axatilimab (Niktimvo)

Indications

• treatment of chronic graft versus host disease (GVHD(in adults & children >= 40 kg who have not responded to at least two prior lines of systemic therapy

Dosage

• 0.3 mg/kg (maximum 35 mg) intravenous infusion over 30 minutes every 2 weeks until disease progression or unacceptable toxicity*
• 1 mg/kg every 2 weeks or 3 mg/kg every 4 weeks

* recommended dose

Adverse effects

• >= 15%
  • infection (pathogen unspecified), musculoskeletal pain, fatigue, nausea, headache, diarrhea, cough, pyrexia, dyspnea
  • increased serum transaminases, decreased serum phosphate, decreased blood hemoglobin, increased serum lipase, increased serum amylase, increased serum calcium, increased serum creatine phosphokinase
• drug discontinuation from treatment-related adverse events occurred in 6% of patients in the 0.3-mg/kg cohort & higher in the 1 mg/kg a & 3 mg/kg cohorts
• fatalities occurred in 1.3% of patients in the 0.3-mg/kg cohort

• drug adverse effects of pharmaceutical monoclonal antibodies

Mechanism of action

• targets colony-stimulating factor 1 receptor (CSF-1 receptor)

More general terms

• pharmaceutical monoclonal antibody