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Isembyld (Apitegromab): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
150 mg/3 mL
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Isembyld

What is ISEMBYLD?

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.

It is not known if ISEMBYLD is safe and effective in children under 2 years of age.

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.

How will I receive ISEMBYLD?

  • You will receive ISEMBYLD from a healthcare provider through a needle placed in a vein (intravenous or IV infusion). The infusion will take about 1 to 2 hours to give you the full dose of medicine.
  • You will receive ISEMBYLD every 4 weeks.
  • Do not stop treatment with ISEMBYLD unless your healthcare provider tells you to.
  • Your healthcare provider will determine the amount of ISEMBYLD needed based on your current weight.

  • If you miss a dose of ISEMBYLD, either:

    • ISEMBYLD should be given (administered) as soon as possible and then restart the dosing schedule 4 weeks after the missed dose is given, or
    • the dose can be skipped and the next dose can be given as originally scheduled.

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 doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of ISEMBYLD.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

You can ask your pharmacist or healthcare provider for information about ISEMBYLD that is written for health professionals.

What are the ingredients in ISEMBYLD?

Active ingredients: apitegromab-mstn

Inactive ingredients: histidine, L-histidine hydrochloride monohydrate, sodium chloride, polysorbate 80, and Water for Injection. Hydrochloric acid was added to adjust the pH.

Manufactured by:

Scholar Rock, Inc.

301 Binney St, Cambridge, MA 02142 USA. U.S. License No. 2372

©2026 Scholar Rock, Inc.

For more information, go to www.ISEMBYLD.com or call 1-877-ISEMBYLD (1-877-473-6295).

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: BLA 761463 · View the label on DailyMed

Revision date stated in the text: September 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Isembyld

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Apitegromab 150 mg/3 mL
Dosage form Injection
Route Intravenous
Marketing status not in the current FDA NDC Directory
Company (applicant) SCHOLAR ROCK INC
FDA approval BLA 761463Biologics License Application (BLA) Approved September 11, 2026
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
150 mg/3 mL – 3 ml in 1 vial / 1 in 1 carton NDC 84717-150-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.