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     1129  0 Kommentare ViiV Healthcare Announces FDA Approval to Lower the Weight Limit for dolutegravir in Children and Adolescents Living With HIV - Seite 4



    Drug Interactions: Co-administration of Tivicay with certain
    inducers of UGT1A and/or CYP3A may reduce plasma concentrations of
    dolutegravir and require dose adjustments of Tivicay. Administer
    Tivicay 2 hours before or 6 hours after taking polyvalent
    cation-containing antacids or laxatives, sucralfate, oral supplements
    containing iron or calcium, or buffered medications. Alternatively,
    Tivicay and supplements containing calcium or iron can be taken with
    food. Consult the full Prescribing Information for Tivicay for more
    information on potentially significant drug interactions, including
    clinical comments.

    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.

    Nursing Mothers: 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 have not been
    established in paediatric patients weighing less than 30kg or in any
    paediatric patients who are INSTI-experienced.

    Full US Prescribing Information for Tivicay is available at: https
    ://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescri
    bing_Information/Tivicay/pdf/TIVICAY-PI-PIL.PDF

    About the Medicines Patent Pool

    The Medicines Patent Pool (MPP) is a United Nations-backed public
    health organisation working to increase access to HIV, viral
    hepatitis C and tuberculosis treatments in low- and middle-income
    countries. Through its innovative business model, the MPP partners
    with industry, civil society, international organisations, patient
    groups and other stakeholders to prioritise, forecast and license
    needed medicines and pool intellectual property to encourage generic
    manufacture and the development of new formulations. To date, the MPP
    has signed agreements with six patent holders for twelve HIV
    antiretrovirals and for one hepatitis C direct-acting antiviral. Its
    generic partners have distributed more than three billion doses of
    low-cost medicines to 117 countries. The MPP was founded and remains
    fully funded by UNITAID.

    About ViiV Healthcare

    ViiV Healthcare is a global specialist HIV company established in
    November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE)
    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
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    ViiV Healthcare Announces FDA Approval to Lower the Weight Limit for dolutegravir in Children and Adolescents Living With HIV - Seite 4 Reduction of weight limit to at least 30kg means more children and adolescents will be eligible for dolutegravir ViiV Healthcare today announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application …

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