Cabotegravir Suspension for Injection

What is this medication?

CABOTEGRAVIR (cab oh teg ra veer) is used with safe sex practices to help reduce the risk of getting HIV in high-risk persons. It is an antiretroviral medication. This medication is not a cure for HIV.

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

COMMON BRAND NAME(S): Apretude

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

They need to know if you have any of these conditions:

• Flu-like symptoms—fever, chills, muscle pain, cough, headache, fatigue
• Liver disease
• Mental health disease
• An unusual or allergic reaction to cabotegravir, other medications, 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 your care team in a hospital or clinic setting. You will receive an injection once every month for the first 2 months, then once every 2 months. Before receiving your first injection, your care team may have you take oral cabotegravir tablets once daily for 1 month to see how well you will tolerate the injection.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

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.

What may interact with this medication?

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

• Certain medications for seizures like carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• Rifampin
• Rifapentine

This medication may also interact with the following medications:

• Methadone
• Rifabutin

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.

You will need an HIV test before you receive each injection.

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

You may experience a local reaction at the injection site; these reactions are common and usually only last a few days. Ask your care team about things you can do to help with these reactions.

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
• Flu-like symptoms—fever, chills, muscle pain, cough, headache, fatigue
• 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
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

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

• Diarrhea
• Dizziness
• Headache
• Nausea
• Pain, redness, or irritation at injection site
• Trouble sleeping

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 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.