Insulin Degludec (IN-su-lin de-GLOO-dek), Liraglutide (lir-a-GLOO-tide)

Treats diabetes.

Brand Name(s):

Xultophy 100/3.6

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in your stomach, thighs, or upper arms.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Always double-check both the concentration (strength) of your insulin and your dose. Concentration and dose are not the same. The dose is how many units of insulin you will use. The concentration tells how many units of insulin are in each milliliter (mL), such as 100 units/mL (U-100), but this does not mean you will use 100 units at a time.
• Check the liquid inside the pen. It should be clear and colorless. Do not use the medicine if it is cloudy, discolored, or has particles in it. Do not mix this medicine with any other insulin or liquids. Do not use this medicine in an insulin infusion pump.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not use the exact same spot for each injection.
• Do not inject into skin areas that are tender, bruised, scaly, hard, damaged, thick, or has pits, lumps, or scars.
• Use a new needle and syringe each time you inject your medicine.
• Always check the label before use, to make sure you have the correct type of insulin. Do not change the brand, type, or concentration unless your doctor tells you to.
• Drink extra fluids so you will urinate more often and help prevent kidney problems.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose of this medicine, use it as soon as you remember. Then take your next daily dose as usual on the following day. Never take extra medicine to make up for a missed dose. If you miss a dose for 3 days or more, call your doctor to talk about how to restart your treatment.
• Store your new, unused medicine pen in the refrigerator, in its original carton, and protect it from light. Do not freeze. Do not use the medicine if it has been frozen. You may store the opened medicine pen in the refrigerator or at room temperature for 21 days. Throw away your used pen after 21 days, even if it still has medicine in it. Remove the needle from the pen before you store it.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can change the amount of insulin you need to use and make it harder for you to control your diabetes. Tell your doctor about all other medicines that you are using.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, digestion problems (including gastroparesis), gallbladder disease, or a history of pancreas problems or angioedema (swelling of the arms, face, hands, mouth, or throat).
• This medicine may cause the following problems:
  • Increased risk of thyroid tumor
  • Pancreatitis (swelling of the pancreas)
  • Low blood sugar or low potassium levels in the blood
  • Kidney problems, including kidney failure
  • Gallbladder problems
  • Fluid retention or heart failure (when used together with a thiazolidinedione [TZD] medicine)
• This medicine can cause low blood sugar. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Never share insulin pens or needles with anyone. Sharing these can pass hepatitis viruses, HIV, or other illnesses from one person to another.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, painful or burning urination
• Dry mouth, increased thirst, muscle cramps, uneven heartbeat
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet, trouble breathing, tiredness
• Shaking, trembling, sweating, fast or pounding heartbeat, hunger, confusion
• Sudden and severe stomach pain, nausea, vomiting, lightheadedness
• Trouble breathing or swallowing, lump in your neck, hoarseness when speaking

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Headache
• Redness, itching, swelling, or any changes in your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088