Applies to the following strengths: 20 mcg/0.2 mL
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Diabetes Type 2
Initial dose: 10 mcg subcutaneously once a day for 14 days
Maintenance dose: Increase to 20 mcg subcutaneously once a day on day 15, and thereafter
-This drug should be administered within 1 hour before the first meal of the day, preferably the same meal each day; if a dose is missed, administer within 1 hour prior to the next meal.
-Concurrent use with short acting insulin has not been studied and is not recommended.
Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Renal Dose Adjustments
-Mild to severe renal impairment (eGFR 15 to 89 mL/min/1.73 m2): Use caution; no dose adjustment required; however closely monitor for gastrointestinal adverse reactions and changes in renal function
-ESRD (eGFR less than 15 mL/min/1.73 m2): Use is not recommended
Liver Dose Adjustments
No adjustment recommended
Not recommended in patients with severe gastroparesis
-When added to sulfonylurea or basal insulin; dose reduction of sulfonylurea or basal insulin is recommended to avoid hypoglycemia.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Not recommended in patients with ESRD
-Administer subcutaneously in the abdomen, thigh, or upper arm
-Give injection once a day one hour before the first meal of the day, preferably the same meal every day.
-If a dose is missed, give within 1 hour prior to the next meal.
-Rotate injections with each dose
-Pen devices should not be shared between patients, even if the pen needle is changed
-Prior to first use:
-Store at 36 to 46F (2C to 8C); do not freeze; do not use if it has been frozen
-Keep pen in original package to protect from light
-After first use:
-Store below 86F (30C); discard 14 days after first use
-Replace pen cap after each use to protect from light
Reconstitution/preparation techniques: Patients should receive proper training from their healthcare provider prior to first use. See product labeling for specific instructions.
-This drug should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
-The concurrent use of short-acting insulin has not been studied and is not recommended.
-Patients may develop antibodies to this drug; this should be considered in patients who have worsening glycemic control, significant injection site reactions or allergic reactions.
-Renal function should be monitored when initiating or escalating doses in patients with renal impairment and in patients with severe gastrointestinal reactions.
-Blood glucose and hemoglobin A1C measurements should be measured periodically to assess efficacy.
-Observe for signs and symptoms of pancreatitis
-Patients should be advised to never share a pen with another person, even if the needle is changed; patients should understand that sharing needles or syringes with another person carries a risk for transmission of blood-borne pathogens
-Patients should be aware of the potential for gastrointestinal reactions and take measures to ensure adequate fluid intake to avoid dehydration and to seek medical advice for persistent and severe events.
-Patients should be instructed to seek medical advice during periods of stress as medical management of diabetes may change.
-Inform patients that hypersensitivity reactions may occur; patients should be instructed to contact their health care professional.
-Patients should be advised their risk of hypoglycemia is increased if they use this drug in combination with a sulfonylurea or basal insulin.
-Patients should be aware of signs and symptoms of hypoglycemia and how it should be managed; patients should be advised to take precautions to avoid hypoglycemia while driving and using machines
More about lixisenatide
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- Drug class: incretin mimetics
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