EXDENSUR Solution for injection Ref.[116117] Active ingredients: Depemokimab

Source: FDA, National Drug Code (US) Revision Year: 2025

Product description

Depemokimab-ulaa is an interleukin-5 (IL-5) antagonist monoclonal antibody (humanized Immunoglobulin G1 [IgG1] kappa). Depemokimab-ulaa is produced by recombinant DNA technology in Chinese hamster ovary cells. The estimated molecular weight of depemokimab-ulaa is 149 kDa.

EXDENSUR (depemokimab-ulaa) injection is a sterile, preservative-free, colorless, yellow to brown, clear to opalescent solution for subcutaneous (SC) use.

EXDENSUR injection is supplied in a single-dose, 1-mL, prefilled pen with a fixed 29-gauge, half-inch needle or in a single-dose, 1-mL, prefilled syringe with a fixed 29-gauge, half-inch needle with a needle guard. Each 1 mL delivers 100 mg depemokimab-ulaa, (8.43 mg) arginine HCl, (0.017 mg) edetate disodium, (1.41 mg) histidine, (2.29 mg) L-histidine HCl monohydrate, (0.20 mg) polysorbate 80, (61.6 mg) trehalose, and Water for Injection with a pH of 6.0.

Dosage Forms and Strengths
Injection: a colorless, yellow to brown, clear to opalescent solution available as: 100 mg/mL solution in a single-dose, prefilled pen 100 mg/mL solution in a single-dose, prefilled syringe with needle guard

How Supplied

EXDENSUR (depemokimab-ulaa) injection is a sterile, preservative-free, colorless, yellow to brown, clear to opalescent solution for subcutaneous (SC) use. The pens and syringes are not made with natural rubber latex. EXDENSUR injection is supplied as described in Table 4.

Table 4. EXDENSUR Injection Package Configuration:

Package Configuration	Strength	NDC
1 single-dose, prefilled pen with attached 29-gauge, half-inch needle in a carton	100 mg/mL	0173-0927-31
1 single-dose, prefilled syringe with attached 29-gauge, half-inch needle with needle guard in a carton	100 mg/mL	0173-0927-42

Manufactured by: GlaxoSmithKline LLC, 2929 Walnut Street, Suite 1700, Philadelphia

Drugs

Drug	Countries
EXDENSUR	Estonia, Lithuania, United States

Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.