Cabotegravir

(ka" boe teg' ra vir)

Brand Name(s): Vocabria®

WHY is this medicine prescribed?

Cabotegravir is used to treathuman immunodeficiency virus type 1 (HIV-1) infection. Cabotegravir is also used for certain periods to prevent human immunodeficiency virus type 1 (HIV-1) infection. 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. Taking these medications and making other life-style changes may decrease the risk of giving the HIV virus to other people.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Cabotegravir comes as a tablet to take by mouth. Take cabotegravir once daily with food for the number of doses your doctor has prescribed. Take cabotegravir at around the same time every day.

Take cabotegravir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Before receiving cabotegravir to prevent HIV infection, your doctor will order a certaintest to check for human immunodeficiency virus type 1 (HIV-1) infection. You must have a negative test before receiving cabotegravir.

Continue to take cabotegravir even if you feel well. Do not stop taking cabotegravir 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.

What SPECIAL PRECAUTIONS should I follow?

Before taking cabotegravir,

  • tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had

  • 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 or plan to become pregnant. If you become pregnant while taking cabotegravir, call your doctor.

  • tell your doctor if you are breastfeeding or plan to breastfeed. Some of the medication and HIV may be passed to your baby in your breast milk. Talk to your doctor about the risks of breastfeeding your baby 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.

  • you should know that some HIV tests can miss an infection in those people recently infected. If youexperience any of the following symptoms, call your doctorimmediately: tiredness, fever, joint or muscle aches, headache, sore throat, vomiting or diarrhea, rash, night sweats, swollen lymph nodes in the neck or groin.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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 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).

What should I know about STORAGE and DISPOSAL of this medication?

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).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

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

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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