DRUG INTERACTIONS- summary)

 • Refer to the full prescribing information for important drug interactions with CABENUVA. (

• Because CABENUVA 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 or cytochrome P450 (CYP)3A4 may decrease the plasma concentrations of the components of CABENUVA. 

• CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes. 

BRIEF SUMMARY-

CABOTEGRAVIR -(Jan 2021)

Indn-   To treat HIV infections

Comp-  400-mg/600-mg Kit  Cabotegravir extended-release injectable suspension and rilpivirine extended release injectable suspension, co-packaged 

ADR-  most common adverse reactions  of subjects receiving  injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash.

CI- Coadministration with drugs where significant decreases in cabotegravir and/or rilpivirine plasma concentrations may occur, which may result in loss of virologic response.

Pat inform-

Patients should not take two doses  on the same day.

Advise pregnant women and females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy.

Advise females of reproductive potential to use effective contraception during treatment with  and for one month after the final dose

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U.S. FDA APPROVED  DRUGS DURING 2021

Sr.No-  2

 ADVERSE REACTIONS-

 The most common adverse reactions (Grades 1 to 4) observed in =2% of subjects receiving CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash.

PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Dosing Instructions- If a dose is missed, it should be taken as soon as the patient remembers on the same day of the missed dose.

Patients should not take two doses of VERQUVO on the same day.

Advise pregnant women and females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy.

Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for one month after the final dose

.

Pregnancy Advise women who are exposed to VERQUVO during pregnancy to report their pregnancy to their healthcare provider.].

Lactation Advise women not to breastfeed during treatment with VERQUVO 

Manufactured by: Bayer AG Leverkusen, Germany For patent information: www.merck.com/product/patent/home.html Copyright © 2021 Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. uspi-mk1242-t-2101r001

CLINICAL PHARMACOLOGY

1. Mechanism of Action-

CABENUVA contains 2 long-acting HIV-1 antiretroviral drugs, cabotegravir and rilpivirine 

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 for CABENUVA), the QT interval is not prolonged to any clinically relevant extent.

USE IN SPECIFIC POPULATIONS

Pregnancy Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CABENUVA during pregnancy.

Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.

Risk Summary There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk of birth defects and miscarriage.

While there are insufficient human data to assess the risk of neural tube defects (NTDs) with exposure to CABENUVA during pregnancy, NTDs were associated with dolutegravir, another integrase inhibitor.

The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%. The APR uses the MACDP as the U.S. reference population for birth defects in the general population.

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

3. Pediatric Use-

The safety and efficacy of CABENUVA have not been evaluated in pediatric patients.

4. Geriatric Use Clinical trials of CABENUVA 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 in administration of CABENUVA in elderly patients reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3)].

5. Renal Impairment Based on studies with oral cabotegravir and population pharmacokinetic analyses of oral rilpivirine, no dosage adjustment of CABENUVA is necessary for patients with mild (creatinine clearance greater than or equal to 60 to less than 90 mL/min) or moderate renal impairment.

6.Hepatic Impairment-

Based on separate studies with oral cabotegravir and oral rilpivirine, no dosage adjustment of CABENUVA 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 cabotegravir or rilpivirine is unknown [see Clinical Pharmacology (12.3)].

 OVERDOSAGE-

 There is no known specific treatment for overdose with cabotegravir or rilpivirine. If overdose occurs, monitor the patient and apply standard supportive treatment as required.

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