Teva and Amgen Resolve Ongoing Dispute Over Teva’s Generic Cinacalet HCl Product - Seite 3

Hypotension, Worsening Heart Failure and/or Arrhythmias: In postmarketing safety surveillance, isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia have been reported in patients with impaired cardiac function, in which a causal relationship to cinacalcet could not be completely excluded and which may be mediated by reductions in serum calcium levels.

Adynamic Bone Disease: Adynamic bone disease may develop if iPTH levels are suppressed below 100 pg/mL.

Drug Interactions with Strong CYP3A4 Inhibitors: Cinacalcet is partially metabolized by CYP3A4. Dose adjustment of cinacalcet may be required if a patient initiates or discontinues therapy with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole). The iPTH and serum calcium concentrations should be closely monitored in these patients.

Drug Interactions with CYP2D6 Substrates: Cinacalcet is a strong inhibitor of CYP2D6. Dose adjustments may be required for concomitant medications that are predominantly metabolized by CYP2D6 (e.g., desipramine, metoprolol, and carvedilol) and particularly those with a narrow therapeutic index (e.g., flecainide and most tricyclic antidepressants).

Common Adverse Reactions: The most common adverse reactions (i.e., incidence ≥25%) associated with cinacalcet were nausea and vomiting.

Please see accompanying Full Prescribing Information.

For more information, please see accompanying Full Prescribing Information, including Boxed Warning. A copy may be requested from Teva US Medical Information at 888-4-TEVA-USA (888-838-2872) or [e-mail], or Teva’s Public Relations or Investor Relations contacts.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 45,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.