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.
Initiation Option 1 |
Day 1 | 927 mg by subcutaneous injection (2 x 1.5 mL injections) 600 mg orally (2 x 300 mg tablets) |
Day 2 | 600 mg orally (2 x 300 mg tablets) |
Initiation Option 2 |
Day 1 | 600 mg orally (2 x 300 mg tablets) |
Day 2 | 600 mg orally (2 x 300 mg tablets) |
Day 8 | 300 mg orally (1 x 300 mg tablet) |
Day 15 | 927 mg by subcutaneous injection (2 x 1.5 mL injections) |
Maintenance |
927 mg by subcutaneous injection (2 x 1.5 mL injections) every 6 months (26 weeks) from the date of the last injection +/-2 weeks. |
• Missed dose: If more than 28 weeks since last injection and clinically appropriate to continue LuciLenacap, restart initiation from Day 1, using either Option 1 or Option 2.
• Two 1.5 mL subcutaneous injections are required for complete dose.
DOSAGE FORMS AND STRENGTHS
Tablets: 300 mg×5 tablets
CONTRAINDICATIONS
Concomitant administration of LuciLenacap 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 LuciLenacap.
If discontinued, initiate an alternative, fully suppressive antiretroviral regimen where possible no later than 28 weeks after the final injection of LuciLenacap. If virologic failure occurs, switch to an alternative regimen if possible.
Injection site reactions may occur, and nodules and indurations may be persistent.
ADVERSE REACTIONS
Most common adverse reactions (incidence greater than or equal to 3%, all grades) are nausea and injection site reactions.
DRUG INTERACTIONS
• Consult the Full Prescribing Information prior to and during treatment for important drug interactions.
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
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