ViiV Healthcare Announces FDA Approval to Lower the Weight Limit for dolutegravir in Children and Adolescents Living With HIV - Seite 3

America, Europe, Asia, Australia, Africa and Latin America.

Tivicay is a registered trademark of the ViiV Healthcare group of
companies.

Important Information about Tivicay® (dolutegravir)

FDA Indications and Usage: Tivicay is a human immunodeficiency
virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI)
indicated in combination with other antiretroviral agents for the
treatment of HIV-1 infection in adults and paediatric patients
weighing at least 30kg.

Use of Tivicay in INSTI-experienced patients should be guided by
the number and type of baseline INSTI substitutions. The efficacy of
Tivicay 50mg twice daily is reduced in patients with an
INSTI-resistance Q148 substitution plus 2 or more additional
INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T,
G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R.

Contraindications: Tivicay is contraindicated (1) in patients with
previous hypersensitivity reaction to dolutegravir, and (2) in
patients receiving dofetilide (antiarrhythmic).

Hypersensitivity Reactions: Hypersensitivity reactions have been
reported and were characterized by rash, constitutional findings, and
sometimes organ dysfunction, including liver injury. The events were
reported in <1% of subjects receiving Tivicay in Phase 3 clinical
trials. Discontinue Tivicay and other suspect agents immediately if
signs or symptoms of hypersensitivity reactions develop, as a delay
in stopping treatment may result in a life-threatening reaction.
Monitor clinical status, including liver aminotransferases, and
initiate appropriate therapy if hypersensitivity reaction is
suspected.

Effects on Serum Liver Biochemistries in Patients with Hepatitis B
or C Co-infection: 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anti-hepatitis therapy was withdrawn.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 or accumulation has been observed in patients
receiving antiretroviral therapy.

Immune Reconstitution Syndrome, including the occurrence of
autoimmune disorders with variable time to onset, has been reported.

Adverse Reactions: The most commonly reported (>=2%) adverse
reactions of moderate to severe intensity in treatment-naïve adult
subjects in any one trial receiving Tivicay in a combination regimen
were insomnia (3%), fatigue (2%), and headache (2%).