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

