Generic drug: empagliflozin and linagliptin
Brand name: Glyxambi
What is Glyxambi (empagliflozin and linagliptin), and how does it work?
Glyxambi (empagliflozin and linagliptin) is a prescription medicine that contains two diabetes medicines, empagliflozin (Jardiance) and linagliptin (Tradjenta). Glyxambi can be used:
- along with diet and exercise to lower blood sugar in adults with type 2 diabetes,
- in adults with type 2 diabetes who have known cardiovascular disease when both empagliflozin (Jardiance) and linagliptin (Tradjenta) is appropriate and empagliflozin (Jardiance) is needed to reduce the risk of cardiovascular death.
Glyxambi is not for people with type 1 diabetes.
Glyxambi is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
If you have had pancreatitis in the past, it is not known if you have a higher chance of getting pancreatitis while you take Glyxambi.
It is not known if Glyxambi is safe and effective in children under 18 years of age.
What are the side effects of Glyxambi?
Serious side effects can happen to people taking Glyxambi, including:
- Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.
Before you start taking Glyxambi, tell your doctor if you have ever had:
- inflammation of your pancreas (pancreatitis)
- a history of alcoholism
- stones in your gallbladder (gallstones)
- high blood triglyceride levels
Stop taking Glyxambi and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
These may be symptoms of heart failure.
- Heart failure. Heart failure means your heart does not pump blood well enough.
Before you start taking Glyxambi, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor right away if you have any of the following symptoms:
- increasing shortness of breath or trouble breathing, especially when you lie down
- swelling or fluid retention, especially in the feet, ankles or legs
- an unusually fast increase in weight
- unusual tiredness
- Dehydration. Glyxambi can cause some people to have dehydration (the loss of body water and salt).
Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up (orthostatic hypotension).
You may be at higher risk of dehydration if you:
- have low blood pressure
- take medicines to lower your blood pressure, including diuretics (water pills)
- are on low sodium (salt) diet
- have kidney problems
- are 65 years of age or older
- Vaginal yeast infection. Women who take Glyxambi may get vaginal yeast infections. 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 Glyxambi 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 doctor about what to do if you get symptoms of a yeast infection of the vagina or penis. Your doctor may tell you to use an over-the-counter antifungal medicine. Talk to your doctor right away if you use an over-the-counter antifungal medicine and your symptoms do not go away.
What is the dosage for Glyxambi?
Prior To Initiation Of Glyxambi
- Assess renal function before initiating Glyxambi and as clinically
indicated. - In patients with volume depletion, correct this condition before
initiating Glyxambi.
Recommended Dosage
The recommended dose of Glyxambi is 10 mg empagliflozin/5 mg linagliptin once daily in the morning, taken with or without food.
Glyxambi may be increased to 25 mg empagliflozin/5 mg linagliptin once daily for additional glycemic control.
Dosage Recommendations In Patients With Renal Impairment
- Glyxambi is not recommended for use in patients with an eGFR less than
30 mL/min/1.73 m² and contraindicated in patients on dialysis.
What drugs interact with Glyxambi?
Table 3 : Clinically Relevant Interactions with Glyxambi
Diuretics
Clinical Impact
Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
Intervention
Before initiating Glyxambi, assess volume status and renal function. In patients with volume depletion, correct this condition before initiating
Glyxambi. Monitor for signs and symptoms of volume depletion, and renal function after initiating therapy.
Insulin or Insulin Secretagogues
Clinical Impact
Empagliflozin or linagliptin in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin was associated with a higher rate of hypoglycemia compared with placebo in a clinical trial.
Intervention
Coadministration of Glyxambi with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
Positive Urine Glucose Test
Clinical Impact
SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests.
Intervention
Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
Interference with 1,5-anhydroglucitol (1,5-AG) Assay
Clinical Impact
Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors.
Intervention
Monitoring glycemic control with 1,5-AG assay is not recommended. Use alternative methods to monitor glycemic control.
Inducers of P-glycoprotein or CYP3A4 Enzymes
Clinical Impact
Rifampin decreased linagliptin exposure, suggesting that the efficacy of linagliptin may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer.
Intervention
Use of alternative treatments is strongly recommended when linagliptin is to be administered with a strong P-gp or CYP3A4 inducer.
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Is Glyxambi safe to use while pregnant or breastfeeding?
- Based on animal data showing adverse renal effects from empagliflozin,
Glyxambi is not recommended during the second and third trimesters of pregnancy. - The limited available data with Glyxambi, linagliptin, or empagliflozin in pregnant women are not sufficient 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.
- There is no information regarding the presence of Glyxambi, or its individual components in human milk, the effects on the breastfed infant, or the effects on milk production. Empagliflozin and linagliptin are present in rat milk.
- Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney.
- Because of the potential for serious adverse reactions in a breastfed infant, including the potential for empagliflozin to affect postnatal renal development, advise patients that use of
Glyxambi is not recommended while breastfeeding.