Scholar Rock

Safety Information | Prescribing Information | Patient Information

Introducing ISEMBYLD™ (apitegromab-mstn), the first and only FDA-approved muscle-targeted treatment for SMA. It is designed to improve motor function in adults and children ages 2 years and older receiving an SMN2-targeted treatment.

[Dear/Hello/Hi/Good morning/Good afternoon/Good evening/Greetings] [Miss/Mr/Mrs/Ms/blank] [First Name] [Last Name],

[Hi [Name], I'm your Rx Onboarding and Care Coordinator (ROCC), and I wanted to share some information about ISEMBYLD with you. I’d also love to find a time to connect so we can walk through the materials together and talk through any questions you may have. / Hi [Name], ahead of our conversation, I wanted to send along some information about ISEMBYLD for you to review. / It was great speaking with you recently. I’m sharing the ISEMBYLD materials we talked about on our call. / Hi [Name], it’s been a while since we connected. I wanted to send along some helpful resources about ISEMBYLD that may be useful to you.]

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. Below are some resources that may be helpful as you learn more about ISEMBYLD and what to expect.

Please see ISEMBYLD Patient Brochure here

Please see ISEMBYLD Patient Infusion Journal here

Please see Scholar Rock Supports™ Brochure here

Please see ISEMBYLD Infusion Day Brochure here

Please see Sample Letter of Appeal for Insurance Coverage of ISEMBYLD here

[The next step is to meet with me, your ROCC. Here are a few times that might work: [XXMonth][XXDay][XXYear] @ [X:XXTime][AM/PM], [XXMonth][XXDay][XXYear] @ [X:XXTime][AM/PM], [XXMonth][XXDay][XXYear] @ [X:XXTime][AM/PM]. If you prefer a different time, please let me know your availability. / I look forward to connecting with you soon. Please reach out with any questions in the meantime. / Please know that as your ROCC, I’m here to help you—every step of the way. And I’ll be checking in at every stage of your journey. If you have any questions, don't hesitate to reach out. / As your ROCC, I’m here to answer your questions and help. Do you need additional info about ISEMBYLD or any assistance getting started? Please let me know if you’d like to meet online—I'm available to help in any way that works for you.]

FDA=US Food and Drug Administration; ROCC=Rx Onboarding and Care Coordinator; SMA=spinal muscular atrophy; SMN2=survival motor neuron 2.

What is ISEMBYLD (apitegromab-mstn)?

IMPORTANT SAFETY INFORMATION

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

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have a history of low bone density or bone fractures

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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

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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?

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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:

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upper respiratory tract infections

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vomiting

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cough

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viral infections

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headache

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