Important Safety Information
WARNING: See full prescribing information for complete boxed warning. Hepatotoxicity
has been reported which may be preceded by evidence of a systemic allergic reaction
(eg, pruritic rash, eosinophilia or elevated IgE). Immediately evaluate patients
with signs or symptoms of hepatitis or allergic reaction.
SELZENTRY should be taken as part of an antiretroviral combination regimen. As with
other antiretrovirals, SELZENTRY should be optimally combined with other antiretrovirals to
which the patient's virus is sensitive.
There is limited experience in patients with reduced hepatic function; therefore,
SELZENTRY should be used with caution in this population.
Discontinuation of SELZENTRY should be considered in any patient with signs or
symptoms of hepatitis, or with increased liver transaminases combined with rash
or other systemic symptoms.
The safety and efficacy of SELZENTRY have not been specifically studied in patients
with significant underlying liver disorders such as patients co-infected with viral
hepatitis B or C. Caution should be used when administering SELZENTRY to patients
with pre-existing liver dysfunction or who are co-infected with viral hepatitis B or C.
Use with caution in patients at increased risk of cardiovascular events.
More cardiovascular events, including myocardial ischemia and/or infarction,
were observed in patients who received SELZENTRY.
Caution should be used when administering SELZENTRY in patients with a history of postural
hypotension or who receive concomitant medication known to lower blood pressure.
Patients should be advised that if they experience dizziness while receiving SELZENTRY,
they should avoid driving or operating machinery.
Immune reconstitution syndrome has been reported in patients treated with combination
antiretroviral therapy, including SELZENTRY.
SELZENTRY antagonizes the CCR5 co-receptor located on some immune cells,
and therefore could potentially increase the risk of developing infections.
The overall incidence and severity of infection, as well as AIDS-defining Category
C infections, was comparable in the treatment groups during the Phase 3 studies of SELZENTRY.
Compared with patients receiving placebo, patients in the SELZENTRY arm had higher
incidences of upper respiratory tract infections (23% vs 13%) and Herpes virus infections
(8% vs 4%). However, patients taking SELZENTRY had a lower incidence of pneumonia (2% vs 5%).
Patients should be monitored closely for evidence of infection while receiving SELZENTRY.
While no increase in malignancy has been observed with SELZENTRY, due to this drugs mechanism of
action it could affect immune surveillance and lead to an increased risk of malignancy.
Long-term follow-up is needed to more fully assess this risk.
The most common adverse events reported with SELZENTRY twice-daily therapy with
frequency rates higher than placebo, regardless of causality, were upper respiratory
tract infections (23% vs 13%), cough (14% vs 5%), pyrexia (13% vs 9%), rash (11% vs 5%),
and dizziness (9% vs 8%).
There are no data available in pediatric patients; therefore, SELZENTRY should not
be used in patients <16 years old.
The safety and efficacy of SELZENTRY have not been specifically studied in patients with
renal impairment; therefore, SELZENTRY should be used with caution in this population.
Patients with a creatinine clearance of less than 50 mL/min should receive SELZENTRY and a
CYP3A inhibitor only if the potential benefit is felt to outweigh the risk, and should be
monitored because of potential increased risk of adverse effects (including dizziness and
postural hypotension) due to increased concentrations of SELZENTRY.
SELZENTRY is a substrate of CYP3A and Pgp. Coadministration with CYP3A/Pgp inhibitors,
including protease inhibitors (except tipranavir/ritonavir) or delavirdine, will increase
the concentration of SELZENTRY. Coadministration with CYP3A inducers, including efavirenz,
may decrease the concentration of SELZENTRY. Physicians should ensure that an appropriate
dose adjustment of SELZENTRY is made when SELZENTRY is coadministered with CYP3A/Pgp inhibitors
and/or CYP3A inducers since concentrations, therapeutic effects, and the safety of SELZENTRY may be affected.
Concomitant use of SELZENTRY and St. John's wort (Hypericum perforatum) or products containing
St. John's wort is not recommended.
Please see full Prescribing Information, including boxed warnings
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