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Sunlenca® Dosing

SUNLENCA Is a Long-acting SC Injectable Administered Only Twice a Year1

A complete HIV-1 treatment regimen that includes SUNLENCA also requires an optimized background regimen1

According to the DHHS guidelines, for multiple or extensive drug resistance with few treatment options, a new regimen should include at least 2, and preferably 3, fully active agents (including those with novel mechanisms of action). If choosing a regimen with fewer than 3 fully active drugs, include as many fully active drugs as possible, along with potentially partially active drugs.2

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.1

Two ways to start SUNLENCA

Oral initiation allows therapeutic drug levels to be reached quickly. A treatment regimen incorporating SUNLENCA begins with 1 of the 2 initiation options, based upon your assessment of which is appropriate for your patient.1,3

Initiation Option 1 (Day 1 First SC Injection)

Initiation Option 2 (Day 15 First SC Injection)

Dosing Regimen
Initiation Option 1 (Day 1 First SC Injection)1

Dosing Regimen
Initiation Option 2 (Day 15 First SC Injection)1

  • Maintenance dosing is administered by subcutaneous injection every 6 months (26 weeks ±2 weeks)* regardless of the initiation regimen1
  • SUNLENCA injections must be administered by a healthcare provider1

From the date of the last injection.

Missed dose information

Planned missed injections1

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.

At 26 to 28 weeks since the last injection, patients should begin taking the maintenance oral dosage of 300 mg, taken once every 7 days for up to 6 months. Maintenance injections should resume within 7 days of the last oral dose.

Unplanned missed injections1

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 passed since the last injection and SUNLENCA tablets have not been taken, restart the initiation dosage regimen from Day 1, using Option 1 or Option 2, and then continue with maintenance injection dosing. Adherence to the injection dosing schedule is strongly recommended.

ADDING EVERY-6-MONTH subcutaneous injections of SUNLENCA TO AN OBR provides HTE ADULTS WITH A LONG-ACTING TREATMENT OPTION1

Click for Important Safety Information for SUNLENCA.

Storage and handling of SUNLENCA1

Icon of two tablets.

SUNLENCA tablets

  • Store at a controlled room temperature
     (20 °C-25 °C, 68 °F-77 °F)
  • SUNLENCA tablets are available in a bottle and blister packs
  • Keep bottle tightly closed
  • Dispense and store only in original bottle or blister pack
Injection set icon.

SUNLENCA injection

  • Store at a controlled room temperature
    (20 °C-25 °C,  68 °F-77 °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
  • Discard any unused portion of the solution
View step-by-step guidance on how to administer SUNLENCA

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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.

The information contained on this site is intended for healthcare provider audiences in the United States only. The content on this site may not apply to non-US audiences as regulatory control, legal requirements, and/or medical practices may vary in other countries.

SUNLENCA, the SUNLENCA Logo, ADVANCING ACCESS, BREAKING BARRIERS IN HIV TREATMENT, GILEAD, and the GILEAD Logo are trademarks of Gilead Sciences, Inc., or its related companies. All other marks are the property of their respective owners.

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