CABENUVA is an extended-release injectable suspension containing the active ingredients cabotegravir, an HIV integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV non-nucleoside reverse transcriptase inhibitor (NNRTI). It is formulated for intramuscular injection with cabotegravir at 200 mg/mL and rilpivirine at 300 mg/mL. Key inactive ingredients include mannitol, polyethylene glycol, citric acid monohydrate, and poloxamer 338. CABENUVA is intended to be used as an antiretroviral therapy for the treatment of HIV infections.

How should I use this medication?

This medication is injected into a muscle. It is given by a care team in a hospital or clinic setting. Do not skip doses. Skipping doses can make HIV resistant to this and other medications. Keep taking this therapy unless your care team tells you to stop. Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 12 years for selected conditions, special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue -Rash, fever, and swollen lymph nodes -Severe back pain, chest pain, headache, trouble breathing after injection -Thoughts of suicide or self-harm, worsening mood, feelings of depression Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Diarrhea -Fatigue -Fever -Headache -Muscle pain -Nausea -Pain, redness, irritation, or bruising at the injection site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Heart disease -Liver disease -Mental health conditions -An unusual or allergic reaction to cabotegravir, rilpivirine, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Certain medications for seizures, such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin -Dexamethasone (more than 1 dose) -Rifabutin -Rifampin -Rifapentine -St. John's wort This medication may also interact with the following: -Certain antibiotics, such as azithromycin, clarithromycin, erythromycin -Methadone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Discuss any new symptoms with your care team. You will need to have important blood work done while on this medication. HIV is spread to others through sexual or blood contact. Talk to your care team about how to stop the spread of HIV. This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.