Cabotegravir (Oral)

Cabotegravir is used with rilpivirine for short-term treatment of 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 decides they meet certain requirements. It is used to check how well you tolerate cabotegravir before getting the cabotegravir/rilpivirine combination injection (Cabenuva) or for patients who will miss a planned injection of Cabenuva.

Cabotegravir is also used for pre-exposure prophylaxis (PrEP) to lower the risk of HIV-1 infection. Your doctor may perform tests to ensure you are negative for HIV-1 infection before you take this medicine for HIV-1 PrEP. This medicine is used to check how well you tolerate cabotegravir before receiving the cabotegravir injection (Apretude) or for patients who will miss a planned injection of Apretude.

Cabotegravir will not cure or prevent HIV infection or AIDS. It helps stop HIV from reproducing and seems to slow down the damage to the immune system. This may help delay issues that are usually related to AIDS or HIV disease from happening. This medicine will not prevent you from spreading HIV to others. People who take this medicine may still experience other issues typically related to AIDS or HIV disease.

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

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

You should not use this medicine with a seizure medicine (for example, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, Trileptal®) or medicine for tuberculosis (for example, 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, a 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.

In deciding to use a medicine, you and your doctor will weigh the risks of taking the medicine against its benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies you have, like to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

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

Geriatric

Appropriate studies so far have not found any specific problems for elderly patients that would limit the usefulness of cabotegravir. However, older patients are more likely to have age-related kidney, liver, or heart issues, which may require caution when using cabotegravir.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when this medication is used during breastfeeding. Consider the potential benefits against the risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together, even if an interaction might occur. In such cases, your doctor may change the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and may not include all possible interactions.

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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both 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

Some medicines should not be taken around mealtime or with certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Depression or
• Liver disease—Use with caution. May worsen these conditions.

• HIV-1 infection, positive or unknown status—Should not be used for HIV-1 PrEP in patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, 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.

In the U.S.

• Vocabria

Available Dosage Forms:

• Tablet

Pharmacologic Class: Integrase Inhibitor

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.