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New NDCs and vial presentations
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New NDC
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New vial presentation
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NDC 50881-036‑17
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9 mg/0.9 mL (10 mg/mL)
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NDC 50881-047‑18
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22 mg/2.2 mL (10 mg/mL)
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The previous vial presentations of 9 mg/0.18 mL (50 mg/mL) and 22 mg/0.44 mL (50 mg/mL) will be discontinued. Payers and providers should update their systems and records accordingly to ensure accurate billing and reimbursement.
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Note to Providers: These new NDCs will be available to order from your wholesaler or distributor beginning September 8, 2026.
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HCPCS Information
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HCPCS Code Descriptor
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(Injection, axatilimab-csfr, 0.1 mg)
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Manufacturer
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Incyte Corporation
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New NDCs
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50881-036‑17
50881-047‑18
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The J‑code (J9038) for the new vials remains the same. There is no change in the clinical profile for Niktimvo.
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NDC Information
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11‑Digit NDC*
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Product Name
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Package
Description
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WAC/Package
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WAC/Mg
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50881-0036-17
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Niktimvo™ (axatilimab-csfr)
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9 mg/0.9 mL (10 mg/mL) solution in a single-dose vial
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$4896
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$544
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50881-0047-18
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Niktimvo™ (axatilimab-csfr)
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22 mg/2.2 mL (10 mg/mL) solution in a single-dose vial
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$11,968
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$544
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The above 11‑digit NDCs are used for claims processing and reimbursement.
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Each 9 mg/0.9 mL or 22 mg/2.2 mL single-dose vial contains 10 mg/mL of axatilimab‑csfr. The final concentration after dilution in the intravenous infusion bag remains unchanged and should continue to be between 0.24 mg/mL and 0.75 mg/mL, per the Prescribing Information. Please verify the concentration of the vial prior to preparation and administration to avoid dosing errors.
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Incyte will provide a replacement plan for vials with previous concentrations. As always, consult the Niktimvo Prescribing Information for specific instructions on dosing and administration.
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INDICATIONS AND IMPORTANT SAFETY INFORMATION
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INDICATIONS AND USAGE
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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.
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IMPORTANT SAFETY INFORMATION
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WARNINGS AND PRECAUTIONS
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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%.
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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.
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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.
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ADVERSE REACTIONS
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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.
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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.
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Clinically relevant adverse reactions in < 10% of patients who received Niktimvo included:
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Eye disorders: periorbital edema
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Skin and subcutaneous skin disorders: pruritus
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Vascular disorders: hypertension
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Immunogenicity: Anti‑Drug Antibody–Associated Adverse Reactions
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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.
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USE IN SPECIFIC POPULATIONS
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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.
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Females and Males of Reproductive Potential
Pregnancy Testing
Verify pregnancy status in females of reproductive potential prior to initiating Niktimvo.
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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.
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DOSAGE AND ADMINISTRATION
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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.
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Please see Full Prescribing Information for Niktimvo.
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