INDICATION ISEMBYLD (apitegromab-mstn) 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. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Fractures ISEMBYLD may increase the risk of fractures, including serious fractures. 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. ADVERSE REACTIONS The most common adverse reactions (incidence ≥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. USE IN SPECIFIC POPULATIONS Pregnancy and Lactation Based on animal data, ISEMBYLD may cause fetal harm. There are no adequate data on the developmental risk associated with the use of ISEMBYLD in pregnant women. There are no data on the presence of ISEMBYLD in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ISEMBYLD, and any potential adverse effects on the breastfed infant. Females and Males of Reproductive Potential Based on animal data, ISEMBYLD may affect male and/or female reproductive function.
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