Vocabria

Last updated on RxList: 7/21/2021
Vocabria Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Vocabria?

Vocabria (cabotegravir) is a human immunodeficiency virus type-1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with Edurant (rilpivirine) for short-term treatment of HIV-1 infection in adults 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 or suspected resistance to either cabotegravir or rilpivirine, for use as oral lead-in to assess the tolerability of cabotegravir prior to administration of Cabenuva (cabotegravir; rilpivirine) extended-release injectable suspensions and for use as oral therapy for patients who will miss planned injection dosing with Cabenuva.

What Are Side Effects of Vocabria?

Side effects of Vocabria include:

  • headache,
  • nausea,
  • abnormal dreams,
  • anxiety, and
  • insomnia

Dosage for Vocabria

The dose of Vocabria is one 30 mg tablet taken orally once daily for approximately 1 month in combination with one tablet of Edurant (rilpivirine) 25 mg taken orally once daily with a meal.

Vocabria In Children

The safety and efficacy of Vocabria have not been established in pediatric patients.

What Drugs, Substances, or Supplements Interact with Vocabria?

Vocabria may interact with other medicines such as:

  • other antiretroviral medications for the treatment of HIV-1 infection,
  • inducers of uridine diphosphate glucuronosyltransferase (UGT)1A1 or 1A9,
  • antacids,
  • anticonvulsants, and
  • antimycobacterials

Tell your doctor all medications and supplements you use.

Vocabria During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Vocabria; it is unknown how it would affect a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Vocabria during pregnancy. It is unknown if Vocabria passes into breast milk. Breastfeeding is not recommended due to the potential for HIV-1 transmission.

Additional Information

Our Vocabria (cabotegravir) Tablets, For Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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.

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Vocabria Consumer Information

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

Stop taking 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.

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 side effects 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.

Read the entire detailed patient monograph for Vocabria (Cabotegravir Tablets for Oral Use)

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Vocabria Professional Information

SIDE EFFECTS

The following adverse reactions are described below and in other sections of the labeling:

  • Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Depressive disorders [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect rates observed in practice. See full prescribing information for CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions for additional safety information. Since VOCABRIA is taken in combination with rilpivirine tablets, the prescribing information for EDURANT (rilpivirine) should be consulted for relevant information on rilpivirine.

The safety assessment of VOCABRIA for oral lead-in therapy prior to therapy with CABENUVA is based on the analysis of pooled 48-week data from 1,182 virologically suppressed subjects with HIV-1 infection in 2 international, multicenter, open-label pivotal trials, FLAIR and ATLAS.

Adverse reactions were reported following exposure to VOCABRIA tablets and EDURANT tablets administered in combination as oral lead-in therapy (median time exposure: 5.3 weeks). Adverse reactions included those attributable to the oral formulation of cabotegravir and rilpivirine administered as a combination regimen. Refer to the prescribing information for EDURANT for other adverse reactions associated with oral rilpivirine.

The most common adverse reactions during the oral lead-in period were headache, nausea, abnormal dreams, anxiety, and insomnia all of which occurred in at least 3 subjects, with an incidence less than or equal to 1%.

During the oral lead-in period, 6 (1%) subjects discontinued due to adverse events, including asthenia, myalgia, depression suicidal, and headache.

Read the entire FDA prescribing information for Vocabria (Cabotegravir Tablets for Oral Use)

© Vocabria Patient Information is supplied by Cerner Multum, Inc. and Vocabria Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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