IT STARTS WITH
UNDERSTANDING SAFETY AND TOLERABILITY
- There are limited data on the use of VOCABRIA + REKAMBYS in pregnancy so it is not recommended unless the expected benefit justifies the potential risk to the foetus. VOCABRIA + REKAMBYS has been detected in systemic circulation for up to 4 years after an injection in some patients; consideration should be given to the potential for foetal exposure
- Patients with HBV were excluded from studies with VOCABRIA + REKAMBYS. Initiating VOCABRIA + REKAMBYS in patients with HBV is not recommended
- Limited data are available in patients with HCV co-infection. Monitoring of liver function is recommended in patients with HCV co-infection
- VOCABRIA + REKAMBYS is not recommended in patients with severe hepatic impairment, while caution is advised in patients with moderate hepatic impairment
Drugs causing QT prolongation
- At the recommended dose, oral rilpivirine is not associated with a clinically relevant effect on QTc. Nevertheless, VOCABRIA + REKAMBYS should be used with caution when co-administered with a medicinal product with a known risk of Torsade de Pointes
- Partial intravenous administration may result in rapid, serious post-injection reactions
- These events were very rare in clinical trials and began to resolve within a few minutes after the injection. Observe patients briefly for 10 minutes after the injections for any post-injection reactions
- Monitoring of liver chemistries is recommended, and treatment with VOCABRIA + REKAMBYS should be discontinued if hepatotoxicity is suspected
- Monitoring of liver function is recommended in patients with hepatitis C co-infection
- Clinical monitoring is recommended for patients on methadone, as methadone maintenance therapy may need to be adjusted
- VOCABRIA + REKAMBYS is not recommended during pregnancy unless the expected benefit justifies the potential risk; however, viral load should be monitored closely if used during pregnancy
GI=gastrointestinal; HBV=hepatitis B virus; HCV=hepatitis C virus; HIV-1=human immunodeficiency virus type 1; OAT=organic anion transporters; pH=power of hydrogen; RNA=ribonucleic acid.
- VOCABRIA Summary of Product Characteristics. ViiV Healthcare.
- REKAMBYS Summary of Product Characteristics. Janssen.
- Oxford University Hospitals NHS Foundation Trust. Medicines Management and Therapeutics Committee. Treatment of venous thromboembolism (VTE) in adults with dalteparin. MIL. 2019;2(2):1–4. REF-144092.
- Antzelevitch C, Sun ZQ, Zhang ZQ, et al. Cellular and ionic mechanisms underlying erythromycin-induced long QT intervals and torsade de pointes. J Am Coll Cardiol. 1996;28(7):1836–1848. doi: 10.1016/S0735-1097(96)00377-4.
- Vieweg WVR, Hancox JC, Hasnain M, et al. Clarithromycin, QTc interval prolongation and torsades de pointes: the need to study case reports. Ther Adv Infect Dis. 2013;1(4):121–138. doi: 10.1177/2049936113497203.
- EDURANT Summary of Product Characteristics. Janssen.
REKAMBYS (rilpivirine long-acting injection), including the trademark, is owned by the Janssen Pharmaceutical Companies and used under licence by the ViiV Healthcare group of companies. All other trademarks are owned by the ViiV Healthcare group.