Bexagliflozin

Bexagliflozin is a prescription medication used for the treatment of Type 2 Diabetes Mellitus.  

• Bexagliflozin is available under the following different brand names: Brenzavvy.

Common side effects of Bexagliflozin include:

• increased urination, 
• vaginal itching, 
• pain during sexual intercourse, 
• pain or discomfort when urinating, 
• abnormal vaginal discharge, 
• pelvic pain, 
• increased urge to urinate, 
• blood in your urine, 
• back pain, 
• nausea, 
• vomiting, and 
• fever

Serious side effects of Bexagliflozin include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• nausea, 
• vomiting, 
• abdominal pain, 
• feeling unwell, 
• shortness of breath, 
• fever, 
• chills, 
• pain and swelling in legs, arms, or spine, 
• sores or ulcers of the legs or feet, 
• leg pain or tenderness, 
• low blood pressure,  
• abnormal lab results (creatinine levels), 
• confusion, 
• fast heartbeat, 
• shakiness, 
• anxiety, 
• lightheadedness, 
• hunger, 
• dizziness, 
• irritability, 
• sweating, 
• pain or tenderness, swelling, redness in the genital or perineal area, 
• vaginal itching, 
• pain during sexual intercourse, 
• pain or discomfort when urinating, and
• abnormal vaginal discharge

Rare side effects of Bexagliflozin include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 20 mg

Type 2 Diabetes Mellitus

Adult dosage

• 20 mg orally every morning

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Bexagliflozin has severe interactions with no other drugs.
• Bexagliflozin has serious interactions with no other drugs.
• Bexagliflozin has moderate interactions with at least 32 other drugs.
• Bexagliflozin has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to bexagliflozin or excipients
• Dialysis

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Bexagliflozin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Bexagliflozin?”

Cautions

• Serious hypersensitivity reactions (eg, angioedema) reported; if a hypersensitivity reaction occurs, discontinue treatment; treat promptly per standard of care, and monitor until signs and symptoms resolve
• Serious urinary tract infections, including urosepsis and pyelonephritis, reported; evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated
• Ketoacidosis
  • Ketoacidosis, a serious, life-threatening condition resulting in urgent hospitalization or death, reported in patients treated with sodium-glucose cotransporter 2 (SGLT2) inhibitors
  • Not indicated for the treatment of type 1 diabetes mellitus
  • Assess for ketoacidosis in patients who present with signs and symptoms consistent with severe metabolic acidosis, regardless of blood glucose levels
  • Ketoacidosis may be present even if blood glucose levels are <250 mg/dL
  • Treatment may require insulin, fluid, and carbohydrate replacement
  • Consider temporarily discontinuing therapy for at least 3 days for patients who undergo scheduled surgery
  • Consider monitoring for ketoacidosis and temporarily discontinuing therapy in other clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or postsurgery); ensure risk factors for ketoacidosis are resolved prior to restarting therapy
  • Restart once the patient’s oral intake is back to baseline and any other risk factors for ketoacidosis (eg, blood acid build-up) are resolved
• Lower limb amputation
  • Increased incidence of lower limb amputations occurred in bexagliflozin-treated patients compared with placebo-treated patients in a randomized, placebo-controlled trial evaluating patients with type 2 diabetes mellitus who either had established cardiovascular disease (CVD) or were at risk for CVD
  • Risk of amputation was highest in patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy
• Volume depletion
  • Intravascular volume depletion, which may manifest as symptomatic hypotension or acute changes in creatinine, occurred
  • Acute kidney injury reported, some required hospitalization and dialysis
  • Patients with impaired renal function (eGFR <60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension
  • Before initiating therapy in patients with one or more of these characteristics, assess volume status and renal function; in patients with volume depletion, correct this condition before initiating treatment; monitor for signs and symptoms of volume depletion and renal function, after initiating therapy
• Necrotizing fasciitis
  • Necrotizing fasciitis of the perineum (Fournier gangrene) reported with SGLT2 inhibitors
  • Signs and symptoms include pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise
  • If suspected, discontinue the SGLT2 inhibitor and start treatment immediately with broad-spectrum antibiotics and surgical débridement if necessary
• Mycotic infections
  • Genital mycotic infections may occur
  • Patients with a history of genital mycotic infections and uncircumcised males are more susceptible
  • Inform male patients that yeast infections of the penis (eg, balanitis or balanoposthitis) may occur; provide them with information regarding signs and symptoms (rash or redness of the glans or foreskin of the penis); advise them of treatment options and when to seek medical advice
• Drug interaction overview
  • UGT enzyme inducers
    • Consider adding another antihyperglycemic agent in patients requiring additional glycemic control
    • UGT inducers may significantly reduce systemic exposure to bexagliflozin and lead to decreased efficacy
  • Insulin and insulin secretagogues
• Dosage modification
  • Hypoglycemia risk increased with insulin and insulin secretagogues (eg, sulfonylureas); a lower dose of insulin or insulin secretagogue may be required
• Lithium
  • Monitor lithium levels more frequently upon SGLT2 inhibitor initiation and discontinuation
  • SGLT2 inhibitors may decrease serum lithium concentrations
• Laboratory testing
  • Urine glucose tests are not recommended in patients taking SGLT2 inhibitors, as SGLT2 inhibitors increase urinary glucose excretion and lead to positive urine glucose tests; use alternative methods to monitor glycemic control
  • 1,5-anhydroglucitol (AG) assay is not recommended, as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors; use alternative methods to monitor glycemic control

Pregnancy and Lactation

• Based on animal data showing adverse renal effects, not recommended during the second and third trimesters of pregnancy
• Limited data available in pregnant females are insufficient to determine a drug-associated risk for major birth defects and miscarriage
• There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy
• Clinical considerations
  • Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications; poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity
• Lactation
  • There is no information regarding drug presence in human milk, including the effects on breastfed infants or on milk production
  • Present in the milk of lactating rats at milk: plasma ratio of ~2
  • Since human kidney maturation occurs in utero and during the first 2 years of life, when lactation exposure may occur, there may be a risk to the developing human kidney
  • Advise females of reproductive potential that bexagliflozin is not recommended while breastfeeding