Cabotegravir and Rilpivirine (CABENUVA) -(Jan 2021)

 

 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 patients to immediately stop taking CABENUVA and seek medical attention if they develop a rash associated with any of the following symptoms,such as

 

- it may be a sign of a more serious reaction such as DRESS or severe hypersensitivity: fever; generally ill feeling; extreme tiredness; muscle or joint aches; blisters; oral blisters or lesions; eye inflammation; facial swelling; swelling of the eyes, lips, tongue, or mouth; difficulty breathing; and/or signs and symptoms of liver problems (e.g., yellowing of the skin or whites of the eyes; dark or tea-colored urine; pale-colored stools or bowel movements; nausea; vomiting; loss of appetite; or pain, aching, or sensitivity on the right side below the ribs).

 

Advise patients that if hypersensitivity occurs, they will be closely monitored, laboratory tests will be ordered, and appropriate therapy will be initiated 

 

Adverse Reactions Following Injections-                                                                      Advise patients that injection site reactions have been reported in the majority of patients receiving CABENUVA. These local reactions typically consist of one or more of the following: pain, erythema, tenderness, pruritus, and local swelling.

 

Systemic reactions have also been reported, such as fever, musculoskeletal pain, and sciatica pain.

 

Serious post-injection reactions were reported within minutes after the injection of rilpivirine, including dyspnea, agitation, abdominal cramping, flushing, sweating, oral numbness, and changes in blood pressure. These events began to resolve within a few minutes after the injection.

 

Advise patients that they will be observed briefly (approximately 10 minutes) after the injection. If they experience a post-injection reaction, they will be monitored, and appropriate treatment administered.

 

Hepatotoxicity-                                                                                                                   Inform patients that hepatotoxicity has been reported with cabotegravir and rilpivirine, components of CABENUVA .

 

Inform patients that monitoring for liver transaminases is recommended. 

 

Depressive Disorders -                                                                                            Inform patients that depressive disorders (including depressed mood, depression,   major depression, mood altered, mood swings, unusual mood, feeling tense, negative thoughts, suicidal ideation or attempt) have been reported with at least one of the components of CABENUVA.

 

Advise patients to seek immediate medical evaluation if they experience depressive symptoms 

 

Drug Interactions -                                                                                                 CABENUVA may interact with other drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products, including St. John’s wort. CABENUVA is an extended-release injectable which may be systemically present for 12 months or longer.

 

These residual concentrations are not expected to affect the exposures of antiretroviral drugs that are initiated after discontinuation of CABENUVA 

 

Adherence to CABENUVA-                                                                                                 Counsel patients about the importance of continued medication adherence and scheduled visits to help maintain viral suppression and to reduce risk of loss of virologic response and development of resistance.

 

 Missed Dose-                                                                                                                    Inform patients that CABENUVA can remain in the body for up to 12 months or longer after receiving their last injection.

 

Advise patients that they should contact their healthcare provider if they miss or plan to miss a scheduled monthly injection visit and that oral therapy may be used to replace up to 2 consecutive monthly injections.

 

Advise patients that if they stop treatment with CABENUVA, they will need to take other medicines to treat their HIV-1 infection.

 

Pregnancy Registry-                                                                                                          Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes in those exposed to CABENUVA during pregnancy.

 

Patients who are of reproductive potential should be informed of the long duration of exposure of CABENUVA and that there is very limited clinical experience in human pregnancy.

 

Lactation-                                                                                                                          Instruct mothers with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk .

 

 

 

CABENUVA and VOCABRIA are trademarks owned by or licensed to the ViiV Healthcare group of companies. 

The other brand listed is a trademark owned by or licensed to its respective owner and is not a trademark owned by or licensed to the ViiV Healthcare group of companies.

 

The maker of this brand is not affiliated with and does not endorse the ViiV Healthcare group of companies or its products. 

 

Manufactured for: 

 

ViiV Healthcare Research Triangle Park, NC 27709 

by: GlaxoSmithKline Research Triangle Park, NC 27709 ©2021 ViiV Healthcare group of companies or its licensor