The only twice-yearly dosing with YEZTUGO¹

Key Steps to Inject. For US healthcare providers only.

Whether you’re injecting YEZTUGO for the first time or during a follow-up visit, this video walks you through an overview of the injection process.

This video is a companion to the full Prescribing Information and Instructions for Use for YEZTUGO, which you should review for complete details.

Indication

YEZTUGO is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) kilograms who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating YEZTUGO.

Important Safety Information

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION

• Individuals must be tested for HIV-1 infection prior to initiating YEZTUGO, and with each subsequent injection of YEZTUGO, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of YEZTUGO by individuals with undiagnosed HIV-1 infection. Do not initiate YEZTUGO unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving YEZTUGO must transition to a complete HIV-1 treatment regimen.

Please see additional Important Safety Information later in this video and accompanying full Prescribing Information for YEZTUGO, including Boxed Warning, available at YeztugoPI.com.

YEZTUGO is a twice-yearly injectable PrEP option that is given every six months (after initiation dosing).

When someone starts YEZTUGO, initiation dosing consists of two 1.5-milliliter subcutaneous injections (927 milligrams total), administered in office with two 300–milligram oral tablets. On Day 2, two more 300-milligram oral tablets are taken at home (with or without food).

Continuation dosing is administered in office with two subcutaneous injections every six months, or 26 weeks, from the date of the last injection, plus or minus two weeks.

Confirm negative HIV-1 status prior to each injection of YEZTUGO, and additionally as clinically appropriate.

See full Prescribing Information for recommended dosage modifications when YEZTUGO is used concomitantly with strong or moderate CYP3A inducers.

Before you open the kit, verify that the name on the kit matches that of the person receiving the injections, as well as confirm the date of the last YEZTUGO injection to make sure it is administered according to their dosing schedule.

Now let’s take a look at what’s inside the YEZTUGO injection kit.

Since each dose is delivered with two injections, each kit contains:

• Two single-dose vials (1.5 milliliters each)
• Two syringes
• Two withdrawal needles (18 gauge, 1.5 inch)
• Two injection needles (22 gauge, 0.5 inch)
• Prescribing Information
• Instructions for Use

Remember that each component is for single use only. The vials provided are ready to use, with no mixing or reconstitution necessary.

As you open the injection kit, check to make sure nothing is missing, damaged, or expired and that the vials contain a yellow solution with no particles. Do not use YEZTUGO injection if the solution is discolored or if it contains particulate matter.

If you need a replacement kit for any reason, contact Gilead Sciences at 1-800-GILEAD-5.

Now we’re ready to review how to administer YEZTUGO by injection.

Remember that initiation dosing consists of 2 subcutaneous injections and 2 oral tablets taken on Day 1, as well as 2 oral tablets on Day 2 (at home). If an individual misses the Day 2 oral loading dose (600 mg), have them take it as soon as possible. They should not take the Day 1 and Day 2 oral loading doses on the same day.

Consider applying an ice pack prior to injections. This consideration for injections is not specific to YEZTUGO. Follow the protocols for your institution.

For the subcutaneous injection of YEZTUGO, keep these 6 key steps in mind to help administer each 6-month injection.

Step 1: Ready the dose by preparing, assembling, and filling the syringe for injection.

Remove the vial cap and clean the stopper with an alcohol wipe.

Attach the pink 18-gauge, 1.5-inch withdrawal needle to the syringe.

Use the syringe to inject 1.5 milliliters of air into the vial before withdrawing all contents from the vial into the syringe.

Then replace the pink needle with the gray 22-gauge, 0.5-inch injection needle.

Expel any air bubbles from the syringe and prime it to 1.5 milliliters.

Once the solution has been drawn into the syringe, the injection should be administered as soon as possible.

Step 2: Pick an injection site. Before injecting someone with YEZTUGO, talk with them about choosing an appropriate site for each injection. Sites to choose from include the abdomen (at least 2 inches from the navel) or thigh. Keep in mind that the two injection sites should be at least 4 inches from each other.

When choosing a site together, find one that allows you to pinch enough skin to properly inject YEZTUGO subcutaneously. Think about the amount of body fat at each site, as areas with more body fat may give you more skin to pinch. Consider other factors for each individual as you help choose an injection site.

It’s important to pick a site that allows you to avoid injecting YEZTUGO into the dermis, as this could cause serious injection site reactions.

Once you agree on a site, clean it using the appropriate aseptic technique.

Step 3: Pinch the skin. Gently pinch a broad portion of skin at the injection site to help fully insert the needle into the subcutaneous layer where the drug depot forms. This pinch may help give you more subcutaneous tissue to target for the injection, especially in participants with thinner body habitus. Make sure the pinch is gentle to avoid injecting into compressed tissue.

Step 4: Find the right angle. Fully insert the needle at an angle between 45 and 90 degrees. A 90-degree angle is preferred.

This may help you inject directly into the subcutaneous layer. Avoid inserting the needle at less than a 45-degree angle.

Step 5: Take it slow and steady. YEZTUGO is a viscous solution that should be injected slowly and carefully. Remove the needle from the injection site at the same angle at which it was inserted.

Then gently apply sterile gauze to the injection site, as needed, for bleeding or residual solution that may leak onto the surface of the skin. Apply a bandage, as needed.

Once the first injection is done, repeat Steps 2 through 5 for the second injection. Please see full Prescribing Information for YEZTUGO and Instructions for Use for more details on how to prepare and administer YEZTUGO.

Remember that the second injection site must be at least 4 inches from the first site and 2 inches from the navel.

Once you finish using each injection kit component, remember to follow the appropriate steps to dispose of them, as well as any unused portion of the solution.

If you want a reminder on the key steps of the injection process, review this video along with the full Prescribing Information.

The injection kit for the next 6-month follow-up visit should be stored at a controlled room temperature. Keep the vials in the original carton until just prior to preparation of the injections in order to protect them from light.

Important Safety Information (continued)

Contraindications

• YEZTUGO is contraindicated in individuals with unknown or positive HIV-1 status.

Warnings and precautions

• Comprehensive risk management:
  • Use YEZTUGO to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs).
  • HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk.
  • Use YEZTUGO only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate.
• Potential risk of resistance:
  • There is a potential risk of developing resistance to YEZTUGO if an individual acquires HIV-1 before or when receiving YEZTUGO, or following discontinuation. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only YEZTUGO, because YEZTUGO alone is not a complete regimen for HIV-1 treatment.
  • To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen.
  • Alternative forms of PrEP should be considered after discontinuation of YEZTUGO for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last YEZTUGO injection.
• Long-acting properties and potential associated risks:
  • Residual concentrations of YEZTUGO may remain in systemic circulation for up to 12 months or longer after the last injection.
  • Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance.
• Serious injection site reactions: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Only administer YEZTUGO subcutaneously.

Adverse reactions

• Most common adverse reactions (≥5%) in YEZTUGO clinical trials were injection site reactions, headache, and nausea.

Drug interactions

• Strong or moderate CYP3A inducers may significantly decrease YEZTUGO concentrations. Dosage modifications are recommended when initiating these inducers.
• It is not recommended to use YEZTUGO with combined P-gp, UGT1A1, and strong CYP3A inhibitors.
• Coadministration of YEZTUGO with sensitive substrates of CYP3A or P-gp may increase their concentrations and result in the increased risk of their adverse events. YEZTUGO may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last injection of YEZTUGO.

Dosage and administration

• HIV screening: Test for HIV-1 infection prior to initiating, prior to each subsequent injection, and as clinically appropriate using an approved or cleared test for the diagnosis of acute or primary HIV-1 infection.
• Dosage: Initiation dosing (injections and tablets) followed by once-every-6-months continuation injection dosing. Tablets may be taken with or without food.
  • Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally.
  • Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks.
• Anticipated delayed injections: If scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, YEZTUGO tablets may be taken on an interim basis (for up to 6 months) until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) once every 7 days. Resume continuation injections within 7 days of the last oral dose.
• Missed injections: If more than 28 weeks have elapsed since the last injection and YEZTUGO tablets have not been taken, restart with initiation dosing if clinically appropriate.
• Dosage modifications of YEZTUGO are recommended when initiating with strong or moderate CYP3A inducers. Consult the full Prescribing Information for recommendations.

Please see full Prescribing Information for YEZTUGO, including BOXED WARNING, available at YeztugoPI.com.

For more information about YEZTUGO, visit YEZTUGOhcp.com.