Cabotegravir (Oral)

Generic name: Cabotegravir
Drug class: Integrase strand transfer inhibitor

Usage of Cabotegravir (Oral)

Cabotegravir is used together with rilpivirine for short-term treatment of the human immunodeficiency virus type 1 (HIV-1) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to patients to replace their current anti-HIV medicines when their healthcare provider determines that they meet certain requirements. It is used to assess how well you tolerate cabotegravir before receiving cabotegravir/rilpivirine combination injection (Cabenuva) or in patients who will miss a planned injection of Cabenuva.

Cabotegravir is also used for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection. Your doctor may do tests to make sure you are negative from HIV-1 infection before taking this medicine for HIV-1 PrEP. This medicine is used to assess how well you tolerate cabotegravir before receiving cabotegravir injection (Apretude) or in patients who will miss a planned injection of Apretude.

Cabotegravir will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. This medicine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

Cabotegravir (Oral) side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

  • Abnormal dreams
  • dark urine
  • difficulty in breathing or swallowing
  • discouragement
  • fast heartbeat
  • feeling sad or empty
  • irritability
  • loss of appetite
  • loss of interest or pleasure
  • nausea or vomiting
  • skin itching, rash, or redness
  • stomach pain
  • swelling of the face, throat, or tongue
  • thoughts of hurting yourself
  • trouble breathing
  • trouble concentrating
  • trouble sleeping
  • unusual tiredness or weakness
  • yellow eyes or skin

    • Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Less common

  • Body aches or pain
  • chills
  • cough
  • diarrhea
  • difficulty in breathing
  • difficulty in moving
  • dizziness
  • ear congestion
  • fever
  • headache
  • joint pain
  • lack or loss of strength
  • loss of voice
  • muscle aches, cramps, pains, or stiffness
  • runny or stuffy nose
  • sleepiness or unusual drowsiness
  • sneezing
  • sore throat

    • Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

    Before taking Cabotegravir (Oral)

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever HAD any unusual or allergic Reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of cabotegravir in children younger than 12 years of age or weighing less than 35 kilograms (kg). Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cabotegravir in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution for patients receiving cabotegravir.

    Breast Feeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Interactions with Medicines

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Carbamazepine
  • Oxcarbazepine
  • Phenobarbital
  • Phenytoin
  • Rifampin
  • Rifapentine

    • Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abacavir
  • Aluminum Carbonate, Basic
  • Aluminum Hydroxide
  • Aluminum Phosphate
  • Amprenavir
  • Atazanavir
  • Calcium carbonate
  • Darunavir
  • Delavirdine
  • Didanosine
  • Dihydroxyaluminum Aminoacetate
  • Dihydroxyaluminum Sodium Carbonate
  • Dolutegravir
  • Doravirine
  • Efavirenz
  • Elvitegravir
  • Emtricitabine
  • Enfuvirtide
  • Etravirine
  • Fosamprenavir
  • Fostemsavir
  • Ibalizumab-uiyk
  • Indinavir
  • Lamivudine
  • Lopinavir
  • Magaldrate
  • Magnesium Carbonate
  • Magnesium hydroxide
  • Magnesium oxide
  • Magnesium Trisilicate
  • Maraviroc
  • Nelfinavir
  • Nevirapine
  • Raltegravir
  • Ritonavir
  • Saquinavir
  • Sodium BIcarbonate
  • Stavudine
  • Tenofovir
  • Tipranavir
  • Zalcitabine
  • Zidovudine

    • Interactions with Food/Tobacco/Alcohol

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Depression or
  • Liver disease—Use with caution. May make these conditions worse.
  • HIV-1 infection, positive or unknown status—Should not be used for HIV-1 PrEP in patients with this condition.

    • Relate drugs

    How to use Cabotegravir (Oral)

    Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

    This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

    Keep taking cabotegravir for the full time of treatment, even if you begin to feel better. Do not stop taking it without checking first with your doctor.

    It is important to take cabotegravir together with rilpivirine. Take all other medicines your doctor has prescribed at the right time of day. This will make your medicines work better.

    You may take this medicine alone with or without food. Take this medicine with food it taking together with rilpivirine.

    Take antacid containing aluminum, magnesium, or calcium 2 hours before or 4 hours after you take cabotegravir.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral doSage form (tablets):
  • For short-term treatment of HIV infection:
  • To assess the tolerability of cabotegravir before receiving Cabenuva:
  • Adults and children 12 years of age and older weighing 35 kilograms (kg) or more—30 milligrams (mg) in combination with 25 mg of rilpivirine once a day for at least 28 days. Your last dose should be taken on the SAMe day Cabenuva injections are started.
  • Children younger than 12 years of age or weighing less than 35 kg—Use and dose must be determined by your doctor.
  • For patients who will miss a monthly planned injection of Cabenuva:
  • Adults and children 12 years of age and older weighing 35 kilograms (kg) or more—If you miss or plan to miss a scheduled monthly injection of Cabenuva by more than 7 days, take 30 milligrams (mg) in combination with 25 mg of rilpivirine once a day. Your first dose should be taken at least 1 month after the last Cabenuva injection and continued until the day injection dosing is restarted.
  • Children younger than 12 years of age or weighing less than 35 kg—Use and dose must be determined by your doctor.
  • For patients who will miss an every-2-month planned injection of Cabenuva:
  • Adults and children 12 years of age and older weighing 35 kilograms (kg) or more—If you miss or plan to miss a scheduled every-2-month injection of Cabenuva by more than 7 days, take 30 milligrams (mg) in combination with 25 mg of rilpivirine once a day. Your first dose should be taken at least 2 months after the last Cabenuva injection and continued until the day injection dosing is restarted.
  • Children younger than 12 years of age or weighing less than 35 kg—Use and dose must be determined by your doctor.
  • For pre-exposure prophylaxis (PrEP) to reduce the risk HIV-1 infection:
  • To assess the tolerability of cabotegravir before receiving Apretude:
  • Adults and children 12 years of age and older weighing 35 kilograms or more—30 milligrams (mg) once a day for at least 28 days. Your first dose of Apretude injection should be given on your last day of Vocabria or within 3 days.
  • Children younger than 12 years of age or weighing less than 35 kg—Use and dose must be determined by your doctor.
  • For patients who will miss a planned injection of Apretude (one every 2-month injection):
  • Adults and children 12 years of age and older weighing 35 kilograms or more—If you miss or plan to miss a scheduled every-2-month injection of Apretude by more than 7 days, take 30 milligrams (mg) once a day. Your first dose should be taken at least 2 months after the last Apretude injection. Restart Apretude injection on your last day of Vocabria or within 3 days.
  • Children younger than 12 years of age or weighing less than 35 kg—Use and dose must be determined by your doctor.

    • Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Warnings

    It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

    You should not use this medicine together with a seizure medicine (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, Trileptal®) or medicine to treat tuberculosis (eg, rifampin, rifapentine, Priftin®, Rifadin®, Rimactane®). Using these medicines together may make cabotegravir less effective.

    This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, fever, general feeling of discomfort or illness, muscle or joint aches, redness or swelling of the eyes, sores or blisters in the mouth, swelling of the mouth, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

    Check with your doctor right away if you have dark urine, clay-colored stools, stomach pain, or yellow eyes or skin. These may be symptoms of a serious liver problem.

    Tell your doctor right away if you start to feel depressed. Report any unusual thoughts or behaviors that trouble you (including suicidal thoughts), especially if they are new or get worse quickly.

    This medicine does not decrease the risk of transmitting HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom. Only use condoms made of latex or polyurethane and use them every time you have contact with semen, vaginal secretions, or blood. Also, do not share needles or equipment with anyone or use dirty needles. If you have any questions about this, check with your doctor.

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