|
TOP
|
|
QTERNMET XR(dapagliflozin, saxagliptin, and metforminhydrochloride)extended-release tablets(十一)
re and disabling arthralgia in patients taking DPP-4inhibitors. The time to onset of symptoms following initiation of drug therapy varied from one day toyears. Patients experienced relief of symptoms upon discontinuation of the medication. A subset ofpatients experienced a recurrence of symptoms restarting the same drug or a different DPP-4 inhibitor.
Consider DPP-4 inhibitors as a possible cause for severe joint pain and discontinue drug if appropriate[see ADVERSE REACTIONS (6)].
5.16 Bullous Pemphigoid
Postmarketing cases of bullous pemphigoid requiring hospitalization have been reported with DPP-4inhibitor use. In reported cases, patients typically recovered with topical or systemic immunosuppressivetreatment and discontinuation of the DPP-4 inhibitor. Tell patients to report development of blisters orerosions while receiving QTERNMET XR. If bullous pemphigoid is suspected, QTERNMET XR shouldbe discontinued and referral to a dermatologist should be considered for diagnosis and appropriate
treatment.
5.17 Macrovascular Outcomes
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with
QTERNMET XR.
6 ADVERSE REACTIONS
The following important adverse reactions are described below or elsewhere in the labeling:
• Lactic Acidosis [see BOXED WARNING and WARNINGS AND PRECAUTIONS (5.1)]
• Pancreatitis [see WARNINGS AND PRECAUTIONS (5.2)]
• Heart Failure [see WARNINGS AND PRECAUTIONS (5.3)]
• Hypotension [see WARNINGS AND PRECAUTIONS (5.4)]
• Ketoacidosis [see WARNINGS AND PRECAUTIONS (5.5)]
• Acute Kidney Injury and Impairment in Renal Function [see WARNINGS AND PRECAUTIONS (5.6)]
• Urosepsis and Pyelonephritis [see WARNINGS AND PRECAUTIONS (5.7)]
•Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues [see WARNINGS ANDPRECAUTIONS (5.8)]
•Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) [see WARNINGS AND PRECAUTIONS(5.9)]
•Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS (5.10)]
•Vitamin B12 Concentrations [see WARNINGS AND PRECAUTIONS (5.11)]
•Genital Mycotic Infections [see WARNINGS AND PRECAUTIONS (5.12)]
•Increases in Low-Density Lipoprotein Cholesterol (LDL-C) [see WARNINGS AND PRECAUTIONS(5.13)]
•Bladder Cancer [see WARNINGS AND PRECAUTIONS (5.14)]
•Severe and Disabling Arthralgia [see WARNINGS AND PRECAUTIONS (5.15)]
•Bullous Pemphigoid [see WARNINGS AND PRECAUTIONS (5.16)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed inthe clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug andmay not reflect the rates observed in practice.
The safety of combined use of 10 mg dapagliflozin and 5 mg saxagliptin has been eva luated in adultsubjects with type 2 diabetes in a pooled safety analysis of three phase 3 active/placebo-controlled clinicaltrials with a median exposure of 51 weeks. The pooled safety analysis included a total of 1169 adults:492 patients in the combination of saxagliptin and dapagliflozin plus metformin group, 341 patients in thedapagliflozin plus metformin group, 336 patients the saxagliptin plus metformin group. The mean age ofthese subjects was 54 years, 0.8% were 75 years or older and 53.7% were f |
|
