What are the possible side effects of CABENUVA?

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

Liver problems. People with a history of hepatitis B or C virus 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 CABENUVA treatment. Liver problems have also happened in people without history of liver problems or other risk factors. Your healthcare provider may do blood tests to check your liver function. 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 or tenderness on the right side of your stomach area
• itching

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 or have had liver problems, including hepatitis B or C infection.

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.

are breastfeeding or plan to breastfeed. Do not breastfeed if you take CABENUVA. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. It is not known if CABENUVA can pass to your baby in your breast milk. Talk with your healthcare provider about the best way to feed your baby during treatment.

How will I receive CABENUVA?

Once a month, a healthcare provider will inject CABENUVA as 2 injections (cabotegravir and rilpivirine), one into each side of your buttocks.

Before receiving your first CABENUVA injections, your healthcare provider will have you take one VOCABRIA (cabotegravir) tablet and one EDURANT (rilpivirine) tablet once a day for one month (at least 28 days) to assess how well you tolerate these medicines.

Stay under the care of a healthcare provider during treatment with CABENUVA. It is important that you attend your planned appointments to receive your injections.

If you miss or plan to miss a scheduled monthly CABENUVA injection by more than 7 days, call your healthcare provider right away to discuss your treatment options.