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.
