Pronunciation: KA-boe-TEG-ra-vir
Generic name: cabotegravir
Brand names: Apretude, Vocabria
Dosage form: extended-release injection for intramuscular use (200 mg/mL), oral tablet (30 mg)
Drug class: Integrase strand transfer inhibitor

Medically reviewed by Carmen Pope, BPharm. Last updated on Mar 12, 2025.

What is cabotegravir?

Cabotegravir is an antiviral medication used for the prevention and treatment of HIV. Cabotegravir when used:

• for HIV prevention (PrEP), is given as a long-acting injection given every 2 months (brand name Apretude)
• for HIV-1 treatment, is given as a daily oral tablet (brand name Vocabria) in combination with rilpivirine (Edurant)
• for checking tolerance before administering the long-acting cabotegravir/rilpivirine injection (Cabenuva) for HIV treatment, is given as a daily tablet for 28 days (brand name Vocabria) in combination with rilpivirine 
• for checking tolerance before administering the long-acting cabotegravir injection (Apretude) for HIV prevention, is given as a daily tablet for 28 days (brand name Vocabria).

Cabotegravir gained FDA approval on January 21, 2021. There is no generic cabotegravir injection or tablet available.

How does cabotegravir work?

Cabotegravir's mechanism of action involves blocking a key enzyme called HIV integrase which allows HIV to insert its genetic material into human cells. By blocking this enzyme cabotegravir:

• Prevents viral replication
• Targets HIV before it can establish an infection in the body 
• Maintains consistent drug levels in the bloodstream
• Provides long-lasting protection against HIV transmission with injections administered every 2 months.

Cabotegravir belongs to the drug class known as HIV-1 integrase strand transfer inhibitors (INSTIs).

Cabotegravir uses

Cabotegravir extended-release injection (brand name Apretude) 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 is administered every 2 months after an initial loading dose period.

Cabotegravir oral tablets (brand name Vocabria) are used short-term as:

• an oral lead for approximately 1 month to determine the tolerability of Apretude (cabotegravir) injection for HIV-1 PrEP
• an oral alternative to Apretude for HIV-1 PrEP in people who will miss planned injection dosing.
• an oral lead for approximately 1 month to determine the tolerability of Cabenuva (cabotegravir/rilpivirine) injection for HIV-1 treatment when used in combination with Edurant (rilpivirine) 25 mg tablets
• an oral alternative to Cabenuva for HIV-1 treatment for up to 2 months to replace up to 2 consecutive missed monthly injections when used in combination with Edurant (rilpivirine) 25 mg tablets.

Cabotegravir extended-release injection is available in combination with rilpivirine extended-release injection (brand name Cabenuva) for HIV-1 treatment in patients 12 years of age and older and weighing at least 35 kg.

• Cabenuva is used to replace the current antiretroviral medications for patients who are virologically suppressed (HIV-1 RNA <50 copies/mL) and stable on antiretroviral medications, with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

Cabotegravir side effects

The most common side effects of cabotegravir injection for HIV-1 PrEP 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.

The most common side effects of cabotegravir oral tablets for HIV-1 PrEP are:

• headache
• diarrhea
• nausea
• dizziness
• tiredness
• drowsiness
• abnormal dreams
• stomach pain
• upper respiratory tract infection.

The most common side effects of cabotegravir oral tablets for HIV-1 treatment are:

• tiredness or fatigue
• headache
• diarrhea
• nausea
• dizziness
• abnormal dreams
• anxiety
• sleep disorders
• stomach pain
• stomach bloating
• weakness.

Serious side effects and warnings

Cabotegravir extended-release injection (Apretude) carries a Boxed Warning for risk of drug resistance if it 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.

Cabotegravir injections and tablets do 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 cabotegravir for HIV-1 PrEP (see Apretude for more information).

• 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 cabotegravir 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 cabotegravir 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 or tablets of cabotegravir when using it for HIV-1 PrEP. 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. If you have HIV-1 and receive only cabotegravir, over time your HIV-1 may become harder to treat.

Cabotegravir may cause allergic reactions. Call your healthcare provider right away if you develop a rash with cabotegravir. Stop receiving cabotegravir 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 receiving cabotegravir 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 while receiving cabotegravir: 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 cabotegravir. 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 cabotegravir for HIV-1 PrEP if you:

• Already have HIV-1 infection. If you are HIV-1 positive, you will need to take other medicines to treat 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. Cabotegravir by itself can only help reduce your risk of getting HIV-1 infection before you are infected
• Have ever had an allergic reaction to cabotegravir, cabotegravir, or any of the inactive ingredients in the injection
• Are taking any of the following medicines: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, or rifapentine.

Do not receive cabotegravir for the treatment of HIV-1 if you are taking rifabutin.

Before taking cabotegravir, 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 cabotegravir will harm your unborn baby. Cabotegravir 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 cabotegravir.

There is a pregnancy registry for those who receive cabotegravir injections or tablets 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

Cabotegravir may pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby while or after receiving cabotegravir if you are taking it for HIV-1 PrEP.

If you take cabotegravir tablets to treat HIV-1 infection, talk to your healthcare provider about the following risks to your baby from breastfeeding during treatment:

• the HIV-1 virus may pass to your baby if your baby does not have HIV-1 infection
• the HIV-1 virus may become harder to treat if your baby has HIV-1 infection

Your baby may get side effects from cabotegravir.

How will I receive cabotegravir?

Cabotegravir injection

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

• Cabotegravir 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 Cabotegravir, 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.

Cabotegravir 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 Cabotegravir. It is important that you receive Cabotegravir as scheduled.

Cabotegravir oral tablets

For the treatment of HIV-1 infection:

• Take 1 cabotegravir tablet and 1 rilpivirine 1 time a day for 1 month (at least 28 days) exactly as your healthcare provider tells you.
• Your healthcare provider may have you take cabotegravir tablets in combination with rilpivirine tablets for 1 month (at least 28 days) before you receive Cabenuva for the first time. This will allow your healthcare provider to assess how well you will tolerate these medicines.
  • Your final dose of cabotegravir and rilpivirine should be taken on the same day you receive your first injections of Cabenuva.
• If you take cabotegravir at the same time as rilpivirine, you should take it with a meal.
• If you miss or plan to miss a scheduled monthly or every-2-month injections of Cabenuva by
  more than 7 days, call your healthcare provider right away to discuss your options.
• Do not run out of cabotegravir. The virus in your blood may increase and the virus may become harder to treat when using cabotegravir to treat HIV-1 infection.

For HIV-1 PrEP:

• Take 1 cabotegravir tablet 1 time a day for 1 month (at least 28 days) exactly as your healthcare provider tells you.
• Your healthcare provider may have you take cabotegravir tablets for 1 month (at least 28 days) before you receive cabotegravir extended-release injection (Apretude) for the first time. This will allow your healthcare provider to assess how well you will tolerate Apretude.
• You should receive your first injection of Apretude on the day of your last dose of cabotegravir or within 3 days.
• If you miss or plan to miss a scheduled every 2-month injection of Apretude by more than 7 days, call your healthcare provider right away to discuss your options.

Cabotegravir dosing

Cabotegravir injection (Apretude)

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.

Cabotegravir oral tablets (Vocabria)

For the treatment of HIV-1 infection: 1 tablet of cabotegravir 30 mg 1 time daily in combination with 1 tablet of rilpivirine 25 mg 1 time daily.

• Take with a meal.

For HIV-1 PrEP: 1 tablet of cabotegravir 30 mg 1 times daily if oral lead-in is used for HIV-1 PrEP. 

What happens if I miss a dose?

If you miss or plan to miss a scheduled cabotegravir extended-release injection by more than 7 days, call your healthcare provider right away to discuss your PrEP options.

If you stop receiving cabotegravir, talk to your healthcare provider about other options to reduce the risk of getting HIV-1 infection.

Do not miss a dose of cabotegravir oral tablets. If you miss a dose of cabotegravir, take it as soon as you remember

What other drugs will affect cabotegravir?

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 Cabotegravir. 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 receive cabotegravir injection and you take carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, or rifapentine.

If you take antacid products that contain aluminum or magnesium hydroxide or calcium carbonate, they should be taken at least 2 hours before or 4 hours after you take cabotegravir oral tablets.

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

Cabotegravir ingredients

Apretude 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.

Vocabria ingredients

Active ingredient: cabotegravir

Inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

The tablet film-coating contains: hypromellose, polyethylene glycol and titanium dioxide.

Vocabria is available as Vocabria 30 mg tablets.

Who makes cabotegravir?

ViiV Healthcare manufactures cabotegravir extended-release injection under the brand name Apretude.

ViiV Healthcare manufactures cabotegravir tablets under the brand name Vocabria.

Further information

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

Medical Disclaimer