Orlistat-ART Interaction Warning Added to Labeling

The label now includes information of possible interactions between Xenical and concomitant drugs
The label now includes information of possible interactions between Xenical and concomitant drugs

The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xenical (orlistat; Genentech) capsules regarding the risk of loss of virological control in patients with HIV infection taking concomitant antiretroviral agents.

The updated labeling now includes wording to reflect that Xenical may interact with concomitant drugs including cyclosporine, levothyroxine, warfarin, amiodarone, antiepileptic drugs, and antiretroviral drugs. In the Drug Interactions section, it now states that loss of virological control has been reported in HIV-infected patients taking orlistat with concomitant antiretroviral agents (eg, atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir/ritonavir, emtricitabine/efavirenz/tenofovir disoproxil fumarate). 

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The drug-drug interaction may be due to an inhibition of the systemic absorption of the antiretroviral agent; the exact mechanism for this interaction is unclear. HIV RNA levels should be frequently monitored in patients who take Xenical while undergoing treatment for HIV. 

If an increase in HIV viral load is confirmed, treatment with Xenical should be discontinued.

Xenical, a reversible inhibitor of gastrointestinal lipases, is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet; and to reduce the risk for weight regain after prior weight loss. It is available as 120mg strength capsules in 90-count bottles.

For more information call (888) 835-2555 or visit Xenical.com.

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