Risks and Side Effects

Do not receive CABENUVA if you:

• have ever had an allergic reaction to cabotegravir or rilpivirine.
• are taking any of the following medicines:
  • carbamazepine
  • oxcarbazepine
  • phenobarbital
  • phenytoin
  • rifabutin
  • rifampin
  • rifapentine
  • dexamethasone (more than a single-dose treatment)
  • St John’s wort (Hypericum perforatum)

CABENUVA may cause serious side effects including:

• Allergic reactions. Call your healthcare provider right away if you develop a rash with CABENUVA. Stop receiving CABENUVA 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
• Post-injection reactions. Post-injection reaction symptoms have happened within minutes in some people after receiving their rilpivirine injection. Most symptoms resolved within minutes after the injection. Symptoms of post-injection reactions may include:
  • trouble breathing
  • narrowing of airways
  • stomach cramps
  • sweating
  • numbness of your mouth
  • pain (eg, back and chest)
  • feeling anxious
  • feeling warm
  • rash
  • feeling lightheaded or feeling like you are going to pass out (faint)
  • blood pressure changes
• 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 CABENUVA. 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 emergency 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 CABENUVA include:

• pain, tenderness, hardened mass or lump, swelling, redness, itching, bruising, and warmth at the injection site
• fever
• tiredness
• headache
• muscle or bone pain
• nausea
• sleep problems
• dizziness
• rash

These are not all the possible side effects of CABENUVA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive CABENUVA, 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 or rilpivirine.
• have ever had liver problems, including hepatitis B or C infection.
• have or ever had kidney problems.
• have ever had mental health problems.
• are pregnant or plan to become pregnant. It is not known if CABENUVA will harm your unborn baby. CABENUVA can remain in your body for up to 12 months or longer after the last injection.
  Pregnancy Registry. There is a pregnancy registry for women who take CABENUVA 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. CABENUVA may pass into your breast milk. Talk to your healthcare provider about risks to your baby from breastfeeding during or after treatment with CABENUVA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines interact with CABENUVA. 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 CABENUVA.

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

• Your healthcare provider will inject CABENUVA into the muscle of each side of your buttocks or on the same side of your buttocks at least 2 cm apart.
• You will receive CABENUVA as 2 injections (cabotegravir and rilpivirine), either one time every month or one time every 2 months.
• Before receiving your first injection doses of CABENUVA, your healthcare provider will have you take 1 VOCABRIA (cabotegravir) tablet and 1 EDURANT (rilpivirine) tablet one time a day for 1 month (at least 28 days). This will allow your healthcare provider to assess how well you tolerate these medicines.
• CABENUVA is a long-acting medicine and may stay in your system for 12 months or longer after your last injection.
• Stay under the care of a healthcare provider during treatment with CABENUVA. It is important that you attend your planned appointments to receive your injection doses of CABENUVA.
• If you miss or plan to miss a scheduled monthly or every-2-month injection of CABENUVA by more than 7 days, call your healthcare provider right away to discuss your treatment options.
• If you stop treatment with CABENUVA you will need to take other medicines to treat your HIV-1 infection and reduce the risk of developing viral resistance. Call your healthcare provider right away to discuss your treatment options.