Cabotegravir

Cabotegravir is a new drug for the treatment of HIV and AIDS.

What is this medication used for?

VOCABRIA 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

How to assess tolerability to this drug?

It can be taken as:

• Oral lead-in to assess the tolerability of cabotegravir prior to administration of CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions.
• Oral therapy for patients who will miss planned injection dosing with CABENUVA.

How is this medication taken?

Take One tablet of VOCABRIA 30 mg 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.

What are the dosages available?

It is available as Tablets: 30 mg

Who should not use Cabotegravir?

• Previous hypersensitivity reaction to cabotegravir.
• Coadministration with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine.

What are the warnings and precautions?

• Hypersensitivity reactions have been reported in association with other integrase inhibitors. Discontinue VOCABRIA immediately if signs or symptoms of hypersensitivity reactions develop.
• Hepatotoxicity has been reported in patients receiving cabotegravir.
• Monitoring of liver chemistries is recommended. Discontinue VOCABRIA if hepatotoxicity is suspected.
• Depressive disorders have been reported with VOCABRIA. Prompt evaluation is recommended for depressive symptoms.

What are the risks?

Risks Associated with Combination Treatment: Physicians are advised to Review the prescribing information for EDURANT for information on rilpivirine prior to initiation of VOCABRIA in combination with EDURANT.

What are the side effects?

The most common adverse reactions (Grades 1 to 4) observed in at least 3 subjects receiving VOCABRIA were headache, nausea, abnormal dreams, anxiety, and insomnia.

What are the drug interactions?

• Refer to the full prescribing information for important drug interactions with VOCABRIA.
• Because VOCABRIA in combination with EDURANT (rilpivirine) is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.
• Drugs that induce uridine diphosphate glucuronosyltransferase (UGT)1A1 may decrease the plasma concentrations of cabotegravir.

Can breast feeding mothers take this?

• Breastfeeding is not recommended due to the potential for HIV1 transmission.

Combination with other HIV agents

• Cabetegravir is FDA approved as Cabenuva (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension), co-packaged for intramuscular use.
• This is the first FDA-approved injectable, complete regimen for HIV-1 infected adults that is administered once a month.
• FDA also approved VOCABRIA (cabotegravir) 30 mg tablets which should be taken in combination with oral rilpivirine (EDURANT) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.

In the news

• Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.

Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter.

• Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug.

Who manufactures and distributes this?

• Manufactured for:ViiV Healthcare Research Triangle Park, NC 27709
• Manufactured by:GlaxoSmithKline Research Triangle Park, NC 27709

Also see

• Cabotegravir/rilpivirine

• Dailymed label info on Cabotegravir
• FDA Cabotegravir