Lixisenatide injection

What is this medicine?

LIXISENATIDE (lix i SEN a tide) is used to improve blood sugar control in adults with type 2 diabetes. This medicine may be used with other oral diabetes medicines.

How should I use this medicine?

This medicine 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 medicine. Use exactly as directed. Take your medicine 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 healthcare provider 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 drug comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this drug. Read the information carefully. Talk to your pharmacist or health care provider if you have questions.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• signs and symptoms of low blood sugar such as feeling anxious, confusion, dizziness, increased hunger, unusually weak or tired, sweating, shakiness, cold, irritable, headache, blurred vision, fast heartbeat, loss of consciousness

• trouble passing urine or change in the amount of urine

• unusual stomach pain or upset

• vomiting

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

• constipation

• diarrhea

• dizziness

• fatigue

• headache

• nausea

What may interact with this medicine?

• acetaminophen

• birth control pills

• digoxin

• other medicines for diabetes

• warfarin

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

• alcohol containing beverages

• antiviral medicines for HIV or AIDS

• aspirin and aspirin-like drugs

• certain medicines 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

• medicines for weight loss

• medicines for allergies, asthma, cold, or cough

• medicines for depression, anxiety, or psychotic disturbances

• niacin

• nicotine

• NSAIDs, medicines 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 medicines 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

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.

Where should I keep my medicine?

Keep out of the reach of children.

Store unopened pen in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze or use if the medicine 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, medicine may leak from the pen.

What should I tell my health care provider before I take this medicine?

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 medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional 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 doctor or health care professional if you have high blood sugar. You might need to change the dose of your medicine. If you are sick or exercising more than usual, you might need to change the dose of your medicine.

Do not skip meals. Ask your doctor or health care professional 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 medicine and dosage times.