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What is CABENUVA?

CABENUVA is a complete prescription regimen used to treat HIV-1 infection in people 12 years and older who weigh at least 77 lbs (35 kg), to replace their current HIV-1 medicines when their healthcare provider determines they meet certain requirements.

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IMPORTANT SAFETY INFORMATION

Do not receive CABENUVA if you:

have ever had an allergic reaction to cabotegravir or rilpivirine.

are taking certain medicines: carbamazepine; oxcarbazepine; phenobarbital; phenytoin; rifabutin; rifampin; rifapentine; dexamethasone (more than a single-dose treatment); St John’s wort (Hypericum perforatum).

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.

Post-injection reactions have happened in some people within minutes after receiving their rilpivirine injection. Most symptoms resolved within minutes. Symptoms may include: trouble breathing; narrowing of airways; stomach cramps; sweating; numbness of the mouth; pain (eg, back and chest); feeling anxious; feeling warm; rash; feeling lightheaded or 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: the skin or the white part of the 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 the 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.

Before receiving 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.

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. Do not start taking a new medicine without telling your healthcare provider.

How will I receive CABENUVA?

Once a month or once every 2 months, a healthcare provider will inject CABENUVA as 2 injections (cabotegravir and rilpivirine), into the muscle of your buttocks.

Before receiving your first CABENUVA injections, your healthcare provider may have you take 1 VOCABRIA (cabotegravir) tablet and 1 EDURANT (rilpivirine) tablet once a day for 1 month (at least 28 days) to assess how you tolerate these medicines.

Stay under the care of a healthcare provider during CABENUVA treatment. It is important that you attend all planned injection appointments.

If you miss or plan to miss a scheduled CABENUVA injection 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the Patient Information for CABENUVA and discuss it with your healthcare provider.

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