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Exploring real experiences starts with you Mar 31, 2024 [View in Browser](?ap=&rhid=62dab5500b8d7fd7c20757b3&lid=6762945) [The BodyPro]()
[The BodyPro](/NTQxLUdLWi0yNDMAAAGSM4A4Lcqtp0ormTm0zsI_0WPTatbKcSo15gkcId1hNzqbj6_-qWTvWwkAhglvxAmWVJaXElo=) This is an industry-prepared promotional message, developed under the direction of and funded by [ViiV Healthcare](). Having trouble reading this email? [Click here](#). [CABENUVA logo]() Full [Prescribing Information]() [WHICH OF YOUR PATIENTS may be right for CABENUVA?] [WHICH OF YOUR PATIENTS may be right for CABENUVA?] For your patients with HIV, hear what some of the real challenges of taking a daily oral therapy may sound like:
[It was just this daily reminder that played a huge role in my medical condition... it feels like a challenge but also a responsibility.]
â Real CABENUVA patient ambassador, diagnosed with HIV-1 in 2001
[See treatment journeys of real patients]() INDICATION
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.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS ⢠Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
⢠Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St Johnâs wort
Please see additional Important Safety Information below. INDICATION
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.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS ⢠Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
⢠Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St Johnâs wort
Please see additional Important Safety Information below. For your patients with HIV, hear what some of the real challenges of taking a daily oral therapy may sound like:
[It was just this daily reminder that played a huge role in my medical condition... it feels like a challenge but also a responsibility.]
â Real CABENUVA patient ambassador, diagnosed with HIV-1 in 2001
[See treatment journeys of real patients]() IMPORTANT SAFETY INFORMATION (contâd)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: ⢠Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
⢠Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
⢠Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
Post-Injection Reactions: ⢠Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
⢠Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
Hepatotoxicity: ⢠Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors
⢠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 CABENUVA should be discontinued if hepatotoxicity is suspected
Depressive Disorders: ⢠Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation, suicide attempt) have been reported with CABENUVA or the individual products
⢠Promptly evaluate patients with depressive symptoms
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: ⢠The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
⢠Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
⢠CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
Long-Acting Properties and Potential Associated Risks with CABENUVA: ⢠Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance
⢠To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
ADVERSE REACTIONS ⢠The most common adverse reactions in adults (incidence â¥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
⢠The safety of CABENUVA in adolescents is expected to be similar to adults
DRUG INTERACTIONS ⢠Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
⢠Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
⢠Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
⢠CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
USE IN SPECIFIC POPULATIONS ⢠Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
⢠Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant Please see full [Prescribing Information]() for CABENUVA. To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or [www.fda.gov/medwatch](). Click to [view]() Rx Drug Pricing Education. This email is intended for US healthcare professionals only. This email was funded and developed by [ViiV Healthcare](). [ViiV Healthcare]() ViiV Healthcare, 410 Blackwell Street, Durham, NC 27701
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©2024 ViiV Healthcare or licensor.
CBREML230092 January 2024
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