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Generic Name: insulin degludec and liraglutide
Dosage Form: Injection
Date of Approval: November 21, 2016
Company: Novo Nordisk

Treatment for: Type 2 Diabetes

FDA Approves Xultophy 100/3.6

Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Important information

Xultophy 100/3.6 may cause serious side effects, including:

  • Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, liraglutide, one of the active ingredients, and medicines that work like liraglutide caused thyroid tumors, including thyroid cancer. It is not known if Xultophy 100/3.6 will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
  • Do not use this medicine if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

What is Xultophy 100/3.6?

Xultophy 100/3.6 is an injectable prescription medicine that contains 2 diabetes medicines, insulin degludec, 100 units/mL, and liraglutide, 3.6 mg/mL. It should be used along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes mellitus when blood sugar levels are not well controlled on: 1) basal insulin (less than 50 units daily) or 2) liraglutide (less than or equal to 1.8 mg daily).

  • It is not recommended as the first choice of medicine for treating diabetes.
  • It is not known if Xultophy 100/3.6 can be used in people who have had pancreatitis.
  • It is not recommended for use in combination with any other product containing liraglutide or another GLP-1 receptor agonist.
  • It is not for use in people with type 1 diabetes or people with diabetic ketoacidosis (increased ketones in the blood or urine).
  • It is not known if Xultophy 100/3.6 can be used with mealtime insulin.
  • It is not known if Xultophy 100/3.6 is safe and effective for use in children under 18 years of age.

Who should not use Xultophy 100/3.6?

Do not use Xultophy 100/3.6 if:

  • you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • you are allergic to insulin degludec, liraglutide or any of the ingredients. See the end of this page for a complete list of ingredients.
  • you are having an episode of low blood sugar (hypoglycemia).

Before using Xultophy 100/3.6

Before you start treatment, tell your healthcare provider about all your medical conditions, including if you:

  • have or have had problems with your pancreas, kidneys, or liver.
  • have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
  • are taking certain medicines called glucagon-like peptide 1 receptor agonists (GLP-1 receptor agonists).
  • are pregnant or plan to become pregnant. It is not known if Xultophy 100/3.6 will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment.
  • are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. You should not use Xultophy 100/3.6 while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Xultophy 100/3.6 may affect the way some medicines work and vice versa. Before starting treatment, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use Xultophy 100/3.6?

  • Read the Instructions for Use that comes with your prescription.
  • Use this medicine exactly as your healthcare provider tells you to.
  • Do not change your dosing schedule without first talking to your healthcare provider. The dose counter on your injection pen shows the number of units of to be injected.
  • Your healthcare provider should show you how to use Xultophy 100/3.6 before you use it for the first time.
  • Xultophy 100/3.6 is injected under the skin (subcutaneously) of your thigh, upper arm or stomach (abdomen).
  • Do not inject it into a muscle (intramuscularly) or vein (intravenously).
  • Use the injection at the same time each day with or without food.
  • If you miss a dose, resume your one time daily dosing schedule at the next scheduled dose. Do not take two doses at the same time or increase your dose to make up for the missed dose. If you miss more than three days of treatment, call your healthcare provider for further instructions about taking the right dose and to help lower your chance of having an upset stomach.
  • Do not mix Xultophy 100/3.6 with any other insulin products or GLP-1 receptor agonists in the same injection.
  • Check the Pen label each time you give your injection to make sure you are using the correct medication.
  • Do not take more than 50 units of Xultophy 100/3.6 each day. Xultophy 100/3.6 contains two medicines: insulin degludec and liraglutide. If you inject too much, it can cause severe nausea and vomiting. Do not take this medicine with other GLP-1 receptor agonists. If you take too much, call your healthcare provider or go to the nearest hospital emergency room right away.
  • Change (rotate) your injection site with each injection to help reduce your chances of getting skin thickening or pits at the injection site. Do not use the same site for each injection.
  • Do not share your injection pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.

Your dose of this and other diabetes medicines may need to change because of:

  • change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

What should I avoid?

While using this medicine, do not:

  • drive or operate heavy machinery, until you know how the medicine affects you.
  • drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

Xultophy side effects

Xultophy 100/3.6 may cause serious side effects that can lead to death, including:

  • See Important information.
  • inflammation of your pancreas (pancreatitis). Stop treatment and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
  • low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use this medicine with another medicine that can cause low blood sugar. Signs and symptoms of low blood sugar may include:
    • dizziness or light-headedness
    • sweating
    • confusion or drowsiness
    • headache
    • blurred vision
    • slurred speech
    • shakiness
    • fast heartbeat
    • anxiety, irritability, or mood changes
    • hunger
    • weakness
    • feeling jittery
  • kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.
  • serious allergic reactions. Stop treatment and get medical help right away, if you have any symptoms of a serious allergic reaction including itching, rash, or difficulty breathing.
  • heart failure. Taking certain diabetes medicines called peroxisome proliferator-activated receptor (PPAR) gamma agonists or PPAR agonists with insulin containing products, including Xultophy 100/3.6, may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take PPAR agonists with Xultophy 100/3.6. Your healthcare provider should monitor you closely while you are taking PPAR agonists during treatment. Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet and sudden weight gain. Treatment with PPAR agonists and Xultophy 100/3.6 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
  • low potassium in your blood (hypokalemia).

The most common side effects may include stuffy or runny nose, sore throat, upper respiratory tract infection, increased blood levels of lipase, nausea, diarrhea, and headache. Talk to your healthcare provider about any side effect that bothers you or does not go away.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep all medicines out of the reach of children and pets.

General information

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.

What are the ingredients?

Active Ingredients: insulin degludec and liraglutide

Inactive Ingredients: glycerol, phenol, zinc, and water for injection

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