Glyxambi

Glyxambi is a combination of empagliflozin and linagliptin. Empagliflozin belongs to a class of antidiabetic medications known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. These medications work by blocking the kidneys from reabsorbing glucose from the urine, promoting more of it to be excreted. Linagliptin belongs to a class of medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors. Their mechanism of action is to block the DPP-4 enzyme, which breaks down incretin hormones, thereby increasing their levels. Incretin hormones are involved in maintaining glucose balance in the body and rise after we eat to keep blood glucose levels in check. You may be required to take Glyxambi with other diabetes medications (such as metformin) to adequately control your blood sugar.

Glyxambi should not be used to manage blood sugar levels in Type 1 diabetics.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Glyxambi. However, the following is a synopsis of the general guidelines for the use of Glyxambi:

• Glyxambi should be used exactly as prescribed.
• It is typically taken once a day with or without food.
• During periods of stress, fever, physical trauma, infection, or surgery, the amount of diabetes medicines you take may need to be changed. Discuss with your healthcare provider right away if any of these situations apply to you.
• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

The most common side effects of Glyxambi seen in clinical trials include:

• Urinary tract infections (UTIs)
• Nasopharyngitis (common cold) symptoms like sore throat, stuffy nose, cough, and congestion
• Upper respiratory tract infections
• Some individuals may experience serious side effects while using Glyxambi. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:
• Symptoms of a more serious UTI such as upper flank and back pain, pelvic pain, blood in the urine, fever, nausea, or vomiting.
• Symptoms of hypoglycemia or low blood sugar events such as headache, breaking out into a cold sweat, feeling shaky or jittery, lightheadedness, drowsiness, weakness, irritability, hunger, confusion, racing heart, and dizziness.
• Symptoms of necrotizing fasciitis or Fournier’s gangrene around the anus or genitals. This is a rare but serious bacterial infection that damages your tissue and can be life-threatening. Watch for pain, tenderness, swelling, and redness in these areas that may be accompanied by fever, weakness, and malaise.
• Pain, tenderness, sores, ulcers, or open wounds in your leg or foot. Prompt attention can prevent these from worsening and requiring amputation.
• Severe joint pain.
• Signs of a skin reaction known as bullous pemphigoid, such as blisters or skin peeling.
• Signs of heart failure include shortness of breath, trouble breathing, especially when you lie down, swelling of the lower extremities, rapid and unexplained weight gain, and unusual tiredness.
• Signs of diabetic ketoacidosis such as nausea, vomiting, stomach pain, tiredness, and trouble breathing.
• Symptoms of pancreatitis such as severe and persistent stomach pain that may radiate to the back and be accompanied by nausea or vomiting.
• Symptoms of a vaginal yeast infection such as odor, itching, and cottage cheese-like discharge.
• Symptoms of a penile yeast infection such as redness, itchiness, swelling, odor, rash, discharge, and pain.
• Signs of a severe allergic reaction, such as rash, hives, difficulty breathing, or swelling of the face, lips, eyes, or tongue.

These are not all of the possible adverse reactions of Glyxambi. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Glyxambi, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Type 1 diabetes
• A history of diabetic ketoacidosis
• Decreased your insulin dose
• A current serious infection
• A history of vaginal or penile infection
• A history of amputation
• Kidney problems
• Liver problems
• A history of UTIs or problems with urination
• Are on a low-sodium diet
• Plans for surgery
• Are eating less or making any other diet changes
• Are dehydrated or have poor fluid intake
• Problems with your pancreas, including pancreatitis
• Drink alcohol, especially if you engage in binge drinking
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed

Do not use Glyxambi if you are on dialysis or have an allergy to empagliflozin, linagliptin, or any of the other ingredients in Glyxambi.

Glyxambi begins to work right after the first dose. However, it may take a couple of weeks of regular use to see the full benefit of Glyxambi.

When Glyxambi is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Diuretics or water pills
• Insulin
• Sulfonylureas and other insulin secretagogues
• Lithium
• Rifampin

Glyxambi tablets are available in the following doses:

• 10 mg empagliflozin/5 mg linagliptin
• 25 mg empagliflozin/5 mg linagliptin

Glyxambi should be stored at room temperature, away from light and moisture, and out of reach of children.

Glyxambi is manufactured by the pharmaceutical company Boehringer Ingelheim.

Currently, there is no generic available for Glyxambi.

Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Glyxambi.

Glyxambi may cause harm to the unborn child and is not recommended during the second and third trimesters of pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is not known if Glyxambi can pass into the breast milk, and it is generally not recommended to be taken while breastfeeding. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.