Invokana Patient Counseling Information

See patient labeling (Medication Guide).
Lower Limb Amputation: Inform patients that INVOKANA is associated with an increased risk of amputations. Counsel patients about the importance of routine preventative foot care. Instruct patients to monitor for new pain or tenderness, sores or ulcers, or infections involving the leg or foot and to seek medical advice immediately if such signs or symptoms develop [see Warnings and Lower Limb Amputation under Precautions].
Hypotension: Inform patients that symptomatic hypotension may occur with INVOKANA and advise them to contact their doctor if they experience such symptoms [see Hypotension under Precautions]. Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake.
Ketoacidosis: Inform patients that ketoacidosis is a serious life-threatening condition. Cases of ketoacidosis have been reported during use of INVOKANA. Instruct patients to check ketones (when possible) if symptoms consistent with ketoacidosis occur even if blood glucose is not elevated. If symptoms of ketoacidosis (including nausea, vomiting, abdominal pain, tiredness, and labored breathing) occur, instruct patients to discontinue INVOKANA and seek medical advice immediately [see Ketoacidosis under Precautions].
Acute Kidney Injury: Inform patients that acute kidney injury has been reported during use of INVOKANA. Advise patients to seek medical advice immediately if they have reduced oral intake (such as due to acute illness or fasting) or increased fluid losses (such as due to vomiting, diarrhea, or excessive heat exposure), as it may be appropriate to temporarily discontinue INVOKANA use in those settings [see Acute Kidney Injury under Precautions].
Serious Urinary Tract Infections: Inform patients of the potential for urinary tract infections, which may be serious. Provide them with information on the symptoms of urinary tract infections. Advise them to seek medical advice if such symptoms occur [see Urosepsis and Pyelonephritis under Precautions].
Necrotizing Fasciitis of the Perineum (Fournier's Gangrene): Inform patients that necrotizing infections of the perineum (Fournier's gangrene) have occurred with INVOKANA. Counsel patients to promptly seek medical attention if they develop pain or tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, along with a fever above 100.4°F or malaise [see Necrotizing Fasciitis of the Perineum (Fournier's Gangrene) under Precautions].
Genital Mycotic Infections in Females (e.g., Vulvovaginitis): Inform female patients that vaginal yeast infection may occur and provide them with information on the signs and symptoms of vaginal yeast infection. Advise them of treatment options and when to seek medical advice [see Genital Mycotic Infections under Precautions].
Genital Mycotic Infections in Males (e.g., Balanitis or Balanoposthitis): Inform male patients that yeast infection of penis (e.g., balanitis or balanoposthitis) may occur, especially in uncircumcised males and patients with prior history. Provide them with information on the signs and symptoms of balanitis and balanoposthitis (rash or redness of the glans or foreskin of the penis). Advise them of treatment options and when to seek medical advice [see Genital Mycotic Infections under Precautions].
Hypersensitivity Reactions: Inform patients that serious hypersensitivity reactions, such as urticaria, rash, anaphylaxis, and angioedema, have been reported with INVOKANA. Advise patients to report immediately any signs or symptoms suggesting allergic reaction, and to discontinue drug until they have consulted prescribing physicians [see Hypersensitivity Reactions under Precautions].
Bone Fracture: Inform patients that bone fractures have been reported in patients taking INVOKANA. Provide them with information on factors that may contribute to fracture risk [see Bone Fracture under Precautions].
Pregnancy: Advise pregnant women, and females of reproductive potential of the potential risk to a fetus with treatment with INVOKANA [see Pregnancy under Use in Pregnancy & Lactation]. Instruct females of reproductive potential to report pregnancies to their physicians as soon as possible.
Lactation: Advise women that breastfeeding is not recommended during treatment with INVOKANA [see Lactation under Use in Pregnancy & Lactation].
Laboratory Tests: Inform patients that due to its mechanism of action, patients taking INVOKANA will test positive for glucose in their urine [see Positive Urine Glucose Test under Interactions].
Missed Dose: If a dose is missed, advise patients to take it as soon as it is remembered unless it is almost time for the next dose, in which case patients should skip the missed dose and take the medicine at the next regularly scheduled time. Advise patients not to take two doses of INVOKANA at the same time.