Adlyxin (Lixisenatide) 100 mcg/ml

Adlyxin
Lixisenatide
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Description

Adlyxin is an injectable prescription medicine that may improve blood sugar (glucose) control in adults when used with diet and exercise. Please note, this is not insulin and is not considered a substitute for insulin. It is not for people with Type 1 diabetes or individuals with diabetic ketoacidosis. This product has not been studied in people with a history of pancreatitis, gastroparesis, and people with diabetes who use short-acting insulin. It is currently unknown if Adlyxin is safe and effective in children.

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

 

Before Taking Adlyxin

You should not use Adlyxin if you are allergic to lixisenatide or have diabetic ketoacidosis (call your doctor for treatment).

To make sure Adlyxin is safe for you, please notify your doctor if you have pancreatitis or gallstones, problems with digestion, alcoholism, or kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

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.

Adlyxin can make birth control pills less effective. If you take a birth control pill, take it at least 1 hour before or 11 hours after using Adlyxin.

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

Usage

Use Adlyxin precisely as prescribed by your doctor.. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Adlyxin is injected under the skin. A healthcare provider may teach you how to use the medication by yourself properly.

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

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Your healthcare provider will show you where on your body to inject Adlyxin. 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 diseases to pass from one person to another.

Side Effects

Adlyxin can cause serious side effects, such as inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Stop using Adlyxin and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel pain from your waist to your back.

Do not use Adlyxin if you are allergic to lixisenatide or any of the other ingredients in Adlyxin.

Symptoms of severe allergic reaction with Adlyxin may include swelling of your face, lips, tongue, or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.

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.

Drug Interactions

Adlyxin 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 using Adlyxin.

-If you also take an antibiotic, take it at least 1 hour before you use Adlyxin.

-If you also take a birth control pill, take it at least 1 hour before or 11 hours after using this medicine.

Other drugs may interact with lixisenatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Storage

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

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

Storing opened (in use) Adlyxin: Store at room temperature in the original package with the pen cap attached. Do not store with a needle attached.

The prefilled injection pen contains 14 pre-set doses for daily use. Throw the pen away after 14 days, even if there is still medicine left inside.

Missed Dose

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 two doses at one time.

Overdose

If you overdose on Adlyxin please seek medical attention immediately, as this can lead to poisoning and death.

Pregnancy Warning

Animal studies have shown reproductive toxicity. Studies in pregnant rats and rabbits at doses of 1 and 6 times the recommended human dose, respectively, were associated with visceral closure and skeletal defects. There are no controlled data in human pregnancy.

In humans, poorly controlled diabetes during pregnancy increases the fetal risk for significant congenital disabilities, stillbirth, and macrosomia-related mortality.

AU TGA pregnancy category B3: Drugs that have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use should be avoided.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not Assigned

Risk Summary: There is insufficient available data in pregnant women to inform a drug-associated risk of significant congenital disabilities and miscarriage.

More Resources

For more information on Adlyxin, you can visit Sanofi Products.