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IncyteCARES is a program for residents 
of the United States and Puerto Rico.

Eligible patients can receive Niktimvo for as little as $15, subject to certain limits

To qualify, patients must:

  • Have commercial prescription drug coverage. Patients insured under federal or state government prescription drug programs—including Medicare Part B or D, Medicare Advantage, Medicaid, or TRICARE—are not eligible. Patients without prescription drug coverage are also not eligible
  • Be a resident of the United States or Puerto Rico
  • Have a valid prescription for Niktimvo for an FDA-approved use

Uninsured, cash-paying, or Alternate Funding Program (AFP) patients are not eligible. Not valid for patients insured through Medicare Part B, 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. Program benefit applies to medication cost only and does not cover any costs to administer the medication. 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 20, 2025.

Uninsured, cash-paying, or Alternate Funding Program (AFP) patients are not eligible. Not valid for patients insured through Medicare Part B, 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. Program benefit applies to medication cost only and does not cover any costs to administer the medication. 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 20, 2025.

How to enroll your patients:

Download an enrollment form to enroll your patients in IncyteCARES. Eligible patients will be automatically 
enrolled in the Savings Program.

If you prefer to enroll them in the Savings Program only, complete an application at 
IncyteCARESsavings.Niktimvo.com.

Once they are enrolled, a patient Member ID number is immediately issued. Your patient can begin receiving their Niktimvo for as little as $15 out-of-pocket cost right away.

For questions about the Savings Program application process, call the Help Desk at 1-833-415-4436,
Monday through Friday, 8 AM–8 PM ET.

 

How to request payment of your Savings Program patient’s coinsurance responsibility

Once your patient has been treated with Niktimvo, you can submit the documentation for your patient’s coinsurance responsibility by fax. We will match their Savings Program Member ID to the documentation for processing, then issue you a check referencing your patient’s name.

Be sure to submit the following proofs of purchase:

  • CMS-1500 claim form
  • Explanation of Benefits (EOB) from the primary commercial payer showing patient name and date of birth, medication name or NDC, patient responsibility amount, and date of service

or Fax payment requests and documentation to 1-833-970-3589.

For questions about this process, call 1-833-415-4436.

Eligible patients can receive medication free of charge

The IncyteCARES Patient Assistance Program (PAP) helps eligible patients who do not have health insurance or who have trouble affording their out-of-pocket costs for Niktimvo. No purchase contingencies or other obligations apply.

To qualify, patients must:

  • Be confirmed as eligible for and enrolled in IncyteCARES
  • Be a resident of the United States or Puerto Rico
  • Have a valid prescription for Niktimvo for an FDA-approved use
  • Meet one of these 3 criteria:

Uninsured

    1. Have no medical coverage and meet household income criteria

Underinsured§

    1. text
    2. Have Medicare Part B, Medicare Part D, or Medicare Advantage and meet household income criteria
    3. Have any other type of health insurance (commercial, Medicaid, etc) but have exhausted or been denied coverage for Niktimvo and meet household income criteria

How to enroll your patients:

First, you must enroll your patient in IncyteCARES.

If you’re not able to provide the patient’s required income information and/or authorizations on the form, a program representative will contact the patient by phone to gather this information.

For questions, call IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET.

Terms and conditions apply. Terms of this program may change at any time.

§Patients who are enrolled in an Alternate Funding Program (AFP) are not eligible to receive free drug.

Patients may be eligible for help with medicine, treatment-related travel, and other costs.

If patients do not qualify for our IncyteCARES Savings Program or Patient Assistance Program, we may be able to provide information about other organizations or independent foundations that offer support. If eligible, these independent organizations sometimes provide help with medicine costs, transportation or lodging expenses related to treatment, or counseling services offered at reduced or no cost. Eligibility and availability of these programs are determined by the individual organizations.

To learn more:

Call IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET.

We can give patients contact information and website addresses to find more information on other organizations and independent foundations that may be able to help with specific needs.

INDICATIONS AND USAGE

Niktimvo™ (axatilimab-csfr) is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions

Niktimvo™ (axatilimab-csfr) can cause infusion-related reactions. Infusion-related reactions, including hypersensitivity reactions, occurred in 18% of patients who received Niktimvo in the clinical trial (AGAVE-201), with Grade 3 or 4 reactions in 1.3%.

Premedicate with an antihistamine and an antipyretic for patients who have previously experienced an infusion-related reaction to Niktimvo. Monitor patients for signs and symptoms of infusion-related reactions, including fever, chills, rash, flushing, dyspnea, and hypertension. Interrupt or slow the rate of infusion or permanently discontinue Niktimvo based on severity of the reaction.

Embryo-Fetal Toxicity

Based on its mechanism of action, Niktimvo may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with Niktimvo and for 30 days after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 44% of patients who received Niktimvo (N=79). Serious adverse reactions in > 2 patients included infection (pathogen unspecified) (14%), viral infection (14%), and respiratory failure (5.1%). Permanent discontinuation of Niktimvo due to an adverse reaction occurred in 10% of patients and dose reduction due to adverse reaction occurred in 8% of patients. Dose interruptions due to an adverse reaction occurred in 44% of patients. The adverse reactions leading to dose interruption in > 2 patients were viral infection, infection (pathogen unspecified), bacterial infection, musculoskeletal pain, and pyrexia.

The most common (≥ 15%) adverse reactions, including laboratory abnormalities, were increased aspartate aminotransferase (AST), infection (pathogen unspecified), increased alanine aminotransferase (ALT), decreased phosphate, decreased hemoglobin, viral infection, increased gamma glutamyl transferase (GGT), musculoskeletal pain, increased lipase, fatigue, increased amylase, increased calcium, increased creatine phosphokinase (CPK), increased alkaline phosphatase (ALP), nausea, headache, diarrhea, cough, bacterial infection, pyrexia, and dyspnea.

Clinically relevant adverse reactions in < 10% of patients who received Niktimvo included:

  • Eye disorders: periorbital edema
  • Skin and subcutaneous skin disorders: pruritus
  • Vascular disorders: hypertension

Immunogenicity: Anti-Drug Antibody–Associated Adverse Reactions

Across treatment arms in patients with cGVHD who received Niktimvo in clinical trials, among the patients who developed anti-drug antibodies (ADAs), hypersensitivity reactions occurred in 26% (13/50) of patients with neutralizing antibodies (NAb) and in 4% (2/45) of those without NAb.

USE IN SPECIFIC POPULATIONS

Lactation

Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 30 days after the last dose of Niktimvo.

Females and Males of Reproductive Potential

Pregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating Niktimvo.

Contraception

Females

Advise females of reproductive potential to use effective contraception during treatment with Niktimvo and for 30 days after the last dose of Niktimvo.

DOSAGE AND ADMINISTRATION

Dosage Modifications for Adverse Reactions

Monitor aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatine phosphokinase (CPK), amylase, and lipase prior to the start of Niktimvo therapy, every 2 weeks for the first month, and every 1 to 2 months thereafter until abnormalities are resolved. See Table 1 in the Prescribing Information for more recommendations.

INDICATIONS AND USAGE

Niktimvo™ (axatilimab-csfr) is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions

Niktimvo™ (axatilimab-csfr) can cause infusion-related reactions. Infusion-related reactions, including hypersensitivity reactions, occurred in 18% of patients who received Niktimvo in the clinical trial (AGAVE-201), with Grade 3 or 4 reactions in 1.3%.

Premedicate with an antihistamine and an antipyretic for patients who have previously experienced an infusion-related reaction to Niktimvo. Monitor patients for signs and symptoms of infusion-related reactions, including fever, chills, rash, flushing, dyspnea, and hypertension. Interrupt or slow the rate of infusion or permanently discontinue Niktimvo based on severity of the reaction.

Embryo-Fetal Toxicity

Based on its mechanism of action, Niktimvo may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with Niktimvo and for 30 days after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 44% of patients who received Niktimvo (N=79). Serious adverse reactions in > 2 patients included infection (pathogen unspecified) (14%), viral infection (14%), and respiratory failure (5.1%). Permanent discontinuation of Niktimvo due to an adverse reaction occurred in 10% of patients and dose reduction due to adverse reaction occurred in 8% of patients. Dose interruptions due to an adverse reaction occurred in 44% of patients. The adverse reactions leading to dose interruption in > 2 patients were viral infection, infection (pathogen unspecified), bacterial infection, musculoskeletal pain, and pyrexia.

The most common (≥ 15%) adverse reactions, including laboratory abnormalities, were increased aspartate aminotransferase (AST), infection (pathogen unspecified), increased alanine aminotransferase (ALT), decreased phosphate, decreased hemoglobin, viral infection, increased gamma glutamyl transferase (GGT), musculoskeletal pain, increased lipase, fatigue, increased amylase, increased calcium, increased creatine phosphokinase (CPK), increased alkaline phosphatase (ALP), nausea, headache, diarrhea, cough, bacterial infection, pyrexia, and dyspnea.

Clinically relevant adverse reactions in < 10% of patients who received Niktimvo included:

  • Eye disorders: periorbital edema
  • Skin and subcutaneous skin disorders: pruritus
  • Vascular disorders: hypertension

Immunogenicity: Anti-Drug Antibody–Associated Adverse Reactions

Across treatment arms in patients with cGVHD who received Niktimvo in clinical trials, among the patients who developed anti-drug antibodies (ADAs), hypersensitivity reactions occurred in 26% (13/50) of patients with neutralizing antibodies (NAb) and in 4% (2/45) of those without NAb.

USE IN SPECIFIC POPULATIONS

Lactation

Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 30 days after the last dose of Niktimvo.

Females and Males of Reproductive Potential

Pregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating Niktimvo.

Contraception

Females

Advise females of reproductive potential to use effective contraception during treatment with Niktimvo and for 30 days after the last dose of Niktimvo.

DOSAGE AND ADMINISTRATION

Dosage Modifications for Adverse Reactions

Monitor aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatine phosphokinase (CPK), amylase, and lipase prior to the start of Niktimvo therapy, every 2 weeks for the first month, and every 1 to 2 months thereafter until abnormalities are resolved. See Table 1 in the Prescribing Information for more recommendations.