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

Helps reduce the risk of getting HIV-1 infection (HIV-1 PrEP).

Brand Name(s):

Apretude

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles. It is usually given at your buttocks.
• A nurse or other health provider will give you this medicine.
• Your doctor may tell you take cabotegravir tablets for at least 28 days before you receive this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

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

• You should not receive this medicine if you are also using a seizure medicine (including carbamazepine, oxcarbazepine, phenobarbital, phenytoin) or medicine to treat tuberculosis (including rifampin, rifapentine).
• Some medicines can affect how cabotegravir works. Tell your doctor if you also using rifabutin.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, or depression.
• Your doctor may do tests to make sure you are negative from HIV-1 infection before receiving this medicine.
• 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.

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
• 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:

• Back or muscle pain
• Diarrhea
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Headache, dizziness, drowsiness
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given
• Tiredness
• 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