Acute Kidney Injury 

 

Inform patients that acute kidney injury has been reported during use of SEGLUROMET. 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 SEGLUROMET use in those settings [see Warnings and Precautions (5.4)].

 

Monitoring of Renal Function 

 

Inform patients about the importance of regular testing of renal function when receiving treatment with SEGLUROMET [see Warnings and Precautions (5.4)].

 

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 (5.5)].

 

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 (5.6)].

 

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 (5.8)].

 

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 (5.8)].

 

Laboratory Tests 

 

Due to the mechanism of action of ertugliflozin, inform patients that their urine will test positive for glucose while taking SEGLUROMET.

 

SPL UNCLASSIFIED SECTION 

 

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of

MERCK & CO., INC., Whitechouse Station, NJ 08889, USA

 

For patent information: www.merck.com/product/patent/home.html

 

Copyright © 2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. 

All rights reserved.

 

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MEDICATION GUIDE 

 

Medication Guide