VOCABRIA Film-coated tablet (2021)

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ViiV Healthcare Company

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1. Indications and Usage

VOCABRIA is indicated in combination with EDURANT (rilpivirine) for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA less ...

2. Dosage and Administration

2.1 Oral Lead-in Dosing to Assess Tolerability of Cabotegravir Consult the prescribing information for CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspension before initiating VOCABRIA ...

3. Dosage Forms and Strengths

VOCABRIA tablets are white, film-coated, oval tablets debossed with SV CTV on one side. Each film-coated tablet contains 30 mg of cabotegravir (equivalent to 31.62 mg cabotegravir sodium).

4. Contraindications

VOCABRIA is contraindicated in patients: with previous hypersensitivity reaction to cabotegravir [see Warnings and Precautions (5.1)]. receiving the following coadministered drugs for which significant ...

5. Warnings and Precautions

5.1 Hypersensitivity Reactions Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with VOCABRIA [see Adverse Reaction (6.1)] ...

6. Adverse Reactions

The following adverse reactions are described below and in other sections of the labeling: Hypersensitivity reactions [see Warnings and Precautions (5.1)] Hepatotoxicity [see Warnings and ...

6.1. 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 ...

7. Drug Interactions

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 [see ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VOCABRIA during pregnancy. Healthcare providers are encouraged to register patients ...

8.2. Lactation

Risk Summary The Centers for Disease Control and Prevention recommends that HIV‑1–infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. ...

8.4. Pediatric Use

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

8.5. Geriatric Use

Clinical trials of VOCABRIA did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. In general, caution should be exercised ...

8.6. Renal Impairment

No dosage adjustment of VOCABRIA is necessary for patients with mild to moderate (creatinine clearance equal to 30 mL/min to less than 90 mL/min) or severe renal impairment (creatinine clearance less than ...

8.7. Hepatic Impairment

No dosage adjustment of VOCABRIA is necessary for patients with mild or moderate hepatic impairment (Child-Pugh A or B). The effect of severe hepatic impairment (Child-Pugh C) on the pharmacokinetics of ...

10. Overdosage

There is no known specific treatment for overdose with VOCABRIA. If overdose occurs, monitor the patient and apply standard supportive treatment as required. As cabotegravir is highly bound to plasma proteins, ...

11. 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 ...

12.1. Mechanism of Action

Cabotegravir is an HIV-1 antiretroviral drug [see Microbiology (12.4)].

12.2. Pharmacodynamics

Cardiac Electrophysiology At a dose of cabotegravir 150 mg orally every 12 hours (10 times the recommended total daily oral lead-in dosage of VOCABRIA) the QT interval is not prolonged to any clinically ...

12.3. Pharmacokinetics

Absorption, Distribution, Metabolism, and Excretion The pharmacokinetic properties of cabotegravir are provided in Table 2. The multiple-dose pharmacokinetic parameters are provided in Table 3. Table ...

12.4. Microbiology

Mechanism of Action Cabotegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Two-year carcinogenicity studies in mice and rats were conducted with cabotegravir. In mice, no drug-related increases in tumor incidence were observed at cabotegravir exposures (AUC) up ...

14. Clinical Studies

14.1 Clinical Trials in Adults The use of VOCABRIA in combination with EDURANT (rilpivirine) as an oral lead-in and in patients who miss planned injections with CABENUVA (cabotegravir; rilpivirine) extended-release ...

16.1. How Supplied

Each VOCABRIA tablet contains 30 mg of cabotegravir and is a white, oval, film-coated, biconvex tablet debossed with SV CTV on one side. Bottle of 30 tablets with child-resistant closure NDC 49702-248-13. ...

16.2. Storage and Handling

Store below 30°C (86°F).

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Reactions Advise patients to immediately contact their healthcare provider if they develop a rash. Instruct ...