Insulin Glargine/Lixisenatide Pen Injector 100 units/33 mcg per mL (3 mL)

Instructions

This medicine is used by injecting it into the skin. Please ask your doctor, nurse or pharmacist for the correct places on your body where this medicine can be injected.

Read and make sure you understand the instructions for measuring dose and using syringe. If you have any questions, talk to your doctor, nurse, or pharmacist.

Always inspect the medicine before using.

The liquid should be clear and colorless.

Do not use the medicine if it contains any particles or if it has changed color.

Keep the medicine in the refrigerator until you are ready to use it. Remove from the refrigerator and let it warm up to room temperature before using. Keep the medicine at room temperature once opened. Do not put it back into the refrigerator. Do not freeze. Discard it if frozen.

Protect medicine from light.

Do not store the medicine pen with the needle attached. Always remove the needle after each use.

Discard the injectable pen 28 days after first use, even if there is medicine left in the pen.

Never use any medicine that has expired.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

Do not inject into red, swollen, itchy, lumpy, pitted, or thickened skin.

Change the location of the injection each time. Choose a location at least 1 inch from the last injection.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget a dose, just wait. Use the next dose at the usual time. Do not use 2 doses at once.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Before using insulin, you should be taught by your doctor or a certified diabetes educator. Follow their instructions carefully. If you have not been trained, speak with your doctor before using this medicine.

Be sure to follow your regular meal plan and exercise as discussed with your doctor.

Tell your doctor if symptoms do not get better or if they get worse.

This medicine can reduce the absorption of other medicines. Talk to your doctor or pharmacist about the best times to use this product.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Patients with very low blood sugar may become very confused, lose consciousness, or have seizures.

Monitor your blood sugar as instructed by your doctor.

Adjust the amount of insulin only as recommended by your doctor.

Do not use the medication any more than instructed.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

Always carry an ID card or wear a medical alert bracelet showing that you are diabetic.

Carry glucose tablets or hard candy with you in case you experience low blood sugar from the insulin.

Symptoms of low blood sugar may include nausea, shaking, sweating, cold skin, fast heartbeat, hunger, and irritability.

Ask your pharmacist how to properly throw away used needles or syringes.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• constipation or diarrhea
• pain, redness, swelling near injection
• nausea and vomiting
• stomach upset or abdominal pain
• weight gain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• blurry vision
• dizziness
• numbness or tingling in hands and feet
• fast or irregular heart beats
• low blood sugar
• signs of kidney damage (such as change in urine color or bubbly urine)
• muscle cramps or weakness
• shakiness
• severe stomach pain that spreads to the back
• sweating
• blurring or changes of vision
• severe or persistent vomiting

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.