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WHAT IS ISEMBYLD (apitegromab-mstn)?

ISEMBYLD is a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children 2 years of age and older who are currently receiving a survival motor neuron 2 (SMN2)-targeted treatment.

IMPORTANT SAFETY INFORMATION

Before taking ISEMBYLD, tell your healthcare provider about all of your medical conditions, including if you:

have a history of low bone density or bone fractures
are pregnant or plan to become pregnant. If you are pregnant or are planning to become pregnant, ask your healthcare provider for advice before taking this medicine. It is not known if ISEMBYLD will harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with ISEMBYLD
are breastfeeding or plan to breastfeed. It is not known if ISEMBYLD passes into breast milk. Talk to your healthcare provider about the best way to feed your baby while on treatment with ISEMBYLD

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare provider, including your pharmacist, when you get a new medicine.

What are the possible side effects of ISEMBYLD?

Fractures. Treatment with ISEMBYLD may increase the risk of bone fractures, including serious fractures. Bone fractures may happen with or without a fall or other injury. Your healthcare provider may consider stopping treatment with ISEMBYLD if you experience a bone fracture during treatment

The most common side effects of ISEMBYLD include:

upper respiratory tract
infections
vomiting
cough
viral infections

headache
stomach flu (gastroenteritis)
sore throat (pharyngitis)
hypersensitivity

These are not all of the possible side effects of ISEMBYLD. Call your healthcare provider for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information and Patient Information.

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US-APIT-0368 09/26