Lenacapavir

Lenacapavir

Another Name
Sunlenca,Gilead GS-620,雷纳卡韦
Indications
Treatment of HIV-1 infection
Reg No
03L1316/25
Inspection No
647-25
dosage form:Tablets
Specs:300mg * 5 Pills
Indate:2 Years
Date：2025-6-8 Views：901
Drug Info

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciLenacap safely and effectively. See full prescribing information for LuciLenacap.

INDICATIONS AND USAGE

LuciLenacap, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

DOSAGE AND ADMINISTRATION

Recommended Dosage

Initiation with one of two options followed by once every 6-months maintenance dosing.

Tablets may be taken without regard to food.

LuciLenacap Dosing Schedule

Treatment PhaseDayDosage & Administration
Initiation Option 1Day 1– 927 mg subcutaneous injection (2 × 1.5 mL)
– 600 mg orally (2 × 300 mg tablets)
Day 2– 600 mg orally (2 × 300 mg tablets)
Initiation Option 2Day 1– 600 mg orally (2 × 300 mg tablets)
Day 2– 600 mg orally (2 × 300 mg tablets)
Day 8– 300 mg orally (1 × 300 mg tablet)
Day 15– 927 mg subcutaneous injection (2 × 1.5 mL)
MaintenanceEvery 6 months– 927 mg subcutaneous injection (2 × 1.5 mL), starting from the date of the last injection
Missed Dose Handling> 28 weeks since last injection– Restart from Day 1 using either Initiation Option 1 or Option 2
Note—– Two 1.5 mL subcutaneous injections are required for a complete 927 mg dose

DOSAGE FORMS AND STRENGTHS

Tablets: 300 mg x 5 tablets

CONTRAINDICATIONS

Concomitant administration of Lucil enacap is contraindicated with strong CYP3A inducers.

WARNINGS AND PRECAUTIONS

Immune reconstitution syndrome: May necessitate further evaluation and treatment.

Residual concentrations of lenacapavir may remain in systemic circulation for up to 12 months or longer. Counsel patients regarding the dosing schedule; non-adherence could lead to loss of virologic response and development of resistance.

May increase exposure and risk of adverse reactions to drugs primarily metabolized by CYP3A initiated within 9 months after the last subcutaneous dose of LuciL enacap. discontinued, initiate an alternative, fully suppressive antiretroviral regimen where possible , ter than 28 weeks after the final injection of LuciL enacap. If virologic failure occurs, switch an alternative regimen if possible.

Injection site reactions may occur, and nodules and indurations may be persistent.

Most common adverse reactions (incidence greater than or equal to 3%, all grades) are nausea an njection site reactions.

DRUG INTERACTIONS

Consult the Full Prescribing Information prior to and during treatment for important drug interactions.

Storage Instructions

  • Recommended storage temperature:
    20°C to 25°C (68°F to 77°F)
  • Permitted temperature excursions:
    Between 15°C and 30°C (59°F and 86°F)
  • Conditions:
    • Store in USP Controlled Room Temperature environment
    • Protect from moisture

Original article, if reprinted, please indicate the link to this article: https://lucius-pharmaceuticals.com/drug/lenacapavir/

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