NIKTIMVO (axatilimab-csfr)

Axatilimab-csfr pharmacokinetics are presented as geometric mean (coefficient of variation [%CV]) in adult patients with cGVHD following axatilimab-csfr 0.3 mg/kg (maximum 35 mg) every 2 weeks, unless otherwise specified. Axatilimab-csfr AUC increased in a greater than dose-proportional manner following single-dose administration of axatilimab-csfr over a dose range of 0.15 mg/kg to 3 mg/kg (0.5 to 10 times the approved recommended dosage) in healthy subjects. There was no axatilimab-csfr system...

The efficacy of NIKTIMVO was evaluated in AGAVE-201 (NCT04710576), a randomized, open-label, multicenter study in adult and pediatric patients with recurrent or refractory cGVHD who had received at least 2 lines of systemic therapy and required additional treatment. Patients with platelet count ≥ 50 × 10 9 /L, absolute neutrophil count ≥ 1 × 10 9 /L, ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN if liver cGVHD was present), total bilirubin ≤ 1.5 × ULN, and creatinine clearance ≥ 30 mL/minute were eligible. Patients with uncontrolled infections were not eligible. Treatment consisted of NIKTIMVO 0.3 mg/kg ...

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, diar...

None. None. ( 4 )

Infusion-Related Reactions: Interrupt or slow the rate of infusion or permanently discontinue NIKTIMVO based on severity of reaction. ( 2.2 , 5.1 ) Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.2 , 8.1 , 8.3 ) 5.1 Infusion-Related Reactions NIKTIMVO can cause infusion-related reactions. Infusion-related reactions, including hypersensitivity reactions, occurred in 18% of patients who r...