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Takeda and Arbor Announce a Licensing Agreement for EDARBI and EDARBYCLOR
Date:9/12/2013

agents. The recommended dose of EDARBI in adults is 80 mg taken once daily. A starting dose of 40 mg may be appropriate for patients on high doses of diuretics. EDARBI is approved in the United States, Canada, Europe and Mexico.

EDARBYCLOR (azilsartan medoxomil and chlorthalidone) is a fixed-dose combination therapy for the treatment of hypertension that combines azilsartan medoxomil and chlorthalidone in a single tablet. Chlorthalidone reduces the amount of water in the body by increasing the flow of urine, which helps lower blood pressure. EDARBYCLOR is indicated for the treatment of hypertension to lower blood pressure in adults; it may be used in patients not adequately controlled with monotherapy and as an initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals. The recommended starting dose of EDARBYCLOR in adults is 40/12.5 mg taken orally once daily. The maximal dose is 40/25 mg.

Important Safety Information
WARNING: FETAL TOXICITY. See full Prescribing Information for complete boxed warning. When pregnancy is detected, discontinue EDARBI or EDARBYCLOR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

EDARBYCLOR is contraindicated in patients with anuria.

Do not coadminister aliskiren with EDARBI or EDARBYCLOR in patients with diabetes.

Fetal Toxicity: Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected, discontinue EDARBI or EDARBYCLOR as soon as possible. Thiazides cross the placental barrier and appear in cord blood and may be associated with adverse reactions, including fetal or neonatal jaundice and thrombocytopenia.

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SOURCE Takeda Pharmaceutical Company Limited
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