Rescriptor (Delavirdine Mesylate) Oral Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012

Summary View

 

PRECAUTIONS

• Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Rescriptor…

Information for Patients

• Patients should be informed that RESCRIPTOR is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections…
• Patients should be advised to avoid doing things that can spread HIV-1 infection to others…

Drug Interactions

• Table 7 Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction (revised)…
• The interaction between Rescriptor and the drug was evaluated in a clinical study. All other drug interactions shown are predicted

PATIENT INFORMATION

General Information about Rescriptor

• Rescriptor does not cure HIV-1 or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using Rescriptor…

Who Should not take Rescriptor?

• We do not know if RESCRIPTOR can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk. Talk with your doctor healthcare provider about the best way to feed your baby.