SUNLENCA® (lenacapavir) Safety Profile | HCP Site

SUNLENCA® Has a Demonstrated Safety and Tolerability Profile Through Week 52 in the CAPELLA Clinical Trial^1-3

Adverse Reactions (All Grades) Reported in ≥3% of HTE Adults With HIV-1 Receiving SUNLENCA Through Week 52 (N=72)¹

Injection site reactions reported in >1% of participants were swelling (36%), pain (31%), erythema (31%), nodule (25%), induration (15%), pruritus (6%), extravasation (3%), and mass (3%). Injection site reactions reported in 1% of participants included discomfort, hematoma, edema, and ulcer¹
- The median time to resolution of all injection site reactions excluding nodules and indurations was 5 days^1,*
Most injection site reactions were mild (Grade 1, 44%) or moderate (Grade 2, 17%)¹
- Four percent of participants experienced a severe (Grade 3) injection site reaction (erythema, pain, swelling) that resolved within 15 days¹
One participant discontinued SUNLENCA after the Week 52 injection due to an injection site nodule (Grade 1)^1,3,†
Improper administration (intradermal injection) has been associated with serious injection site reactions¹

The range of all injection site reactions was 1 to 183 days. The median time to resolution of nodules and indurations was 148 (range: 41 to 727) and 70 (range: 3 to 252) days, respectively.¹ When reported, nodules and indurations were palpable but not visible and were approximately 1 to 4 cm in size. Qualitative descriptions were not routinely reported, nor were measurements routinely performed or standardized.¹

No PARTICIPANTS who received
SUNLENCA experienced a
study drug–related serious
adverse event or death
through week 52 (N=72)^2,3

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Learn about twice-yearly dosing with SUNLENCA in addition to an OBR

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 whose current antiretroviral regimen is failing 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 whose current antiretroviral regimen is failing due to resistance, intolerance, or safety considerations.

Tap for Important Safety Information

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 whose current antiretroviral regimen is failing 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. Improper administration (intradermal injection) has been associated with serious injection site reactions.

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 injection 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.
Planned missed injections: If scheduled injection is to be missed by more than 2 weeks, SUNLENCA tablets may be used for oral bridging for up to 6 months until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) every 7 days.
Unplanned missed injections: During the maintenance period, if more than 28 weeks have elapsed since the last injection and tablets have not been taken for oral bridging, restart the initiation dosage regimen from Day 1, using Option 1 or Option 2, if clinically appropriate.

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 with HIV-1 infection should be informed of the potential risks of breastfeeding.

Please see full Prescribing Information for SUNLENCA.