Lixisenatide Injection

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
• Have or have had pancreatitis
• Having surgery
• Kidney disease
• Stomach or intestine problems, such as problems digesting food
• An unusual or allergic reaction to lixisenatide, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

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
• Estrogen and progestin hormones
• Digoxin
• Other medications for diabetes
• Warfarin

Medications that may affect your blood sugar levels include:

• Alcohol
• Antiviral medications for HIV or AIDS
• Aspirin and aspirin-like medications
• Certain antibiotics, such as ciprofloxacin, levofloxacin, sulfamethoxazole; trimethoprim
• Certain medications for blood pressure, heart disease, irregular heartbeat
• Chromium
• Diuretics, such as hydrochlorothiazide (HCTZ)
• Estrogen and progestin hormones
• Fenofibrate
• Gemfibrozil
• Isoniazid
• Lanreotide
• MAOIs, such as Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Medications for weight loss
• Medications for allergies, asthma, cold, or cough
• Medications for depression, anxiety, or other mental health conditions
• Niacin
• Nicotine
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Octreotide
• Pasireotide
• Pentamidine
• Phenytoin
• Probenecid
• Some herbal dietary supplements
• Steroid medications, such as prednisone or cortisone
• Testosterone
• Thyroid hormones

Medications that may mask symptoms of low blood sugar include:

• Beta blockers, such as 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. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication. Your care team will monitor your HbA1C (A1C). This test shows what your average blood sugar (glucose) level was over the past 2 to 3 months.

Know the symptoms of low blood sugar and know how to treat it. Always carry a source of quick sugar with you. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink if your blood sugar is too low and you are unable to care for yourself. Get medical help at once.

Tell your care team if you have high blood sugar. Your medication dose may change if your body is under stress. Some types of stress that may affect your blood sugar include fever, infection, and surgery.

Do not share pens or cartridges with anyone, even if the needle is changed. Each pen should only be used by one person. Sharing could cause an infection.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

Make sure you stay hydrated while taking this medication. Drink water often. Eat fruits and veggies that have a high water content. Drink more water when it is hot or you are active. Talk to your care team right away if you have fever, infection, vomiting, diarrhea, or if you sweat a lot while taking this medication. The loss of too much body fluid may make it dangerous for you to take this medication.

If you are going to need surgery or a procedure, tell your care team that you are taking this medication.

Estrogen and progestin hormones that you take by mouth may not work as well while you are taking this medication. Talk to your care team about contraceptive options. They can help you find the option that works for you.

Do not take this medication without first talking to your care team if you may be or could become pregnant. Your care team can help you find the option that works for you. Weight loss is not recommended during pregnancy. Maintaining healthy blood sugar levels can help reduce the risk of pregnancy complications.

Talk to your care team if you are breastfeeding. When recommended, this medication may be taken. Its use during breastfeeding has not been well studied. Lactation may help lower your blood sugar levels. Your care team may recommend changes to your treatment plan.

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 or 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
• Thoughts of suicide or self-harm, worsening mood, feelings of depression
• Thyroid cancer—new mass or lump in the neck, pain or trouble swallowing, trouble breathing, hoarseness

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

• Diarrhea
• Dizziness
• Headache
• Loss of appetite
• Nausea
• Upset stomach

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.