Scholar Rock

Important Safety Information | Prescribing Information

The First and Only Muscle-Targeted Treatment Designed to Improve Motor Function in SMA Is Here.¹

[Dear/Hello/Hi/Good morning/Good afternoon/Good evening/Greetings] [Dr/Doctor/Miss/Mr/Mrs/Ms] [Type in recipient’s name],

[It’s a pleasure to meet you over email. In your ongoing efforts to provide the best care for people with SMA, I thought the ISEMBYLD information linked below would be of interest to you.

I‘m looking forward to meeting you soon. In the interim, I wanted to share some ISEMBYLD information with you.

It was great to connect with you recently. Based on our conversation, I wanted to share the discussed ISEMBYLD information with you.

In your ongoing efforts to provide the best care for people with SMA, I thought the ISEMBYLD information linked below would be of interest to you.]

ISEMBYLD is the first and only FDA-approved muscle-targeted treatment for adults and pediatric patients aged 2 years and older living with SMA who are currently receiving an SMN2-targeted treatment.¹ Below, please find some resources that could be helpful to you and your practice as you get started with ISEMBYLD.

Please see the ISEMBYLD Magnum PI here

Please see the HCP Infusion Guide here

Please see the Patient Infusion Day Brochure here

Please see the Scholar Rock Supports™ Program Brochure here

Please see the ISEMBYLD Ordering & Distribution Overview here

Please see the ISEMBYLD At-A-Glance Booklet here

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.

Please see full Prescribing Information.

[I’d love to discuss the above and more about ISEMBYLD with you. Please let me know a day, time, and location that works best for you and I will follow up with a meeting invitation.

I look forward to meeting with you soon. Please reach out with any questions in the meantime.

After reviewing the material, if you have any questions that you still need addressed, please reach out to me at any time.

I’d love the opportunity to share more about ISEMBYLD with you. Please let me know a day, time, and location that works best for you and I will follow up with a meeting invitation.]

[Sincerely] [Best] [Regards],

[Scholar Rock Field Team Member first name and last name]

[Scholar Rock Field Team Member title]

[Scholar Rock Field Team Member phone number]

[Scholar Rock Field Team Member email address]

SMA=spinal muscular atrophy; SMN2=survival motor neuron 2.

In accordance with applicable state law, pricing information for ISEMBYLD (apitegromab-mstn) is available here.

Reference:
1. ISEMBYLD. Prescribing Information. Scholar Rock, Inc; 2026.

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Cambridge, MA 02142

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