AXA-00050  09/25