Ketoacidosis 

 

Inform patients that ketoacidosis is a serious life-threatening condition. Cases of ketoacidosis have been reported during use of STEGLATRO. 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 STEGLATRO and seek medical advice immediately [see Warnings and Precautions (5.2)].

Acute Kidney Injury 

 

Inform patients that acute kidney injury has been reported during use of STEGLATRO. Advise patients to seek medical advice immediately if they have reduced oral intake (due to acute illness or fasting) or increased fluid losses (due to vomiting, diarrhea, or excessive heat exposure), as it may be appropriate to temporarily discontinue STEGLATRO use in those settings [see Warnings and Precautions (5.3)].

 

Monitoring of Renal Function 

 

Inform patients about the importance of regular testing of renal function when receiving treatment with STEGLATRO [see Warnings and Precautions (5.3)].

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 Warnings and Precautions (5.4)].

 

Amputation 

 

Inform patients of the potential for 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 Precautions (5.5)].

 

Genital Mycotic Infections in Females (e.g., Vulvovaginitis) 

 

Inform female patients that vaginal yeast infections 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 Warnings and Precautions (5.7)].

Genital Mycotic Infections in Males (e.g., Balanitis or Balanoposthitis) 

Inform male patients that yeast infections of the penis (e.g., balanitis or balanoposthitis) may occur, especially in uncircumcised males. 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 Warnings and Precautions (5.7)].

Fetal Toxicity 

Advise pregnant patients of the potential risk to a fetus with treatment with STEGLATRO. Instruct patients to immediately inform their healthcare provider if pregnant or planning to become pregnant [see Use in Specific Populations (8.1)].

Lactation 

Advise patients that use of STEGLATRO is not recommended while breastfeeding [see Use in Specific Populations (8.2)].

Laboratory Tests