Cabenuva

Cabenuva is a prescription medication used to treat human immunodeficiency virus (HIV) infection.

Cabenuva comes as 2 co-packaged injectable medications, cabotegravir and rilpivirine. Cabotegravir belongs to a group of drugs called integrase strand transfer inhibitors (INSTIs). Rilpivirine is in a class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Both medications work by blocking enzymes the virus needs in order to reproduce. 

Cabenuva is an extended-release medication to be given by injection into the muscle of the buttocks one time every month.

Common side effects include injection site reactions, fever, fatigue, and headache.

Cabenuva is a prescription medicine used without other Human Immunodeficiency Virus-1 (HIV-1) medicines to treat HIV-1 infection in adults to replace their current HIV-1 medicines when their healthcare provider determines that they meet certain requirements.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). Cabenuva contains 2 different medicines:
• cabotegravir
• rilpivirine

It is not known if Cabenuva is safe and effective in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• ViiV Healthcare

Serious side effects have been reported with Cabenuva. See the "Cabenuva Precautions" section.

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.

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

Do not receive Cabenuva if you 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)

This is not a complete list of Cabenuva drug interactions. Talk to your doctor or pharmacist for more information.

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 a few minutes after the injection. Symptoms of post-injection reactions may include:

• trouble breathing
• stomach cramps
• sweating
• numbness of your mouth
• feeling anxious
• feeling warm
• feeling lightheaded or feeling like you are going to pass out (faint) 
• blood pressure changes

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 treatment with Cabenuva. 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

Depression or mood changes. Call your healthcare provider or get emergency medical help right away if you have 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

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)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Cabenuva, there are no specific foods that you must exclude from your diet when receiving this medication.

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.

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. 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 with Cabenuva.

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

Tell your doctor if you 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.

Tell your doctor if you 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 with Cabenuva.

• Your healthcare provider will inject Cabenuva into the muscle of each side of your buttocks.
• You will receive Cabenuva as 2 injections (cabotegravir and rilpivirine), one time every month.
• 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 one 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 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.

The recommended first Cabenuva dose is 600 mg of cabotegravir and 900 mg of rilpivirine on the last day of oral lead-in. Injections of Cabenuva (400 mg of cabotegravir and 600 mg of rilpivirine) should be given every month thereafter.

If overdose is suspected, contact your healthcare provider or seek emergency medical attention.