Cabotegravir; Rilpivirine Suspensions for Injection

What is this medication?

CABOTEGRAVIR; RILPIVIRINE (cab oh teg ra veer; RIL pi VIR een) is an antiretroviral medicine. It is used to treat HIV. This medicine is not a cure for HIV. This medicine can lower, but not fully prevent, the risk of spreading HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): CABENUVA

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 disease
• an unusual or allergic reaction to cabotegravir, rilpivirine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

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 pediatrician regarding the use of this medication in children. While this medication may be prescribed for children as young as 12 years old 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 health care provider if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• dexamethasone (more than 1 dose)
• certain medicines for seizures like carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• rifabutin
• rifampin
• rifapentine
• St. John's wort; Hypericum perforatum

This medicine may also interact with the following medications:

• certain antibiotics like 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 doctor or health care provider for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider 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. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• fast, irregular heartbeat
• rash, fever, and swollen lymph nodes
• suicidal thoughts or other mood changes

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• fever
• headache
• dizziness
• nausea, vomiting
• pain, redness, or irritation at site where injected

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.

Where should I keep my medication?

This medicine 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.