SELZENTRY™ (maraviroc) tabletsWarnings and Precautions

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Prescribing Information

SELZENTRY^™ (maraviroc) tablets
Warnings and Precautions


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Hepatotoxicity
A case of possible SELZENTRY-induced hepatotoxicity with allergic features has been reported in a study of healthy volunteers. In addition, an increase in hepatic adverse events with SELZENTRY was observed during studies of treatment-experienced subjects with HIV infection, although there was no overall increase in ACTG Grade 3/4 liver function test abnormalities [see Adverse Reactions]. 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. In studies of treatment-experienced HIV-infected subjects, approximately 6% of subjects were co-infected with hepatitis B and approximately 6% were co-infected with hepatitis C. Due to the small number of co-infected subjects studied, no conclusions can be drawn regarding whether they are at an increased risk for hepatic adverse events with SELZENTRY administration. However, 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.

Cardiovascular Events
Use with caution in patients at increased risk for cardiovascular events. Eleven subjects (1.3%) who received SELZENTRY had cardiovascular events including myocardial ischemia and/or infarction during the Phase 3 studies (total exposure 267 patient-years), while no subjects who received placebo had such events (total exposure 99 patient-years). These subjects generally had cardiac disease or cardiac risk factors prior to SELZENTRY use, and the relative contribution of SELZENTRY to these events is not known.

When SELZENTRY was administered to healthy volunteers at doses higher than the recommended dose, symptomatic postural hypotension was seen at a greater frequency than in placebo. However, when SELZENTRY was given at the recommended dose in HIV subjects in Phase 3 studies, postural hypotension was seen at a rate similar to placebo (approximately 0.5%). Caution should be used when administering SELZENTRY in patients with a history of postural hypotension or on concomitant medication known to lower blood pressure.

Immune Reconstitution Syndrome
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including maraviroc. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as infection with Mycobacterium avium, cytomegalovirus, Pneumocystis jirovecii, Mycobacterium tuberculosis, or reactivation of Herpes simplex and Herpes zoster), which may necessitate further evaluation and treatment.

Potential Risk of Infection
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. While there was a higher rate of certain upper respiratory tract infections reported in the SELZENTRY arm compared to placebo (20.0% versus 11.5%), there was a lower rate of pneumonia (2.1 % vs 4.8%) reported in patients receiving SELZENTRY. A higher incidence of Herpes virus infections (11.4 per 100 patient-years) was also reported in the SELZENTRY arm when adjusted for exposure compared to placebo (8.2 per 100 patient-years). Patients should be monitored closely for evidence of infections while receiving SELZENTRY.

Potential Risk of Malignancy
While no increase in malignancy has been observed with SELZENTRY, due to this drug’s 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.

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SELZENTRY Safety Information

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