jesduvroq daprodustat 8 mg
1 INDICATIONS AND USAGE JESDUVROQ is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. Limitations of Use JESDUVROQ has not been shown to improve quality of life, fatigue, or patient well-being. JESDUVROQ is not indicated for use: • As a substitute for red blood cell transfusions in patients who require immediate correction of anemia. • For treatment of anemia of chronic kidney disease in patients who are not on dialysis. JESDUVROQ is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months. ( 1 ) Limitations of Use Not shown to improve quality of life, fatigue, or patient well-being. Not indicated for use: • As a substitute for transfusion in patients requiring immediate correction of anemia. • In patients not on dialysis.
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied JESDUVROQ tablets contain 1 mg, 2 mg, 4 mg, 6 mg or 8 mg of
DAPRODUSTAT. Tablet Strength Package Configuration and NDC Number Tablet Description and Markings 1 mg 30 count bottle (NDC 0173-0897-13) round, gray, biconvex, film-coated tablets debossed with “GS KF” on one side 100 count blister pack (NDC 0173-0897-56) 2 mg 30 count bottle (NDC 0173-0903-13) round, yellow, biconvex, film-coated tablets debossed with “GS V7” on one side 100 count blister pack (NDC 0173-0903-56) 4 mg 30 count bottle (NDC 0173-0906-13) round, white, biconvex, film-coated tablets debossed with “GS 13” on one side 100 count blister pack (NDC 0173-0906-56) 6 mg 30 count bottle (NDC 0173-0911-13) round, pink, biconvex, film-coated tablets debossed with “GS IM” on one side 100 count blister pack (NDC 0173-0911-56) 8 mg 30 count bottle (NDC 0173-0914-13) round, orange, biconvex, film-coated tablets debossed with “GS 5E” on one side 100 count blister pack (NDC 0173-0914-56) Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F). [See USP Controlled Room Temperature].
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