LuciLenacap 300 MG (Lenacapavir)

Description

Lenacapavir Tablets 300mg

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 fai ling 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.

Initation Option 1

Day 1 927 mg by subcutaneous injection (21.5ml injections) 600mg orally (2300 mg tablets) Day 2 600 mg orally (2300 mg tablets) Initation Option 2 Day 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 tablets) Day 15 927 mg by subcutaneous injection (21.5ml injections) Maintenance 927 mg by subcutaneous injection (21.5ml injections) every 6 months (26 weeks) from the date of the last injection +/-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 l.5 mL subcutaneous injections are required for complete dose.

DOSAGE FORMS AND STRENGTHS

Tablets: 300 mgx5 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 po ssible , 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 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.