Safety

Isentress (raltegravir potassium) tablet and chewable tablet

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

February 2015

Summary View

Includes Oral Suspension, Chewable Tablets, and Film-coated Tablets

DRUG INTERACTIONS

Effect of Other Agents on the Pharmacokinetics of Raltegravir
  • Table 8, updated information regarding the coadministration of raltegravir within 6 hours of taking: aluminum and/or magnesium containing antacid.
Drugs without Clinically Significant Interactions with Isentress
  • In drug interaction studies, raltegravir did not have a clinically meaningful effect on the pharmacokinetics of the following: hormonal contraceptives, methadone, lamivudine, tenofovir, etravirine, darunavir/ritonavir, or boceprevir. Moreover, atazanavir, atazanavir/ritonavir, boceprevir, calcium carbonate antacids, darunavir/ritonavir, efavirenz, etravirine, omeprazole, or tipranavir/ritonavir did not have a clinically meaningful effect on the pharmacokinetics of raltegravir. No dose adjustment is required when ISENTRESS is coadministered with these drugs.

 

April 2014

including:

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 DRUG INTERACTIONS

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

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

 

Page Last Updated: 03/11/2015
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