Yeztugo® (lenacapavir)
Dosing and Administration
Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.
Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.
Yeztugo® (lenacapavir)
Dosing and Administration
Some data may be outside of the US FDA-approved prescribing information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA-approved prescribing information.
The full indication, important safety information, and boxed warning are available at:
www.gilead.com/-/media/files/pdfs/medicines/hiv/yeztugo/yeztugo_pi.
Summary
Dosage
The LEN dosing schedule in adults and adolescents weighing at least 35 kg consists of a required initiation dosing (SUBQ injections and oral tablets) followed by once every 6‑months continuation dosing (SUBQ injections). LEN oral tablets may be taken with or without food. See Table 1 for dosing schedule.
Administration
- LEN injection is only for SUBQ 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.
- SUBQ administered LEN forms a drug depot whereby LEN is slowly released from the site of administration.
Product Labeling1
Dosage and Administration
HIV-1 Screening for Individuals Receiving LEN for HIV-1 PrEP
Screen all individuals for HIV-1 infection prior to initiating LEN, prior to each subsequent injection of LEN, 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 LEN, 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 LEN initiation. When screening for HIV-1 infection prior to continuing LEN, negative results from a rapid, point-of-care antigen/antibody test should be confirmed using a more sensitive assay.
Adherence to LEN
Prior to starting LEN, 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 LEN dosing visits to help reduce the risk of acquiring HIV-1 infection and development of resistance.
Recommended Dosage
The LEN dosing schedule in adults and adolescents weighing at least 35 kg consists of a required initiation dosing (SUBQ injections and oral tablets) followed by once every 6‑months continuation dosing (SUBQ injections; Table 1). LEN oral tablets may be taken with or without food.
Table 1. Dosing Schedule for LEN Initiation and Continuation in
Adults and Adolescents weighing ≥35 kg
Time | Dosage | |
| Dosage of LEN: Initiationa | |
Day 1 | 927 mg by SUBQ injection (2 x 1.5 mL injections) and 600 mg orally (2 x 300 mg tablets) | |
Day 2 | 600 mg orally (2 x 300 mg tablets) | |
| Dosage of LEN: Continuation | |
Every 6-months (26 weeks)b +/- 2 weeks | 927 mg SUBQ injection (2 x 1.5 mL injections) | |
a The complete initiation dosing schedule, consisting of SUBQ injections and oral tablets, is required; the efficacy of LEN has only been established with this dosing schedule.
b From the date of the last injection.
Dosing Schedule for Missed Dose
Missed Oral Initiation Dose
If the Day 2 oral initiation dose (600 mg; Table 1) is missed, it should be taken as soon as possible. Day 1 and Day 2 oral initiation doses should not be taken 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, LEN tablets may be taken on an interim basis (for up to 6 months if needed), until injections resume (Table 2).
Table 2. Dosing Schedule for Anticipated Delayed Injections: Weekly Oral Dosage
Time since last injection | Dosage of LEN |
26 to 28 weeks | Oral dosage of 300 mg taken once every 7 days.a
Resume the continuation injection dosage within 7 days after the last oral dose. |
a Use on an interim basis only (for up to 6 months if needed).
Missed Injections
Individuals who miss a scheduled injection visit should be clinically reassessed to ensure resumption of LEN 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 LEN tablets have not been taken see Table 3 for the dosing schedule after missed injections. Adherence to the injection dosing schedule is strongly recommended.
Table 3. Dosing Schedule after Missed Injections
Time since last injection | Dosage of LEN |
More than 28 weeks | Reinitiate with initiation dosing schedule from Day 1 (Table 1) and then continue with continuation injection dosing. |
Dose Modifications for Co-administration with Strong or Moderate CYP3A4 Inducers
Supplemental doses of LEN are recommended for individuals initiating therapy with either strong CYP3A4 inducers (Table 4) or moderate CYP3A4 inducers (Table 5).
Strong CYP3A4 inducers may be initiated starting at least 2 days after LEN is first initiated, while moderate CYP3A4 inducers may be started any time after LEN is first initiated.
Table 4. Dosing Recommendations for Individuals Receiving LEN and Initiating Therapy with Strong CYP3A Inducersa
Maintain Scheduled Continuation Injection Dosing | Schedule of Supplemental Doses of LEN | |
Time | Dosage | |
Continue to administer once every 6-months scheduled continuation dosing of LEN 927 mg SUBQ (2 x 1.5 mL injections; Table 1), plus administer supplemental doses of LEN as shown in this table | On day strong CYP3A inducer is initiated (which should be at least 2 days after LEN is first initiated) | Supplemental dosage: Step 1 927 mg SUBQ (2 x 1.5 mL injections) And 600 mg orally (2 x 300 mg tablets) |
On day after strong CYP3A inducer is initiated | Supplemental dosage: Step 2 600 mg orally (2 x 300 mg tablets) | |
If strong CYP3A inducer is co-administered for longer than 6 months | Subsequent supplemental dosage Every 6-monthsb from initiation of strong CYP3A inducer, continue to administer supplemental doses of LEN as described above in Steps 1 and 2. | |
After stopping the strong CYP3A inducer, continue the once every 6-months scheduled continuation injection dosing of LEN (Table 1). | ||
a Dosing recommendations are not available for the initiation of LEN in individuals already receiving strong CYP3A inducers, nor in individuals receiving the weekly oral dosage of LEN (Table 2).
b 26 weeks +/- 2 weeks.
Table 5. Dosing Recommendations for Individuals Receiving LEN and Initiating Therapy with Moderate CYP3A Inducersa
Maintain Scheduled Continuation Injection Dosing | Schedule of Supplemental Doses of LEN | |
Time | Dosage | |
Continue to administer once every 6-months scheduled continuation dosing of LEN 927 mg SUBQ (2 x 1.5 mL injections; Table 1), plus administer supplemental doses of LEN as shown in this table | On day moderate CYP3A inducer is initiated | Supplemental dosage 463.5 mg SUBQ (1 x 1.5 mL injections) |
If moderate CYP3A inducer is co-administered for longer than 6 months | Subsequent supplemental dosage Every 6-monthsb from initiation of moderate CYP3A inducer, continue to administer supplemental doses of LEN as described above. | |
After stopping the moderate CYP3A inducer, continue the once every 6‑months scheduled continuation injection dosing of LEN (Table 1). | ||
a Dosing recommendations are not available for the initiation of LEN in individuals already receiving moderate CYP3A inducers, nor in individuals receiving the weekly oral dosage of LEN (Table 2).
b 26 weeks +/- 2 weeks.
Preparation and Administration of SUBQ Injection
LEN injection is only for SUBQ 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 when preparing the injections. Visually inspect the solution in the vials and prepared syringe for particulate matter and discoloration prior to administration. LEN injection is a yellow solution. Do not use LEN injection if the solution is discolored or if it contains particulate matter. Once the solution is withdrawn from the vials, the SUBQ 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 singly use only. Two 1.5 mL injections are required for a complete dose.
Figure 1. LEN Withdrawal Needle Injection Kit Components
Figure 2. LEN Injection Steps for Withdrawal Needle Injection Kit
Administer the second injection at least 4 inches apart from the first injection site. If administering in the abdomen, ensure injections are at least 2 inches away from the navel.
SUBQ administered LEN forms a drug depot whereby LEN is slowly released from the site of administration.
Clinical Considerations
SUBQ Injection technique for administration1-3
Healthcare provider administration is required.
LEN is administered by SUBQ injection in the abdomen or thigh by a healthcare provider at two separate injection sites, at least 4 inches apart from each other. When injecting in the abdomen, ensure injection is at least 2 inches from the navel.
When injecting LEN, it is important that the drug is injected deep into the SUBQ, or fatty tissue. Injecting too superficially may increase the chance of an injection site reaction.2
With one hand, gently pinch a fold of skin where injection is to be given.
With the other hand, insert the needle into the pinched skin at a 45 to 90 angle. A 90 angle is preferred when feasible, to ensure LEN is deposited into the SUBQ tissue deeper.
The needle should be fully inserted. Caution should be taken not to inadvertently withdraw the needle while injecting.
Pause for several seconds after the injection is complete prior to withdrawing the needle to ensure that the full dose has been administered.
Repeat this process for the second dose.
Figure 3. SUBQ Injection Techniques
References
- Enclosed, Gilead Sciences Inc. YEZTUGO® (lenacapavir) tablets, for oral use. YEZTUGO® (lenacapavir) injection, for subcutaneous use. U.S. Prescribing Information. Foster City, CA.
- Kroger A, Bahta L, Long S, Sanchez P. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). Available at: www.cdc.gov/vaccines/hcp/acip-recs/generalrecs/downloads/general-recs.pdf. Accessed: 30 May 2025. 2023.
- Gilead Sciences Inc. Data on File.
Abbreviations
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ISR=injection site reaction
LEN=lenacapavir
SUBQ=subcutaneous(ly)
Product Label
For the full indication, important safety information, and boxed warning, please refer to the Yeztugo US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/hiv/yeztugo/yeztugo_pi.
Follow-Up
For any additional questions, please contact Gilead Medical Information at:
☎1‐866‐MEDI‐GSI (1‐866‐633‐4474) or www.askgileadmedical.com
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Please report all adverse events to:
Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
www.gilead.com/utility/contact/report-an-adverse-event
FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or www.accessdata.fda.gov/scripts/medwatch
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