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U.S. Department of Health and Human Services


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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)


April 2014


ISENTRESS (raltegravir) film-coated tablets, 400 mg,
ISENTRESS (raltegravir) chewable tablets, 25 mg and 100 mg
ISENTRESS (raltegravir) for oral suspension, 100 mg

Summary View


7.1 Effect of Raltegravir on the Pharmacokinetics of Other Agents
  • raltegravir did not have a clinically meaningful effect on the pharmacokinetics of the following: .....boceprevir.
7.2 Effect of Other Agents on the Pharmacokinetics of Raltegravir

Table 8

  • added ..... telaprevir 


October 2013

Summary View


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



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...


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