FDA Approves Tibotec's Prezista

Prezista is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors.

Darunavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Prezista is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS.

PREZISTA® (darunavir), is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors.

PREZISTA is always taken with and at the same time as ritonavir (Norvir ® ), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA should also be taken with food.

The use of other medicines active against HIV in combination with PREZISTA/ritonavir (Norvir ® ) may increase your ability to fight HIV. Your healthcare professional will work with you to find the right combination of HIV medicines

It is important that you remain under the care of your healthcare professional during treatment with PREZISTA

Prezista is an HIV medication. It is in a category of HIV medicines called protease inhibitors. Prezista prevents cells infected by HIV from producing new virus. This reduces the amount of virus in your body.

Prezista must be used with low-dose Norvir (ritonavir) and in combination with other HIV drugs.

Prezista, manufactured by Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, LP, was initially approved by the U.S. Food and Drug Administration (FDA) on June 23, 2006, for treatment-experienced HIV-positive adults. It was approved for HIV-positive people beginning treatment for the first time on October 22, 2008.

Prezista (darunavir) is a HIV-1 protease inhibitor (PI). It is designed to disrupt formation of HIV viral particles in infected patients.

Prezista is specifically indicated for the treatment of HIV-1 infections in combination with ritonavir and other antiviral agents in treatment-experienced patients, including patients who have failed prior courses of treatment with other PIs.

Prezista is supplied as an orange, oval-shaped, film-coated tablet for oral administration. The recommended initial dosing regimen is 600 mg twice daily, in combination with 100 mg ritonavir twice daily, with food.