Glyxambi 25mg/5mg Tablets

Glyxambi is a fixed-dose combination of empagliflozin and linagliptin. Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, which reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, leading to increased urinary glucose excretion and reduced plasma glucose concentrations. Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which slows the inactivation of incretin hormones (GLP-1 and GIP). This increases the concentrations of active incretin hormones, enhancing glucose-dependent insulin release from pancreatic beta cells and decreasing glucagon secretion from pancreatic alpha cells, thereby improving glycemic control.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of fluid and electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Abnormal or rapid heartbeat
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Feeling extremely tired or weak
+ Decreased appetite
+ Difficulty urinating or changes in urine output
+ Dry mouth
+ Dry eyes
+ Severe stomach upset or vomiting
Signs of kidney problems, such as:
+ Difficulty urinating
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of acidosis (too much acid in the blood), including:
+ Confusion
+ Rapid breathing
+ Abnormal heartbeat
+ Severe stomach pain or vomiting
+ Feeling extremely sleepy
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower abdominal pain
+ Pelvic pain
Vaginal yeast infection: Report any itching, unusual odor, or discharge
Yeast infection of the penis: Report any pain, swelling, rash, or discharge
Severe headache
Joint pain that is severe, disabling, or persistent: Contact your doctor immediately
Bullous pemphigoid, a skin reaction characterized by blisters or skin breakdown: Seek medical attention right away if you experience any of these symptoms

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

Nose or throat irritation
Signs of a common cold

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have type 1 diabetes, as this medication is not intended to treat this condition.
If you have a condition that affects the acidity of your blood.
If you have kidney disease or any kidney problems.
If you are dehydrated, as this may require special consideration.
If you are taking rifampin, as this may interact with the medication.
If you are pregnant or think you might be pregnant. It is crucial to note that this medication should not be taken during the second or third trimester of pregnancy.
If you are breastfeeding, as you should not breastfeed while taking this medication.

This list is not exhaustive, and it is vital to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health issues. Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.

Be aware that low blood sugar (hypoglycemia) can occur, especially when this medication is used in combination with other diabetes medications. Symptoms of low blood sugar may include dizziness, headache, feeling sleepy or weak, shaking, rapid heartbeat, confusion, hunger, or sweating. If you experience any of these symptoms, contact your doctor immediately and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or consuming certain fruit juices.

Do not operate a vehicle if you have recently experienced low blood sugar, as this can increase your risk of being involved in an accident. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and exercise caution when climbing stairs.

Before consuming alcohol, consult with your doctor to discuss any potential risks or interactions.

There is a risk of severe and potentially life-threatening pancreas problems (pancreatitis) associated with this medication. Seek immediate medical attention if you experience severe stomach pain, severe back pain, or severe nausea and vomiting.

Additionally, this medication can cause a condition called ketoacidosis, which is characterized by an excess of acid in the blood or urine. This condition can be life-threatening and may require hospitalization. People with diabetes or pancreas problems are at a higher risk of developing ketoacidosis, as are those who are ill, dehydrated, or have difficulty eating or drinking. The risk is also increased in individuals who follow a ketogenic diet, have undergone surgery, or take insulin and miss doses or take less than the prescribed amount. Monitor your ketone levels as directed by your doctor, and consult with them if you have any questions or concerns.

Severe urinary tract infections (UTIs) have been reported in people taking this medication, and in some cases, hospitalization was required. Kidney problems can also occur, which may necessitate hospitalization or dialysis.

If you have a history of heart failure or kidney problems, inform your doctor, as this medication can increase the risk of heart failure. Contact your doctor immediately if you experience extreme fatigue, shortness of breath, significant weight gain, or swelling in your arms or legs.

This medication may also increase the risk of lower limb amputations, particularly toe and foot amputations. Discuss with your doctor ways to properly care for your feet, and inform them if you have a history of amputations, blood vessel disease, nerve disease, or foot ulcers related to diabetes. Seek medical attention immediately if you experience new pain, tenderness, sores, ulcers, or infections in your legs or feet.

A rare but potentially life-threatening infection can occur with medications like this one. Seek immediate medical attention if you experience tenderness, redness, or swelling in the genital area or the area between the genitals and rectum, accompanied by a fever or general feeling of illness.

If you are pregnant or become pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby.

• Diuretics (e.g., loop or thiazide diuretics): Increased risk of volume depletion and hypotension with empagliflozin.
• Insulin and Insulin Secretagogues (e.g., sulfonylureas): Increased risk of hypoglycemia when co-administered with linagliptin or empagliflozin. Dose reduction of insulin or sulfonylurea may be required.
• Rifampin (strong P-gp/CYP3A4 inducer): Decreased linagliptin exposure, but generally not considered clinically significant enough to warrant dose adjustment.

• Signs and symptoms of hypoglycemia (sweating, tremor, confusion, hunger)
• Signs and symptoms of diabetic ketoacidosis (nausea, vomiting, abdominal pain, rapid breathing, unusual fatigue, fruity breath odor)
• Signs and symptoms of urinary tract infection (burning urination, frequent urination, urgency, fever, back pain)
• Signs and symptoms of genital mycotic infection (itching, redness, discharge)
• Signs and symptoms of volume depletion (dizziness, lightheadedness, orthostatic hypotension)
• Signs and symptoms of Fournier's gangrene (tenderness, redness, or swelling in the genital or perineal area, fever, malaise)
• Signs and symptoms of severe arthralgia (joint pain that is severe and disabling)

Not recommended during the second and third trimesters of pregnancy due to potential adverse renal effects in the developing fetus from empagliflozin. Limited human data on linagliptin use in pregnancy.

Not recommended during breastfeeding. It is unknown if empagliflozin or linagliptin are excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness have not been established in pediatric patients.

No dose adjustment is recommended based on age. However, older patients may be at increased risk for volume depletion and renal impairment. Monitor renal function and hydration status more frequently in this population.

• Glyxambi is a once-daily oral medication that combines two different mechanisms of action to improve glycemic control in type 2 diabetes.
• Patients should be well-hydrated before starting and while taking Glyxambi to minimize the risk of volume depletion.
• Educate patients on the signs and symptoms of diabetic ketoacidosis (DKA), even if blood glucose levels are not severely elevated (euglycemic DKA), as this is a rare but serious side effect of SGLT2 inhibitors.
• Counsel patients on proper hygiene to reduce the risk of genital mycotic infections and urinary tract infections.
• Renal function must be assessed before initiation and monitored periodically during treatment, as empagliflozin efficacy is dependent on renal function and it is contraindicated in severe renal impairment.
• Patients on insulin or sulfonylureas may require dose adjustments of those medications to reduce the risk of hypoglycemia when starting Glyxambi.

• Metformin
• Sulfonylureas (e.g., glipizide, glyburide)
• Thiazolidinediones (e.g., pioglitazone)
• GLP-1 Receptor Agonists (e.g., liraglutide, semaglutide)
• Insulin
• Other SGLT2 inhibitors (e.g., Jardiance, Farxiga)
• Other DPP-4 inhibitors (e.g., Tradjenta, Januvia)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the overdose, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.