Cabenuva: Package Insert and Label Information

CABENUVA- cabotegravir and rilpivirine
ViiV Healthcare Company

1 INDICATIONS AND USAGE

CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <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 [see Microbiology (12.4), Clinical Studies (14.1)].

2 DOSAGE AND ADMINISTRATION

2.1 Dosage and Administration Overview

CABENUVA contains cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial [see Dosage Forms and Strengths ( 3 )] .
CABENUVA must be administered by a healthcare provider by gluteal intramuscular injection [see Dosage and Administration ( 2.9 )] .
CABENUVA may be initiated with oral cabotegravir and oral rilpivirine prior to the intramuscular injections or the patient may proceed directly to injection of CABENUVA without an oral lead-in [see Dosage and Administration ( 2.3 )] .
CABENUVA can be injected monthly or every 2 months [see Dosage and Administration ( 2.4 , 2.5 )] . Healthcare providers should discuss these 2 dosing options with the patient prior to starting CABENUVA and decide which injection dosing frequency would be the most appropriate option for the patient [see Adverse Reactions ( 6.1 ), Microbiology ( 12.4 ), Clinical Studies ( 14.1 )] .

2.2 Adherence to CABENUVA

Prior to starting CABENUVA, healthcare providers should carefully select patients who agree to the required monthly or every2-month injection dosing schedule and counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance with missed doses [see Warnings and Precautions ( 5.6)].

2.3 Recommended Optional Oral Lead-in Dosing to Assess Tolerability of CABENUVA in Adults and Adolescents 12 Years of Age and Older and Weighing at Least 35 kg

The healthcare provider and patient may decide to use an oral lead-in with oral cabotegravir and oral rilpivirine prior to the initiation of CABENUVA to assess the tolerability of cabotegravir and rilpivirine, or the healthcare provider and patient may proceed directly to injection of CABENUVA without the use of an oral lead-in.

If oral lead-in is used, the recommended oral lead-in daily dose is one 30-mg tablet of VOCABRIA (cabotegravir) and one 25-mg tablet of EDURANT (rilpivirine) taken with a meal for approximately 1 month (at least 28 days), followed by intramuscular initiation injections of CABENUVA. See Tables 1 and 2 for recommended oral lead-in and monthly or every-2-month intramuscular injection dosing schedule for CABENUVA [see Dosage and Administration ( 2.4 , 2.5 )] .

2.4 Recommended Monthly Gluteal Intramuscular Injection Dosing with CABENUVA in Adults and Adolescents 12 Years of Age and Older and Weighing at Least 35 kg

Initiation Injections (CABENUVA 600-mg/900-mg Kit)

Initiate injections on the last day of current antiretroviral therapy or oral lead-in, if used [see Dosage and Administration ( 2.3 )] . The recommended initial injection doses of CABENUVA are a single 600-mg (3-mL) intramuscular injection of cabotegravir and a single 900-mg (3-mL) intramuscular injection of rilpivirine. Administer cabotegravir and rilpivirine at separate gluteal injection sites (on opposite sides or at least 2 cm apart) during the same visit [see Dosage and Administration ( 2.9 )] . Continuation injections should be initiated a month after the initiation injections.

Continuation Injections (CABENUVA 400-mg/600-mg Kit)

After the initiation injections, the recommended monthly continuation injection doses of CABENUVA are a single 400-mg (2-mL) intramuscular injection of cabotegravir and a single 600-mg (2-mL) intramuscular injection of rilpivirine at each visit (Table 1). Administer cabotegravir and rilpivirine at separate gluteal injection sites (on opposite sides or at least 2 cm apart) during the same visit [see Dosage and Administration (2.9)]. Patients may be given CABENUVA up to 7 days before or after the date the patient is scheduled to receive monthly injections.

Table 1. Recommended Dosing Schedule with Optional Oral Lead-in or Direct to Injection for Monthly Injection
a The optional oral therapy should be continued until the day the first injection is administered.
b Given on the last day of current antiretroviral therapy or oral lead-in if used.

Drug

Optional Oral Lead-ina (at Least 28 Days)

Intramuscular (Gluteal) Initiation Injections (One-Time Dosing)

Intramuscular (Gluteal) Continuation Injections (Once-Monthly Dosing)

Month (at Least 28 Days) Prior to Starting Injections

Initiate Injections at Month 1b

One Month after Initiation Injection and Monthly Onwards

Cabotegravir

30 mg once daily with a meal

600 mg (3 mL)

400 mg (2 mL)

Rilpivirine

25 mg once daily with a meal

900 mg (3 mL)

600 mg (2 mL)

2.5 Recommended Every-2-Month Gluteal Intramuscular Injection Dosing with CABENUVA in Adults and Adolescents 12 Years of Age and Older and Weighing at Least 35 kg

Initiation Injections (CABENUVA 600-mg/900-mg Kit)

Initiate injections on the last day of current antiretroviral therapy or oral lead-in, if used [see Dosage and Administration ( 2.3 )] . The recommended initiation injection doses of CABENUVA are a single 600-mg (3-mL) intramuscular injection of cabotegravir and a single 900-mg (3-mL) intramuscular injection of rilpivirine 1 month apart for 2 consecutive months ( Table 2 ). Administer cabotegravir and rilpivirine at separate gluteal injection sites (on opposite sides or at least 2 cm apart) during the same visit [see Dosage and Administration ( 2.9 )] . Patients may be given CABENUVA up to 7 days before or after the date the patient is scheduled to receive the second initiation injections.

Continuation Injections (CABENUVA 600-mg/900-mg Kit)

After the 2 initiation doses given consecutively 1 month apart (Months 1 and 2), the recommended continuation injection doses (Month 4 onwards) of CABENUVA are a single 600-mg (3-mL) intramuscular injection of cabotegravir and a single 900-mg (3-mL) intramuscular injection of rilpivirine administered every 2 months (Table 2). Administer cabotegravir and rilpivirine at separate gluteal injection sites (on opposite sides or at least 2 cm apart) during the same visit [see Dosage and Administration (2.9)]. Patients may be given CABENUVA up to 7 days before or after the date the patient is scheduled to receive the injections.

Table 2. Recommended Dosing Schedule with Optional Oral Lead-in or Direct to Injection for Every-2-Month Injection

a The optional oral therapy should be continued until the day the first injection is administered.
b For the every-2-month injection dosing schedule in adults, Initiation Injections are injections administered at Month 1 and Month 2 and Continuation Injections are injections administered every 2 months onwards (starting Month 4).
c Given on the last day of current antiretroviral therapy or oral lead-in if used.

Drug

Optional Oral Lead-ina

(at Least 28 Days)

Intramuscular (Gluteal) Injectionsb

Month (at Least 28 Days) Prior to Starting Injections

Initiate Injectionsc at Month 1, Month 2, and then Every 2 Months Onwards (Starting at Month 4)

Cabotegravir

30 mg once daily with a meal

600 mg (3 mL)

Rilpivirine

25 mg once daily with a meal

900 mg (3 mL)

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