Label Changes for:

Prezista (darunavir) tablets

June 2009

Changes have been made to the PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009

DRUG INTERACTIONS

  • include results from a drug-drug interaction study between darunavir/ritonavir twice daily and buprenorphine/naloxone
  • Narcotic Analgesic/Treatment of Opioid Dependence: No dose adjustment for buprenorphine or buprenorphine/naloxone is required with concurrent administration of Prezista/rtv. Clinical monitoring is recommended if Prezista/rtv. and buprenorphine or buprenorphine/naloxone are coadministered.

PATIENT PACKAGE INSERT

Can prezista be taken with other Medications?
  • Tell your doctor if your taking any of the following medecines: buprenorphine/naloxone
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