Increase Platelet Counts
Initiate and Maintain
SVR=sustained virologic response defined as the percentage of patients with undetectable HCV-RNA at 24 weeks after completion of antiviral treatment. 1
PROMACTA is indicated for the treatment of thrombocytopenia in patients with chronic hepatitis C
to allow the initiation and maintenance of interferon-based therapy.
Limitations of use:
PROMACTA should not be used to normalize platelet counts. PROMACTA should be used only in patients
with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based
therapy or limits the ability to maintain interferon-based therapy. Safety and efficacy have not been
established in combination with direct acting antiviral agents approved for treatment of chronic hepatitis C
genotype 1 infection.
Important Safety Information for PROMACTA
PROMACTA may cause hepatotoxicity. PROMACTA, in combination with interferon and ribavirin
in patients with chronic hepatitis C, may increase the risk of hepatic decompensation. Patients
receiving therapy with PROMACTA must have regular monitoring of serum liver tests (see
Laboratory Monitoring). Discontinue PROMACTA if ALT levels increase to ≥3X upper limit of
normal (ULN) in patients with normal liver function or ≥3X baseline in patients with pre-treatment
elevations in transaminases and are: progressive; or persistent for ≥ 4 weeks; or accompanied
by increased direct bilirubin; or accompanied by clinical symptoms of liver injury or evidence of
hepatic decompensation. Reinitiating treatment with PROMACTA is not recommended and should
be considered only with close medical supervision and under exceptional circumstances where the
potential benefit outweighs the risk.