infection, as these patients have an increased risk of hepatotoxicity.
Liver function tests should be performed prior to initiating therapy
with APTIVUS/r, and frequently throughout the duration of treatment.
-- Treatment-experienced patients with chronic hepatitis B or hepatitis C
co-infection or elevations in transaminases are at approximately 2-fold
risk for developing Grade 3 or 4 transaminase elevations or hepatic
decompensation. In the RESIST trials, Grade 3 and 4 increases in
hepatic transaminases were observed in 10.3% (10.9/100 PEY) of patients
receiving APTIVUS/r through week 48. In a study of treatment-nave
patients, 20.3% (21/100 PEY) experienced Grade 3 or 4 hepatic
transaminase elevations while receiving APTIVUS/r through week 48.
-- APTIVUS/r is contraindicated in patients with moderate or severe
(Child-Pugh Class B or C, respectively) hepatic impairment.
-- The drug-drug interaction potential of APTIVUS/r when co-administered
with multiple classes of drugs must be considered prior to and during
-- APTIVUS/r is contraindicated with amiodarone, bepridil, flecainide,
propafenone, quinidine, rifampin, dihydroergotamine, ergonovine,
ergotamine, methylergonovine, cisapride, St. John's wort, lovastatin,
simvastatin, pimozide, midazolam and triazolam due to the potential for
serious and/or life-threatening events or loss of efficacy.
-- A drug interaction study in healthy subjects has shown that ritonavir
significantly increases plasma fluticasone propionate exposures.
Concomitant use of APTIVUS/r and fluticasone propionate may produce
systemic corticosteroid side effects, including Cushing's syndrome and
adrenal suppression. APTIVUS/r should not be taken with fluticasone
|SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.|
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