JARDIANCE (empagliflozin) tablets - America[美国药品]

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JARDIANCE (empagliflozin) tablets

2015-11-15 06:42:31 来源: 作者: 【大中小】浏览:410次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use JARDIANCE safely and effectively. See full prescribing information for JARDIANCE. JARDIANCE ® (empagliflozin) tablets, for oral use Initial U.S. Approval: 2014 INDICATIONS AND USAGE JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1) Limitation of Use: Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis (1.1) DOSAGE AND ADMINISTRATION The recommended dose of JARDIANCE is 10 mg once daily, taken in the morning, with or without food (2.1) Dose may be increased to 25 mg once daily (2.1) Assess renal function before initiating JARDIANCE. Do not initiate JARDIANCE if eGFR is below 45 mL/min/1.73 m2 (2.2) Discontinue JARDIANCE if eGFR falls persistently below 45 mL/min/1.73 m2 (2.2) DOSAGE FORMS AND STRENGTHS Tablets: 10 mg, 25 mg (3) CONTRAINDICATIONS History of serious hypersensitivity reaction to JARDIANCE (4) Severe renal impairment, end-stage renal disease, or dialysis (4) WARNINGS AND PRECAUTIONS Hypotension: Before initiating JARDIANCE assess and correct volume status in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy. (5.1) Impairment in renal function: Monitor renal function during therapy. More frequent monitoring is recommended in patients with eGFR below 60 mL/min/1.73 m2 (5.2) Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating JARDIANCE (5.3) Genital mycotic infections: Monitor and treat as appropriate (5.4) Urinary tract infections: Monitor and treat as appropriate (5.5) Increased LDL-C: Monitor and treat as appropriate (5.6) Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with JARDIANCE (5.7) ADVERSE REACTIONS The most common adverse reactions associated with JARDIANCE (5% or greater incidence) were urinary tract infections and female genital mycotic infections (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or 1-800-459-9906 TTY, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONS Pregnancy: No adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. (8.1) Nursing mothers: Discontinue JARDIANCE or discontinue nursing (8.3) Geriatric patients: Higher incidence of adverse reactions related to volume depletion and reduced renal function (5.1, 5.2, 8.5) Patients with renal impairment: Higher incidence of adverse reactions related to reduced renal function (2.2, 5.2, 8.6) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 6/2015 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Limitation of Use 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage 2.2 Patients with Renal Impairment 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Hypotension 5.2 Impairment in Renal Function 5.3 Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues 5.4 Genital Mycotic Infections 5.5 Urinary Tract Infections 5.6 Increased Low-Density Lipoprotein Cholesterol (LDL-C) 5.7 Macrovascular Outcomes 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 7 DRUG INTERACTIONS 7.1 Diuretics 7.2 Insulin or Insulin Secretagogues 7.3 Positive Urine Glucose Test 7.4 Interference with 1,5-anhydroglucitol (1,5-AG) Assay 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 8.7 Hepatic Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Monotherapy 14.2 Combination Therapy 14.3 Renal Impairment 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS AND USAGE JARDIANCE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)]. 1.1 Limitation of Use JARDIANCE is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage The recommended dose of JARDIANCE is 10 mg once daily in the morning, taken with or without food. In patients tolerating JARDIANCE, the dose may be increased to 25 mg [see Clinical Studies (14)]. In patients with volume depletion, correcting this condition prior to initiation of JARDIANCE is recommended [see Warnings and Precautions (5.1), Use in Specific Populations (8.5), and Patient Counseling Information (17)]. 2.2 Patients with Renal Impairment Assessment of renal function is recommended prior to initiation of JARDIANCE and periodically thereafter. JARDIANCE should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m2. No dose adjustment is needed in patients with an eGFR greater than or equal to 45 mL/min/1.73 m2. JARDIANCE should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m2 [see Warnings and Precautions (5.1, 5.2), and Use in Specific Populations (8.6)]. 3 DOSAGE FORMS AND STRENGTHS JARDIANCE (empagliflozin) 10 mg tablets are pale yellow, round, biconvex and bevel-edged, film-coated tablets debossed with “S 10” on one side and the Boehringer Ingelheim company symbol on the other side. JARDIANCE (empagliflozin) 25 mg tablets are pale yellow, oval, biconvex, film-coated tablets debossed with “S 25” on one side and the Boehringer Ingelheim company symbol on the other side. 4 CONTRAINDICATIONS History of serious hypersensitivity to JARDIANCE. Severe renal impairment, end-stage renal disease, or dialysis [see Use in Specific Populations (8.6)]. 5 WARNINGS AND PRECAUTIONS 5.1 Hypotension JARDIANCE causes intravascular volume contraction. Symptomatic hypotension may occur after initiating JARDIANCE [see Adverse Reactions (6.1)] particularly in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Before initiating JARDIANCE, assess for volume contraction and correct volume status if indicated. Monitor for signs and symptoms of hypotension after initiating therapy and increase monitoring in clinical situations where volume contraction is expected [see Use in Specific Populations (8.5)]. 5.2 Impairment in Renal Function JARDIANCE increases serum creatinine and decreases eGFR [see Adverse Reactions (6.1)]. The risk of impaired renal function with JARDIANCE is increased in elderly patients and patients with moderate renal impairment. More frequent monitoring of renal function is recommended in these patients [see Use in Specific Populations (8.5, 8.6)]. Renal function should be eva luated prior to initiating JARDIANCE and periodically thereafter. 5.3 Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues Insulin and insulin secretagogues are known to cause hypoglycemia. The risk of hypoglycemia is increased when JARDIANCE is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin [see Adverse Reactions (6.1)]. Therefore, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia when used in combination with JARDIANCE. 5.4 Genital Mycotic Infections JARDIANCE increases the risk for genital mycotic infections [see Adverse Reactions (6.1)]. Patients with a history of chronic or recurrent genital mycotic infections were more likely to develop mycotic genital infections. Monitor and treat as appropriate. 5.5 Urinary Tract Infections JARDIANCE increases the risk for urinary tract infections [see Adverse Reactions (6.1)]. Monitor and treat as appropriate.
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