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Molecule

Axatilimab

Colony Stimulating Factor-1 Receptor Blocker
Available on requestBiologicOrphanCold chain
Presentations
4
Brands
1
Manufacturers
1
Available from stock
0

Axatilimab is a colony stimulating factor-1 receptor blocker indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult, among other approved uses. MedsAcross supplies Axatilimab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Colony Stimulating Factor-1 Receptor Blocker, Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors
US FDA first approval
14 August 2024
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII R96Z451BMCCAS 2155851-88-8Q129182153

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

NIKTIMVO is 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. NIKTIMVO 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.

Source: US FDA prescribing information

How it works

Axatilimab-csfr is a monoclonal antibody that binds to colony stimulating factor-1 receptors (CSF-1R) expressed on monocytes and macrophages. Blocking CSF-1R with axatilimab-csfr reduces the levels of these circulating proinflammatory and profibrotic monocytes and monocyte-derived macrophages, as demonstrated by a reduction of nonclassical monocyte counts in nonclinical studies with axatilimab-csfr, and inhibits the activity of pathogenic macrophages in tissues.

Source: US FDA prescribing information

Dosing overview

Administer only as an intravenous infusion over 30 minutes. The recommended dosage of NIKTIMVO is 0.3 mg/kg (maximum 35 mg) every 2 weeks in adult and pediatric patients weighing 40 kg and above. See Full Prescribing Information for dosage modifications for adverse reactions and preparation and administration instructions.

Source: US FDA prescribing information

Warnings and precautions

Infusion-Related Reactions: Interrupt or slow the rate of infusion or permanently discontinue NIKTIMVO based on severity of reaction. Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

Source: US FDA prescribing information

Side effects

The following adverse reactions are described elsewhere in the labeling. Infusion-Related Reactions The most common (≥ 15%) adverse reactions, including laboratory abnormalities, are increased AST, infection (pathogen unspecified), increased ALT, decreased phosphate, decreased hemoglobin, viral infection, increased GGT, musculoskeletal pain, increased lipase, fatigue, increased amylase, increased calcium, increased CPK, increased ALP, nausea, headache, diarrhea, cough, bacterial infection, pyrexia, and dyspnea.

Source: US FDA prescribing information

Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

4 presentations of Axatilimab, sorted by availability.

MedicineManufacturerRegisterAvailability
Niktimvo 22 mg/0.44 mL injectionIntravenous Cold chainIncyteUS FDAAvailable on request
Niktimvo 22 mg/2.2 mL injectionIntravenous Cold chainIncyteUS FDAAvailable on request
Niktimvo 9 mg/0.18 mL injectionIntravenous Cold chainIncyteUS FDAAvailable on request
Niktimvo 9 mg/0.9 mL injectionIntravenous Cold chainIncyteUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Niktimvo

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 14 August 2024Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Axatilimab available for export from India?

Yes, on request. MedsAcross lists 4 presentations of Axatilimab and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Axatilimab have?

The catalogue lists 1 brand names for Axatilimab, including Niktimvo.

Is Axatilimab approved by the US FDA?

Yes. The US FDA first approved Axatilimab on 14 August 2024, according to Drugs@FDA.

Does Axatilimab need cold chain shipping?

At least one listed presentation of Axatilimab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

References

  1. NIKTIMVO prescribing information (Incyte). U.S. National Library of Medicine, DailyMed. Retrieved 25 September 2026

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