Cabotegravir

Cabotegravir is used along with rilpivirine (Edurant) as a short-term treatment 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 is used as a short-term prevention of human immunodeficiency virus type 1 (HIV-1) infection in certain adults and adolescents 12 years of age or older wighing at least 77 pounds (35 kg). It is used to see if the body can tolerate cabotegravir before receiving the cabotegravir injection and in certain cases of missed doses of cabotegravir injection. Cabotegravir is in a class of medications called HIV integrase inhibitors. It works by decreasing the amount of HIV in the blood. Although cabotegravir does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other life-style changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

Cabotegravir comes as a tablet to take by mouth. For treatment of HIV-1 infection, it is usually taken along with rilpivirine once daily with food. Take cabotegravir along with rilpivirine at around the same time every day. Cabotegravir is taken along with rilpivirine for about one month (for at least 28 days) prior to starting treatment with the long-acting injectable forms of these medications or for up to 2 months if the injectable treatment schedule is missed for more than 7 days. For prevention of HIV-1 infection, it is usually taken alone once daily with food. Take cabotegravir at around the same time every day. Cabotegravir is taken for about one month (at least 28 days) prior to starting the long-acting injectable form or for up to 2 months if the injectable schedule is missed for more than 7 days. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cabotegravir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take cabotegravir even if you feel well. Do not stop taking cabotegravir or your other anti-HIV medications without talking to your doctor. If you stop taking cabotegravir or skip doses, your condition may become worse and the virus may become resistant to treatment.

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

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

Before taking cabotegravir,

• tell your doctor and pharmacist if you are allergic to cabotegravir, any other medications, or any of the ingredients in cabotegravir tablets. Ask your pharmacist for a list of the ingredients.
• some medications should not be taken with 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 taking cabotegravir, please get the advice of your doctor or pharmacist.
• if you are taking antacids containing calcium, magnesium, or aluminum (Maalox, Mylanta, Tums, others), take them 2 hours before or 4 hours after taking cabotegravir.
• 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.
• 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.

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

Take the missed dose as soon as you remember it, with a meal. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• headache
• nausea
• abnormal dreams
• anxiety
• difficulty falling asleep or staying asleep

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 depressed or altered mood including suicidal ideation or attempts. Talk to your doctor about the risks of taking this medication. Make sure to tell your doctor about any changes in mood you may be having such as persistent feelings of sadness, sleeping too much or unable to sleep, difficulty concentrating or thoughts of harming oneself.

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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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

Keep a supply of cabotegravir on hand. Do not wait until you run out of medication to refill your prescription.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.

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