Initial US Approval:
2024
Key Clinical Studies:
AGAVE-201 (NCT04710576)
Drug Class/Description:
Colony stimulating factor-1 receptor (CSF-1R)-blocking antibody
Indications and Usage:
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.
Dosage Administration:
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.
Dosage Forms and Strengths:
Injection: 50 mg/mL solution in a single-dose vial.
Contraindications:
None.
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.
Adverse 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.
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Adapted from:
https://www.niktimvo.com/pdf/prescribing-information.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
