Yeztugo Dosage

HIV-1 Screening for Individuals Receiving YEZTUGO for HIV-1 Pre-Exposure Prophylaxis

Screen all individuals for HIV-1 infection prior to initiating YEZTUGO, prior to each subsequent injection of YEZTUGO, and additionally as clinically appropriate, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. When screening for HIV-1 infection prior to initiating YEZTUGO, if an antigen/antibody-specific test is used and provides negative results, then such negative results should be confirmed using an RNA-specific assay, even if the results of the RNA-assay are available after YEZTUGO initiation. When screening for HIV-1 infection prior to continuing YEZTUGO, negative results from a rapid, point-of-care antigen/antibody test should be confirmed using a more sensitive assay.

Adherence to YEZTUGO

Prior to starting YEZTUGO, healthcare providers should select individuals who agree to the required testing and every 6 month injection dosing schedule, and counsel individuals about the importance of adherence to scheduled YEZTUGO dosing visits to help reduce the risk of acquiring HIV-1 infection and development of resistance.

Recommended Dosage

The YEZTUGO dosing schedule in adults and adolescents weighing at least 35 kg consists of a required initiation dosing (subcutaneous injections and oral tablets) followed by once every 6-months continuation dosing (subcutaneous injections) (Table 1). YEZTUGO oral tablets may be taken with or without food.

Dosing Schedule for Missed Dose

Missed Oral Initiation Dose

If the Day 2 oral initiation dose (600 mg; see Table 1) is missed, take it as soon as possible. Do not take Day 1 and Day 2 oral initiation doses on the same day.

Anticipated Delayed Injections

During continuation dosing, if the 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 if needed), until injections resume. Refer to Table 2 below for the dosing schedule for delayed injections.

Missed Injections

Individuals who miss a scheduled injection visit should be clinically reassessed to ensure resumption of YEZTUGO remains appropriate and that the individual remains HIV-1 negative. During continuation dosing, if more than 28 weeks have elapsed since the last injection and YEZTUGO tablets have not been taken, see Table 3 below for the dosing schedule after missed injections. Adherence to the injection dosing schedule is strongly recommended.

Dosage Modifications for Co-administration with Strong or Moderate CYP3A Inducers

Supplemental doses of YEZTUGO are recommended for individuals initiating therapy with either strong CYP3A inducers (see Table 4) or moderate CYP3A inducers (see Table 5).

Strong CYP3A inducers may be initiated starting at least 2 days after YEZTUGO is first initiated, while moderate CYP3A inducers may be started any time after YEZTUGO is first initiated.

Preparation and Administration of Subcutaneous Injection

YEZTUGO injection is only for subcutaneous administration into the abdomen by a healthcare provider. The thigh can be used as an alternative injection site if preferred. Do NOT administer intradermally due to risk of serious injection site reactions.

Use aseptic technique. Visually inspect the solution in the vials and prepared syringe for particulate matter and discoloration prior to administration. YEZTUGO injection is a yellow solution. Do not use YEZTUGO 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.

Figure 1 identifies the components for use in the administration steps for the withdrawal needle injection kit, and the administration steps are provided in Figure 2. The 18-gauge needle is for withdrawal only in this kit.

The injection kit components are for single use only. Two 1.5 mL injections are required for a complete dose.

Figure 1 YEZTUGO Withdrawal Needle Injection Kit Components

Figure 2 YEZTUGO Injection Steps for Withdrawal Needle Injection Kit