New Dose for Isentress
May 26, 2017 – The U.S. FDA has approved Isentress® HD (raltegravir), a new formulation of Isentress®, a human immunodeficiency virus (HIV) integrase strand transfer inhibitor, manufactured by Merck. The new drug is dosed at 1,200mg orally once-daily, whereas the originally approved Isentress dosage was 600mg tablets, taken twice-a-day along with other antiretroviral drugs to treat adults and children who weigh 40 kg (88 pounds) or more and who have HIV-1.
Patients who are new to HIV therapy and patients whose HIV load is suppressed while they are taking 1,600mg of Isentress (two 400mg tablets twice a day) are candidates for Isentress HD. However, Isentress HD is not interchangeable with chewable or liquid forms of Isentress. Isentress HD is expected to launch approximately one month following approval.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.