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NOW AVAILABLE

Niktimvo™ (axatilimab-csfr) is a prescription medicine approved by the FDA that is 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).

AVAILABILITY UPDATE

Incyte, the company that makes [Niktimvo], is dedicated to making sure that people living with cGVHD can get [Niktimvo] as soon as possible.

 

What to know about Niktimvo

Learn about what to expect with Niktimvo, how Niktimvo is given, and important side effect information.

Ask your doctor if Niktimvo might be right for you

What to expect with Niktimvo

Niktimvo is given as an intravenous (IV) infusion once every 2 weeks to start

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You will be given Niktimvo at your doctor’s office or in an infusion center.

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Each IV infusion of Niktimvo lasts about 30 minutes.

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The starting dose of Niktimvo is based on your weight.

Infusion-related reactions are common and can be serious. Before you receive each Niktimvo infusion, your doctor or nurse may give you medicines called diphenhydramine and acetaminophen to help prevent infusion-related reactions.

Support and resources for people taking Niktimvo

IncyteCARES for Niktimvo Patient Support Program

At IncyteCARES for Niktimvo, our team can help with access and support for your treatment.

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Coverage verification

We can check with a patient’s insurance plan about their coverage for Niktimvo and any out-of-pocket costs required.

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Insurance assistance

We can help patients understand how their insurance plan works. We can also offer information about prior authorization requirements and appealing insurance denials or restrictions.

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Savings program

For patients with commercial prescription drug coverage—eligible patients pay as little as $0 per month, subject to certain limits.*

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Patient Assistance Program (PAP)

Free product is offered to eligible patients who are uninsured or underinsured for Niktimvo.

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Temporary coverage

For insurance coverage delays, eligible patients can receive a free short-term supply of Niktimvo.

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Patient education and support

Through our call center, IncyteCARES for Niktimvo representatives can answer patient and caregiver questions about chronic graft-versus-host disease and Niktimvo.

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Connection to other support services

For patients who need additional support beyond what we can provide directly, IncyteCARES for Niktimvo can offer information about other independent organizations that may be able to help.

Connect with IncyteCARES to learn more

Visit www.IncyteCARES.com or call 1-855-452-5234

Monday through Friday, 8 AM – 8 PM ET.

*Uninsured, cash-paying, or Alternate Funding Program (AFP) patients are not eligible. Not valid for patients insured through Medicare Part D, Medicare Advantage, Medicaid, TRICARE, or any state medical or pharmaceutical assistance program. Patient enrollment in a copay adjustment program, such as a maximizer or accumulator program, may impact the value of this offer. Annual benefit maximum applies, as may other restrictions. Valid prescription for Niktimvo™ (axatilimab-csfr) for an FDA-approved indication or compendia-recognized use is required. Please see the full Patient Terms and Conditions or call IncyteCARES for Niktimvo at 1-855-452-5234. Update effective as of January 1, 2025.

Terms and conditions apply. Terms of these programs may change at any time. No purchase contingencies or other obligations apply.

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.