Sunlenca

Sunlenca is an FDA-registered drug product whose active ingredient is LENACAPAVIR SODIUM. It is labelled by Gilead Sciences, Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 61958-3001, application NDA215974, label effective 20260827. It is one of 2 FDA drug label records sharing the active ingredient LENACAPAVIR SODIUM. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing LENACAPAVIR SODIUM are most often described in connection with: antiretroviral regimen, treatment hiv-, heavily treatment-experienced, oral loading, human immunodeficiency, virus type, multidrug resistant, failing due. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE SUNLENCA, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, is indicated: in combination with other antiretroviral(s), for the treatment of 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. ( 1.1 ) for oral loading as a component of the initiation regimen for BIXLENVO (bictegravir [BIC]/lenacapavir [LEN]), a complete regimen for the treatment of HIV-1 infection, in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of BIXLENVO. ( 1.2 ) 1.1 Treatment of HIV-1 in Heavily Treatment-Experienced Adults 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. 1.2 Oral Loading for Initiation of BIXLENVO SUNLENCA tablets are indicated for oral loading as a component of the initiation regimen for BIXLENVO (bictegravir [BIC]/lenacapavir [LEN]), a complete regimen for treatment of HIV-1 infection, in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of BIXLENVO [see Dosage and Administration (2.3) ] .

2 DOSAGE AND ADMINISTRATION Recommended dosage in heavily treatment-experienced adults: 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 ) 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. Recommended dosage for oral loading for initiation of BIXLENVO: Refer to Table 3 of the full prescribing information for dosing schedule. ( 2.3 ) 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. ( 2.4 ) Unplanned missed injections: If more than 28 weeks have elapsed 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. ( 2.4 ) SUNLENCA injection is for subcutaneous administration only. Two 1.5 mL injections are required for complete dose. ( 2.5 ) 2.1 Adherence to Treatment Regimen in Heavily Treatment-Experienced Adults Prior to starting SUNLENCA for the treatment of HIV-1 in heavily treatment-experienced adults, 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) ] . 2.2 Recommended Dosage for Treatment of HIV-1 in Heavily Treatment-Experienced Adults SUNLENCA can be initiated using one of the two recommended dosage regimens in Table 1 and Table 2 below. 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 for Treatment of HIV-1 in Heavily Treatment-Experienced Adults, Option 1 Treatment Time Dosage of SUNLENCA: Initiation Day 1 927 mg by subcutaneous injection (2 × 1.5 mL injections) and 600 mg orally (2 × 300 mg tablets) Day 2 600 mg orally (2 × 300 mg tablets) Dosage of SUNLENCA: Maintenance Every 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 for Treatment of HIV-1 in Heavily Treatment-Experienced Adults, Option 2 Treatment Time Dosage of SUNLENCA: Initiation 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) Dosage of SUNLENCA: Maintenance Every 6 months (26 weeks) From the date of the last injection. +/-2 weeks 927 mg by subcutaneous injection (2 × 1.5 mL injections) 2.3 Recommended Dosage for Oral Loading for Initiation of BIXLENVO SUNLENCA tablets are used as a component of the initiation regimen for BIXLENVO. See BIXLENVO prescribing information. The BIXLENVO dosing schedule in adults requires a two-day initiation regimen of BIXLENVO tablets plus SUNLENCA tablets taken orally, followed by a maintenance regimen of one tablet of BIXLENVO taken orally once daily (see Table 3 ). BIXLENVO must be taken with SUNLENCA tablets during the two-day initiation period. SUNLENCA is only indicated for the oral initiation of BIXLENVO treatment and is not to be used for the maintenance of BIXLENVO treatment. BIXLENVO and SUNLENCA tablets may be taken with or without food. Table 3 SUNLENCA Tablets: Recommended Dosage for Oral Loading for Initiation of BIXLENVO Treatment Time Dosage: Initiation (BIXLENVO and SUNLENCA) Day 1 BIXLENVO 75 mg/50 mg (1 tablet) orally See BIXLENVO prescribing information. and SUNLENCA 600 mg orally (2 × 300 mg tablets) Day 2 BIXLENVO 75 mg/50 mg (1 tablet) orally and SUNLENCA 600 mg orally (2 × 300 mg tablets) Dosage: Maintenance (BIXLENVO only) Day 3 and thereafter BIXLENVO 75 mg/50 mg (1 tablet) orally once daily 2.4 Recommended Dosing Schedule for Missed Dose Treatment of HIV-1 in Heavily Treatment-Experienced Adults: 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 4 below for the recommended dosage after planned missed injections. Table 4 Recommended Dosage after Planned Missed Injections: Weekly Oral Maintenance Time since Last Injection Recommendation 26 to 28 weeks Maintenance 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 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 5 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 5 Recommended Dosage after Unplanned Missed Injections Time since Last Injection Recommendation More than 28 weeks Reinitiate with Option 1 (Table 1) or Option 2 (Table 2) and then continue with maintenance injection dosing. Oral Loading for Initiation of BIXLENVO: Missed Oral Initiation Dose If the Day 1 or Day 2 oral initiation dose of SUNLENCA (600 mg; see Table 3 ) is missed, take it as soon as possible. Do not take SUNLENCA Day 1 and Day 2 oral initiation doses on the same day. For BIXLENVO missed dose instructions, see BIXLENVO prescribing information. 2.5 Preparation and Administration of Subcutaneous Injection 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 SUNLENCA injection kits available [see How Supplied/Storage and Handling (16) ] : Vial Access Device Injection Kit Withdrawal Needle Injection Kit (withdrawal needle may be supplied with or without a safety shield) The Vial Access Device Injection Kit differs from the Withdrawal Needle Injection Kit only in how SUNLENCA injection is prepared (the components and associated method for withdrawal of the solution from the vials. The Withdrawal Needle Injection Kit contains withdrawal needles that may be supplied with or without a safety shield. The presence or absence of a safety shield does not change how SUNLENCA injection is prepared. 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 (withdrawal needle without safety shield) Figure 3 identifies the components for use in the administration steps for the Withdrawal Needle Injection Kit (withdrawal needle supplied without a safety shield), 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 (withdrawal needle without safety shield) Figure 4 SUNLENCA Injection Steps for Withdrawal Needle Injection Kit (withdrawal needle without safety shield) Withdrawal Needle Injection Kit (withdrawal needle with safety shield) Figure 5 identifies the components for use in the administration steps for the Withdrawal Needle Injection Kit (withdrawal needle supplied with a safety shield), and the administration steps are provided in Figure 6 . The 18-gauge safety needle is for withdrawal only in this kit. Figure 5 SUNLENCA Withdrawal Needle Injection Kit Components (withdrawal needle with safety shield) Figure 6 SUNLENCA Injection Steps for Withdrawal Needle Injection Kit (withdrawal needle with safety shield) Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6

4 CONTRAINDICATIONS 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 [see Drug Interactions (7.1) ] . Concomitant administration of SUNLENCA is contraindicated with strong CYP3A inducers. ( 4 )

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Immune Reconstitution Syndrome [see Warnings and Precautions (5.1) ] Injection Site Reactions [see Warnings and Precautions (5.3) ]. Most common adverse reactions (incidence greater than or equal to 3%, all grades) are nausea and injection site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Treatment of HIV-1 in Heavily Treatment-Experienced Adults The primary safety assessment of SUNLENCA was based on data from heavily treatment-experienced adult participants with HIV who received SUNLENCA in a Phase 2/3 trial (CAPELLA; N=72) through Week 52 (median duration on study of 71 weeks) [see Clinical Studies (14.1) ] , as well as supportive data in treatment-naïve adult participants with HIV who received SUNLENCA in a Phase 2 trial (CALIBRATE; N=157) through Week 54 (median duration of exposure of 66 weeks). The most common adverse reactions (all Grades) reported in at least 3% of participants in CAPELLA were nausea and injection site reactions. The proportion of participants in CAPELLA who discontinued treatment with SUNLENCA due to adverse events, regardless of severity, was 1% (Grade 1 injection site nodule in 1 participant). Table 6 displays the frequency of adverse reactions (all Grades) greater than or equal to 3% in the SUNLENCA group. Table 6 Adverse Reactions (All Grades) Reported in ≥ 3% Frequencies of adverse reactions are based on all adverse events attributed to trial drug by the investigator, based on all participants (cohorts 1 and 2) in CAPELLA. of Heavily Treatment Experienced Adults with HIV-1 Receiving SUNLENCA in CAPELLA (Week 52 Analysis) Adverse Reactions SUNLENCA + Background Regimen (N=72) Injection Site Reactions 65% Nausea 4% The majority (96%) of all adverse reactions associated with SUNLENCA were mild or moderate in severity. Injection-Associated Adverse Reactions Local Injection Site Reactions (ISRs) : The most frequent adverse reactions were ISRs. Of the 72 participants in CAPELLA, 65% had experienced an ISR attributed to study drug through at least the Week 52 visit. Most participants had mild (Grade 1, 44%) or moderate (Grade 2, 17%) ISRs. Four percent of participants experienced a severe (Grade 3) ISR (erythema, pain, swelling) that resolved within 15 days. The ISRs reported in more than 1% of participants were swelling (36%), pain (31%), erythema (31%), nodule (25%), induration (15%), pruritus (6%), extravasation (3%) and mass (3%). ISRs reported in 1% of participants included discomfort, hematoma, edema, and ulcer. Nodules and indurations at the injection site took longer to resolve than other ISRs. The median time to resolution of all ISRs, excluding nodules and indurations, was 5 days (range: 1 to 183). The median time to resolution of nodules and indurations associated with the first injections of SUNLENCA was 148 (range: 41 to 727) and 70 (range: 3 to 252) days, respectively. 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. Qualitative descriptions of injection site nodules and indurations were not routinely reported, but, where reported, the majority of injection site nodules and indurations were palpable but not visible. Measurements of injection site nodules and indurations were not routinely performed or standardized, but where measurements were reported, the maximum size for the majority of injection site nodules and indurations was approximately 1 to 4 cm [see Warnings and Precautions (5.3) ] . Laboratory Abnormalities The frequency of laboratory abnormalities (Grades 3 to 4) occurring in at least 2% of participants in CAPELLA are presented in Table 7 . A causal association between SUNLENCA and these laboratory abnormalities has not been established. Table 7 Selected Laboratory Abnormalities (Grades 3 to 4) Reported in ≥ 2% of Participants Receiving SUNLENCA in CAPELLA (Week 52 Analysis) Laboratory Parameter Abnormality SUNLENCA + Background Regimen (N=72) Frequencies are based on treatment-emergent laboratory abnormalities in all participants (cohorts 1 and 2) in CAPELLA. Percentages were calculated based on the number of participants with post-baseline toxicity grades for each laboratory parameter (n=72 for all parameters except hyperglycemia fasting n=57). ALT= alanine aminotransferase; AST= aspartate aminotransferase; ULN = upper limit of normal Creatinine ( >1.8 × ULN or ≥1.5 × baseline) 13% Glycosuria (>2+) Grade 3 only (no Grade 4 values reported). 6% Hyperglycemia (fasting) (>250 mg/dL) 5% Proteinuria (>2+) 4% ALT (≥5 × ULN) 3% AST (≥5 × ULN) 3% Direct Bilirubin (>ULN) 3% 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postmarketing use. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General disorders and administration site conditions Injection site necrosis [see Warnings and Precautions (5.3) ] .

FDA lists 2 drug label records with LENACAPAVIR SODIUM as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Sunlenca used for?
1 INDICATIONS AND USAGE SUNLENCA, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, is indicated: in combination with other antiretroviral(s), for the treatment of 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. ( 1.1 ) for oral loading as …

Who makes Sunlenca?
Gilead Sciences, Inc. is the labeler of record for Sunlenca. 2 FDA label records share the active ingredient LENACAPAVIR SODIUM, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Sunlenca come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Sunlenca prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing LENACAPAVIR SODIUM?
Yes. 2 FDA drug label records list LENACAPAVIR SODIUM as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Sunlenca been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.