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Acquiring SUNLENCA® for your practice

Once prescribed, SUNLENCA can be ordered through the Gilead-designated specialty pharmacy or an authorized specialty distributor as determined by your patient's insurance.

Specialty Pharmacy

If obtaining SUNLENCA through a pharmacy, SUNLENCA will only be available through the authorized specialty pharmacy*, which is equipped to facilitate dispensing, reimbursement, and case management.

CVS Specialty is the Specialty Pharmacy for SUNLENCA.

CVS Specialty may be able to:

  • Provide benefits verification to confirm coverage for your patient
  • Provide prior authorization and appeals support, if applicable
  • Coordinate with your patient and office to deliver SUNLENCA around scheduled, twice-yearly injection appointments
  • Collect any medication-related co-pays or coinsurance from your patient
  • Coordinate with Advancing Access® to support your patient, if applicable

Initiation Guide

Learn more about how to initiate SUNLENCA in your practice

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In some cases, the authorized specialty pharmacy can be used to acquire SUNLENCA when it is covered under the patient's medical benefit, via an Assignment of Benefits (AOB) process.

Specialty Distributor (Buy-and-Bill Process)

With buy-and-bill, prescribed SUNLENCA can be acquired through an authorized specialty distributor if your patient's insurance requires it, or if you choose to utilize buy-and-bill. Your office will be responsible for storing the medication and having it available for your patient's scheduled injection appointment. Your practice will bill the health plan for reimbursement of SUNLENCA and collect the co-pay and coinsurance from each patient.

In many cases, only the injectable component will be covered under medical benefit and acquired via the buy-and-bill process.

The oral component of SUNLENCA is typically ordered from the specialty pharmacy. The specialty pharmacy will work with your office to coordinate the shipment of the oral component.

Distributor
Telephone
Website
Cardinal Health Specialty
Telephone (866) 677-4844
ASD Healthcare
Telephone (800) 746-6273

The list of authorized distributors is updated periodically and subject to change.
Please visit gilead.com/purpose/medication-access/authorized-distributors for updates.

Initiation Guide

Learn more about how to initiate SUNLENCA in your practice

Download icon.

Click here to download

VIEW EDUCATIONAL RESOURCES FOR HCPs AND PATIENTS

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 infection failing their current antiretroviral regimen 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 infection failing their current antiretroviral regimen 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 infection failing their current antiretroviral regimen 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.

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 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.
  • Missed Dose: During the maintenance period, if more than 28 weeks have elapsed since the last injection and if clinically appropriate to continue SUNLENCA treatment, restart the initiation dosage regimen from Day 1, Option 1 or Option 2.

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 infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

Please see full Prescribing Information for SUNLENCA.