Lixisenatide

What is Lixisenatide?

Lixisenatide (ADLYXIN) is a glucagon-like peptide-1 (GLP-1) receptor agonist used for the treatment of type 2 diabetes.

What are the uses of this medicine?

• This medicine is used to improve blood sugar (glucose) control in adults with type 2 diabetes, when used with diet and exercise.

Limitation of use:

• ADLYXIN is not insulin.
• ADLYXIN is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
• ADLYXIN has not been studied in people with a history of pancreatitis.
• ADLYXIN has not been studied in people who use short-acting insulin.
• ADLYXIN has not been studied in people who have a stomach problem that causes slow emptying of the stomach (gastroparesis). ADLYXIN is not for people with slow emptying of the stomach.
• It is not known if ADLYXIN is safe and effective in children.

How does this medicine work?

• Lixisenatide (lix" i sen' a tide) is a glucagon-like peptide-1 (GLP-1) analogue (also called a GLP-1 receptor agonist) that acts like the native gastrointestinal hormone (incretin) to increase insulin secretion.
• Lixisenatide, like other GLP-1 analogues, also suppress glucagon production and slows gastric emptying, features that may increase the beneficial effects in type 2 diabetes.
• Lixisenatide is a recombinant DNA-produced polypeptide that is 44 amino acids in length with a single proline substitution and a modified C-terminus of six lysine molecules that makes it relatively resistant to degradation by dipeptidyl peptidase 4 (DPP4) and extends its half-life allowing for once daily dosing.
• In multiple preregistration clinical trials, lixisenatide was shown to improve glycemic control and lower HbA1c levels in patients with inadequately controlled type 2 diabetes.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known hypersensitivity to lixisenatide or to any component of ADLYXIN. Hypersensitivity reactions including anaphylaxis have occurred with ADLYXIN.

What drug interactions can this medicine cause?

• ADLYXIN delays gastric emptying which may reduce the rate of absorption of orally administered medications. Use caution when coadministering oral medications.
• Patients taking oral contraceptives should be advised to take them at least 1 hour before ADLYXIN administration or at least 11 hours after the dose of ADLYXIN.
• When ADLYXIN is added to a sulfonylurea or basal insulin, there is a potential risk of hypoglycemia. A reduction of the concomitantly administered sulfonylurea or basal insulin may be necessary.

Is this medicine FDA approved?

• It was approved for use in the United States in 2016.

How should this medicine be used?

Recommended Dosage:

• The starting dose of ADLYXIN is 10 mcg subcutaneously once daily for 14 days.
• Increase the dose to the maintenance dose of 20 mcg once daily starting on Day 15.

Administration

• ADLYXIN comes as a disposable prefilled pen.
• Use ADLYXIN exactly as your healthcare provider tells you to. Do not change your dose unless your healthcare provider has told you to change your dose.
• Your healthcare provider should teach you how to inject ADLYXIN before you use it for the first time. If you have questions or do not understand the instructions, talk to your healthcare provider.
• Use ADLYXIN 1 time each day within 60 minutes (1 hour) before the first meal of the day and at the same time each day.
• If you miss a dose of ADLYXIN, take it within 1 hour before your next meal.
• Check the label on the pen each time you give your ADLYXIN injection to make sure you are using the correct medication.
• You must activate each ADLYXIN pen before you use it for the first time.
• Do not re-use or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.
• Inject your dose of ADLYXIN under the skin (subcutaneously) of your abdomen, thigh or upper arm. Do not inject into a vein.
• Change (rotate) your injection sites within the area you chose with each dose. Do not use the same spot for each injection.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 50 mcg/mL in 3 mL in green prefilled pen (for 14 pre-set doses; 10 mcg per dose).
• Injection: 100 mcg/mL in 3 mL in burgundy prefilled pen (for 14 pre-set doses; 20 mcg per dose).

This medicine is available in fallowing brand namesː

• ADLYXIN

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• vomiting
• headache
• diarrhea
• feeling dizzy

ADLYXIN may cause serious side effects including:

• Severe allergic reactions
• Low blood sugar (hypoglycemia)
• Kidney problems (kidney failure)

What special precautions should I follow?

• Anaphylaxis and serious hypersensitivity Reactions may occur. Discontinue ADLYXIN and promptly seek medical advice.
• Pancreatitis may occur. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.
• Never share ADLYXIN pen between patients, even if the needle is changed.
• When ADLYXIN is used with a sulfonylurea or basal insulin, consider lowering the dose of the sulfonylurea or basal insulin to reduce the risk of hypoglycemia.
• Acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis has been reported. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. ADLYXIN is not recommended in patients with end stage renal disease.
• Patients may develop antibodies to lixisenatide following treatment with ADLYXIN. If there is worsening glycemic control or failure to achieve targeted glycemic control, significant injection site reactions or allergic reactions, alternative antidiabetic therapy should be considered.

What to do in case of emergency/overdose?

• An increased incidence of gastrointestinal disorders was observed.

Management for overdosage:

• In case of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.

Can this medicine be used in pregnancy?

• The limited available data with lixisenatide in pregnant women are not sufficient to inform a drug-associated risk of major birth defects and miscarriage.

Can this medicine be used in children?

• Safety and effectiveness of ADLYXIN have not been established in pediatric patients below 18 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: lixisenatide
• Inactive ingredients: glycerol 85%, sodium acetate trihydrate, methionine, metacresol, hydrochloric acid, sodium hydroxide solution and water for injection.

Who manufactures and distributes this medicine?

• Manufactured by: sanofi-aventis U.S. LLC, Bridgewater, NJ 08807. A SANOFI COMPANY.

What should I know about storage and disposal of this medication?

• Store your new, unused ADLYXIN pen in the refrigerator at 36°F to 46°F (2°C to 8°C).
• After activation, store your ADLYXIN pen at room temperature no higher than 86°F (30°C).
• Do not freeze ADLYXIN pens and do not use ADLYXIN if it has been frozen.
• Protect the pen from light.
• Replace the pen cap after each use to protect the container window from light.
• After activation, use the ADLYXIN pen for up to 14 days. Throw away the used ADLYXIN pen after 14 days, even if there is some medicine left in the pen.
• Do not use ADLYXIN past the expiration date printed on the label of the carton and pen.
• Do not store the ADLYXIN pen with the needle attached. If the needle is left on, this might lead to contamination and cause air bubbles which might affect your dose of medicine.
• See the Instructions for Use about the right way to throw away the ADLYXIN pen.
• Keep your ADLYXIN pen, pen needles, and all medicines out of the reach of children.

• Dailymed label info on Lixisenatide
• FDA Lixisenatide

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