Insulin Glargine; Lixisenatide injection

What is this medicine?

INSULIN GLARGINE; LIXISENATIDE (IN su lin GLAR geen; lix i SEN a tide) is a combination of 2 medicines used to treat type 2 diabetes. This medicine lowers blood sugar. Treatment is combined with a balanced diet and exercise.

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. Use your medicine at regular intervals. Do not use it more often than directed.

Always check the appearance of your medicine before using it. This medicine should be clear and colorless like water. Do not use it if it is cloudy, thickened, colored, or has solid particles in it.

If you use a pen, be sure to take off the outer needle cover before using the dose.

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

• signs and symptoms of high blood sugar such as dizziness, dry mouth, dry skin, fruity breath, nausea, stomach pain, increased hunger or thirst, increased urination

• 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):

• increase or decrease in fatty tissue under the skin due to overuse of a particular injection site

• itching, burning, swelling, or rash at site where injected

• diarrhea

• fatigue

• headache

• nausea

• runny nose

• sore throat

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?

It is important not to miss a dose. Your health care professional or doctor should discuss a plan for missed doses with you. If you do miss a dose, follow their plan. Do not take double doses.

Where should I keep my medicine?

Keep out of the reach of children.

Unopened Pens:

Soliqua Pens: Store 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. Protect from light. Throw away any unopened and unused medicine that has been stored in the refrigerator after the expiration date.

Pens that you are using:

Soliqua Pens: Store at room temperature below 25 degrees C (77 degrees F). Do not refrigerate or freeze. Replace the pen cap after each use to protect from light. Do not store your pen with the needle attached. If the needle is left on, medicine may leak from the pen. Throw the pen away after 28 days, even if it still has medicine left in it.

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

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

• episodes of low blood sugar

• eye disease, vision problems

• 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 insulin, lixisenatide, metacresol, 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.

Insulin glargine; Lixisenatide pens should never be shared. Even if the needle is changed, sharing may result in passing of viruses like hepatitis or HIV.

Each time you get a new box of pen needles, check to see if they are the same type as the ones you were trained to use. If not, ask your health care professional to show you how to use this new type properly.

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