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Label Changes for:

Valturna (aliskiren/valsartan) combination tablets

August 2010

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

  • Tekturna (aliskiren) tablets
  • Tekturna HCT (aliskiren/hydrochlorothiazide) tablets
  • Valturna (aliskiren/valsartan) Combination tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2010


Post-marketing Experience Hypersensitivity
  • angioedema requiring airway management and hospitalization
  • Peripheral edema


Effects of Other Drugs on Aliskiren
  • P-glycoprotein Effects: Pgp (MDR1/Mdr1a/1b) was found to be the major efflux system involved in absorption and disposition of aliskiren in preclinical studies. The potential for drug interactions at the Pgp site will likely depend on the degree of inhibition of this transporter.
  •  Atorvastatin: Coadministration of atorvastatin, resulted in about a 50% increase in aliskiren Cmax and AUC after multiple dosing.
  • Ketoconazole: Coadministration of 200 mg twice-daily ketoconazole, with aliskiren resulted in an approximate 80% increase in plasma levels of aliskiren. A 400-mg oncedaily dose was not studied but would be expected to increase aliskiren blood levels further.
  • Cyclosporine: Coadministration of 200 mg and 600 mg cyclosporine, with 75 mg aliskiren resulted in an approximately 2.5-fold increase in Cmax and 5-fold increase in AUC of aliskiren. Concomitant use of aliskiren with cyclosporine is not recommended.
  • Verapamil: Coadministration of 240 mg of verapamil, a moderate Pgp inhibitor, with 300 mg aliskiren resulted in an approximately 2-fold increase in Cmax and AUC of aliskiren. However, no dosage adjustment is necessary.