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Limitation of Use: BRENZAVVY is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.
Contraindications
BRENZAVVY (bexagliflozin) is contraindicated in patients:
• With hypersensitivity to bexagliflozin or any excipient in BRENZAVVY. Anaphylaxis and angioedema have been reported with sodium-glucose co-transporter 2 (SGLT2) inhibitors.
• On dialysis
Warnings And Precautions
Ketoacidosis
Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, have been identified in clinical trials and postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus who received SGLT2 inhibitors, including BRENZAVVY (bexagliflozin). Fatal cases of ketoacidosis have been reported for patients taking SGLT2 inhibitors. In placebo-controlled trials of patients with type 1 diabetes, the risk of ketoacidosis was increased in patients who received SGLT2 inhibitors compared to patients who received placebo. BRENZAVVY is not indicated for the treatment of patients with type 1 diabetes mellitus.
Patients treated with BRENZAVVY (bexagliflozin) who present with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of blood glucose levels, as ketoacidosis associated with BRENZAVVY may be present even if the blood glucose levels are less than 250 mg/dL. If ketoacidosis is suspected, BRENZAVVY should be discontinued, the patient should be evaluated, and prompt treatment should be instituted. Treatment of ketoacidosis may require insulin, fluid, and carbohydrate replacement.
In many of the reported cases, and particularly in patients with type 1 diabetes, the presence of ketoacidosis was not immediately recognized, and the institution of treatment was delayed because the presenting blood glucose levels were below those typically expected for diabetic ketoacidosis (often less than 250 mg/dL). Signs and symptoms at presentation were consistent with dehydration and severe metabolic acidosis and included nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. In some but not all cases, factors predisposing to ketoacidosis, such as insulin dose reduction, acute febrile illness, reduced caloric intake, surgery, pancreatic disorders suggesting insulin deficiency (e.g., type 1 diabetes, history of pancreatitis or pancreatic surgery), and alcohol abuse were identified.
Before initiating BRENZAVVY (bexagliflozin), consider factors in the patient history that may predispose to ketoacidosis, including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse.
For patients who undergo scheduled surgery, consider temporarily discontinuing BRENZAVVY (bexagliflozin) for at least 3 days prior to surgery. Consider monitoring for ketoacidosis and temporarily discontinuing BRENZAVVY in clinical situations known to predispose to ketoacidosis (e.g., prolonged fasting due to acute illness or post-surgery). Ensure risk factors for ketoacidosis are resolved prior to restarting BRENZAVVY. Educate patients on the signs and symptoms of ketoacidosis and instruct patients to discontinue BRENZAVVY and seek medical attention immediately if signs and symptoms occur.
Lower Limb Amputation
An increased incidence of lower limb amputations occurred in BRENZAVVY (bexagliflozin)-treated patients compared to placebo-treated patients (8.3 versus 5.1 events per 1,000 patient-years) in a randomized, placebo-controlled trial evaluating patients with type 2 diabetes who had either established cardiovascular disease (CVD) or were at risk for CVD.
Of the 23 BRENZAVVY (bexagliflozin)-treated patients who had amputations, 15 were amputations of the toe and midfoot and 8 were amputations above and below the knee. Some patients had multiple amputations.
Lower limb infections, gangrene, ischemia, and osteomyelitis were the most common precipitating medical events leading to the need for an amputation. The risk of amputation was highest in patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy.
Before initiating BRENZAVVY (bexagliflozin), consider factors in the patient history that may predispose to the need for amputations, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Counsel patients about the importance of routine preventative foot care. Monitor patients receiving BRENZAVVY for signs and symptoms of infection (including osteomyelitis), new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue BRENZAVVY if these complications occur.
Volume Depletion
BRENZAVVY (bexagliflozin) can cause intravascular volume contraction which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors. Patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, patients with low systolic blood pressure, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Before initiating BRENZAVVY 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 BRENZAVVY. Monitor for signs and symptoms of volume depletion and renal function after initiating therapy.
Urosepsis and Pyelonephritis
There have been reports of serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization in patients receiving SGLT2 inhibitors, including BRENZAVVY (bexagliflozin). Treatment with SGLT2 inhibitors, including BRENZAVVY, increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.
Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues
Insulin and insulin secretagogues (e.g., sulfonylureas) are known to cause hypoglycemia. BRENZAVVY (bexagliflozin) may increase the risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with BRENZAVVY.
Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene)
Reports of necrotizing fasciitis of the perineum (Fournier’s Gangrene), a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in postmarketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors. Cases have been reported in both females and males. Serious outcomes have included hospitalization, multiple surgeries, and death.
Patients treated with BRENZAVVY (bexagliflozin) presenting with pain or tenderness, erythema, or swelling in the genital or perineal areas, along with fever or malaise, should be assessed for necrotizing fasciitis. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue BRENZAVVY, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.
Genital Mycotic Infections
BRENZAVVY (bexagliflozin) increases the risk of genital mycotic infections. Patients who have a history of genital mycotic infections or who are uncircumcised are more likely to develop genital mycotic infections. Monitor and treat appropriately.
Adverse Reactions
The most common adverse reactions (incidence > 5%) were female mycotic infections, urinary tract infection, and increased urination.
Use in Specific Populations
• Pregnancy: Advise females of the potential risk to a fetus especially during the second and third trimesters. BRENZAVVY (bexagliflozin) is not recommended during the second and third trimesters of pregnancy.
• Lactation: Not recommended when breastfeeding
• Geriatric patients: Higher incidence of adverse reactions related to volume depletion
• Renal Impairment: Higher incidence of adverse reactions related to reduced renal function
• Hepatic Impairment: Not recommended for patient with severe hepatic impairment
Drug Interactions
UGT Enzyme Inducers
For additional important safety information about BRENZAVVY, please see the Prescribing Information.
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© 2023 TheracosBio, LLC
Last Updated on March 16, 2023
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© 2023 TheracosBio, LLC
Limitation of Use: BRENZAVVY (bexagliflozin) is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.
Contraindications
BRENZAVVY is contraindicated in patients with hypersensitivity to bexagliflozin or any excipient in BRENZAVVY. Anaphylaxis and angioedema have been reported with sodium-glucose co-transporter 2 (SGLT2) inhibitors.
Warnings and Precautions
Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis
BRENZAVVY increases the risk of life-threatening ketoacidosis in patients with type 1 diabetes. Type 2 diabetes and pancreatic disorders are also risk factors for ketoacidosis and fatal events of ketoacidosis have been reported in patients with type 2 diabetes using SGLT2 inhibitors. Precipitating conditions for diabetic ketoacidosis or other ketoacidosis include under-insulinization due to insulin dose reduction or missed insulin doses, acute febrile illness, reduced caloric intake, ketogenic diet, surgery, volume depletion, and alcohol abuse. Signs and symptoms of diabetic ketoacidosis are consistent with dehydration and severe metabolic acidosis and include nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. Assess patients who present with signs and symptoms of metabolic ketoacidosis, regardless of blood glucose levels. If suspected, discontinue BRENZAVVY, treat promptly and monitor for resolution before restarting. Consider ketone monitoring in patients with type 1 diabetes mellitus as well as in others at risk for ketoacidosis. Withhold BRENZAVVY in clinical situations known to predispose to ketoacidosis and resume when clinically stable. Educate all patients on the signs and symptoms of ketoacidosis and instruct patients to discontinue BRENZAVVY and seek medical attention immediately if signs and symptoms occur.
Lower Limb Amputation
Lower limb amputations have been observed in patients treated with BRENZAVVY in a study of patients with type 2 diabetes who had either established cardiovascular disease (CVD) or were at risk for CVD. Of the 23 BRENZAVVY-treated patients who had amputations, 15 were amputations of the toe and midfoot and 8 were amputations above and below the knee. Some patients had multiple amputations. Lower limb infections, gangrene, ischemia, and osteomyelitis were the most common precipitating medical events leading to the need for an amputation. The risk of amputation was highest in patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy.
Before initiating BRENZAVVY, consider factors in the patient’s history that may predispose to the need for amputations, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Counsel patients receiving BRENZAVVY about the importance of routine preventative foot care and monitor for signs and symptoms of diabetic foot infection (including osteomyelitis), new pain or tenderness, sores or ulcers involving the lower limbs, and institute appropriate treatment.
Volume Depletion
BRENZAVVY can cause intravascular volume contraction which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. Acute kidney injury requiring hospitalization and dialysis has been reported in patients with type 2 diabetes receiving SGLT2 inhibitors. Before initiating, assess volume status and renal function in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, patients with low systolic blood pressure, or patients on loop diuretics. In patients with volume depletion, correct this condition. After initiating, monitor for signs and symptoms of volume depletion and renal function.
Urosepsis and Pyelonephritis
Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been identified in patients receiving SGLT2 inhibitors, including BRENZAVVY. Treatment with BRENZAVVY increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat them promptly.
Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues
Insulin and insulin secretagogues (e.g., sulfonylureas) are known to cause hypoglycemia. BRENZAVVY may increase the risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with BRENZAVVY.
Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene)
Serious, life-threatening cases requiring urgent surgical intervention have been identified in postmarketing surveillance in both males and females with diabetes mellitus receiving SGLT2 inhibitors. Serious outcomes have included hospitalization, multiple surgeries, and death. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal areas, along with fever or malaise. If suspected, start treatment, and discontinue BRENZAVVY.
Genital Mycotic Infections
BRENZAVVY increases the risk of genital mycotic infections. Patients who have a history of genital mycotic infections or who are uncircumcised are more likely to develop genital mycotic infections. Monitor and treat appropriately.
MOST COMMON ADVERSE REACTIONS (>5%): Female genital mycotic infections, urinary tract infection and increased urination.
USE IN SPECIFIC POPULATIONS
• Pregnancy: BRENZAVVY is not recommended during the second and third trimesters.
• Lactation: BRENZAVVY is not recommended when breastfeeding.
• Geriatric patients: There is a higher incidence of adverse reactions related to volume depletion.
• Renal Impairment: There is a higher incidence of adverse reactions related to reduced renal function.
• Hepatic Impairment: BRENZAVVY is not recommended for patients with severe hepatic impairment.
DRUG INTERACTIONS:
Inducers of UGT1A9 could result in more rapid clearance of BRENZAVVY by metabolism. Doses of insulin and sulfonylureas may need to be reduced to offset the action of BRENZAVVY. The safety of BRENZAVVY is compromised when it is coupled with insulin or an insulin secretagogue (sulfonylureas and meglitinides – the latter rarely used in the US). Lithium carbonate is used as a mood stabilizer in bipolar disorder. Lithium ions might be preferentially (compared to sodium ions) taken up with glucose in the kidney. Empirical evidence has shown that lithium levels can be lower when SGLT2 inhibitors are administered. SGLT2 inhibitors produce pronounced glucosuria, which makes urine testing for glucose diagnostically useless. Measurements of 1,5 anhydroglucitol are also compromised.
For additional important safety information about BRENZAVVY, please see the full Prescribing Information.
Do not take BRENZAVVY (bexagliflozin) if you:
• Are allergic to bexagliflozin or any ingredients in BRENZAVVY
BRENZAVVY can cause serious side effects, including:
Diabetic Ketoacidosis: (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. BRENZAVVY can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who: are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood.
Stop taking BRENZAVVY and call your healthcare provider or get medical help right away if you get any of the following. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL.
Amputations: BRENZAVVY may increase your risk of lower limb amputations. Amputations mainly involve removal of the toe or part of the foot, however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation.
You may be at a higher risk of lower limb amputation if you:
• have a history of amputation
• have heart disease or are at risk for heart disease
• have had blocked or narrowed blood vessels, usually in your leg, or have damage to the nerves (neuropathy) in your leg
• have had diabetic foot ulcers or sores
Call your healthcare provider right away if you have new pain or tenderness or any sores, ulcers, or infections in your leg or foot. Your healthcare provider may decide to stop your BRENZAVVY treatment for a while if you have these signs or symptoms. Talk to your healthcare provider about proper foot care.
Dehydration: BRENZAVVY can cause some people to become dehydrated (the loss of body water and salt). Dehydration can make you feel dizzy, faint, light-headed, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden worsening of kidney function in people who are taking BRENZAVVY.
You may be at higher risk of dehydration if you:
• have low blood pressure
• take medicines that lower your blood pressure, including diuretics (water pills), or are on a low-sodium (salt) diet
• have kidney problems
• are 65 years of age or older
Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you are sick and cannot eat, or start to lose liquids from your body due to conditions like vomiting or diarrhea.
Vaginal yeast infection: Women who take BRENZAVVY may get vaginal yeast infections.
Yeast infections can be a serious but common side effect of taking BRENZAVVY. Symptoms of a vaginal yeast infection include:
• vaginal odor
• white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
• vaginal itching
Yeast infection of the penis (balanitis or balanoposthitis): Men who take BRENZAVVY may get a yeast infection of the skin around the penis. Men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis.
Other symptoms of yeast infection of the penis include:
Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider as soon as possible if you use an over-the-counter antifungal medication and your symptoms do not go away.
The most common side effects of BRENZAVVY (bexagliflozin) include:
• vaginal yeast infections
• urinary tract infection
• changes in urination including an urgent need to urinate more often, in larger amounts, or at night.
Before you take BRENZAVVY, tell your healthcare provider about all of your medical conditions, including if you:
• have type 1 diabetes or have had diabetic ketoacidosis
• have a decrease in your insulin dose
• have a serious infection
• have a history of infection of the vagina or penis
• have a history of amputation
• have had blocked or narrowed blood vessels, usually in your leg
• have damage to the nerves (neuropathy) in your leg
• have had diabetic foot ulcers or sores
• have kidney problems
• have liver problems
• have a history of urinary tract infections or problems with urination
• have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas
• are on a low sodium (salt) diet. Your healthcare provider may change your diet or your dose.
• are going to have surgery. Your healthcare provider may stop your BRENZAVVY before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking BRENZAVVY and when to start it again.
• are eating less or there is a change in your diet
• are dehydrated
• drink alcohol very often or drink a lot of alcohol in the short term (“binge” drinking).
• have ever had an allergic reaction to BRENZAVVY
• are pregnant or planning to become pregnant. BRENZAVVY may harm your unborn baby. If you become pregnant while taking BRENZAVVY, tell your healthcare provider as soon as possible. Talk with your healthcare provider about the best way to control your blood sugar while you are pregnant.
• are breastfeeding or plan to breastfeed. BRENZAVVY may pass into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take BRENZAVVY. Do not breastfeed while taking BRENZAVVY.
Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
BRENZAVVY may affect the way other medicines work, and other medicines may affect how BRENZAVVY works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
What are the possible side effects of BRENZAVVY?
Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking BRENZAVVY. Tell your healthcare provider if you have signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.
Low blood sugar (hypoglycemia). If you take BRENZAVVY with another medicine that can cause low blood sugar such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered while you take BRENZAVVY. Signs or symptoms of low blood sugar may include:
A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in people who take BRENZAVVY. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have a fever or you are feeling very weak, tired or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around your anus and genitals:
Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking BRENZAVVY and call your healthcare provider right away or go to the nearest hospital emergency room. Symptoms of a serious allergic reaction to BRENZAVVY may include:
• skin rash
• raised red patches on your skin (hives)
• swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing
Your healthcare provider may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For additional important safety information about BRENZAVVY, please see the Medication Guide.