See Supplemental Patient Information
- Therapy may cause intravascular volume contraction and symptomatic hypotension particularly in patients with impaired renal function (eGFR < 60 mL/min/1.73 m2), elderly patients, patients on either diuretics or medications that interfere with the renin-angiotensin-aldosterone system. Closely monitor patients
- Assess volume status before and regularly after initiating therapy
- Drug increases serum creatinine and decreases eGFR, patients with hypovolemia are more susceptible to renal function impairment.
- Frequent renal function monitoring is recommended in patients with an eGFR < 60 mL/min/1.73 m2
- Therapy may increase the risk of hypoglycemia with insulin and insulin secretagogues, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination
- Genital mycotic infections may occur, uncircumcised males and patients with history of genital mycotic infections are more susceptible. Monitor closely and treat appropriately
- Dose-related increases in LDL-C have been reported. Monitor LDL-C and treat per standard of care after initiating therapy
- An imbalance in bladder cancers was observed in clinical trials. Should not be used in patients with active bladder cancer and used with caution with a history of bladder cancer.
- There have been no clinical studies establishing conclusive evidence of macro vascular risk reduction.
Supplemental Patient Information
- It is recommended that the health care provider give the FDA approved Medication Guide supplied by the manufacture
Pregnancy Category:C
Breastfeeding: Safety unknown; as many drugs are excreted in breast milk and because of the potential for serious adverse reactions in nursing infants, manufacturer advises to make a decision whether to discontinue nursing while taking the drug or to discontinue therapy, taking into account the importance of the drug to the mother.
