Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Coinfection: Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of Tivicay. In some cases the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation particularly in the setting where anti-hepatitis therapy was withdrawn. Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with Tivicay are recommended in patients with underlying hepatic disease such as hepatitis B or C.
Fat Redistribution: Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy.
Immune Reconstitution Syndrome: During the initial phase of treatment, immune reconstitution syndrome can occur, which may necessitate further evaluation and treatment. Autoimmune disorders have been reported to occur in the setting of immune reconstitution; the time to onset is more variable and can occur many months after initiation of treatment.
Adverse Reactions: The most commonly reported (greater than or equal to2%) adverse reactions of moderate to severe intensity in treatment naive adult subjects in any one trial receiving Tivicay in a combination regimen were insomnia (3%), fatigue (2%), and headache (2%).
Drug Interactions: Co-administration of Tivicay with drugs that are strong inducers of UGT1A1 and/or CYP3A4 may result in reduced plasma concentrations of dolutegravir and require dose adjustments of Tivicay.
-- Tivicay should be taken 2 hours before or 6 hours after taking cation-containing antacids or laxatives, sucralfate, oral iron supplements, oral calcium supplements, or buffered medications.
-- Consult the full Prescribing Information for Tivicay for more information on potentially significant drug interactions, including clinical comments.
Pregnancy: Pregnancy category B. Tivicay should be used during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.
Breastfeeding: Breastfeeding is NOT recommended due to the potential for HIV transmission and the potential for adverse reactions in nursing infants.
Paediatric Patients: Safety and efficacy of Tivicay has not been established in children younger than 12 years old, or weighing <40 kg, or in INSTI-experienced paediatric patients with documented or clinically suspected INSTI resistance.
Please visit the following link for the full US prescribing and patient information: https://www.viivhealthcare.com/media/585....
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer dedicated to delivering advances in treatment and care for people living with HIV. Shionogi (TYO: 4507) joined in October 2012. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit http://www.viivhealthcare.com
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in infectious diseases and vaccines, oncology, immunology, neuroscience, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.
CONTACT: Contact: Sébastien Desprez (UK), Global Communications, ViiVHealthcare, +44 7920 567 707; Marc Meachem (US), US Communications , ViiVHealthcare, +1 919 483 8756; GSK enquiries: UK Media enquiries: Simon Steel+44 (0) 20 8047 5502 (London), David Daley +44 (0) 20 8047 5502 (London);US Media enquiries: Sarah Alspach +1 202 715 1048 (Washington, DC), SarahSpencer +1 215 751 3335 (Philadelphia); Analyst/Investor enquiries: ZibaShamsi +44 (0) 20 8047 5543 (London), Tom Curry + 1 215 751 5419(Philadelphia), Gary Davies +44 (0) 20 8047 5503 (London), James Dodwell+44 (0) 20 8047 2406 (London) Jeff McLaughlin +1 215 751 7002(Philadelphia)
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