Apretude

Pronunciation: Ap-reh-tood
Generic name: cabotegravir
Dosage form: extended-release injection for intramuscular use
Drug class: Integrase strand transfer inhibitor

Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 13, 2024.

What is Apretude?

Apretude is an extended-release injection that is used to reduce the risk of getting HIV-1 infection from sex in adults and adolescents who weigh at least 77 pounds (at least 35 kg).

• Apretude (cabotegravir) is a type of HIV-1 PrEP (pre-exposure prophylaxis).
• Apretude injection is administered every 2 months after an initial loading dose period.
• Apretude is estimated to be 99% effective at reducing the risk of getting HIV from sex when used exactly as prescribed.
• Individuals must have a negative HIV-1 test before starting Apretude.

Apretude’s mechanism of action involves blocking an enzyme called HIV integrase that is essential for HIV replication. Apretude belongs to the drug class known as HIV-1 integrase strand transfer inhibitors (INSTIs).

Apretude gained FDA approval on January 21, 2021. There is no Apretude generic available.

• Vocabria is an oral form of cabotegravir that may be given initially to see how well you tolerate cabotegravir.

Another injectable form of HIV-1 PrEp is Cabenuva (see Apretude vs. Cabenuva). Oral HIV-1 PrEP options include Descovy (see Apretude vs Descovy) and Truvada.

Apretude side effects

The most common side effects of Apretude are:

• pain, tenderness, hardened mass or lump, swelling, bruising, redness, itching, warmth, loss of sensation at the injection site, abscess, and discoloration at the injection site
• diarrhea
• headache
• fever
• tiredness
• sleep problems
• nausea
• dizziness
• passing gas
• stomach pain
• vomiting
• muscle pain
• rash
• loss of appetite
• drowsiness
• back pain
• upper respiratory infection.

Serious side effects and warnings

Apretude injection carries a Boxed Warning for risk of drug resistance if Apretude is used in people with an undiagnosed HIV-1 infection.

Drug resistance. Before receiving Apretude to reduce your risk of getting HIV-1, you must be HIV-1 negative. You must get tested to make sure that you do not already have HIV-1 infection. Do not receive Apretude for HIV-1 PrEP unless you are confirmed to be HIV-1 negative.

Some HIV-1 tests can miss HIV-1 infection in a person who has recently become infected. If you have flu-like symptoms, you could have recently become infected with HIV-1. Tell your healthcare provider if you had a flu-like illness within the last month before starting Apretude or at any time while receiving it. Symptoms of new HIV-1 infection include:

• tiredness
• fever
• joint or muscle aches
• headache
• sore throat
• vomiting or diarrhea
• rash
• night sweats
• enlarged lymph nodes in the neck or groin.

Apretude injection does not prevent other sexually transmitted infections. Practice safer sex by using a latex or polyurethane condom to reduce the risk of getting sexually transmitted infections.

• 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.
• Ask your partners with HIV-1 if they are taking anti-HIV-1 medicines and have an undetectable viral load. An undetectable viral load is when the amount of virus in the blood is too low to be measured in a lab test. To maintain an undetectable viral load, your partners must keep taking HIV-1 medicine as prescribed. 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 sexually transmitted infections such as syphilis, chlamydia, and gonorrhea. These infections make it easier for HIV-1 to infect you.
• If you think you were exposed to HIV-1, tell your healthcare provider right away. They may want to do more tests to be sure you are still HIV-1 negative.

Get information and support to help reduce sexual risk behaviors.

Do not miss any injections of Apretude. Missing injections increases your risk of getting HIV-1 infection.

• If you do become HIV-1 positive, you will need to take other medicines to treat HIV-1. Apretude is not approved for treatment of HIV-1. If you have HIV-1 and receive only Apretude, over time your HIV-1 may become harder to treat.

Apretude may cause allergic reactions. Call your healthcare provider right away if you develop a rash with Apretude injection. 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 the 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. Your healthcare provider may do blood tests to check your liver function. Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems:

• your skin or the white part of your eyes turns yellow (jaundice)
• dark or “tea-colored” urine
• light-colored stools (bowel movements)
• nausea or vomiting
• loss of appetite
• pain, aching, or tenderness on the right side of your stomach area
• itching.

Depression or mood changes. Call your healthcare provider or get medical help right away if you develop any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, having thoughts of hurting yourself (suicide), or have tried to hurt yourself.

These are not all the possible side effects of Apretude. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA1088

Related/similar drugs

Before receiving

Do not receive Apretude if you:

• Already have HIV-1 infection. If you are HIV-1 positive, you will need to take other medicines to treat HIV-1. Apretude is not approved for the treatment of HIV-1
• Do not know your HIV-1 infection status. You may already be HIV-1 positive. You need to take other medicines to treat HIV-1. Apretude injection can only help reduce your risk of getting HIV-1 infection before you are infected.
• Have ever had an allergic reaction to cabotegravir, Apretude, or any of the inactive ingredients in the injection
• Are taking any of the following medicines: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, or rifapentine.

Before taking 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
• are breastfeeding or plan to breastfeed.

Pregnancy

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 or after receiving Apretude.

There is a pregnancy registry for those who receive Apretude during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

Breastfeeding

Apretude may pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby while or after receiving Apretude.

How will I receive Apretude?

Apretude will be given to you as an injection into the muscle of your buttock by your healthcare provider.

• Apretude is initially given 1 time every month for the first 2 months, then as an injection 1 time every 2 months thereafter.
• Before receiving your first injection dose of Apretude, your healthcare provider may have you take 1 Vocabria (cabotegravir) tablet 1 time a day for 1 month (at least 28 days). This will allow your healthcare provider to assess how well you will 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.

Apretude dosing

Recommended Apretude initial dose for adults and adolescents: Apretude 600 mg (3 mL) injection given as a single dose, followed by another dose 1 month later.

• Give on the last day or within 3 days of an oral lead-in of cabotegravir (Vocabria) if used.

Recommended Apretude maintenance dose for adults and adolescents: Apretude 600 mg (3 mL) every 2 months.

What happens if I miss a dose?

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.

What other drugs will affect 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 when you get a new medicine.

Especially tell your healthcare provider if you take carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, or rifapentine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with Apretude. Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to receive Apretude with other medicines.

Apretude injection ingredients

Active ingredient: cabotegravir

Inactive ingredients: mannitol, polyethylene glycol (PEG) 3350, polysorbate 20, and Water for Injection.

Apretude is available as a single-dose vial of 600 mg/3 mL (200 mg/mL) of cabotegravir extended-release injectable suspension.

Who makes Apretude?

ViiV Healthcare manufactures Apretude.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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