Cabotegravir (ka-boe-TEG-ra-vir)

Treats HIV-1 infection and helps reduce the risk of getting HIV-1 infection (HIV-1 PrEP). This medicine does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease.

Brand Name(s):

Vocabria

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Cabotegravir only: You may take this medicine with or without food.
• Cabotegravir with rilpivirine: It is best to take this medicine with food or milk.
• Take all of the medicines your doctor has prescribed at the right time of day and in the correct order. Do not change your dose or stop using any of your medicines unless your doctor tells you to.
• Do not change the dose or stop using this medicine without checking first with your doctor. If you stop the medicine even for a short time, the virus may become harder to treat. Contact your doctor or pharmacist when your supply is running low so you do not run out.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are also using a seizure medicine (including carbamazepine, oxcarbazepine, phenobarbital, phenytoin) or medicine to treat tuberculosis (including rifampin, rifapentine).
• Take antacids that contain aluminum, magnesium, or calcium at least 2 hours before or 4 hours after you take cabotegravir.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease or depression.
• For HIV-1 PrEP: Your doctor may do tests to make sure you are negative from HIV-1 infection before taking this medicine.
• Do not breastfeed if you are taking this medicine to treat HIV-1 infection. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause the following problems:
  • Liver problems
  • Changes in mood or behavior (including depression, suicidal thoughts)
• Always practice safe sex, even if your partner also has HIV. If you stop taking this medicine or do not take it as prescribed, you may spread HIV to others. Do not reuse or share needles, or other items, that may have blood or body fluids on them.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blisters, sores in mouth, redness or swelling of eyes
• Bone or muscle pain, feeling ill
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Depression, unusual changes in behaviors or moods, thoughts of hurting yourself

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Headache, dizziness, drowsiness
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

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