Drug information of lixisenatide

lixisenatide


Lixisenatide is an injectable diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin more efficiently.

Lixisenatide is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Lixisenatide is not for treating type 1 diabetes.

Stop using lixisenatide and call your doctor at once if you have nausea and vomiting with severe pain in your upper stomach spreading to your back.

Mechanism of effect

Lixisenatide is a selective glucagon-like peptide-1 (GLP-1) receptor agonist. Acting on the same receptor as the endogenous hormone incretin, lixisenatide increases glucose-dependent insulin secretion, decreases inappropriate glucagon secretion, and slows gastric emptying.

Diabetes mellitus, type 2: Treatment of type 2 diabetes mellitus (noninsulin dependent, NIDDM) to improve glycemic control in adult patients as an adjunct to diet and exercise

Pharmacokinetics

Vz/F: ~100 L

Metabolism

Presumed to undergo proteolytic degradation

Excretion

Urine

Time to Peak

1 to 3.5 hours

Half-Life Elimination

~3 hours

Drug indications

Diabetes mellitus, type 2: Treatment of type 2 diabetes mellitus (noninsulin dependent, NIDDM) to improve glycemic control in adult patients as an adjunct to diet and exercise

Dosage

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

Comments:
-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

Drug contraindications

Hypersensitivity to lixisenatide or any component of the formulation

Side effects

Along with its needed effects, lixisenatide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lixisenatide:

More common

  • Anxiety
  • bloating
  • bluish or pale skin
  • blurred vision
  • chills
  • cold sweats
  • confusion
  • constipation
  • cough
  • darkened urine
  • depression
  • difficulty swallowing
  • dizziness
  • fainting
  • fast heartbeat
  • fever
  • headache
  • hives, itching, redness, skin rash
  • increased hunger
  • indigestion
  • loss of appetite
  • nausea
  • nervousness
  • nightmares
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • seizures
  • shakiness
  • shortness of breath
  • slurred speech
  • tightness in the chest
  • troubled breathing
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin

Incidence not known

  • Agitation
  • decreased urine output
  • hostility
  • irritability
  • lethargy
  • muscle twitching
  • rapid weight gain
  • stupor
  • swelling of the face, ankles, or hands

Get emergency help immediately if any of the following symptoms of overdose occur while taking lixisenatide:

Symptoms of overdose

  • Diarrhea
  • loss of appetite
  • nausea or vomiting
  • stomach pain, fullness, or discomfort
  • indigestion
  • passing of gas

Some side effects of lixisenatide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Diarrhea

Less common

  • Acid or sour stomach
  • belching
  • bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • heartburn
  • pressure in the stomach
  • stomach discomfort, upset, or pain

Alerts

Lixisenatide is not approved for use by anyone younger than 18 years old.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Points of recommendation

You should not use lixisenatide if you are allergic to it.

To make sure lixisenatide is safe for you, tell your doctor if you have:

  • a history of pancreatitis or gall stones;
  • problems with digestion;
  • kidney disease;
  • a history of alcoholism; or
  • diabetic ketoacidosis (call your doctor for treatment with insulin).

Follow your doctor's instructions about using lixisenatide if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.

Lixisenatide can make birth control pills less effective. Ask your doctor about using a nonhormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

Lixisenatide is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Lixisenatide comes in a prefilled injection pen that contains 14 pre-set doses. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Lixisenatide is usually injected once per day. Use lixisenatide within 60 minutes (1 hour) before your first meal of the day. Try to use the medicine at the same time each day.

Your care provider will show you the best places on your body to inject lixisenatide. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and 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, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Lixisenatide is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Storing unopened (not in use) lixisenatide: Refrigerate and protect from light. Take the injection pen out of the refrigerator and allow it to reach room temperature before using.

Do not freeze lixisenatide, and throw away the medicine if it has been frozen.

Storing opened (in use) lixisenatide: Store at room temperature with the pen cap attached, and use within 14 days. Do not store the injection pen with a needle attached.

Wait until your next meal and use the medicine within 1 hour before you eat. Then go back to your regular injection schedule the next day. Do not use extra medicine to make up the missed dose.

Lixisenatide can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

  • If you also take acetaminophen (Tylenol), take it at least 1 hour before you use lixisenatide.
  • If you also take any type of antibiotic, take it at least 1 hour before you use lixisenatide.
  • If you also take a birth control pill, take it at least 1 hour before or 11 hours after you use lixisenatide.
  • Storage

    Prior to initial use, store under refrigeration at 2°C to 8°C (36°F to 46°F); after initial use, may store at <30°C (<86°F). Do not freeze. Protect from light (keep in original package). Pen should be discarded 14 days after initial.

Pregnancy level

HAVE NOT BEEN ESTABLISHED

Use should be avoided.
AU TGA pregnancy category: B3
US FDA pregnancy category: Not Assigned

Risk Summary: There is no enough available data in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.

Comments:
-Insulin is generally considered the drug of choice during pregnancy.
-Use of adequate methods of contraception should be encouraged in women of childbearing potential; if a patient wishes to become pregnant, or pregnancy occurs, this drug should be discontinued.
-Administration times for oral contraceptives should be at least 1 hour before or 11 hours after dosing of this drug.

Breast feeding warning

Use is not recommended

Excreted into human milk: Unknown
Excreted into animal milk: Yes

In lactating rats, milk transfer of this drug and its metabolites was low (9.4%) and levels of unchanged drug in the gastric contents of weaning offspring was negligible (0.01%). There is no information on its presence in human milk, the effects on the breastfed infant, or the effects on milk production.

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Drug forms

Adlyxin , Adlyxin Starter Pack

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