Vocabria

VOCABRIA- cabotegravir sodium tablet, film coated
ViiV Healthcare Company

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 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 [see Dosage and Administration (2.1)]:

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

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 to ensure therapy with CABENUVA is appropriate. See full prescribing information for CABENUVA.

Oral lead-in should be used for approximately 1 month (at least 28 days) to assess the tolerability of cabotegravir prior to the initiation of CABENUVA. The recommended oral daily dose is one 30-mg tablet of VOCABRIA in combination with one 25-mg tablet of EDURANT (rilpivirine). The last oral dose should be taken on the same day injections with CABENUVA are started.

Take VOCABRIA once daily with EDURANT at approximately the same time each day with a meal [see Clinical Pharmacology (12.3)].

Because VOCABRIA is indicated in combination with rilpivirine tablets, the prescribing information for EDURANT should also be consulted.

2.2 Oral Dosing to Replace Planned Missed Injections of CABENUVA (Up to 2 Consecutive Monthly Injections)

If a patient plans to miss a scheduled injection of CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions by more than 7 days, take daily oral therapy to replace up to 2 consecutive monthly injection visits. The recommended oral daily dose is one 30-mg tablet of VOCABRIA (cabotegravir) and one 25-mg tablet of EDURANT (rilpivirine). Take VOCABRIA with EDURANT at approximately the same time each day with a meal. The first dose of oral therapy should be taken approximately 1 month after the last injection dose of CABENUVA and continued until the day injection dosing is restarted. See full prescribing information for CABENUVA to resume monthly injection dosing.

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 decreases in cabotegravir plasma concentrations may occur due to uridine diphosphate (UDP)-glucuronosyl transferase (UGT)1A1 enzyme induction, which may result in loss of virologic response [see Drug Interactions (7.3), Clinical Pharmacology (12.3)]:
Anticonvulsants: Carbamazepine, oxcarbazepine, phenobarbital, phenytoin
Antimycobacterials: Rifampin, rifapentine

Prior to initiation of VOCABRIA, note that use of CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions with rifabutin is contraindicated.

Since VOCABRIA is taken in combination with rilpivirine tablets, the prescribing information for EDURANT should be consulted for additional contraindications.

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)]. Remain vigilant and discontinue VOCABRIA if a hypersensitivity reaction is suspected.

Discontinue VOCABRIA immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash, or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, mucosal involvement [oral blisters or lesions], conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing). Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated [see Dosage and Administration (2.1), Contraindications (4), Adverse Reactions (6.1)].

5.2 Hepatotoxicity

Hepatotoxicity has been reported in patients receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors [see Adverse Reactions (6.1)].

Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations.

Monitoring of liver chemistries is recommended and treatment with VOCABRIA should be discontinued if hepatotoxicity is suspected.

5.3 Depressive Disorders

Depressive disorders (including depressed mood, depression, mood altered, mood swings) have been reported with VOCABRIA [see Adverse Reactions (6.1)]. Promptly evaluate patients with depressive symptoms to assess whether the symptoms are related to VOCABRIA and to determine whether the risks of continued therapy outweigh the benefits.

5.4 Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions

The concomitant use of VOCABRIA and other drugs may result in known or potentially significant drug interactions, some of which may lead to adverse events, loss of virologic response of VOCABRIA, and possible development of viral resistance [see Contraindications (4), Drug Interactions (7.3)].

See Table 1 for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during therapy with VOCABRIA; review concomitant medications during therapy with VOCABRIA.

5.5 Risks Associated with Rilpivirine Treatment

VOCABRIA is indicated for use in combination with EDURANT (rilpivirine) [see Dosage and Administration (2.1)]. Review the prescribing information for EDURANT for information on rilpivirine prior to initiation of VOCABRIA in combination with rilpivirine.

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 Precautions (5.2)
Depressive disorders [see Warnings and Precautions (5.3)]

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 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.

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