NIKTIMVO 50 mg/mL
axatilimab-csfr · INJECTION · Incyte Corporation
NIKTIMVO is a injection containing axatilimab-csfr at 50 mg/mL, taken intravenous. Manufactured by Incyte Corporation.
Key Facts
- Brand Name
- NIKTIMVO
- Generic Name
- axatilimab-csfr
- NDC Code (Product)
50881-012- Manufacturer
- Incyte Corporation
- Strength
- 50 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761411
- Drug Class
- Colony Stimulating Factor-1 Receptor Blocker [EPC]
- Marketing Start
- 08/14/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 nor…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS 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 AGA…
Frequently Asked Questions
What is NIKTIMVO used for?
NIKTIMVO contains axatilimab-csfr. It is a injection taken intravenous. Consult your doctor for specific uses.
Is NIKTIMVO a controlled substance?
NIKTIMVO is not classified as a controlled substance by the DEA.
What is the generic name for NIKTIMVO?
The generic name for NIKTIMVO is axatilimab-csfr. There are no other listed brand versions of axatilimab-csfr.
What is the NDC code for NIKTIMVO 50 mg/mL?
The NDC (National Drug Code) for NIKTIMVO 50 mg/mL is 50881-012, listed by Incyte Corporation.
Other NIKTIMVO Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)