viernes, 20 de octubre de 2017

Changes to the REYTAZ Label Approved

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The REYTAZ (atazanavir) package insert was updated to include the following:
  • In Section 2 Dosage and Administration a new subsection was added regarding renal and hepatic laboratory testing before and during treatment with REYTAZ. This information is consistent with current labeling practice.
2.2 Testing Prior to Initiation and During Treatment with REYATAZ
Renal laboratory testing should be performed in all patients prior to initiation of REYATAZ and continued during treatment with REYATAZ. Renal laboratory testing should include serum creatinine, estimated creatinine clearance, and urinalysis with microscopic examination.
  • Section 4 Contraindications was updated to include elbasvir/grazoprevir because concomitant use may increase the risk of ALT elevations due to a significant increase in grazoprevir plasma concentrations.
  • Section 5 Warnings and Precautions, section 6 Adverse Reactions and section 17 Patient Counseling were updated to include information on chronic kidney disease based on post-marketing data.
5.5   Chronic Kidney Disease
Chronic kidney disease in HIV-infected patients treated with atazanavir, with or without ritonavir, has been reported during postmarketing surveillance. Reports included biopsy-proven cases of granulomatous interstitial nephritis associated with the deposition of atazanavir drug   crystals in the renal parenchyma. Consider alternatives to REYATAZ in patients at high risk for renal disease or with preexisting renal disease. Renal laboratory testing (including serum creatinine, estimated creatinine clearance, and urinalysis with microscopic examination) should be conducted in all patients prior to initiating therapy with REYATAZ and continued during treatment with REYATAZ. Expert consultation is advised for patients who have confirmed renal laboratory abnormalities while taking REYATAZ.  In patients with progressive kidney disease, discontinuation of REYATAZ may be considered.

Postmarketing Experience
Renal System: nephrolithiasis, interstitial nephritis, granulomatous interstitial nephritis, chronic kidney disease.

17 Patient Counseling Information
Chronic Kidney Disease
Inform patients that treatment with REYATAZ may lead to the development of chronic kidney disease, and to maintain adequate hydration while taking REYATAZ.
The updated label will soon be available at drugs@fda or DailyMed
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Visit the FDA Patient Network for more Information about the HIV Liaison Program 

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