Dosage & administration
| Initiation Option 1 | |
| Day 1 | 927 mg by subcutaneous injection (2 × 1.5 mL injections) 600 mg orally (2 × 300 mg tablets) |
| Day 2 | 600 mg orally (2 × 300 mg tablets) |
| Initiation 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 tablet) |
| Day 15 | 927 mg by subcutaneous injection (2 × 1.5 mL injections) |
| Maintenance | |
| 927 mg by subcutaneous injection (2 × 1.5 mL injections) every 6 months (26 weeks) from the date of the last injection +/-2 weeks. | |
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Sunlenca prescribing information
Dosage and Administration (Prior to starting SUNLENCA, healthcare providers should carefully select patients who agree to the required every 6 month injection dosing schedule and counsel patients about the importance of adherence to scheduled SUNLENCA dosing visits and concomitant oral antiretroviral therapy to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance with missed doses [see Warnings and Precautions (5.2), Microbiology (12.4)] .Planned Missed Injections During the maintenance period, if a patient plans to miss a scheduled 6-month injection visit by more than 2 weeks, SUNLENCA tablets may be taken for up to 6 months until injections resume. Refer to Table 3 below for the recommended dosage after planned missed injections.
Unplanned Missed Injections Patients who miss a scheduled injection visit should be clinically reassessed, including consideration of lenacapavir resistance testing, to ensure resumption of therapy remains appropriate. During the maintenance period, if more than 28 weeks have elapsed since the last injection and SUNLENCA tablets have not been taken, see Table 4 below for the recommended dosage after unplanned missed injections. Adherence to the injection dosing schedule is strongly recommended [see Dosage and Administration (2.1)and Microbiology (12.4)] .
SUNLENCA injection is only for subcutaneous administration into the abdomen by a healthcare provider. Do NOT administer intradermally due to risk of serious injection site reactions [see Warnings and Precautions (5.3)]. Use aseptic technique. Visually inspect the solution in the vials and prepared syringe for particulate matter and discoloration prior to administration. SUNLENCA injection is a yellow solution. Do not use SUNLENCA injection if the solution is discolored or if it contains particulate matter. Once the solution is withdrawn from the vials, the subcutaneous injections should be administered as soon as possible [see How Supplied/Storage and Handling (16)]. There are two available injection kits, which differ only in how SUNLENCA injection is prepared (the components and associated method for withdrawal of the solution from the vials) [see How Supplied/Storage and Handling (16)] . Refer to the figures below for the relevant injection kit.The injection kit components are for single use only. Two 1.5 mL injections are required for a complete dose. Vial access device injection kit Figure 1 identifies the components for use in the administration steps for the vial access device injection kit, and the administration steps are provided in Figure 2. Use of a vial access device is required in this kit. Figure 1 SUNLENCA Vial Access Device Injection Kit Components  Figure 2 SUNLENCA Injection Steps for Vial Access Device Injection Kit  Withdrawal needle injection kit Figure 3 identifies the components for use in the administration steps for the withdrawal needle injection kit, and the administration steps are provided in Figure 4. The 18-gauge needle is for withdrawal only in this kit. Figure 3 SUNLENCA Withdrawal Needle Injection Kit Components  Figure 4 SUNLENCA Injection Steps for Withdrawal Needle Injection Kit  | 11/2024 | ||||||||
Warnings and Precautions (Administration of SUNLENCA may result in local injection site reactions (ISRs). If clinically significant ISRs occur, evaluate and institute appropriate therapy and follow-up. Manifestations of ISRs may include swelling, pain, erythema, nodule, induration, pruritus, extravasation or mass. Nodules and indurations at the injection site may take longer to resolve than other ISRs. In clinical studies, after a median follow-up of 553 days, 30% of nodules and 13% of indurations (in 10% and 1% of participants, respectively) associated with the first injections of SUNLENCA had not fully resolved. Measurements and qualitative assessments of ISRs were not routinely reported. Where described, the majority of the injection site nodules and indurations were palpable but not visible, and had a maximum size of approximately 1 to 4 cm [see Adverse Reactions (6.1)] .The mechanism driving the persistence of injection site nodules and indurations in some patients is not fully understood, but based on available data, they may be related to the presence of the subcutaneous drug depot. In some patients who had a skin biopsy performed of an injection site nodule or induration, dermatopathology revealed foreign body inflammation or granulomatous response. Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer [see Adverse Reactions (6)] . Ensure SUNLENCA is only administered subcutaneously in the abdomen[see Dosage and Administration (2.4)] . | 11/2024 |
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.
- Recommended dosage – Initiation with one of two options followed by once every 6 months maintenance injection dosing. Tablets may be taken without regard to food. ()
2.2 Recommended DosageSUNLENCA can be initiated using one of the two recommended dosage regimens in Table 1and Table 2below. Maintenance dosing is administered by subcutaneous injection every 6 months regardless of the initiation regimen. Healthcare providers should determine the appropriate initiation regimen for the patient. SUNLENCA oral tablets may be taken with or without food
[see Clinical Pharmacology (12.3)].Table 1 Recommended Treatment Regimen for SUNLENCA Initiation and Maintenance, Option 1 Treatment Time Dosage of SUNLENCA: InitiationDay 1 927 mg by subcutaneous injection (2 × 1.5 mL injections)
600 mg orally (2 × 300 mg tablets)Day 2 600 mg orally (2 × 300 mg tablets) Dosage of SUNLENCA: MaintenanceEvery 6 months (26 weeks)From the date of the last injection.+/-2 weeks 927 mg by subcutaneous injection (2 × 1.5 mL injections) Table 2 Recommended Treatment Regimen for SUNLENCA Initiation and Maintenance, Option 2 Treatment Time Dosage of SUNLENCA: InitiationDay 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 by subcutaneous injection (2 × 1.5 mL injections) Dosage of SUNLENCA: MaintenanceEvery 6 months (26 weeks)From the date of the last injection.+/-2 weeks 927 mg by subcutaneous injection (2 × 1.5 mL injections)
| Initiation Option 1 | |
| Day 1 | 927 mg by subcutaneous injection (2 × 1.5 mL injections) 600 mg orally (2 × 300 mg tablets) |
| Day 2 | 600 mg orally (2 × 300 mg tablets) |
| Initiation 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 tablet) |
| Day 15 | 927 mg by subcutaneous injection (2 × 1.5 mL injections) |
| Maintenance | |
| 927 mg by subcutaneous injection (2 × 1.5 mL injections) every 6 months (26 weeks) from the date of the last injection +/-2 weeks. | |
- 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. Recommended dosage is 300 mg orally once every 7 days. ()
2.3 Recommended Dosing Schedule for Missed DosePlanned Missed InjectionsDuring the maintenance period, if a patient plans to miss a scheduled 6-month injection visit by more than 2 weeks, SUNLENCA tablets may be taken for up to 6 months until injections resume. Refer to Table 3 below for the recommended dosage after planned missed injections.Table 3 Recommended Dosage after Planned Missed Injections: Weekly Oral Maintenance Time since Last InjectionRecommendation 26 to 28 weeksMaintenance oral dosage of 300 mg taken once every 7 days for up to 6 months.
Resume the maintenance injection dosage within 7 days after the last oral dose.Unplanned Missed InjectionsPatients who miss a scheduled injection visit should be clinically reassessed, including consideration of lenacapavir resistance testing, to ensure resumption of therapy remains appropriate. During the maintenance period, if more than 28 weeks have elapsed since the last injection and SUNLENCA tablets have not been taken, see Table 4 below for the recommended dosage after unplanned missed injections. Adherence to the injection dosing schedule is strongly recommended[see Dosage and Administration (2.1)and Microbiology (12.4)].Table 4 Recommended Dosage after Unplanned Missed Injections Time since Last InjectionRecommendation More than 28 weeksReinitiate with Option 1 (Table 1) or Option 2 (Table 2) and then continue with maintenance injection dosing. - Unplanned missed injections: If more than 28 weeks since last injection and tablets have not been taken for oral bridging, restart initiation from Day 1 (using Option 1 or Option 2) if clinically appropriate. ()
2.3 Recommended Dosing Schedule for Missed DosePlanned Missed InjectionsDuring the maintenance period, if a patient plans to miss a scheduled 6-month injection visit by more than 2 weeks, SUNLENCA tablets may be taken for up to 6 months until injections resume. Refer to Table 3 below for the recommended dosage after planned missed injections.Table 3 Recommended Dosage after Planned Missed Injections: Weekly Oral Maintenance Time since Last InjectionRecommendation 26 to 28 weeksMaintenance oral dosage of 300 mg taken once every 7 days for up to 6 months.
Resume the maintenance injection dosage within 7 days after the last oral dose.Unplanned Missed InjectionsPatients who miss a scheduled injection visit should be clinically reassessed, including consideration of lenacapavir resistance testing, to ensure resumption of therapy remains appropriate. During the maintenance period, if more than 28 weeks have elapsed since the last injection and SUNLENCA tablets have not been taken, see Table 4 below for the recommended dosage after unplanned missed injections. Adherence to the injection dosing schedule is strongly recommended[see Dosage and Administration (2.1)and Microbiology (12.4)].Table 4 Recommended Dosage after Unplanned Missed Injections Time since Last InjectionRecommendation More than 28 weeksReinitiate with Option 1 (Table 1) or Option 2 (Table 2) and then continue with maintenance injection dosing. - SUNLENCA injection is for subcutaneous administration only. Two 1.5 mL injections are required for complete dose. ()
2.4 Preparation and Administration of Subcutaneous InjectionSUNLENCA injection is only for subcutaneous administration into the abdomen by a healthcare provider. Do NOT administer intradermally due to risk of serious injection site reactions[see Warnings and Precautions (5.3)].Use aseptic technique. Visually inspect the solution in the vials and prepared syringe for particulate matter and discoloration prior to administration. SUNLENCA injection is a yellow solution. Do not use SUNLENCA injection if the solution is discolored or if it contains particulate matter. Once the solution is withdrawn from the vials, the subcutaneous injections should be administered as soon as possible
[see How Supplied/Storage and Handling (16)].There are two available injection kits, which differ only in how SUNLENCA injection is prepared (the components and associated method for withdrawal of the solution from the vials)[see How Supplied/Storage and Handling (16)]. Refer to the figures below for the relevant injection kit.The injection kit components are for single use only. Two 1.5 mL injections are required for a complete dose.
Vial access device injection kitFigure 1 identifies the components for use in the administration steps for the vial access device injection kit, and the administration steps are provided in Figure 2. Use of a vial access device is required in this kit.
Figure 1 SUNLENCA Vial Access Device Injection Kit ComponentsFigure 2 SUNLENCA Injection Steps for Vial Access Device Injection KitWithdrawal needle injection kitFigure 3 identifies the components for use in the administration steps for the withdrawal needle injection kit, and the administration steps are provided in Figure 4. The 18-gauge needle is for withdrawal only in this kit.Figure 3 SUNLENCA Withdrawal Needle Injection Kit ComponentsFigure 4 SUNLENCA Injection Steps for Withdrawal Needle Injection KitFigure 1 Figure 2 Figure 3 Figure 4
Tablets: 300 mg
Injection: 463.5 mg/1.5 mL (309 mg/mL) in single-dose vials. (
Tablets: 300 mg
Injection: 463.5 mg/1.5 mL (309 mg/mL) in single-dose vials.
SUNLENCA tablets: Each tablet contains 300 mg of lenacapavir (present as 306.8 mg of lenacapavir sodium). The tablets are beige, capsule-shaped, film-coated, and debossed with 'GSI' on one side of the tablet and '62L' on the other side of the tablet.
SUNLENCA injection: Each single-dose vial contains 463.5 mg/1.5 mL (309 mg/mL) of lenacapavir (present as 473.1 mg/1.5 mL of lenacapavir sodium). The lenacapavir injectable solution is sterile, preservative-free, clear, and yellow with no visible particles.
There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to SUNLENCA during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.
Concomitant administration of SUNLENCA with strong CYP3A inducers is contraindicated due to decreased lenacapavir plasma concentrations, which may result in the loss of therapeutic effect and development of resistance to SUNLENCA
Lenacapavir is a substrate of P-gp, UGT1A1, and CYP3A.
Drugs that are strong or moderate inducers of CYP3A may significantly decrease plasma concentrations of lenacapavir
Combined P-gp, UGT1A1, and strong CYP3A inhibitors may significantly increase plasma concentrations of SUNLENCA. Concomitant administration of SUNLENCA with these inhibitors is not recommended.