SUNLENCA

Generic Name/API: lenacapavir

Manufacturer: Gilead Sciences, Inc.

Dosage Forms & Strength & Pack Size:
Tablets: 300 mg. 1 pouch containing 5 tablets
Injection: 463.5 mg/1.5 mL (309 mg/mL) in single-dose vials. 2 x 1.5 mL single-dose vials

Storage:
SUNLENCA tablets, 300 mg are beige, capsule-shaped, and film-coated with “GSI”
debossed on one side and “62L” on the other side.
SUNLENCA tablets are packaged as follows:
• SUNLENCA 4-Tablets™ blister pack contains 4 tablets (NDC 61958-3001-1)
• SUNLENCA 5-Tablets™ blister pack contains 5 tablets (NDC 61958-3001-2)
Within the blister packs, tablets are packaged in a clear blister film sealed to a foil
lidding material. The blister card is fitted between two paperboard cards, and
packaged with silica gel desiccant in a sealed child-resistant flexible laminated pouch.
Store at 20 °C – 25 °C (68 °F – 77 °F), excursions permitted to 15 °C – 30 °C
(59 °F – 86 °F).
Dispense and store only in original blister pack.

SUNLENCA injection is packaged in a dosing kit (NDC 61958-3002-1) containing:
• 2 single-dose clear glass vials, each containing sufficient volume to allow
withdrawal of 463.5 mg/1.5 mL (309 mg/mL) of lenacapavir. The injection solution
is sterile, preservative-free, clear, and yellow with no visible particles. Vials are
sealed with a stopper and aluminium overseal with flip-off cap.
• 2 vial access devices, 2 disposable syringes, and 2 injection safety needles for
subcutaneous injection (22-gauge, ½ inch).
The vial stoppers are not made with natural rubber latex.
Store at 20 °C – 25 °C (68 °F – 77 °F), excursions permitted to 15 °C – 30 °C
(59 °F – 86 °F).
Keep the vials in the original carton until just prior to preparation of the injections in
order to protect from light.
Once the solution has been drawn into the syringes, the injections should be
administered as soon as possible.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION
SUNLENCA, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (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.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

Coadministration: Concomitant administration of SUNLENCA is contraindicated with strong CYP3A inducers.
WARNINGS AND PRECAUTIONS

Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported in patients treated with combination antiretroviral (ARV) therapy.
INDICATION
SUNLENCA, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (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.

Long-acting properties and potential associated risks with SUNLENCA: Residual concentrations of SUNLENCA may remain in the systemic circulation of patients for up to 12 months or longer. SUNLENCA may increase exposure, and potential risk of adverse reactions, to drugs primarily metabolized by CYP3A initiated within 9 months after last injection. Counsel patients regarding the dosing schedule because nonadherence could lead to loss of virologic response and development of resistance. If virologic failure occurs, switch to an alternative regimen if possible. If discontinuing SUNLENCA, begin alternate suppressive ARV regimen within 28 weeks from last injection.
Injection site reactions may occur, and nodules and indurations may be persistent.
ADVERSE REACTIONS

Most common adverse reactions (incidence ≥3%, all grades) are injection site reactions (65%) and nausea (4%).
DRUG INTERACTIONS

Prescribing information: Consult the full prescribing information for SUNLENCA for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
Enzymes/transporters: Drugs that are strong or moderate inducers of CYP3A may significantly decrease the concentration of SUNLENCA. Drugs that strongly inhibit CYP3A, P-gp, and UGT1A1 together may significantly increase the concentration of SUNLENCA. SUNLENCA may increase the exposure of drugs primarily metabolized by CYP3A, when initiated within 9 months after the last injection of SUNLENCA, which may increase the potential risk of adverse reactions.
DOSAGE AND ADMINISTRATION

Dosage: Initiation with 1 of 2 options, followed by maintenance dosing once every 6 months. Tablets may be taken with or without food.
Initiation Option 1: Day 1: 927 mg by subcutaneous injection and 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.
Maintenance: 927 mg by subcutaneous injection every 26 weeks +/- 2 weeks from date of last injection.
Missed Dose: During the maintenance period, if more than 28 weeks have elapsed since the last injection and if clinically appropriate to continue SUNLENCA treatment, restart the initiation dosage regimen from Day 1, Option 1 or Option 2.
PREGNANCY AND LACTATION

Pregnancy: There is insufficient human data on the use of SUNLENCA during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established.
Lactation: Individuals infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

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