Source: FDA, National Drug Code (US) Revision Year: 2026
Apitegromab-mstn, which targets proforms of myostatin, is a fully human IgG4 lambda monoclonal antibody produced by recombinant DNA technology in Chinese Hamster Ovary cells and has an approximate molecular weight of 147 kDa.
ISEMBYLD (apitegromab-mstn) injection is a sterile, preservative-free, clear to moderately opalescent, colorless to slightly yellow solution supplied in a single-dose glass vial for intravenous use.
Each 3 mL single-dose vial contains 150 mg apitegromab-mstn and histidine (4.44 mg), L-histidine hydrochloride monohydrate (6.57 mg), sodium chloride (22.80 mg), polysorbate 80 (0.6 mg), and Water for Injection, USP. Hydrochloric acid was added to adjust the pH. The pH is approximately 6.0.
| Dosage Forms and Strengths |
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Injection: 150 mg/3 mL (50 mg/mL) apitegromab-mstn as a clear to moderately opalescent, colorless to slightly yellow solution in a single-dose vial. |
| How Supplied |
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ISEMBYLD (apitegromab-mstn) injection is a clear to moderately opalescent, colorless to slightly yellow solution. It is supplied as one 150 mg/3 mL (50 mg/mL) single-dose glass vial per carton (NDC 84717-150-01). Manufactured by: Scholar Rock, Inc., 301 Binney Street, Cambridge, MA 02142 USA |
| Drug | Countries | |
|---|---|---|
| ISEMBYLD | United States |
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