Vocabria

Generic name: cabotegravir
Drug class: Integrase strand transfer inhibitor

Medically reviewed by  A Ras MD.

What is Vocabria?

Vocabria is a prescription medicine that is used in combination with another Human Immunodeficiency Virus-1 (HIV-1) medicine called Edurant (rilpivirine) for short-term treatment of HIV-1 infection in adults to replace their current HIV-1 medicines when their healthcare provider determines that they meet certain requirements.

Vocabria is for use to assess the tolerability of cabotegravir before receiving the long-acting medicine called Cabenuva (cabotegravir; rilpivirine) extended-release injectable suspensions,  oral therapy for people who will miss planned injection dosing with Cabenuva.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

You should also read the Patient Information for Edurant.

It is not known if Vocabria is safe and effective in children.

Who should not take Vocabria?

• have ever had an allergic reaction to cabotegravir.
• are taking any of the following medicines:
  • carbamazepine
  • oxcarbazepine
  • phenobarbital
  • phenytoin
  • rifampin
  • rifapentine

Description

VOCABRIA contains cabotegravir, as cabotegravir sodium, an HIV integrase strand transfer inhibitor (INSTI). The chemical name of cabotegravir sodium is sodium (3S,11aR)-N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido [1,2-d]pyrazine-8-carboxamide. The empirical formula is C19H16F2N3NaO5 and the molecular weight is 427.34 g/mol. It has the following structural formula:

Cabotegravir sodium is a white to almost white crystalline solid that is slightly soluble in water.

Each immediate-release film-coated tablet of VOCABRIA for oral administration contains 30 mg of cabotegravir (equivalent to 31.62 mg cabotegravir sodium) and the inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablet film-coating contains hypromellose, polyethylene glycol, and titanium dioxide.

What should I tell my healthcare provider before taking Vocabria?

Before you take Vocabria, tell your healthcare provider about all your medical conditions, including if you:

• have ever had a skin rash or an allergic reaction to medicines that contain cabotegravir.
• have ever had liver problems.
• have ever had mental health problems.
• are pregnant or plan to become pregnant. It is not known if Vocabria will harm your unborn baby.
  Pregnancy Registry. There is a pregnancy registry for women who take Vocabria during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
• are breastfeeding or plan to breastfeed. Do not breastfeed if you take Vocabria.
  • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
  • It is not known if Vocabria can pass to your baby in your breast milk. Talk with your healthcare provider about the best way to feed your baby during treatment with Vocabria.

Tell your healthcare provider about all the medicines you take, including prescriptions and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines interact with Vocabria. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with Vocabria.

Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Vocabria with other medicines.

How should I take Vocabria?

• Take 1 Vocabria tablet and 1 Edurant (rilpivirine) tablet one time a day for one month (at least 28 days) exactly as your healthcare provider tells you.
• You will receive treatment with Vocabria tablets in combination with Edurant tablets for one month (at least 28 days) before you receive Cabenuva (cabotegravir; rilpivirine) extended-release injectable suspensions for the first time. This will allow your healthcare provider to assess how well you tolerate these medicines.
• Your final dose of Vocabria and Edurant tablets should be taken on the same day you receive your first injections of Cabenuva.
• If you miss or plan to miss a scheduled monthly injection of Cabenuva by more than 7 days, call your healthcare provider right away to discuss your treatment options.
• Vocabria may be taken with or without food.
• If you take Vocabria at the same time as Edurant, you should take it with a meal.
• If you take antacid products that contain aluminum or magnesium hydroxide or calcium carbonate, they should be taken at least 2 hours before or 4 hours after you take Vocabria. Do not miss a dose of Vocabria. If you miss a dose of Vocabria, take it as soon as you remember.
• Stay under the care of a healthcare provider during treatment with Vocabria.
• Do not change your dose or stop taking Vocabria without talking to your healthcare provider.
• Do not miss a dose of Vocabria. If you miss a dose of Vocabria, take it as soon as you remember.
• Do not run out of Vocabria. The virus in your blood may increase and the virus may become harder to treat.
• If you take too much Vocabria, go to the nearest hospital emergency room right away.

What are the possible side effects of Vocabria?

Vocabria may cause serious side effects including:

• Allergic reactions. Call your healthcare provider right away if you develop a rash with Vocabria. Stop taking Vocabria and get medical help right away if you develop a rash with any of the following signs or symptoms:
  • fever
  • generally ill feeling
  • tiredness
  • muscle or joint aches
  • trouble breathing
  • blisters or sores in mouth
  • blisters
  • redness or swelling of the eyes
  • swelling of the mouth, face, lips, or tongue
• Liver problems. Liver problems have happened in people with or without history of liver problems or other risk factors. Your healthcare provider may do blood tests to check your liver function. Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems:
  • your skin or the white part of your eyes turns yellow (jaundice)
  • dark or “tea-colored” urine
  • light-colored stools (bowel movements)
  • nausea or vomiting
  • loss of appetite
  • pain, aching, or tenderness on the right side of your stomach area
  • itching
• Depression or mood changes.Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms:
  • feeling sad or hopeless
  • feeling anxious or restless
  • have thoughts of hurting yourself (suicide) or have tried to hurt yourself

The most common side effects of Vocabria include:

• headache
• nausea
• abnormal dreams
• anxiety
• sleep disorders

These are not all the possible side effects of Vocabria. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

General information about the safe and effective use of Vocabria

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Vocabria for a condition for which it was not prescribed. Do not give Vocabria to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Vocabria that is written for health professionals.

How should I store Vocabria?

• Store Vocabria below 86°F (30°C).

Keep Vocabria and all medicines out of the reach of children.

What are the ingredients in Vocabria?

Active ingredient: cabotegravir

Inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

The tablet film-coating contains: hypromellose, polyethylene glycol and titanium dioxide.

Label

PRINCIPAL DISPLAY PANEL

• NDC 49702-248-13
• VOCABRIA
• (cabotegravir)
• Tablets
• 30 mg
• Rx Only
• Note to pharmacist:
• Do not cover ALERT box with pharmacy label.
• ALERT: Find out about medicines that should NOT be taken with VOCABRIA.
• 30 tablets
• Each tablet contains 30 mg of cabotegravir equivalent to 31.62 mg of cabotegravir sodium
• This package is child-resistant.
• Keep out of reach of children.
• Store below 30°C (86°F).
• Do not accept if membrane seal under cap is missing or broken.
• See prescribing information for dosage information.
• Mfd for:
• ViiV Healthcare
• RTP, NC 27709
• by:
• GlaxoSmithKline
• RTP, NC 27709
• Made in Singapore

62000000039717 Rev.11/20

SRC: NLM .