Sunlenca

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 Dosage

  SUNLENCA 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: Initiation
  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)
  	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, 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)
  )

• 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 Dose

  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.

  Table 3 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 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 Injection	Recommendation
  More than 28 weeks	Reinitiate 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 Dose

  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.

  Table 3 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 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 Injection	Recommendation
  More than 28 weeks	Reinitiate 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 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 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

  

  

  

  

  

  )

Tablets: 300 mg

Injection: 463.5 mg/1.5 mL (309 mg/mL) in single-dose vials. (

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.