TM Owner Incyte / Syndax
Niktimvo 9mg/0.9mL (10mg/mL) or 9mg/0.18mL (50mg/mL) - no 9mg/0.6mL presentation exists IV Infusion
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Indications & Clinical Uses
- Niktimvo 9 mg (axatilimab-csfr) is a colony-stimulating factor-1 receptor (CSF-1R)-blocking antibody given by intravenous infusion to treat chronic graft-versus-host disease (chronic GVHD) in adults and children weighing 40 kg or more whose disease has not responded to at least two prior lines of systemic therapy.
- Niktimvo is used after other treatments, such as corticosteroids and other targeted therapies, have already been tried, in patients who have undergone allogeneic stem cell or bone marrow transplantation.
- It is given only in a hospital or specialist infusion clinic under the supervision of a healthcare provider experienced in treating graft-versus-host disease and is not a self-administered or take-home medicine.
- It was approved by the FDA in 2024 as the first CSF-1R-targeted therapy for this condition.
Side Effects
- Niktimvo commonly causes laboratory changes rather than symptoms you would notice yourself: your healthcare team will watch for raised liver enzymes (AST in over 60% of patients, ALT in over half), low phosphate, and a drop in hemoglobin.
- Noticeable side effects reported by a large proportion of patients include infections (including viral infections), musculoskeletal pain, fatigue and nausea.
- Infusion-related reactions - fever, chills, flushing, rash or shortness of breath during or shortly after the infusion - occur in around 1 in 5 patients and are usually mild, though a small number are severe; your infusion team will monitor you and may give an antihistamine or fever-reducing medicine beforehand if you have reacted before.
- Tell your care team immediately about any fever, breathing difficulty, severe fatigue, or unusual bruising or bleeding between infusions.
Precautions & Warnings
- Niktimvo can harm an unborn baby, so anyone who could become pregnant must use effective contraception during treatment and for at least 30 days after the last dose, and must not breastfeed during treatment or for 30 days afterward.
- Blood tests are required before starting Niktimvo - including liver enzymes (AST, ALT, alkaline phosphatase), creatine kinase, amylase and lipase - and are repeated every 2 weeks for the first month, then every 1 to 2 months during treatment, to catch liver or muscle problems early.
- Niktimvo is given only as an intravenous infusion over about 30 minutes in a hospital or infusion clinic; it must never be given as a rapid injection or self-administered at home.
- No boxed warning applies to this label.
- Tell your care team about any history of liver disease before starting treatment.
Avoid Interactions
- No formal drug-interaction studies have been reported for Niktimvo (axatilimab-csfr) in the current prescribing information, but because it is a monoclonal antibody given by infusion in a hospital setting, your healthcare team will still review every other prescription medicine, over-the-counter drug, herbal product and supplement you take before and during treatment.
- There is no requirement from the label to avoid specific foods, alcohol or live vaccines, but any planned vaccination should be discussed with your care team beforehand, since immune-modulating therapies can sometimes affect vaccine response.
- Always tell your infusion team about any new medicine started between visits.
References
Frequently Asked Questions
Niktimvo (axatilimab-csfr) treats chronic graft-versus-host disease (chronic GVHD) in adults and children weighing 40 kg or more whose disease did not respond to at least two earlier treatments. It works by blocking CSF-1R, a receptor on immune cells that drives chronic GVHD inflammation and scarring.
Niktimvo is given as an intravenous infusion over about 30 minutes, once every 2 weeks, by a healthcare provider in a hospital or infusion clinic. The dose is based on your body weight (0.3 mg/kg, up to a maximum of 35 mg) and is not given at home.
Niktimvo commonly raises liver enzymes and lowers phosphate and hemoglobin on blood tests, and can cause infections, musculoskeletal pain, fatigue and nausea. About 1 in 5 people have an infusion reaction - fever, chills, flushing or breathlessness - usually mild. Tell your care team about any fever or breathing trouble right away.
Avoid pregnancy while using Niktimvo and for 30 days after your last dose, since it may harm an unborn baby - use effective contraception. Do not breastfeed during treatment or for 30 days afterward. Tell your care team about every other medicine, supplement or vaccine you are considering.
Before starting Niktimvo, your care team checks liver enzymes, creatine kinase, amylase and lipase. These are repeated every 2 weeks for the first month, then every 1 to 2 months, to catch liver or muscle side effects early. Report any new muscle pain, dark urine or unusual bruising between tests.
A Niktimvo infusion takes about 30 minutes and is given every 2 weeks in a hospital or infusion clinic, where you are monitored for reactions such as fever, chills, flushing or shortness of breath. If you have reacted before, you may be given an antihistamine or fever-reducing medicine beforehand.
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