Vocabria is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body. HIV is the virus that can cause acquired immunodeficiency syndrome (AIDS).

Vocabria tablets are used together with another antiviral called rilpivirine for treatment of HIV in people 12 years and older weighing at least 77 pounds (35 kg) to replace their current HIV medicines.

Vocabria is also used in HIV negative patients to lower the chance of getting HIV infection in people 12 years and older weighing at least 77 pounds (35 kg). You must be HIV negative to start and keep using Vocabria to lower the chance of getting HIV infection.

Vocabria and rilpivirine are given as a daily "lead-in dose" to help determine that you can safely use a combination form of these medicines given as an injection.

Vocabria and rilpivirine may also be given short-term in place of the injectable combination if you plan to miss an injection by more than 7 days.

Vocabria and rilpivirine is for use in adults who have already used other antiviral HIV medications that have controlled their viral load. These medicines are not a cure for HIV or AIDS.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Take Vocabria tablets exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Vocabria and rilpivirine tablets are usually given once per day starting at least 28 days before you switch to the injectable combination.

Cabotegravir injection is injected into the muscle of your buttock once every month for the first 2 months, then once every 2 months.

Take Vocabria and rilpivirine tablets with a meal. If you take the medicines at separate times, Vocabria may be taken with or without food.

On the last day you take Vocabria and rilpivirine tablets, you will receive your first injectable dose of these medicines.

If you miss or plan to miss an injection by more than 7 days, call your healthcare provider to discuss your treatment options.

You must remain under the care of a doctor while using Vocabria and rilpivirine. Stay on schedule to get the most benefit. Missing doses can increase your risk of HIV that is resistant to medication.

If you stop using Vocabria and rilpivirine, you will need to start using other HIV medicines to prevent your condition from becoming resistant. Call your healthcare provider right away to discuss your treatment options.

You will need frequent medical tests. Vocabria and rilpivirine can have long lasting effects on your body (up to 12 months after your last dose). You may still need medical tests for a short time after you stop using this medicine.

Usual Adult Dose for HIV Infection:

30 mg orally once a day

Comments:
-To be taken with rilpivirine tablets (25 mg orally once a day)
-Oral lead-in should be used for about 1 month (at least 28 days) to assess tolerability of cabotegravir before the initiation of cabotegravir-rilpivirine IM.
-The last oral dose should be administered on the same day injections with cabotegravir-rilpivirine IM are started.
-If a patient plans to miss a scheduled cabotegravir-rilpivirine IM injection by more than 7 days, this drug may be used with rilpivirine tablets once a day to replace up to 2 consecutive monthly injection visits.
---The first dose of oral therapy should be administered about 1 month after the last injection dose of cabotegravir-rilpivirine IM and continued until the day injection dosing is restarted.
---The manufacturer product information for cabotegravir-rilpivirine IM should be consulted regarding resumption of monthly injection dosing.

Uses: In combination with rilpivirine tablets, for short-term treatment of HIV-1 infection in patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known/suspected resistance to either cabotegravir or rilpivirine, as:
-Oral lead-in to assess tolerability of this drug before starting cabotegravir-rilpivirine IM
-Oral therapy for patients who will miss planned injection dosing with cabotegravir-rilpivirine IM

You should not use Vocabria if you are allergic to cabotegravir.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with Vocabria. Your doctor may change your treatment plan if you also use:

• certain antibiotics - rifabutin, rifampin, rifapentine; or

• seizure medicine - carbamazepine, oxcarbazepine, phenobarbital, phenytoin.

To make sure Vocabria is safe for you, tell your doctor if you have ever had:

• a skin rash or an allergic reaction after using medicine that contains cabotegravir;

• liver disease; or

• mental illness.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether cabotegravir will harm an unborn baby. However, HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of cabotegravir on the baby.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Vocabria is not approved for use by anyone younger than 12 years old or weighing less than 77 pounds (35 kilograms).

Take the medicine as soon as you can. Do not take two doses at one time.

Try not to miss any doses, and be sure you have enough tablets for required doses.

Call your doctor for instructions if you miss a dose of Cabotegravir injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Vocabria and rilpivirine is a complete treatment. Do not use other HIV medications unless your doctor tells you to.

Using this medicine may not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Ask your doctor how to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe.

Get emergency medical help if you have signs of an allergic reaction to Vocabria: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and get medical help at once if you have a skin rash with any of the following symptoms:

• extreme tiredness, fever, not feeling well;

• muscle or joint pain;

• blisters or sores in or around your mouth;

• red or puffy eyes; or

• swelling in your face or mouth, trouble breathing.

Vocabria may cause serious side effects. Call your doctor at once if you have:

• unusual changes in mood such as feeling sad, hopeless, anxious, or restless;

• suicidal thoughts or actions; or

• liver problems - loss of appetite, nausea, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Vocabria side effects of Vocabria may include:

• nausea;

• abnormal dreams;

• feeling anxious;

• headache; or

• sleep problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Some antacids can make Vocabria much less effective when taken at the same time. If you take an antacid, take it at least 2 hours before or 4 hours after you take Vocabria.

Other drugs may interact with cabotegravir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.