Generic name: empagliflozin and linagliptin (EM pa gli FLOE zin and LIN a GLIP tin)
Brand name: Glyxambi
Drug class: Antidiabetic combinations
Glyxambi contains a combination of empagliflozin and linagliptin. Empagliflozin and linagliptin are oral diabetes medicines that help control blood sugar levels. Empagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Linagliptin works by regulating the levels of insulin your body produces after eating.
Glyxambi is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
Glyxambi is also used to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.
This medicine is not for treating type 1 diabetes.
You should not use Glyxambi if you have severe kidney disease (or if you are on dialysis) or diabetic ketoacidosis, or if you have ever had a severe allergic reaction to empagliflozin or linagliptin.
Call your doctor at once if you have signs of a serious side effect, such as severe pain in your upper stomach spreading to your back, vomiting, fast heart rate, dizziness, feeling very thirsty or hot, decreased urination, heavy sweating, or hot and dry skin.
In rare cases, Glyxambi can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.
Before taking this medicine
You should not use Glyxambi if you are allergic to empagliflozin and linagliptin, or if you have:
- severe kidney disease (or if you are on dialysis);
- a history of severe allergic or skin reaction after taking linagliptin; or
- diabetic ketoacidosis (call your doctor for treatment).
To make sure Glyxambi is safe for you, tell your doctor if you have ever had:
- liver or kidney disease;
- a bladder infection or urination problems;
- a pancreas disorder;
- heart failure, low blood pressure;
- a genital infection (penis or vagina);
- if you are on a low salt diet; or
- if you are 65 or older.
Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.
You should not breastfeed while using Glyxambi.
How should I take Glyxambi?
Take Glyxambi exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Glyxambi is usually taken in the morning, with or without food.
Your blood sugar will need to be checked often, and you may also need to test the level of ketones your urine. Empagliflozin can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have ketones in the urine.
You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).
Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.
Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.
Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your Glyxambi dose or dosing schedule.
This medicine can affect the results of certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Glyxambi.
Store at room temperature away from moisture and heat.
Usual Adult Dose of Glyxambi for Diabetes Type 2:
Initial dose: Empagliflozin 10 mg-linagliptin 5 mg orally once a day in the morning
-For patients tolerating therapy, may increase to empagliflozin 25 mg-linagliptin 5 mg once a day
Maximum dose: Empagliflozin 25 mg-linagliptin 5 mg per day
-Empagliflozin has been shown to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV; however, the effectiveness of this combination drug on reducing the risk of CV death in patients with type 2 diabetes mellitus and CV disease has not been established.
-When used in combination with insulin or insulin secretagogues, a lower dose of the insulin secretagogues or insulin may be necessary to reduce the risk of hypoglycemia.
Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A Glyxambi overdose can cause life threatening hypoglycemia.
Symptoms of severe hypoglycemia include extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).
What to avoid
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.
Glyxambi side effects
Get emergency medical help if you have signs of an allergic reaction to Glyxambi: hives, itching, flaking or peeling skin; trouble swallowing, difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical attention right away if you have signs of a rare but serious genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.
Stop taking this medicine and call your doctor at once if you have:
- severe or ongoing pain in your joints;
- serious skin reaction - itching, blisters, breakdown of the outer layer of skin;
- ketoacidosis (too much acid in the blood) - nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
- pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
- dehydration symptoms - dizziness, weakness, feeling light-headed (like you might pass out);
- signs of a bladder infection - pain or burning when you urinate, blood in your urine, pain in pelvis or back; or
- symptoms of heart failure - shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.
Common Glyxambi side effects may include:
- sore throat; or
- runny nose, stuffy nose, sinus pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Glyxambi?
Other drugs may increase or decrease the effects of Glyxambi on lowering your blood sugar. Tell your doctor about all your current medicines and any you start or stop using, especially:
- insulin, or other oral diabetes medicine;
- rifampin (to treat tuberculosis); or
- a diuretic or "water pill."
This list is not complete. Other drugs may interact with empagliflozin and linagliptin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.