Lixisenatide Injection [ Adlyxin ]

What is this medication?

LIXISENATIDE (lix i SEN a tide) treats type 2 diabetes. It works by increasing insulin levels in your body, which decreases your blood sugar (glucose). It also reduces the amount of sugar released into your blood and slows down your digestion. Changes to diet and exercise are often combined with this medication.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ADLYXIN

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Gallbladder disease
• History of alcohol abuse problem
• History of pancreatitis
• Kidney disease or if you are on dialysis
• Liver disease
• Previous swelling of the tongue, face, or lips with difficulty breathing, difficulty swallowing, hoarseness, or tightening of the throat
• Stomach problems
• An unusual or allergic reaction to lixisenatide, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for injection under the skin of your upper leg, stomach area, or upper arm. Use once a day within 60 minutes (1 hour) before the first meal of the day. Use at the same time each day. You will be taught how to prepare and give this medication. Use exactly as directed. Take your medication at regular intervals. Do not take it more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it 1 hour prior to the next meal. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Acetaminophen
• Birth control pills
• Digoxin
• Other medications for diabetes
• Warfarin

Many medications may cause changes in blood sugar, these include:

• Alcohol-containing beverages
• Antiviral medications for HIV or AIDS
• Aspirin and aspirin-like medications
• Certain medications for blood pressure, heart disease, irregular heart beat
• Chromium
• Diuretics
• Female hormones, such as estrogens or progestins, birth control pills
• Fenofibrate
• Gemfibrozil
• Isoniazid
• Lanreotide
• Male hormones or anabolic steroids
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Medications for weight loss
• Medications for allergies, asthma, cold, or cough
• Medications for depression, anxiety, or psychotic disturbances
• Niacin
• Nicotine
• NSAIDs, medications for pain and inflammation, like ibuprofen or naproxen
• Octreotide
• Pasireotide
• Pentamidine
• Phenytoin
• Probenecid
• Quinolone antibiotics such as ciprofloxacin, levofloxacin, ofloxacin
• Some herbal dietary supplements
• Steroid medications such as prednisone or cortisone
• Sulfamethoxazole; trimethoprim
• Thyroid hormones

Some medications can hide the warning symptoms of low blood sugar (hypoglycemia). You may need to monitor your blood sugar more closely if you are taking one of these medications. These include:

• Beta-blockers, often used for high blood pressure or heart problems (examples include atenolol, metoprolol, propranolol)
• Clonidine
• Guanethidine
• Reserpine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress.

A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.

Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.

Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.

Tell your care team if you have high blood sugar. You might need to change the dose of your medication. If you are sick or exercising more than usual, you might need to change the dose of your medication.

Do not skip meals. Ask your care team if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.

Pens should never be shared. Even if the needle is changed, sharing may result in passing of viruses like hepatitis or HIV.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medication and dosage times.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching, hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Dizziness
• Headache
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store unopened pen in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze or use if the medication has been frozen. Replace the pen cap after each use to protect from light. After you first use the pen, it can be stored at room temperature 30 degrees C (86 degrees F). Throw away your used pen 14 days after first use or after the expiration date, whichever comes first.

Do not store your pen with the needle attached. If the needle is left on, medication may leak from the pen.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What Is Adlyxin?

Adlyxin (lixisenatide) Injection, for subcutaneous use acts as a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

What Are Side Effects of Adlyxin?

Adlyxin may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• itching,
• severe rash,
• rapid heartbeats,
• trouble swallowing,
• severe pain in your upper stomach spreading to your back,
• nausea,
• vomiting,
• fast heart rate,
• headache,
• hunger,
• sweating,
• irritability,
• dizziness,
• nausea,
• fast heart rate,
• anxious,
• shakiness,
• little or no urination,
• painful or difficult urination,
• swelling in your feet or ankles,
• tiredness, and shortness of breath

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Adlyxin include

• nausea,
• vomiting,
• headache,
• diarrhea,
• dizziness,
• indigestion,
• constipation,
• abdominal distention,
• abdominal pain,
• injection site reactions (pain, itching, redness),
• hypoglycemia (low blood sugar – symptoms include headache, dizziness, drowsiness, confusion, weakness, irritability, hunger, sweating, fast heartbeat, feeling jittery), and
• severe allergic reaction (anaphylaxis).

Description for Adlyxin

ADLYXIN contains lixisenatide, which acts as a GLP-1 receptor agonist. Lixisenatide is a peptide containing 44 amino acids, which is amidated at the C-terminal amino acid (position 44). The order of the amino acids is given in the figure below. Its molecular weight is 4858.5 and its molecular formula is C₂₁₅H₃₄₇N₆₁O₆₅S. Lixisenatide has the following chemical structure:

 

 

ADLYXIN injection is a sterile, clear, colorless aqueous solution for subcutaneous administration. ADLYXIN is supplied in two single-patient use prefilled pens. Each green prefilled pen contains 3 mL solution and each mL contains 50 mcg lixisenatide. Each burgundy prefilled pen contains 3 mL solution, and each mL contains 100 mcg lixisenatide. Inactive ingredients for both prefilled pens are glycerol 85% (54 mg), sodium acetate trihydrate (10.5 mg), methionine (9.0 mg), metacresol (8.1 mg), and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

Uses for Adlyxin

ADLYXIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations Of Use

• ADLYXIN has not been studied in patients with chronic pancreatitis or a history of unexplained pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis [see WARNINGS AND PRECAUTIONS].
• ADLYXIN should not be used in patients with type 1 diabetes mellitus.
• ADLYXIN has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis.

Dosage for Adlyxin

Dosing Instructions

• 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.