Pronunciation: Ap-reh-tood
Generic name: cabotegravir
Other brand names of cabotegravir include Apretude(
Dosage form: extended-release injectable suspension (600 mg/3 mL)
Drug class: Integrase strand transfer inhibitor

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

What is Apretude?

Apretude (cabotegravir) is an FDA-approved injectable medication used for HIV pre-exposure prophylaxis (PrEP). It helps reduce the risk of acquiring HIV-1 through sex in adults and adolescents weighing at least 77 pounds (35 kg). Unlike daily oral PrEP medications, Apretude is administered every two months by a healthcare professional, offering a long-acting alternative for individuals at high risk of HIV.

Effectiveness of Apretude for HIV Prevention

Clinical trials estimate that Apretude is 99% effective in preventing HIV-1 transmission when used correctly. Before starting treatment, a negative HIV test is required to prevent drug resistance.

Key Benefits of Apretude for PrEP

• First FDA-approved long-acting injectable PrEP medication (approved in January 2021)
• Administered every two months after an initial oral lead-in phase with Vocabria (cabotegravir tablets)
• Highly effective for HIV prevention
• May improve adherence compared to daily oral PrEP
• Recommended for individuals at substantial risk of HIV infection
• Eliminates the burden of daily medication.

Injectable vs. Oral PrEP

• Reduces the need for daily adherence
• Provides consistent drug levels for long-term protection
• May offer higher efficacy in some populations

Considerations Before Using Apretude

• Requires an initial oral lead-in phase to assess tolerability
• Must be administered by a healthcare professional
• Not suitable for everyone; individual assessment is necessary
• Requires routine HIV testing before each injection

How Does Apretude Work?

Apretude belongs to the drug class integrase strand transfer inhibitors (INSTIs). It blocks the HIV integrase enzyme, preventing the virus from inserting its genetic material into human cells. This action:

• Inhibits viral replication
• Blocks HIV before it can establish an infection
• Maintains consistent drug levels in the bloodstream
• Provides long-lasting protection when administered every two months.

Potential Side Effects of Apretude

While Apretude is generally well-tolerated, some side effects may occur:

Injection Site Reactions:

• Pain, swelling, bruising
• Redness, itching, warmth
• Possible abscess formation or discoloration
• Temporary numbness or sensation loss.

Gastrointestinal Effects:

• Diarrhea
• Nausea, vomiting
• Stomach pain, loss of appetite
• Excessive gas.

Systemic Side Effects:

• Headache, fever
• Fatigue, dizziness
• Sleep disturbances, muscle pain
• Respiratory infections.

Skin Reactions:

• Rash, localized skin changes.

Additional Symptoms:

• Drowsiness, back pain.

If symptoms persist or worsen, consult a healthcare provider. Report severe reactions immediately.

Serious Warnings and Precautions

Apretude carries a Boxed Warning for the risk of developing drug-resistant HIV-1 if used in individuals with undiagnosed HIV infection. To prevent this risk:

• Patients must test HIV-negative before starting Apretude
• Routine HIV testing is required before each injection
• If symptoms of acute HIV infection occur (e.g., fever, rash, sore throat, night sweats, swollen lymph nodes), notify a healthcare provider immediately.

Apretude Does Not Prevent Other STIs. While Apretude protects against HIV, it does not prevent other sexually transmitted infections (STIs) such as chlamydia, gonorrhea, or syphilis. Using barrier protection (e.g., condoms) is still recommended to reduce the risk of STIs.

Potential Severe Reactions

• Allergic Reactions: Stop Apretude immediately and seek medical attention if symptoms such as rash, fever, muscle pain, difficulty breathing, or swelling of the face or lips occur.
• Liver Problems: Apretude may cause liver issues, even in individuals without prior liver conditions. Symptoms of liver problems include jaundice (yellowing of the skin or eyes), dark urine, nausea, vomiting, light-colored stools, and right-side abdominal pain.
• Mental Health Changes: Some users experience mood changes, including depression or suicidal thoughts. Seek medical help if symptoms of depression, anxiety, or suicidal thoughts arise.

Reporting Side Effects. If you experience side effects, contact your doctor. You can also report adverse reactions to the FDA at 1-800-FDA-1088.

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Maintaining HIV Prevention with Apretude

To stay HIV-negative while using Apretude:

• Know your own HIV status and that of your partners
• Encourage partners with HIV to adhere to their treatment to maintain an undetectable viral load
• Undergo HIV-1 testing with every injection
• Get tested regularly for other STIs
• If exposed to HIV, seek immediate medical evaluation.

Missed Doses and HIV Risk

Missing injections increases the risk of acquiring HIV-1. If an injection is missed, consult a healthcare provider to determine the best course of action.

Apretude is Not a Treatment for HIV

If a person with HIV-1 unknowingly continues using Apretude without additional treatment, their virus may develop resistance, making future treatment more difficult. If HIV-1 infection is detected, Apretude should be discontinued, and a full HIV treatment regimen should be initiated.

Before receiving

Do not receive Apretude if you:

• Already have an HIV infection. If you are HIV-1 positive, you will need to take other medicines to treat this infection because Apretude is not approved for HIV treatment
• 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 by your healthcare provider.

• 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 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. You must receive Apretude as scheduled.

Apretude dosing

Initial dose for adults and adolescents:

• Apretude 1 injection (600 mg/3 mL). Repeat the dose 1 month later.
• Give the injection on the last day or within 3 days of an oral lead-in of cabotegravir (Vocabria) if used.

Maintenance dose for adults and adolescents:

• Apretude 1 injection every 2 months.

What happens if I miss a dose?

If you miss or plan to miss a scheduled Apretude injection 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?

Apretude is manufactured by ViiV Healthcare, a global pharmaceutical company headquartered in Brentford, United Kingdom. ViiV Healthcare is a collaboration between GlaxoSmithKline (majority owner), Pfizer, and Shionogi and specializes in HIV/AIDS treatments: Other notable HIV medications by this company include:

• Juluca
• Dovato
• Triumeq
• Tivicay
• Rukobia.

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