Asking about APRETUDE
Feeling uneasy about talking to your healthcare provider about long-acting PrEP?
Go easy on yourself: Talking about sex isn’t everyone’s cup of tea.
Approach the conversation like you would any important relationship. Be open and honest and ask for what you think you need.
APRETUDE is given every other month by a healthcare provider after initiation injections have been given 1 month apart for 2 consecutive months. Stay under a provider’s care while receiving APRETUDE. You must receive it as scheduled. If you will miss a scheduled injection by more than 7 days, call your provider right away.
- First, ask yourself these questions:
- Are you HIV-1 negative?
- You must be HIV-1 negative to start and stay on APRETUDE. Your healthcare provider will test you for HIV before each injection, in addition to testing you for sexually transmitted infections (STIs) while you are taking APRETUDE
- Do you sometimes have sex without a condom?
- Have you ever had an STI?
- Do you live in an area with a high rate of HIV?
- Does your sexual partner(s) have an unknown HIV status?
- Does an injection every other month work for your schedule?
- It’s important to attend all APRETUDE appointments
Then, think about these things:
- Do you struggle fitting a daily PrEP pill into your daily routine?
- Do you sometimes forget to take your daily PrEP pill?
- Could a PrEP option you get every other month work for your lifestyle?
- Are you concerned that people may see your PrEP pill and ask about it?
If you answered yes to any of these questions or have any other questions, it may be helpful to ask your healthcare provider about APRETUDE.
Can APRETUDE keep me HIV-1 negative?
APRETUDE for PrEP is used to reduce the risk of sexually getting HIV-1 infection in adults and adolescents weighing at least 77 pounds (35 kg).
To help you stay continuously protected from HIV, it is important that you receive APRETUDE as scheduled. Stay under the care of a healthcare provider while receiving APRETUDE.
How long has APRETUDE been around?
APRETUDE was approved by the FDA in 2021.
What medicine does APRETUDE contain?
APRETUDE contains the prescription medicine cabotegravir.
How do I start taking APRETUDE?
Book AppointmentThe first step is to talk to your healthcare provider. If we prescribe APRETUDE, we will discuss how it is a long-acting HIV prevention option dosed every other month and can answer any questions that may come up.
APRETUDE is given every other month by us after initiation injections have been given 1 month apart for 2 consecutive months. You will remain under our care while receiving APRETUDE. You must receive it as scheduled. If you will miss a scheduled injection by more than 7 days, call your provider right away.
How much does APRETUDE cost? Will my insurance cover it?
If you’re prescribed APRETUDE, you can enroll in ViiVConnect to determine your insurance coverage and find out if you’re eligible for programs that may help lower your out-of-pocket costs.
The amount you pay for APRETUDE will largely depend on your insurance coverage, so contact your provider, as they know the details of your plan. Federal law requires that insurance plans cover certain items and services associated with PrEP. Your doctor’s office, insurance provider, and ViiVConnect can help you better understand your out-of-pocket costs.
APRETUDE Savings Program
Eligible patients may pay as little as a $0 copay per fill on select prescribed ViiV Healthcare medications.
Click to learn about eligible medications and their yearly coverage amounts.
Who injects APRETUDE?
APRETUDE is given to you by our medical assistants, providers, and trained healthcare professionals at our facility.
Does the injection hurt?
In the APRETUDE clinical studies, the most common side effect was injection-site reactions.
Injection-site reactions included pain, tenderness, hardened mass or lump, swelling, bruising, redness, itching, warmth, loss of sensation at the injection site, abscess, and discoloration.
Where on my body do I receive the injection?
During your appointment, our medical assistant will give you 1 injection into the muscle of your buttock.
Can I return to regular activities right after my injection appointment?
We ask that you wait about 10-15 minutes after your injection so we can monitor you. Following that, it should be fine to return to your daily activities. Your provider will advise you of any deviation from this. Be sure to ask your provider if you have questions.
What if I am traveling and can't make my injection appointment?
While it is important that you receive APRETUDE as scheduled, things do come up. If you can’t make your scheduled Target Appointment Date, be sure to contact us right away to set up a new appointment and to talk about your options. You’ll have a Flexible Appointment Window—from 7 days before to 7 days after your Target Appointment Date.
If you miss a dose or stop your injections, contact us right away to help you stay protected from HIV.
Does someone need to drive me to and from my appointment?
It should be fine to drive yourself to and from your appointment, but you should always check with us to be sure.
Who is most at risk for HIV? Am I at risk of getting HIV through sex?
Book NowHIV can affect anyone regardless of sexual orientation, race, ethnicity, gender, age, or where they live. APRETUDE is only for sexually getting HIV-1. If you have sex without condoms with someone who is living with HIV or has an unknown status, if you have multiple partners, or if you have sex within a community where HIV is more common, you may want to talk to your provider about PrEP.
How often should I get tested for HIV while on APRETUDE?
If you're prescribed APRETUDE, you will get tested prior to each injection. We may do additional HIV testing as needed.
What kinds of sex put you at risk for HIV?
Most people get HIV through anal or vaginal sex. You can help protect yourself by using condoms and PrEP.
Do women need PrEP?
Women represent about 1 in 5 new HIV diagnoses each year, according to a 2018 study. 55% of women diagnosed with HIV are Black and 18% are Hispanic/Latina, according to a 2019 study.
Is PrEP just for gay men?
Many people think that HIV only impacts gay men, but that simply isn’t the case.
A lot of people can benefit from PrEP, including cisgender women and transgender women.
Does PrEP prevent sexually transmitted infections (STIs)?
PrEP doesn’t prevent STIs. To help you stay protected, always practice safer sex and use a condom.
Can I get HIV from someone on PrEP?
People who take APRETUDE, or any other PrEP, must be HIV-1 negative prior to and while taking it. No PrEP medicine is 100% effective, so regular HIV testing is important. APRETUDE is a prescription medicine that is used to reduce the risk of getting HIV-1. It helps lower the chances of getting HIV through sex.
To reduce your risk of getting HIV, know your HIV-1 status, get regular testing for other sexually transmitted infections, and practice safer sex by using a condom. Talk to your healthcare provider about other ways to reduce the risk of infection.
IMPORTANT SAFETY INFORMATION
What is the most important thing I should know about APRETUDE?
Before receiving APRETUDE to reduce your risk of getting HIV-1, you must be HIV-1 negative to start APRETUDE. Do not receive APRETUDE unless you are tested and confirmed to be HIV-1 negative.
Some HIV-1 tests can miss HIV-1 infection in a person who has recently become infected. Tell your healthcare provider if you had a flu-like illness within the last month before starting or at any time while receiving APRETUDE. Symptoms of new HIV-1 infection include: tiredness; joint or muscle aches; sore throat; rash; enlarged lymph nodes in the neck or groin; fever; headache; vomiting or diarrhea; or night sweats
While you are receiving APRETUDE for HIV-1 PrEP:
- APRETUDE does not prevent other sexually transmitted infections (STIs). Practice safer sex by using a latex or polyurethane condom to reduce the risk of getting STIs
- You must stay HIV-1 negative to keep receiving APRETUDE for HIV-1 PrEP
- Know your HIV-1 status and the HIV-1 status of your partners. If you think you were exposed to HIV-1, tell your healthcare provider right away
- Your risk of getting HIV-1 is lower if your partners with HIV-1 are taking effective treatment
- Get tested for HIV-1 with each APRETUDE injection or when your healthcare provider tells you. You should not miss any HIV-1 tests. If you become HIV-1 infected and continue receiving APRETUDE because you do not know you are HIV-1 infected, the HIV-1 infection may become harder to treat
- Get tested for other STIs. These infections make it easier for HIV-1 to infect you
- Talk to your healthcare provider about ways to reduce your HIV-1 risk
- Do not miss any injections of APRETUDE. Missing injections increases your risk of getting HIV-1 infection
Who should not receive APRETUDE?
Do not receive APRETUDE if you:
- already have HIV-1 or do not know your HIV-1 status. If you are HIV-1 positive, you need to take other medicines to treat HIV-1. APRETUDE can only help reduce your risk of getting HIV-1 infection before you are infected. If you have HIV-1 and receive only APRETUDE, over time, your HIV-1 may become harder to treat
- are allergic to cabotegravir
- are taking certain medicines: carbamazepine; oxcarbazepine; phenobarbital; phenytoin; rifampin; or rifapentine
What are the possible side effects of APRETUDE?
APRETUDE may cause serious side effects:
- Allergic reactions. Call your healthcare provider right away if you develop a rash with APRETUDE. Stop receiving APRETUDE and get medical help right away if you develop a rash with any of the following signs or symptoms: fever; generally ill feeling; tiredness; muscle or joint aches; trouble breathing; blisters or sores in mouth; blisters; redness or swelling of the eyes; swelling of the mouth, face, lips, or tongue
- Liver problems. Liver problems have happened in people with or without a history of liver problems or other risk factors. Call your healthcare provider right away if you have any of the following symptoms: your skin or the white part of your eyes turns yellow; dark or “tea-colored” urine; light-colored stools; nausea or vomiting; loss of appetite; pain, aching, or tenderness on the right side of your stomach area; or itching
- Depression or mood changes. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms: feeling sad or hopeless; feeling anxious or restless; have thoughts of hurting yourself (suicide) or have tried to hurt yourself
The most common side effects of APRETUDE include:
- Pain, tenderness, hardened mass or lump, swelling, bruising, redness, itching, warmth, loss of sensation at the injection site, abscess, and discoloration; diarrhea; headache; fever; tiredness; sleep problems; nausea; dizziness; passing gas; stomach pain; vomiting; muscle pain; rash; loss of appetite; drowsiness; back pain; or upper respiratory infection
- These are not all the possible side effects of APRETUDE. Call your healthcare provider for medical advice about side effects
Before receiving APRETUDE, tell your healthcare provider about all your medical conditions, including if you:
- have ever had a skin rash or an allergic reaction to medicines that contain cabotegravir
- have or have had liver problems
- have ever had mental health problems
- are pregnant or plan to become pregnant. It is not known if APRETUDE will harm your unborn baby. APRETUDE can remain in your body for up to 12 months or longer after the last injection. Tell your healthcare provider if you become pregnant while receiving APRETUDE
- are breastfeeding or plan to breastfeed. It is not known if APRETUDE can pass to your baby in your breast milk. Talk with your healthcare provider about the best way to feed your baby while receiving APRETUDE
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- Some medicines may interact with APRETUDE. Keep a list of your medicines and show it to your healthcare provider and pharmacist. Do not start a new medicine without telling your healthcare provider
How will I receive APRETUDE?
- APRETUDE is initially given as an injection into the muscle of your buttock 1 time every month for the first 2 months, then as an injection 1 time every 2 months
- Before receiving your first APRETUDE injection, your healthcare provider may have you take 1 oral cabotegravir tablet 1 time a day for 1 month (at least 28 days) to assess how well you tolerate cabotegravir
- APRETUDE is a long-acting medicine and may stay in your body for 12 months or longer after your last injection
- Stay under the care of a healthcare provider while receiving APRETUDE. It is important that you receive APRETUDE as scheduled
- If you miss or plan to miss a scheduled injection of APRETUDE by more than 7 days, call your healthcare provider right away to discuss your PrEP options
- If you stop receiving APRETUDE, talk to your healthcare provider about other options to reduce the risk of getting HIV-1 infection
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please read the Patient Information for APRETUDE and discuss it with your healthcare provider.
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