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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)
ISENTRESS (raltegravir) film-coated tablets, 400 mg,
ISENTRESS (raltegravir) chewable tablets, 25 mg and 100 mg
ISENTRESS (raltegravir) for oral suspension, 100 mg
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
- added ..... telaprevir
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.
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?
- trouble sleeping
- allergic reaction
- breast cancer
- genital herpes
- herpes zoster including shingles
- kidney failure
- kidney stones
- stomach pain
- suicidal thoughts and actions