SUNLENCA Solution for injection Ref.[50154] Active ingredients: Lenacapavir

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

Product name and form

Sunlenca 464 mg solution for injection.

Pharmaceutical Form

Solution for injection (injection).

Clear, yellow to brown solution.

Qualitative and quantitative composition

Each single-dose vial contains lenacapavir sodium equivalent to 463.5 mg of lenacapavir in 1.5 mL.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lenacapavir

Lenacapavir is a multistage, selective inhibitor of HIV-1 capsid function that directly binds to the interface between capsid protein (CA) subunits. Lenacapavir inhibits HIV-1 replication by interfering with multiple, essential steps of the viral lifecycle, including capsid-mediated nuclear uptake of HIV-1 proviral DNA, virus assembly and release, and capsid core formation.
List of Excipients

Macrogol (E1521)
Water for injections

Pack sizes and marketing

Sunlenca injection is packaged in a dosing kit containing:

  • 2 clear glass vials, each containing 1.5 mL solution for injection. Vials are sealed with an elastomeric butyl rubber closure and aluminum overseal with flip off cap;
  • 2 vial access devices, 2 disposable syringes, and 2 injection safety needles for subcutaneous injection (22-gauge, 12.7 mm).

Marketing authorization holder

Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

Marketing authorization dates and numbers

EU/1/22/1671/02

Drugs

Drug Countries
SUNLENCA Austria, Estonia, France, Croatia, Ireland, Israel, Italy, Lithuania, Romania, United Kingdom
 
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.

⇈