QTERNMET XR(dapagliflozin, saxagliptin, and metforminhydrochloride)extended-release tablets(三)
. QTERNMET XR should not be used in patientswith active bladder cancer and should be used with caution in patients witha prior history of bladder cancer. (5.14)
Arthralgia: Severe and disabling arthralgia has been reported in patientstaking DPP-4 inhibitors. Consider as a possible cause for severe joint painand discontinue drug if appropriate. (5.15, 6.1, 6.2)
Bullous Pemphigoid: There have been postmarketing reports of bullouspemphigoid requiring hospitalization in patients taking DPP-4 inhibitors.
Tell patients to report development of blisters or erosions. If bullouspemphigoid is suspected, discontinue QTERNMET XR. (5.16)
Macrovascular Outcomes: There have been no clinical studies establishingconclusive evidence of macrovascular risk reduction with QTERNMETXR. (5.17)
ADVERSE REACTIONS
Adverse reactions reported in ≥5% of subjects treated with dapagliflozin andsaxagliptin plus metformin were: upper respiratory tract infection, urinarytract infection, and dyslipidemia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AstraZenecaat 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Strong CYP3A4/5 Inhibitors (e.g., Ketoconazole): Do not coadministerQTERNMET XR with strong cytochrome P450 3A4/5 inhibitors. (2.4, 7)
Carbonic anhydrase inhibitors: May increase the risk of lactic acidosis.Consider more frequent monitoring. (7)
Drugs that reduce metformin clearance (such as ranolazine, vandetanib,dolutegravir, and cimetidine): May increase the accumulation ofmetformin. Consider the benefits and risks of concomitant use. (7)
Alcohol: Can potentiate the effect of metformin on lactate metabolism. Warnpatients against excessive alcohol intake. (7)
Renal Impairment: Higher incidence of adverse reactions related to reducedintravascular volume and renal function. (2.2, 5.6, 6.1, 8.6)
Hepatic Impairment: Avoid use of QTERNMET XR in patients with clinicalor laboratory evidence of hepatic impairment. (2.3, 8.7)
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide
Revised: 5/2019
-----------------------------------------------------------
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: LACTIC ACIDOSIS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Prior to Initiation of QTERNMET XR
2.2 Dosage
2.3 Patients with Renal Impairment
2.4 Use with Strong CYP3A4/5 Inhibitors
2.5 Discontinuation for Iodinated Contrast Imaging Procedures
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Lactic Acidosis
5.2 Pancreatitis
5.3 Heart Failure
5.4 Hypotension
5.5 Ketoacidosis
5.6 Acute Kidney Injury and Impairment in Renal Function
5.7 Urosepsis and Pyelonephritis
5.8 Hypoglycemia with Concomitant Use of Insulin or InsulinSecretagogues
5.9 Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene)
5.10 Hypersensitivity Reactions
5.11 Vitamin B12 Concentrations
5.12 Genital Mycotic Infections
5.13 Increases in Low-Density Lipoprotein Cholesterol (LDL–C)
5.14 Bladder Cancer
5.15 Severe and Disabling Arthralgia
5.16 Bullous Pemphigoid
5.17 Macrovascular Outcomes
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females |
