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The following safety warnings and precautions are essential for individuals using Brenzavvy (bexagliflozin). Please review these carefully and discuss any concerns with your healthcare provider.

• Ketoacidosis Warning: Brenzavvy may lead to a serious condition called ketoacidosis, especially in individuals with diabetes. This condition occurs when the body produces too many ketones, causing the blood to become acidic. The risk increases if you are ill, consuming fewer calories, drinking excessive alcohol, have recently undergone surgery or have reduced your insulin dosage. Be vigilant for symptoms such as dry mouth, fruity breath, fatigue, nausea, vomiting, abdominal pain, or difficulty breathing. If these occur, discontinue the medication and seek immediate medical attention.

• Risk of Lower Limb Amputation: Brenzavvy may increase the likelihood of foot or leg amputations, although this is rare. Factors that heighten this risk include a history of amputation, blood circulation issues, or nerve problems. Common causes for amputations in patients using this medication are leg infections and damaged tissue. Notify your healthcare provider if you experience new pain, tenderness, sores, ulcers, or infections in your legs or feet. Regular follow-ups for foot examinations are advised.

• Dehydration and Low Blood Pressure: The use of Brenzavvy might lead to decreased fluid levels, potentially causing dehydration, low blood pressure, or kidney damage. This risk is elevated in individuals over 65, those with kidney issues, those on a low-sodium diet, or those taking loop diuretics. It is important to stay hydrated while on this medication. Contact your provider if you experience dizziness, reduced urination, or after episodes of vomiting or diarrhea, to ensure adequate fluid levels.

• Genital and Urinary Tract Infections: Brenzavvy can increase the risk of genital and urinary tract infections, including UTIs and yeast infections, which in severe cases may require hospitalization. Seek medical advice if you notice symptoms such as a burning sensation during urination, frequent urination, lower abdominal pain, blood in urine, genital odor, or any pain, itching, swelling, redness, or tenderness around the genital area.

• Hypoglycemia Risk: When used in conjunction with other diabetes medications such as insulin or sulfonylureas, Brenzavvy can increase the risk of hypoglycemia, a potentially life-threatening condition. Symptoms include nervousness, anxiety, shaking, drowsiness, weakness, confusion, a rapid heartbeat, sweating, and excessive hunger. Monitor your blood sugar if you experience these symptoms and consult your provider for guidance.

Contraindications: Brenzavvy should not be used by individuals undergoing dialysis. If you are on dialysis, consult your healthcare provider to discuss alternative treatments.

Ensure you follow these guidelines to minimize risks and maintain your health while using Brenzavvy.

Common side effects:

• Frequent urination
• Dizziness
• Lightheadedness

Less common but important to monitor:

• Symptoms of a urinary tract infection
• Vaginal yeast infections in women
• Genital yeast infections in men
• Dehydration
• Low blood sugar

Serious side effects:

• Severe allergic reactions
• Fournier's gangrene
• Unusual tiredness, nausea, vomiting, or stomach pain (high ketone levels in the blood)
• Lower limb amputation

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Beta blockers (such as metoprolol, Propranolol, Timolol)