Raltegravir is a human immunodeficiency virus integrase strand transfer inhibitor sold in the U.S. under 2 brand and generic names, for hiv infections. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Isentress (application NDA022145). Other raltegravir products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
ISENTRESS and ISENTRESS HD can be administered with or without food ( 2.1 ). Do not substitute ISENTRESS chewable tablets or ISENTRESS for oral suspension for the ISENTRESS 400 mg or 600 mg film-coated tablet. See specific dosing guidance for chewable tablets and the formulation for oral suspension ( 2.1 ). Adults • Treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily: o 1200 mg (2 × 600 mg) film-coated tablet orally, once daily or o 400 mg film-coated tablet orally, twice daily ( 2.2 ). • Treatment-experienced patients: o 400 mg film-coated tablet orally, twice daily ( 2.2 ). • During coadministration with rifampin in adults, 800 mg (2 × 400 mg) twice daily ( 2.2 ). Pediatrics • If weighing at least 40 kg, and either o treatment-naïve patients or o patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily: ▪ 1200 mg (2 × 600 mg) film-coated tablet orally, once daily or ▪ 400 mg film-coated tablet orally, twice daily or ▪ 300 mg (3 × 100 mg) chewable tablets, twice daily ( 2.3 ). • If weighing at least 25 kg: One 400 mg film-coated tablet orally, twice daily. If unable to swallow a tablet, consider the chewable tablet, as specified in Table 2 ( 2.3 ). • If weighing at least 3 kg to less than 25 kg: Weight-based dosing using the chewable…
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. • The most common adverse reactions of moderate to severe intensity (≥2%) are insomnia, headache, dizziness, nausea and fatigue ( 6.1 ). • Creatine kinase elevations were observed in subjects who received ISENTRESS or ISENTRESS HD. Myopathy and rhabdomyolysis have been reported. Use with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medications known to cause these conditions and patients with a history of rhabdomyolysis, myopathy or increased serum creatine kinase ( 6.2 ). To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Treatment-Naïve Adults The safety of ISENTRESS was evaluated in HIV-infected treatment-naïve subjects in 2 Phase III studies: STARTMRK evaluated ISENTRESS 400 mg twice daily versus efavirenz, both in combination with emtricitabine (+) tenofovir disoproxil fumarate (TDF), and ONCEMRK evaluated ISENTRESS HD 1200 mg (2 × 600 mg) once daily versus ISENTRESS 400 mg twice daily, both in combination with emtricitabine (+)…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Suspension | — | — | View → | |
| 2 | Not yet rated | Prescription | Tablet | — | — | View → |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
None None ( 4) .
Coadministration of ISENTRESS or ISENTRESS HD and other drugs may alter the plasma concentration of raltegravir. The potential for drug-drug interactions must be considered prior to and during therapy ( 7 ). • Coadministration of ISENTRESS or ISENTRESS HD with drugs that are strong inducers of UGT1A1, such as rifampin, may result in reduced plasma concentrations of raltegravir ( 2.1 , 7.1 ). 7.1 Effect of Other Agents on the Pharmacokinetics of Raltegravir Raltegravir is not a substrate of cytochrome P450 (CYP) enzymes. Based on in vivo and in vitro studies, raltegravir is eliminated mainly by metabolism via a UGT1A1-mediated glucuronidation pathway. Coadministration of ISENTRESS with drugs that inhibit UGT1A1 may increase plasma levels of raltegravir and coadministration of ISENTRESS with drugs that induce UGT1A1, such as rifampin, may reduce plasma levels of raltegravir (see Table 11 ). Selected drug interactions are presented in Table 11 [see Clinical Pharmacology (12.3) ] . In some cases, recommendations differ for ISENTRESS versus ISENTRESS HD. Table 11: Selected Drug Interactions in Adults Concomitant Drug Class: Drug Name Effect on Concentration of Raltegravir Clinical Comment for ISENTRESS Clinical Comment for ISENTRESS HD Metal-Containing Antacids Aluminum and/or magnesium-containing antacids ↓ Coadministration or staggered administration is not…