Vocabria (Cabotegravir sodium): Uses, Side Effects and Dosage

What is the most important information I should know about VOCABRIA?

Important information for people who take VOCABRIA to help reduce their risk of getting human immunodeficiency virus-1 (HIV-1) infection, also called pre-exposure prophylaxis or “PrEP”:

Before taking VOCABRIA to reduce your risk of getting HIV-1:

• You must be HIV-1 negative to start VOCABRIA. You must get tested to make sure that you do not already have HIV-1 infection.
• Do not take VOCABRIA 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 VOCABRIA or at any time while taking VOCABRIA. 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
• night sweats

While you are taking VOCABRIA for HIV-1 PrEP:

• VOCABRIA 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 taking VOCABRIA 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 when your healthcare provider tells you.
  • 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 doses of VOCABRIA. Missing doses 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. VOCABRIA by itself is not a complete treatment for HIV-1.

If you have HIV-1 and take only VOCABRIA, over time your HIV-1 may become harder to treat.

What is VOCABRIA?

VOCABRIA is a prescription medicine that may be used in two different ways when a person’s healthcare provider determines that they meet certain requirements. VOCABRIA is used:

• to treat HIV-1 infection

  • in combination with another HIV-1 medicine called EDURANT (rilpivirine) for short-term treatment of HIV-1 infection in people 12 years of age and older who weigh at least 77 pounds (35 kg) to replace their current HIV-1 medicines to assess the tolerability of cabotegravir before receiving the long-acting medicine called CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension).
  • as oral therapy for people who will miss planned injection dosing with CABENUVA.

• for HIV-1 PrEP to reduce the risk of getting HIV-1 infection

  • for short-term PrEP in adults and adolescents who weigh at least 77 pounds (at least 35 kg) to assess the tolerability of cabotegravir before receiving the long-acting medicine called APRETUDE (cabotegravir extended-release injectable suspension).
  • as oral dosing for people who will miss planned injection dosing with APRETUDE.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

If you are taking VOCABRIA to treat HIV-1 infection, you should also read the Patient Information for EDURANT.

It is not known if VOCABRIA for treatment of HIV-1 infection is safe and effective in children younger than 12 years of age or weighing less than 77 pounds (35 kg).

It is not known if VOCABRIA is safe and effective in reducing the risk of HIV-1 infection in children younger than 12 years of age or weighing less than 77 pounds (less than 35 kg).

Do not take VOCABRIA if you:

• have ever had an allergic reaction to cabotegravir.
• are taking any of the following medicines:

• carbamazepine
• oxcarbazepine
• phenobarbital

• phenytoin
• rifampin
• rifapentine

For people taking VOCABRIA for treatment of HIV-1 infection:

Do not take VOCABRIA for HIV-1 infection if you are taking rifabutin.

For people taking VOCABRIA for HIV-1 PrEP:

Do not take VOCABRIA 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. VOCABRIA by itself is not a complete treatment for 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. VOCABRIA can only help reduce your risk of getting HIV-1 infection before you are infected.
• are allergic to cabotegravir.
• are taking any of the medicines listed above. See “Do not take VOCABRIA for HIV-1 infection if you:”

Before taking VOCABRIA, 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, including hepatitis B or C infection.
• have ever had mental health problems.

• are pregnant or plan to become pregnant. It is not known if VOCABRIA will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with VOCABRIA.

  Pregnancy Registry. There is a pregnancy registry for those who take VOCABRIA 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.

• are breastfeeding or plan to breastfeed. VOCABRIA may pass into your breast milk.

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

    • 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 VOCABRIA.
  • If you take VOCABRIA for HIV-1 PrEP, talk with your healthcare provider about the best way to feed your baby while receiving VOCABRIA.

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 VOCABRIA. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with VOCABRIA.

Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take VOCABRIA with other medicines.

How should I take VOCABRIA?

• For treatment of HIV-1 infection:

  • Take 1 VOCABRIA tablet and 1 EDURANT 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 VOCABRIA tablets in combination with EDURANT 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 VOCABRIA and EDURANT should be taken on the same day you receive your first injections of CABENUVA.
  • 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.

  • If you take VOCABRIA at the same time as EDURANT, you should take it with a meal.

  • Do not run out of VOCABRIA. The virus in your blood may increase and the virus may become harder to treat when using VOCABRIA to treat HIV-1 infection.

• For HIV-1 PrEP:

  • Take 1 VOCABRIA 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 VOCABRIA tablets for 1 month (at least 28 days) before you receive 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 VOCABRIA 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.
• VOCABRIA may be taken with or without food.
• 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 VOCABRIA.
• Stay under the care of a healthcare provider while taking VOCABRIA.
• Do not change your dose or stop taking VOCABRIA without talking to your healthcare provider.
• Do not miss a dose of VOCABRIA. If you miss a dose of VOCABRIA, take it as soon as you remember.
• If you take too much VOCABRIA, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of VOCABRIA?

VOCABRIA may cause serious side effects including:

• Allergic reactions. Call your healthcare provider right away if you develop a rash with VOCABRIA.

  Stop taking VOCABRIA 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 history of liver problems or other risk factors. Your healthcare provider may do blood tests to check your liver function. People with a history of liver problems or people who have certain liver function test changes may have an increased risk of developing new or worsening changes in certain liver tests during treatment with VOCABRIA.

  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
  • have thoughts of hurting yourself (suicide) or have tried to hurt yourself

The most common side effects of VOCABRIA for HIV-1 treatment include:

• fatigue
• headache
• diarrhea
• nausea
• dizziness
• abnormal dreams

• anxiety
• sleep disorders
• stomach pain
• stomach bloating
• weakness

The most common side effects of VOCABRIA for HIV-1 PrEP include:

• headache
• diarrhea
• nausea
• dizziness
• upper respiratory tract infection

• tiredness
• drowsiness
• abnormal dreams
• stomach pain

These are not all the possible side effects of VOCABRIA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

How should I store VOCABRIA?

Store VOCABRIA below 86°F (30°C).

Keep VOCABRIA and all medicines out of the reach of children.

General information about the safe and effective use of VOCABRIA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VOCABRIA for a condition for which it was not prescribed. Do not give VOCABRIA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about VOCABRIA that is written for health professionals.

What are the ingredients in VOCABRIA?

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.

Manufactured for:

ViiV Healthcare

Durham, NC 27701

APRETUDE, CABENUVA, and VOCABRIA are trademarks owned by or licensed to the ViiV Healthcare group of companies.

The other brand listed is a trademark owned by or licensed to its respective owner and is not a trademark owned by or licensed to the ViiV Healthcare group of companies. The maker of this brand is not affiliated with and does not endorse the ViiV Healthcare group of companies or its products.

©2025 ViiV Healthcare group of companies or its licensor.

VCB:7PIL

For more information call 1-877-844-8872.

• This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 4/2025