Insulin Glargine; Lixisenatide Injection

What is this medication?

INSULIN GLARGINE; LIXISENATIDE (IN su lin GLAR geen; lix i SEN a tide) treats type 2 diabetes. It works by decreasing your blood sugar (glucose). 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): SOLIQUA

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

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

Always check the appearance of your medication before using it. This medication 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 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?

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

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 care team 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 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—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Low blood sugar (hypoglycemia)—tremors or shaking, anxiety, sweating, cold or clammy skin, confusion, dizziness, rapid heartbeat
• Low potassium level—muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, constipation
• 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
• Headache
• Nausea
• Runny or stuffy nose
• Sore throat

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.

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 medication has been frozen. Protect from light. Throw away any unopened and unused medication 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, medication may leak from the pen. Throw the pen away after 28 days, even if it still has medication left in it.

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.