Cabotegravir (ka-boe-TEG-ra-vir), Rilpivirine (ril-pi-VIR-een)

Treats HIV-1 infection. This medicine does not cure HIV or AIDS, but it may slow the progress of the disease.

Brand Name(s):

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 each side of your buttocks.
• A nurse or other health provider will give you this medicine.
• Your doctor may ask you to take 1 tablet of cabotegravir and 1 tablet of rilpivirine once a day for 1 month (at least 28 days) before receiving your first injection.
• If you stop treatment with this medicine, you will need to take other medicines for HIV infection. Talk with your doctor if you have any concerns about this.
• 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.

• Do not use this medicine if you are also using dexamethasone, St John's wort, medicine to treat tuberculosis (including rifabutin, rifampin, rifapentine), or seizure medicine (including carbamazepine, oxcarbazepine, phenobarbital, phenytoin).
• Some medicine can affect how cabotegravir and rilpivirine works. Tell your doctor if you also use any of the following:
  • Methadone
  • Medicine to treat infections (including azithromycin, clarithromycin, erythromycin)
  • Medicine that may cause heart rhythm problems

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease, or depression.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause the following problems:
  • Drug reaction with eosinophilia and systemic symptoms (DRESS), which may damage organs including the liver, kidney, or heart
  • Post-injection reactions
  • Liver problems
  • Changes in mood or behavior, including depression
• 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
• Anxiety, back pain, chest pain or tightness, dizziness, lightheadedness, fainting, feeling of warmth, numbness of your mouth, stomach cramps, sweating, 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 or attempts of hurting yourself

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

• Fever, headache
• 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