Axatilimab-Csfr: uses, dosing, side effects & brands
Axatilimab-Csfr is a medicine sold in the U.S. under one brand, for bronchiolitis obliterans syndrome. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Bronchiolitis Obliterans Syndrome
- Available as
- Injectable
- Sold as
- Niktimvo
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How axatilimab-csfr is dosed
From the FDA label for Niktimvo (application BLA761411). Other axatilimab-csfr products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer only as an intravenous infusion over 30 minutes. ( 2.3 ) 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. ( 2.1 ) See Full Prescribing Information for dosage modifications for adverse reactions ( 2.2 ) and preparation and administration instructions. ( 2.3 ) 2.1 Recommended Dosage For patients weighing at least 40 kg, administer NIKTIMVO 0.3 mg/kg, up to a maximum dose of 35 mg, as an intravenous infusion over 30 minutes every 2 weeks until progression or unacceptable toxicity. 2.2 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. For recommended NIKTIMVO dosage modifications due to adverse reactions, see Table 1. Table 1: Recommended NIKTIMVO Dosage Modifications for Adverse Reactions AST = aspartate aminotransferase; ALT = alanine aminotransferase; ULN = upper limit of normal; ALP = alkaline phosphatase; CPK = creatine phosphokinase. Adverse Reaction Severity Graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5. Dosage Modification Infusion-related…
Axatilimab-Csfr side effects
The following adverse reactions are described elsewhere in the labeling. Infusion-Related Reactions [see Warnings and Precautions ( 5.1 )] 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Chronic Graft-Versus-Host Disease The safety of NIKTIMVO was evaluated in 79 adult and pediatric patients with cGVHD treated with NIKTIMVO 0.3 mg/kg intravenously every 2 weeks in the AGAVE‑201 trial [see Clinical Studies ( 14 )] . The median duration of treatment was 10.3 months (range: 0.5 to 28.6 months), and 73.4% were treated for more than 6 months. Serious adverse reactions occurred in 44% of…
Who shouldn’t take axatilimab-csfr
None. None. ( 4 )
Every axatilimab-csfr product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Niktimvo.
Related calculators
Frequently asked questions
What is axatilimab-csfr?
Niktimvo (Axatilimab-Csfr) is a medication used to treat Bronchiolitis Obliterans Syndrome.
Can you take axatilimab-csfr with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run axatilimab-csfr against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does axatilimab-csfr come in?
Across the brands we track, axatilimab-csfr is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic axatilimab-csfr?
We do not currently list a generic-labelled axatilimab-csfr product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Axatilimab-Csfr: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/axatilimab-csfr
- MLA
- “Axatilimab-Csfr: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/axatilimab-csfr.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for axatilimab-csfr on DailyMed (NIH) ↗.