Cabotegravir injection is used for prevention of human immunodeficiency virus type 1 (HIV-1) infection in certain adults and adolescents 12 years of age or older weighing at least 77 pounds (35 kg).

Cabotegravir injection comes as a suspension (liquid) to be injected into a muscle by a healthcare provider. You will receive cabotegravir injection once every month for 2 months and then every 2 months after that given as an injection into your buttocks.

Before receiving your first cabotegravir injection, you may be asked to take cabotegravir (Vocabria) tablet orally (by mouth) once daily for one month (at least 28 days) to see if you can tolerate these medications.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before taking cabotegravir injection,

• tell your doctor and pharmacist if you are allergic to cabotegravir, any other medications, or any of the ingredients in cabotegravir injection. Ask your pharmacist for a list of the ingredients.
• Some medications should not be taken while receiving cabotegravir or their doses may need to be adjusted or additional monitoring may need to occur. Make sure you have discussed any prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are currently taking or plan to take before starting cabotegravir with your doctor and pharmacist. Before starting, stopping or changing any medications while receiving cabotegravir, please get the advice of your doctor or pharmacist.
• tell your doctor if you have or have ever had depression or other mental illness, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking cabotegravir, call your doctor. You should not breastfeed if you are infected with HIV or if you are taking cabotegravir.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using cabotegravir injection.
• you should know that cabotegravir may cause changes in your thoughts, behavior, or mental health. Call your doctor immediately if you develop any of the following symptoms while you are taking cabotegravir: new or worsening depression, or thinking about killing yourself or planning or trying to do so. Be sure your family knows which symptoms may be serious so that they can call your doctor if you are unable to seek treatment on your own.

It is very important to stay on your cabotegravir administration schedule for the medication to work to prevent HIV-1 infection. If you miss a cabotegravir injection appointment by more than 7 days, call your doctor right away to discuss your treatment options.

Unless your doctor tells you otherwise, continue your normal diet.

Cabotegravir injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain, tenderness, swelling, redness, itching, bruising, or warmth at injection site
• diarrhea
• headache
• fatigue
• fever

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• rash with or without: fever; extreme tiredness; muscle or joint aches; blisters; mouth sores; swelling of the eyes, lips, tongue, or mouth; or difficulty breathing
• yellow eyes or skin; right upper abdominal pain; bruising; bleeding; loss of appetite; confusion; yellow or brown-colored urine; or pale stools

Cabotegravir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to cabotegravir.

Ask your pharmacist any questions you have about cabotegravir injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Apretude®