Apitegromab

ISEMBYLD is indicated for the treatment of spinal muscular atrophy (SMA) in adults and pediatric patients 2 years of age and older who are currently receiving a survival motor neuron 2 (SMN2)-targeted treatment. ISEMBYLD is a recombinant monoclonal antibody targeting proforms of myostatin, indicated for the treatment of spinal muscular atrophy (SMA) in adults and pediatric patients 2 years of age and older who are currently receiving a survival motor neuron 2 (SMN2)-targeted treatment.

ISEMBYLD is a fully human monoclonal IgG4 antibody that binds to promyostatin and latent myostatin and inhibits the activation of myostatin, blocking myostatin signaling.

The recommended dosage of ISEMBYLD is 10 mg/kg administered once every 4 weeks as an intravenous infusion over approximately 60 minutes to 120 minutes at an infusion rate no greater than 150 mL/hour. ISEMBYLD must be diluted in 0.9% Sodium Chloride Injection prior to administration. See Full Prescribing Information for important preparation and administration instructions.

None. None.

Fractures: Serious fracture events have occurred in patients treated with ISEMBYLD. Use with caution in patients with a history of low bone density or multiple fractures. In patients who experience fractures, weigh the risks and benefits of continuing ISEMBYLD.

The following clinically significant adverse reactions are described elsewhere in the labeling: Fractures Most common adverse reactions in SMA (incidence greater than or equal to 20% of patients treated with ISEMBYLD and more frequent than placebo) were upper respiratory tract infections, vomiting, cough, other viral infections, headache, gastroenteritis, pharyngitis, and hypersensitivity.

Store ISEMBYLD vials in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. For storage of the diluted infusion solution, see Dosage and Administration.