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U.S. Department of Health and Human Services

Safety

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Isentress (raltegravir potassium) tablet and chewable tablet

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

 

October 2013

Summary View

DRUG INTERACTIONS

Effect of Other Agents on the Pharmacokinetics of Raltegravir
  • Coadministration of Isentress with antacids containing divalent metal cations may reduce raltegravir absorption by chelation, resulting in a decrease of raltegravir plasma levels. Taking an aluminum and magnesium antacid within 2 hours of Isentress administration significantly decreased raltegravir plasma levels. Therefore, coadministration of Isentress with aluminum and/or magnesium-containing antacids is not recommended. Coadministration of Isentress with a calcium carbonate antacid decreased raltegravir plasma levels; however, this interaction is not considered clinically meaningful. Therefore, when Isentressis coadministered with calcium carbonate-containing antacids, no dose adjustment is recommended.

 

June 2013

Summary View

 

ADVERSE REACTIONS

Clinical Trials Experience: Treatment-Naïve Adults
  • During double-blind treatment, the total follow-up for subjects receiving Isentress 400 mg twice daily + emtricitabine (+) tenofovir was 1104 patient-years and 1036 patient years for subjects receiving efavirenz 600 mg at bedtime + emtricitabine (+) tenofovir.
  • In Protocol 021, the rate of discontinuation of therapy due to adverse events was 5% in subjects receiving Isentress + emtricitabine (+) tenofovir and 10% in subjects receiving efavirenz + emtricitabine (+) tenofovir.
  • Tables Updated...

PATIENT INFORMATION

What are the possible effects of ISENTRESS?
In clinical trials, the most common (≥2%) side effects of ISENTRESS include:
  • headache
  • nausea
  • tiredness
  • trouble sleeping
  • dizziness
In clinical trials, less common (<2%) side effects include:
  • allergic reaction
  • breast cancer
  • depression
  • hepatitis
  • genital herpes
  • herpes zoster including shingles
  • kidney failure
  • kidney stones
  • stomach pain
  • suicidal thoughts and actions
  • vomiting
  • weakness