Drug Database: Cabotegravir / Rilpivirine

What is Cabenuva?What is Cabenuva?

What is Cabenuva?

Cabenuva is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and adolescents 12 years of age and older who weigh at least 77 lb (35 kg) and who meet certain requirements, as determined by a health care provider.

Cabenuva is a complete HIV treatment regimen and should not be used with other HIV medicines.

Cabenuva contains two different medicines: cabotegravir and rilpivirine.

For more information on the use of Cabenuva in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.

HIV medicines cannot cure HIV/AIDS, but using HIV medicines as directed by your health care provider, helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, do not skip or stop taking them unless your health care provider tells you to.

What should I tell my health care provider before receiving Cabenuva?What should I tell my health care provider before receiving Cabenuva?

What should I tell my health care provider before receiving Cabenuva?

Before you receive Cabenuva, tell your health care provider:

• If you are allergic to any of the medicines in Cabenuva (cabotegravir or rilpivirine) or any other medicines.
• If you have ever had liver problems, including hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV).
• If you have ever had mental health problems.
• If you have ever had kidney problems.
• If you have any other medical conditions.
• If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of receiving Cabenuva during pregnancy. Cabenuva can remain in your body for up to 12 months or longer after the last injection. For more information on the use of Cabenuva during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
• If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
• If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (including St. John’s wort) you are taking or plan to take. Cabenuva may affect the way other medicines or products work, and other medicines or products may affect how Cabenuva works. Receiving Cabenuva together with certain medicines or products may cause serious side effects.

How will I receive Cabenuva?How will I receive Cabenuva?

How will I receive Cabenuva?

Cabenuva comes as a co-packaged kit of single-dose vials in the following strengths:

• 400 mg/2 mL of cabotegravir extended-release injectable suspension and 600 mg/2 mL of rilpivirine extended-release injectable suspension
• 600 mg/3 mL of cabotegravir extended-release injectable suspension and 900 mg/3 mL of rilpivirine extended-release injectable suspension

Your healthcare provider will administer Cabenuva as two intramuscular injections (cabotegravir and rilpivirine), either one time every month or one time every 2 months.

Before receiving your first injection doses of Cabenuva, your health care provider may have you take one cabotegravir tablet (brand name: Vocabria) in combination with one rilpivirine tablet (brand name: Edurant) once daily for 1 month to assess your tolerance of these medicines.

It is important that you attend your planned appointments to receive your injection doses of Cabenuva. If you stop treatment with Cabenuva, you will need to take other medicines to treat your HIV infection and reduce the risk of developing resistance.

Cabenuva is a long-acting medicine that may stay in your body for 12 months or longer after your last injection.

Tell your healthcare provider right away if you stop treatment with Cabenuva.

For more information about how you will receive Cabenuva, see the FDA drug label.

What should I do if I forget a dose?What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss or plan to miss a scheduled monthly or every-2-month injection of Cabenuva by more than 7 days, contact your health care provider right away to discuss your treatment options.

What side effects can Cabenuva cause?What side effects can Cabenuva cause?

What side effects can Cabenuva cause?

Cabenuva may cause side effects. Some side effects of Cabenuva can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.

Other possible side effects of Cabenuva include post-injection reactions. Post-injection reaction symptoms have happened within minutes in some people after receiving their rilpivirine injection. Most symptoms went away within a few minutes after the injection. Symptoms of post-injection reactions include:

• Trouble breathing
• Narrowing of airways
• Stomach cramps
• Sweating
• Numbness of your mouth
• Pain (for example, back and chest pain)
• Feeing anxious
• Feeling warm
• Rash
• Feeling lightheaded or feeling like you are going to pass out (faint)
• Blood pressure changes.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Cabenuva. To learn more about possible side effects of Cabenuva, read the drug label or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

Where can I find more information about Cabenuva?Where can I find more information about Cabenuva?

Where can I find more information about Cabenuva?

• For more information on the use of Cabenuva in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
• This Patient Version drug summary is based on the following FDA label(s): Kit (injection). The Patient Package Insert and Instructions For Use include information for people using Cabenuva.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for cabotegravir and rilpivirine injections available from MedlinePlus.
• Cabenuva-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)
• A list of FDA-approved HIV medicines, from HIVinfo

Manufacturer InformationManufacturer Information

Manufacturer Information

ViiV Healthcare

Main number: 877-844-8872
Patient assistance (ViiV Connect): 844-588-3288