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HELPS PROVIDE 2 MONTHS OF CONTINUOUS HIV PROTECTION WITH EACH INJECTION

Administered as an intramuscular injection by a healthcare professional every 2 months after 2 initiation injections administered one month apart.

Starting Your Patients on APRETUDE*

APRETUDE is administered by a healthcare provider as a single 600-mg (3-mL) gluteal intramuscular injection

Healthcare providers should carefully select individuals who agree to the required injection dosing and testing schedule and counsel patients on the importance of adherence to help reduce the risk of HIV-1 infection and development of resistance.

APRETUDE injections can be given up to 7 days before or after the Target Injection Date^†

*For patients concomitantly receiving rifabutin, please see full Prescribing Information for the adjusted recommended dosing schedule for APRETUDE.

^†After the first injection.

Optional oral lead-in

Oral lead-in is not required but may be used prior to initiation of APRETUDE to assess the tolerability of cabotegravir.

The recommended oral lead-in dose is one 30-mg tablet of cabotegravir daily for approximately 1 month (at least 28 days).
Initiation injections should be administered on the last day of oral lead-in, if used, or within 3 days thereafter.

HIV-1 testing

PRE-INITIATION VISIT

Screen for HIV-1 acquisition.

If HIV-1 negative, begin benefit verification before initiating APRETUDE

INITIATION AND CONTINUATION INJECTIONS

Individuals must be tested prior to initiating APRETUDE or oral cabotegravir and with each subsequent injection.

Use a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection
- If an antigen/antibody test was used and was negative, confirm results with an HIV RNA test
- Results of confirmatory HIV RNA test can be pending at the time of administration

HIV-1 testing should also occur:
- When recent exposure to HIV is suspected or clinical symptoms consistent with HIV-1 (eg, fever, fatigue, myalgia, skin rash) are present
- Upon diagnosis of any other STI
If positive HIV-1 status is confirmed, transition to a complete HIV-1 treatment

When a payer covers PrEP, HIV testing should also be covered.¹ The payer or your lab can help you understand which tests may be covered and available

FDA=US Food and Drug Administration; PrEP=pre-exposure prophylaxis; STI=sexually transmitted infection.

Injection Education

Preparing and Administering APRETUDE

Play video

FRAME 1: Opening

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FRAME 2: Opening

This is an instructional video for the administration of APRETUDE.

Please see Important Safety Information for APRETUDE below on the web page. Please click on the link on the web page to view the full Prescribing Information, including the Boxed Warning and Instructions for Use for APRETUDE.

FRAME 3: Opening

Two topics will be reviewed in this video: Chapter 1 explains the preparation steps for APRETUDE, with Chapter 2 focusing on the steps for injection.

Please read the full Instructions for Use (IFU) contained in the APRETUDE Dosing Kit and available in the Prescribing Information at APRETUDEHCP.com.

FRAME 4: Opening

The information in this video is based on the APRETUDE Instructions for Use leaflet.

Where supplementary information is provided, a light bulb icon will appear to signify that this is the case.

FRAME 5: Opening

APRETUDE is available in a kit that includes a single-use vial of cabotegravir 600 milligrams per 3 milliliters extended-release injectable suspension. APRETUDE is for gluteal intramuscular use only and must be administered by a healthcare provider.

FRAME 6: Opening

A complete dose of APRETUDE requires 1 injection: 600 milligrams per 3 milliliters of cabotegravir. It does not need further dilution or reconstitution.

FRAME 7: Opening

APRETUDE should be stored in its original packaging at 36 degrees Fahrenheit to
77 degrees Fahrenheit until ready to use. APRETUDE does not require refrigeration.

FRAME 8: Cover

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FRAME 9: Take the Dosing Kit

When removing the Dosing Kit from your office storage, you will find the following:

FRAME 10: Your Dosing Kit contains

An Instructions for Use leaflet
One single-dose vial containing 600 milligrams per 3 milliliters of cabotegravir. This vial has a brown tint to the glass with an orange cap
One 23-gauge, 1½-inch injection needle
One syringe and
One vial adapter

FRAME 11: Needle’s length

While the Dosing Kit contains a 23-gauge, 1½-inch needle, you should consider the patient’s build and use medical judgment to select an appropriate needle length.

FRAME 12: Needle’s length

Longer needle lengths may be required for individuals with higher BMI to ensure that the injection is administered intramuscularly as opposed to subcutaneously.

FRAME 13: You will also need

You will also require additional supplies not included in the packaging:

Non-sterile gloves
2 alcohol wipes
2 gauze pads
And a suitable sharps container.

FRAME 14: You will also need

An adhesive bandage may be used if bleeding occurs.

FRAME 15: Allow vial to come to room temperature

If the pack has been stored in the refrigerator, the vial should be brought to room temperature before you are ready to give the injection, but make sure the vial does not get above 86 degrees Fahrenheit.

Do not use any heating methods, other than using the warmth of your hands.

FRAME 16: Inspect vial

Before proceeding, inspect the vial. If the expiration date has passed

FRAME 17: Inspect vial

or if you can see foreign matter in the vial, do not use.

If the pack has been stored in the refrigerator, allow the medication to come to room temperature.

FRAME 18: Shake vigorously

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FRAME 19: Shake vigorously

Hold it firmly and vigorously shake for a full 10 seconds as demonstrated to resuspend the contents.

FRAME 20: Inspect medicine

Next, invert the vial and check the suspension. Confirm the suspension is uniform. If it is not, shake the vial again. It is normal to see some small air bubbles.

FRAME 21: Remove vial cap

Next, remove the cap from the vial.

FRAME 22: Wipe rubber stopper

Wipe the rubber stopper with an alcohol wipe, and do not allow anything to touch it afterward.

FRAME 23: Peel open vial adapter

Peel off the paper backing from the vial adapter packaging in preparation for the next step.

FRAME 24: Peel open vial adapter

With the vial resting in an upright position on a flat surface,

FRAME 25: Attach vial adapter

press the vial adapter straight down onto the vial using the packaging, as shown.

The vial adapter should click securely into place.

FRAME 26: Attach vial adapter

When you are ready, lift off the vial adapter packaging.

FRAME 27: Prepare syringe withdrawing air

Remove the syringe from the packaging, and draw 1 milliliter of air into the syringe.

This will make it easier to draw up the medicine later. If this step is not completed, some medicine may flow back into the vial unintentionally, leaving less than intended in the syringe.

FRAME 28: Attach syringe and push air

With the vial on a flat surface, hold the vial adapter and vial firmly, as shown. Screw the syringe securely onto the vial adapter.

Press the plunger all the way down

FRAME 29: Attach syringe and push air

to push the air into the vial.

FRAME 30: Slowly draw up dose

Invert the syringe and vial and slowly withdraw as much of the medicine as possible into the syringe.

It is worth noting that there will be more medicine than the dose amount.

FRAME 31: Unscrew syringe

Hold the syringe plunger firmly in place as shown to prevent leakage. It is normal to feel some back pressure. Unscrew the syringe from the vial adapter, holding the vial adapter as shown. Check again that the medication looks uniform and milky white.

Once the medication has been drawn into the syringe, it is best to inject as soon as possible.

FRAME 32: Unscrew syringe

However, the medication can remain in the syringe for up to 2 hours before injecting. You must discard the medicine, syringe, and needle if this time limit is exceeded.

The filled syringe should not be placed in the refrigerator.

FRAME 33: Peel open needle packaging

Now, peel open the needle packaging part way to expose

FRAME 34: Peel open needle packaging

the needle base.

FRAME 35: Attach needle

While keeping the syringe upright, firmly twist the syringe onto the needle

FRAME 36: Attach needle

then finally remove the needle packaging from the needle.

FRAME 37: Cover

Now you're ready for the injection steps.

FRAME 38: Site Injections

The first step is to identify the injection site.

It is important to note that this injection is for gluteal intramuscular use only. Do not administer intravenously.

There are two possible sites for injection: the ventrogluteal and the upper outer quadrant of the dorsogluteal site. The injection should not be administered in any other site.

FRAME 39: Ventrogluteal site

The ventrogluteal site is recommended because it is located away from major nerves and blood vessels.

FRAME 40: Dorsogluteal site pop-up

You may also consider the upper outer quadrant of the dorsogluteal injection site, shown here, if preferred.

FRAME 41: Patient injection position pop-up

To receive an injection at the ventrogluteal site, the patient can lie in one of two positions. The first option for the patient is to lie on their side, with the knee bent.

The second option is to lie face down.

Regardless of the patient's body position, it is important to make sure that the muscle is relaxed prior to injection.

FRAME 42: Identify injection site pop-up

To locate the injection site,

FRAME 43: Identify injection site pop-up

place the heel of the hand over the patient’s greater trochanter

FRAME 44: Identify injection site pop-up

using the left hand for the patient's right hip or the right hand for the patient's left hip. Position the index finger on or toward the anterior superior iliac spine. Stretch the middle finger away from the index finger, creating a "V" or triangle.

FRAME 45: Identify injection site pop-up

The injection site is located within the triangle created by the index finger, the middle finger, and the iliac crest.

FRAME 46: Clean injection site

Clean the injection site with an alcohol wipe. Allow the skin to air dry before continuing. Once the site has been identified and the patient is in the correct position, you can proceed to administer the injection.

FRAME 47: Remove needle cap

Fold the needle guard away from the needle

FRAME 48: Remove needle cap

and pull off the injection needle cap.

FRAME 49: Remove extra medicine

Hold the syringe with the needle pointing up. Press the plunger to the 3-milliliter dosing mark to remove extra liquid and any air bubbles, ensuring you have the correct dose prepared.

FRAME 50: Z-track injection technique

Use the Z-track injection technique to minimize medication leakage from the injection site.

FRAME 51: Z-track injection technique

Firmly drag the skin covering the injection site, displacing it by about an inch.

Keep it held in this position for the injection.

FRAME 52: Insert needle

Insert the needle to its full depth or deep enough to reach the muscle.

FRAME 53: Inject the dose

Still holding the stretched skin, slowly press the plunger all the way down and ensure that the syringe is empty.

FRAME 54: Withdraw needle and release skin

Withdraw the needle and release the stretched skin immediately.

FRAME 55: Assess injection site pop-up

Once the needle has been removed, apply pressure to the injection site using gauze. Do not massage the area. A small adhesive bandage may be used if bleeding occurs.

FRAME 56: Make needle safe

Fold the needle guard over the needle.

Gently apply pressure using a hard surface to lock the needle guard in place.

FRAME 57: Make needle safe

The needle guard will make a click when it locks.

FRAME 58: Dispose safely

Dispose of the used needle, syringe, vial, and adapter

FRAME 59: Dispose safely

according to local health and safety laws.

FRAME 60: Closing

Thank you for watching this step-by-step guide for the preparation and injection of APRETUDE. For more information, visit APRETUDEHCP.com.

Please see link to full Prescribing Information, including Boxed Warning, for APRETUDE on this website

FRAME 61: References

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Dosing after missed injections

Dosing schedule after planned missed injections

Adherence to the injection dosing schedule is strongly recommended. Individuals who miss their Target Injection Date should be clinically reassessed to ensure that resumption of APRETUDE remains appropriate.

If your patient plans to miss their Target Injection Date by >7 days, daily oral cabotegravir can be prescribed for a duration of up to 2 months to replace 1 missed scheduled every-2-month injection of APRETUDE.^‡

The first dose of oral cabotegravir should be taken approximately 2 months after the last injection dose of APRETUDE.

Restart injections with APRETUDE on the day oral dosing completes or within 3 days.

How much time has passed since your patient’s missed Target Injection Date?

≤1 month since missed Target Injection Date
Resume injections on final day of oral cabotegravir or within 3 days Continue with every-2-month dosing schedule thereafter

>1 month since missed Target Injection Date
Repeat initiation injections (2 injections 1 month apart) on final day of oral cabotegravir or within 3 days Continue with every-2-month dosing schedule thereafter

^‡For oral PrEP durations greater than 2 months, an alternative oral regimen is recommended.

Dosing schedule after unplanned missed injections

Adherence to scheduled injection visits is important.

If your patient missed their Target Injection Date by >7 days and did not plan for it by taking oral cabotegravir, clinically reassess them to determine whether APRETUDE remains appropriate, and if so, confirm HIV-1–negative status prior to injection.

How much time has passed since your patient’s missed Target Injection Date?

≤1 month since missed Target Injection Date
Resume injections as soon as possible Continue with every-2-month dosing schedule thereafter

>1 month since missed Target Injection Date
Repeat initiation injections (2 injections 1 month apart) Continue with every-2-month dosing schedule thereafter

Established and Other Potentially Significant Drug Interactions with APRETUDE

Portrait of a Caucasian man and a Black woman with blonde hair on a purple background

Use this tool to determine your patient’s APRETUDE injection schedule

You will be able to select a Target Injection Date and view a potential schedule, including subsequent injection dates and dosing window.

Create an injection schedule

Find an Alternative Site of Care (ASOC) with ViiVConnect

The ViiVConnect ASOC Locator tool can help you locate medical facilities that may administer APRETUDE to patients and manage the administration process.

Find an ASOC

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Reference:

Dept of Labor, Dept of Health and Human Services (HHS), the Treasury. FAQs About Affordable Care Act Implementation Part 47. July 19, 2021. https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-47.pdf

INDICATION

APRETUDE is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION

INDICATION

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION

Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, 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 APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.

CONTRAINDICATIONS

Do not use APRETUDE in individuals:
- with unknown or positive HIV-1 status
- with previous hypersensitivity reaction to cabotegravir
- receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine

WARNINGS AND PRECAUTIONS
Comprehensive Management to Reduce the Risk of HIV-1 Infection:

Use APRETUDE 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). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs)
Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection
When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs
Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment
Counsel individuals without HIV-1 to strictly adhere to the recommended dosing and testing schedule for APRETUDE

Potential Risk of Resistance with APRETUDE:

There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE

Long-Acting Properties and Potential Associated Risks with APRETUDE:

Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance

Hypersensitivity Reactions:

Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with APRETUDE
Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated

Hepatotoxicity:

Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors
Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated

Depressive Disorders:

Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE
Promptly evaluate patients with depressive symptoms

Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:

The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE
Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.

DRUG INTERACTIONS

Refer to the full Prescribing Information for important drug interactions with APRETUDE
Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir

USE IN SPECIFIC POPULATIONS

Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation
Pediatrics: Not recommended in individuals weighing less than 35 kg

Please see full Prescribing Information, including Boxed Warning, for APRETUDE.

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PMUS-CBTWCNT240070 October 2024

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