What are the most important things to know about cabotegravir?
Cabotegravir can cause serious side effects. These include severe skin rash and allergic reactions,problems, and or mood changes.
Contact your health care provider right away if you develop a rash while taking cabotegravir. Stop taking cabotegravir and get medical help right away if you develop a rash with any of the following symptoms:
- General ill feeling
- Extreme tiredness
- Muscle or joint aches
- Blistering or peeling skin
- Blisters or sores in your mouth
- Redness or swelling of your eyes ( )
- Swelling of your face, lips, mouth, tongue, or throat
- Trouble breathing or swallowing
Some people taking cabotegravir may develop liver problems. People with a history of liver disease may have an increased risk of developing new or worsening liver problems while taking cabotegravir. Liver problems have also occurred in people without a history of liver problems or other risk factors. Liver function tests may be done before and during treatment with cabotegravir.
Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:
- Yellowing of your skin or the whites of your eyes ( )
- Dark-colored urine
- Light-colored bowel movements
- Loss of appetite for several days or longer
- Nausea or vomiting
- Pain, aching, or tenderness on the right side of your stomach area/abdominal area
Contact your health care provider right away if you have any of the following symptoms that could be signs of depression or mood changes:
- Feeling sad or hopeless
- Feeling anxious or restless
- Harming yourself or having thoughts about harming yourself (including suicidal thoughts)
Cabotegravir tablets and cabotegravir extended-release injectable suspension (also known as long-acting injectable cabotegravir) can be used for(PrEP) to reduce the risk of getting HIV in people who are HIV negative. Do not use cabotegravir for PrEP unless a health care provider has confirmed that you do not have HIV.
While using cabotegravir, it is important to keep all of your appointments with your health care provider.
What is cabotegravir?
Cabotegravir is a prescription medicine approved by the U.S.(FDA). It is approved as two different under two different brand names for the following uses:
- Cabotegravir oral tablet (brand name: Vocabria)
- For the short-term treatment of HIV infection in adults and adolescents 12 years of age and older who weigh at least 77 lb (35 kg) and who meet certain requirements, as determined by a health care provider. When used for HIV treatment, cabotegravir is always used with the HIV medicine rilpivirine (brand name: Edurant).
- For short-term PrEP to reduce the risk of HIV infection in adults and adolescents who weigh at least 77 lb (35 kg).
- Long-acting injectable cabotegravir (brand name: Apretude)
- For HIV PrEP to reduce the risk of HIV infection in adults and adolescents who weigh at least 77 lb (35 kg).
For more information on the use of cabotegravir in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
Whether you are using cabotegravir for HIV prevention or for HIV treatment (in combination with rilpivirine), do not cut down on, skip, or stop taking your HIV medicine(s) unless your health care provider tells you to.
What should I tell my health care provider before using cabotegravir?
Before using cabotegravir, tell your health care provider:
- If you are allergic to cabotegravir or any other medicines.
- If you have ever had liver problems.
- If you have ever had mental health problems.
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of using cabotegravir during pregnancy. Long-acting injectable cabotegravir can remain in your body for up to 12 months or longer after your last injection.
- If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
- If you are using HIV and Birth Control infographic. -based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the HIVinfo
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Cabotegravir may affect the way other medicines or products work, and other medicines or products may affect how cabotegravir works. Using cabotegravir together with certain medicines or products may cause serious side effects.
Before receiving cabotegravir for HIV PrEP, you must get tested to be sure you are HIV negative. Do not use cabotegravir to reduce the risk of getting HIV unless you are confirmed to be HIV negative.
Before receiving cabotegravir for PrEP, also tell your health care provider:
- If you had a flu-like illness anytime in the month before starting cabotegravir or if you have a flu-like illness at any time while receiving cabotegravir. Flu-like symptoms may be a sign that you could have recently gotten HIV. The flu-like symptoms of a new HIV infection may include: tiredness, fever, nighttime sweating, rash, vomiting, diarrhea, joint or muscle aches, headache, sore throat, or enlarged in the neck or groin.
- If you think that you were exposed to HIV. Your health care provider may want to do more tests to be sure you are still HIV negative.
While receiving cabotegravir for PrEP, you will get tested for HIV each time you receive a cabotegravir injection or when your health care provider tells you.
How should I use cabotegravir?
Cabotegravir comes in the following forms and strengths:
- 30-mg tablets
- 600 mg/3 mL single-dose vials of extended-release injectable suspension
Use cabotegravir according to your health care provider’s instructions. Do not miss aof cabotegravir, and do not change your dose or stop using cabotegravir without first talking with your health care provider.
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 tablets.
Before receiving the long-acting injectable regimen of cabotegravir and rilpivirine (brand name: Cabenuva), your health care provider may have you take cabotegravir tablets in combination with rilpivirine tablets for 1 month to assess your of these medicines. Take a cabotegravir tablet and a rilpivirine tablet by mouth at approximately the same time each day with food.
Before receiving your first injection of cabotegravir for HIV PrEP, your health care provider may have you take a cabotegravir tablet one time each day for 1 month to assess your tolerance of cabotegravir. Take cabotegravir tablets with or without food.
Long-acting injectable cabotegravir for HIV PrEP will be administered by your health care provider. Initially, you will receive an(IM) injection of cabotegravir one time each month for the first 2 months. After that, you will receive an IM injection of cabotegravir one time every 2 months.
Long-acting injectable cabotegravir can stay in your body for 12 months or longer after your last injection. It is important that you receive cabotegravir for PrEP as scheduled and not just when you think you were exposed to HIV. Always use PrEP in combination with condoms and other safe sex practices. If you stop receiving long-acting injectable cabotegravir, talk to your health care provider about options to reduce the risk of getting HIV infection.
If you have taken too much cabotegravir, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.
What should I do if I forget a dose?
If you miss aof oral cabotegravir, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.
If you miss or plan to miss a scheduled injection of long-acting cabotegravir by more than 7 days, contact your health care provider right away to discuss your PrEP options.
What side effects can cabotegravir cause?
Cabotegravir may cause side effects. Some side effects of cabotegravir can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIV fact sheet on HIV Medicines and Side Effects for more information.
Other possible side effects of cabotegravir tablets for HIV treatment and/or PrEP include:
- Abnormal dreams
- Sleep disorders
- Upper respiratory tract infection
- Stomach pain
Other possible side effects of long-acting injectable cabotegravir include:
- , including pain, tenderness, hardened mass or lump, swelling, bruising, redness, itching, warmth, loss of sensation, abscess, and discoloration
- Sleep problems
- Passing gas
- Stomach pain
- Muscle pain
- Loss of appetite
- Back pain
- Upper respiratory infection
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of cabotegravir. To learn more about possible side effects of cabotegravir tablets and long-acting injectable cabotegravir, read the drug labels or Vocabria or Apretude or talk to your health care provider or pharmacist.for
You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.
How should cabotegravir be stored?
- Store cabotegravir tablets below 86°F (30°C).
- Keep cabotegravir in the container that it came in and keep the container tightly closed.
- Do not use cabotegravir if the original seal over the container opening is broken or missing.
- Throw away cabotegravir that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep cabotegravir and all medicines out of reach of children.
Where can I find more information about cabotegravir?
- For more information on the use of cabotegravir in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
- This Patient Version drug summary is based on the following FDA label(s): Tablet (film-coated) and Kit. The Patient Package Insert and Instructions For Use include information for people using cabotegravir.
- The American Hospital Formulary Service (AHFS) Patient Medication Information for cabotegravir and cabotegravir injection available from MedlinePlus.
- Cabotegravir-related research studies, from . (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search.)
- A list of FDA-approved HIV medicines, from HIVinfo.