em (e.g., angiotensin-converting-enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs]), or patients with low systolic blood pressure. Before initiating INVOKANA in patients with one or more of these characteristics, volume status should be assessed and corrected. Monitor for signs and symptoms after initiating therapy.
5.2 Impairment in Renal Function
INVOKANA increases serum creatinine and decreases eGFR. Patients with hypovolemia may be more susceptible to these changes. Renal function abnormalities can occur after initiating INVOKANA [see Adverse Reactions (6.1)]. More frequent renal function monitoring is recommended in patients with an eGFR below 60 mL/min/1.73 m2.
5.3 HyperkalemiaINVOKANA can lead to hyperkalemia. Patients with moderate renal impairment who are taking medications that interfere with potassium excretion, such as potassium-sparing diuretics, or medications that interfere with the renin-angiotensin-aldosterone system are more likely to develop hyperkalemia [see Adverse Reactions (6.1)].
Monitor serum potassium levels periodically after initiating INVOKANA in patients with impaired renal function and in patients predisposed to hyperkalemia due to medications or other medical conditions.
5.4 Hypoglycemia with Concomitant Use with Insulin and Insulin SecretagoguesInsulin and insulin secretagogues are known to cause hypoglycemia. INVOKANA can increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue [see Adverse Reactions (6.1)]. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with INVOKANA.
5.5 Genital Mycotic InfectionsINVOKANA increases the risk of genital mycotic infections. Patients with a history of genital mycotic infections and uncircumcised males were more likely to develop genital mycotic infections [see Adverse Reactions (6.1)]. Monitor and treat appropriately.
5.6 Hypersensitivity ReactionsHypersensitivity reactions (e.g., generalized urticaria), some serious, were reported with INVOKANA treatment; these reactions generally occurred within hours to days after initiating INVOKANA. If hypersensitivity reactions occur, discontinue use of INVOKANA; treat per standard of care and monitor until signs and symptoms resolve [see Contraindications (4) and Adverse Reactions (6.1)].
5.7 Increases in Low-Density Lipoprotein (LDL-C)Dose-related increases in LDL-C occur with INVOKANA [see Adverse Reactions (6.1)]. Monitor LDL-C and treat per standard of care after initiating INVOKANA.
5.8 Macrovascular OutcomesThere have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with INVOKANA or any other antidiabetic drug.
6 ADVERSE REACTIONSThe following important adverse reactions are described below and elsewhere in the labeling:
◦Hypotension [see Warnings and Precautions (5.1)]
◦Impairment in Renal Function [see Warnings and Precautions (5.2)]
◦Hyperkalemia [see Warnings and Precautions (5.3)]
◦Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.4)]
◦Genital Mycotic Infections [see Warnings and Precautions (5.5)]
◦Hypersensitivity Reactions [see Warnings and Precautions (5.6)]
◦Increases in Low-Density Lipoprotein (LDL-C) [see Warnings and Precautions (5.7 |
