WINREVAIR Solution for injection Ref.[109322] Active ingredients: Sotatercept

Source: FDA, National Drug Code (US)  Revision Year: 2024 

Product description

Sotatercept-csrk is a homodimeric recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA (ActRIIA) linked to the human IgG1 Fc domain. The molecular weight based on the amino acid sequence of sotatercept-csrk is approximately 78 kDa as a homodimer.

Sotatercept-csrk for injection is a sterile, preservative-free, white to off-white lyophilized cake or powder appearance in single-dose vials for subcutaneous administration after reconstitution.

Each 45 mg single-dose vial provides 45 mg of sotatercept-csrk and citric acid monohydrate (0.40 mg), polysorbate 80 (0.18 mg), sodium citrate (1.84 mg), and sucrose (72 mg) at pH 5.8. After reconstitution with 1 mL Sterile Water for Injection, the resulting concentration is 50 mg/mL of sotatercept-csrk and the nominal deliverable volume is 0.9 mL.

Each 60 mg single-dose vial provides 60 mg of sotatercept-csrk and citric acid monohydrate (0.53 mg), polysorbate 80 (0.24 mg), sodium citrate (2.45 mg), and sucrose (96 mg) at pH 5.8. After reconstitution with 1.3 mL Sterile Water for Injection, the resulting concentration is 50 mg/mL of sotatercept-csrk and the nominal deliverable volume is 1.2 mL.

Dosage Forms and Strengths

For injection: 45 mg white to off-white lyophilized cake or powder appearance in a single-dose vial.

For injection: 60 mg white to off-white lyophilized cake or powder appearance in a single-dose vial.
How Supplied

WINREVAIR (sotatercept-csrk) for injection is a white to off-white lyophilized cake or powder appearance supplied in single-dose vials (45 mg or 60 mg) packaged in kits that contain one measuring syringe and one safety needle. Each kit also contains Sterile Water for Injection in prefilled syringes necessary to reconstitute the product, vial adapter(s), and alcohol pads, as shown in Table 5.

Table 5. Kit Contents:

KitVial
Adapters		Alcohol
Pads 		Sterile Water for Injection
in prefilled syringes 		NDC
(1) 45 mg vial 1 4 (1) 1 mL syringe NDC # 0006-5090-01
(1) 60 mg vial 1 4 (1) 1.3 mL syringe NDC # 0006-5091-01
(2) 45 mg vials 2 8 (2) 1 mL syringes NDC # 0006-5087-01
(2) 60 mg vials 2 8 (2) 1.3 mL syringes NDC # 0006-5088-01

Manufactured by: Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA

Drugs

Drug Countries
WINREVAIR United States
 
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