This product is used to help reduce the risk of getting HIV infection. Cabotegravir belongs to a class of drugs known as integrase inhibitors. It works by blocking the virus from growing and infecting more cells. This product does not protect against other sexually transmitted infections (such as gonorrhea, syphilis).

To decrease your risk of getting HIV and other sexually transmitted infections, use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity as directed by your doctor. Do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

When cabotegravir is given in combination with rilpivirine, it is used to help control HIV infection.

Read the Patient Information Leaflet if available from your pharmacist before you start using cabotegravir and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Before starting treatment with this product, you must first get tested to make sure you do not already have HIV infection. Do not receive this medication unless you are confirmed to be HIV negative.

To see how well you can take this medication, your doctor may have you take the form of cabotegravir taken by mouth for one month (at least 28 days) before starting treatment with this form of cabotegravir. Carefully follow your doctor's directions for taking all your medications.

This product is given by injection into a muscle as directed by your doctor, usually once every month for the first 2 months, then once every 2 months. It is given by injection into a buttock muscle by a health care professional. The dosage is based on your medical condition and response to treatment.

It is very important to keep using this medication exactly as prescribed by your doctor. To help you remember, mark your calendar with a reminder. If you miss or will miss a planned injection by more than 7 days, tell your health care professional right away to get directions for your continued HIV prevention.

Injection site pain/discomfort, swelling, redness, itching, bruising, or a hardened mass or lump may occur. Diarrhea, headache, dizziness, tiredness, and trouble sleeping may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)
• mental/mood changes (such as depression, thoughts of suicide)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this product, tell your doctor or pharmacist if you are allergic to cabotegravir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease
• mental/mood disorders (such as depression)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Do not use this medication with other products that contain cabotegravir.

Other medications can affect the removal of cabotegravir from your body, which may affect how this product works. Examples include efavirenz, rifamycins (such as rifampin, rifapentine), certain drugs used to treat seizures (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: fast/irregular heartbeat, severe dizziness, fainting.

Lab and/or medical tests (such as HIV tests, liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This product is given in a hospital or clinic or doctor's office and will not be stored at home.