Xultophy 100/3.6 100 unit-3.6 mg/mL (3 mL) subcutaneous insulin pen

Generic name:
Insulin degludec/liraglutide - injection

Pronunciation
(IN-su-lin de-GLOO-dek/LIR-a-GLOO-tide)

Brand name(s)
Xultophy

This medication can cause a certain type of thyroid tumor (thyroid C-cell tumors) in rats and mice. It is unknown if this medication can cause similar tumors in humans. Talk with your doctor about the benefits and risks of treatment with this medication. Do not use this medication if you have a certain inherited disease (multiple endocrine neoplasia syndrome type 2 or MEN 2) or if you have a personal/family history of a certain type of cancer (medullary thyroid carcinoma). While using this medication, tell your doctor right away if you notice any signs or symptoms of thyroid tumors, including unusual growth or lump in the neck, difficulty swallowing, shortness of breath, or unusual/lasting hoarseness.

This medication is a combination of insulin degludec and liraglutide and is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

Insulin degludec is a man-made product that is similar to human insulin. It acts longer than regular insulin, providing a low, steady level of insulin. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. Liraglutide is similar to a natural hormone in your body (incretin). It works by causing insulin release in response to high sugar levels (such as after a meal) and decreasing the amount of sugar your liver makes.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually once daily. This medication may be used with or without food. The injection is given in the thigh, abdomen, or upper arm. Do not inject into a vein or muscle because very low blood sugar (hypoglycemia) may occur.

The dosage is based on your medical condition and response to treatment. Your doctor will start you on a low dose first to decrease your risk of stomach/abdominal side effects, and gradually increase your dose. If more than 3 days have passed since your last dose of this medication, ask your doctor if you should restart the medication with the low dose to reduce your chance of side effects. Follow your doctor's instructions carefully.

Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin (for example, pits/lumps or thickened skin). Do not inject into skin that is red, swollen, itchy, or damaged. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Do not share your pen device with another person, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Tell your doctor if your condition does not get better or if it gets worse (your blood sugar is too high or too low).

See also Warning section.

Nausea, vomiting, stomach upset, decreased appetite, diarrhea, constipation, stuffy/runny nose, weight gain, or pain/redness/irritation at the injection site may occur. Nausea usually lessens as you continue to use this medication. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Vomiting/diarrhea that doesn't stop may result in dehydration. Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness.

Tell your doctor right away if you have any serious side effects, including:

• signs of low potassium level in the blood (such as muscle cramps, weakness, irregular heartbeat)
• signs of kidney problems (such as change in the amount of urine)
• mental/mood changes (such as depression, thoughts of suicide)

Get medical help right away if you have any very serious side effects, including:

• signs of pancreas or gallbladder disease (such as nausea/vomiting that doesn't stop, severe stomach/abdominal pain)

This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include increased thirst/urination. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to insulin degludec or liraglutide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Do not use this medication when you have low blood sugar (hypoglycemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney disease
• liver disease
• disease of the pancreas (pancreatitis)
• gallbladder disease
• stomach/intestinal disorders (such as gastroparesis)
• mental/mood disorders (such as depression, thoughts of suicide)

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do anything that needs alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while using this medication because it can increase your risk of developing low blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Check your blood sugar before and after exercise. You may need a snack beforehand.

Older adults may be more sensitive to the side effects of this drug, especially low blood sugar.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

Insulin degludec passes into breast milk. It is unknown if liraglutide passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are not affected by these drugs.

Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: shakiness, fast heartbeat, sweating, loss of consciousness.

Do not share this medication with others.

Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.

Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed and share the results with your doctor.

Lab and/or medical tests (such as liver/kidney function, fasting blood glucose, hemoglobin A1c) should be done while you are using this medication. Keep all medical and lab appointments.

If you miss a dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store in the refrigerator before first use. Do not freeze. Do not use this medication if it has been frozen. Keep the medication in the original carton to protect from light. If the unopened medication is stored at room temperature, discard after 21 days. After first use, store the medication at room temperature or in the refrigerator away from heat and light. Discard the medication 21 days after first use, even if some drug remains in the pen. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.