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:

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

How should I use this medication?

This medication is injected 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?

Some medications may affect your blood sugar levels or hide the symptoms of low blood sugar (hypoglycemia). Talk with your care team about all of the medications you take. They may suggest changes to your insulin dose or checking your blood sugar levels more often.

Medications that may affect your blood sugar levels include:

• Alcohol
• Certain antibiotics, such as ciprofloxacin, levofloxacin, sulfamethoxazole; trimethoprim
• Certain medications for blood pressure or heart disease, such as benazepril, enalapril, lisinopril, losartan, valsartan
• Certain medications for mental health conditions, such as fluoxetine or olanzapine
• Diuretics, such as hydrochlorothiazide (HCTZ)
• Estrogen and progestin hormones
• Other medications for diabetes
• 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 skip meals. Ask your care team if you should avoid alcohol. Many cough and cold products contain sugar or alcohol. These can affect blood sugar levels.

Always keep an extra supply of insulin and related supplies on hand. Only use syringes once. Get rid of syringes and needles in a closed container to prevent accidental needle sticks.

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.

Do not use a syringe to take insulin out of an insulin pen. Doing this may result in the wrong dose of insulin.

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.

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
• 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
• 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
• Headache
• Loss of appetite
• Nausea
• Runny or stuffy nose
• Sore throat
• 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 (not in-use) pens in a refrigerator until the expiration date. Once opened (in-use), store at room temperature up to 25 degrees C (77 degrees F) for up to 28 days. Get rid of any unused medication after it expires or 28 days after opening, whichever is first.

Do not freeze. Protect from direct light and heat. Do not use if it is exposed to temperatures above 37 degrees C (98.6 degrees F). Do not use if it has been frozen.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

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.