Xultophy 100/3.6 is an injectable prescription medication used to lower blood sugar in adults with type 2 diabetes when blood sugar levels are not well controlled.

It is a single product containing 2 medications: insulin degludec and liraglutide. Insulin degludec is an "ultra-long acting" insulin that helps keep blood glucose at consistent levels for long periods of time, allowing the time between doses to be extended. Liraglutide belongs to a group of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. These drugs control blood glucose (sugar) by causing the pancreas to release insulin when blood sugar levels are high. 

This medication comes in an injectable form in a prefilled pen. Xultophy 100/3.6 is given just under the skin, once daily.

Common side effects of Xultophy 100/3.6 include stuffy or runny nose, sore throat, and upper respiratory tract infections.

Xultophy 100/3.6 is a prescription medication used to treat type 2 diabetes. This medication is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes when blood sugar levels are not well controlled.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported Xultophy 100/3.6. See the "Xultophy Precautions” section.

Common side effects of Xultophy include the following:

• stuffy or runny nose
• sore throat
• upper respiratory tract infection such as common cold, sore throat, or ear infection
• increased blood levels of lipase (enzyme that helps to digest fats)
• nausea
• diarrhea 
• headache

This is not a complete list of Xultophy 100/3.6 side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Some medications can increase the risk of hypoglycemia (low blood sugar) and affect your Xultophy 100/3.6 treatment. Xultophy 100/3.6 dose adjustment may be required when you take one of the following medications:

• other medicines for diabetes (oral and injectable)
• sulfonamide antibiotics (e.g., trimethoprim and sulfamethoxazole)
• monoamine oxidase (MAO) inhibitors (e.g., phenelzine)
• angiotensin converting enzyme (ACE) inhibitors (e.g., lisinopril)
• angiotensin II receptor blocking agents (e.g., losartan)
• disopyramidine
• fibrates (e.g., fenofibrate)
• fluoxetine
• pentoxifylline
• pramlintide
• propoxyphene
• salicylates (e.g., bismuth subsalicylate)
• somatostatin analogs (e.g., octreotide)

Some medications may decrease the blood glucose lowering effect of Xultophy 100/3.6 such as the following:

• typical antipsychotics (e.g., haloperidol)
• corticosteroids (e.g., prednisone)
• danazol
• diuretics (e.g. hydrochlorothiazide)
• glucagon 
• isoniazid
• niacin
• oral contraceptives
• phenothiazines (e.g., prochlorperazine)
• protease inhibitors (e.g., ritonavir)
• sympathomimetic agents (e.g., albuterol)
• thyroid hormones (e.g., levothyroxine)

Some medications may increase or decrease the blood glucose lowering effect of Xultophy 100/3.6 such as the following:

• alcohol
• beta-blockers (e.g. metoprolol)
• clonidine
• lithium salts 
• pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia

Some medications may mask signs and symptoms of hypoglycemia. More frequent blood sugar monitoring may be needed when you take one of the following medications:

• beta-blockers (e.g., metoprolol)
• clonidine 
• guanethidine
• reserpine

This is not a complete list of Xultophy drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Xultophy 100/3.6 including the following: 

• Risk of thyroid c-cell tumors.
  • Before you start taking Xultophy, tell your healthcare provider if you or any of your family members have had thyroid cancer, especially medullary thyroid cancer, or Multiple Endocrine Neoplasia syndrome type 2. Do not take Xultophy if you or any of your family members have medullary thyroid cancer, or if you have Multiple Endocrine Neoplasia syndrome type 2. People with these conditions already have a higher chance of developing medullary thyroid cancer in general and should not take Xultophy.
  • While taking Xultophy, 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.

• Inflammation of pancreas (pancreatitis), which may be severe and lead to death.

  Before taking Xultophy, tell your healthcare provider if you have had:

  • pancreatitis
  • stones in your gallbladder (gallstones)
  • a history of alcoholism
  • high blood triglyceride levels

These medical conditions can make you more likely to get pancreatitis in general. It is not known if having these conditions will lead to a higher chance of getting pancreatitis while taking Xyltophy 100/3.6.

Stop taking Xyltophy 100/3.6 and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may happen with or without vomiting. The pain may be felt going from your abdomen through to your back. This type of pain may be a symptom of pancreatitis.

• Low blood sugar (hypoglycemia). If you get too low blood sugar, eat glucose tablets or another high sugar snack, like sweets, biscuits or fruit juice (always carry glucose tablets or a high sugar snack, just in case). Signs of low blood sugar include:
  • headache
  • slurred speech
  • fast heartbeat
  • cold sweat
  • cool pale skin
  • feeling sick
  • feeling very hungry
  • tremor
  • feeling nervous or worried
  • feeling unusually tired, weak and sleepy
  • feeling confused
  • difficulty in concentrating
  • short-lasting changes in your sight
• Kidney problems (kidney failure). Xultophy 100/3.6 may cause nausea, vomiting or diarrhea leading to loss of fluids (dehydration). Dehydration may cause kidney failure which can lead to the need for dialysis. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration.
• Serious allergic reactions. Serious allergic reactions can happen with Xultophy 100/3.6. Stop using Xultophy, and get medical help right away if you have any symptom of a serious allergic reaction. Symptoms of a serious allergic reaction may include:
  • swelling of your face, lips, tongue, or throat
  • fainting or feeling dizzy
  • very rapid heartbeat
  • problems breathing or swallowing
  • severe rash or itching
• Low potassium in your blood (hypokalemia).
• Heart failure. Taking Xultophy 100/3.6 may cause fluid accumulation and heart failure in some people.  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 Xultophy 100/3.6 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
• Hyperglycemia or Hypoglycemia (high or low blood sugar) with changes in Xultophy 100/3.6 regimen. Changes should be done under medical supervision.
• Overdose due to medication errors. Xultophy 100/3.6 contains two drugs: insulin degludec and liraglutide. Administration of more than 50 units of Xultophy 100/3.6 daily can result in overdose of the liraglutide component. Do not exceed the 1.8 mg maximum recommended dose of liraglutide or use with other glucagon-like peptide-1 receptor agonists.
• This pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.

• To avoid accidental mix-ups with other insulin products, always check the drug label before each injection.

• Never share Xultophy 100/3.6 pen between patients, even if the needle is changed.
• There is no evidence of heart attack/stroke risk reduction with Xultophy 100/3.6, no well-controlled studies have been done to find out the possibility of risk reduction.

While taking this medication do not:

• Drive or operate heavy machinery, until you know how this medication affects you.
• Drink alcohol while using Xultophy 100/3.6. If you drink alcohol, your need for insulin may change. Your blood sugar level may either rise or fall. You should therefore monitor your blood sugar level more often than usual.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Xultophy 100/3.6, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Xultophy 100/3.6, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• or any of your family members have a history of Medullary Thyroid Cancer
• have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• are allergic to Xultophy 100/3.6 or any of the other ingredients in Xyltophy 100/3.6
• 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 while using Xultophy 100/3.6.
• are breastfeeding or plan to breastfeed. It is not known if Xultophy 100/3.6 passes into your breast milk. You should not use Xultophy 100/3.6 while breastfeeding.

Before using Xultophy 100/3.6, 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.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Xultophy 100/3.6 crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Xultophy 100/3.6.

Take Xultophy 100/3.6 exactly as prescribed.

Xultophy 100/3.6 comes in prefilled pen form and is injected under the skin once-daily at the same time each day with or without food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Xultophy 100/3.6 at the same time.

This pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.

How to use Xultophy 100/3.6 pen:

1. Wash your hands with soap and water.

2. Before you start to prepare your injection, check the Xultophy 100/3.6 pen label before each use to make sure it is your Xultophy 100/3.6 pen.

3. Do not use Xultophy 100/3.6 past the expiration date printed on the label or 21 days after you start using the pen.

4. Pull pen cap straight off.

5. Xultophy 100/3.6 should look clear and colorless. Do not use Xultophy 100/3.6 if it is cloudy or colored.

6. Select a new needle. Always use a new needle for each injection to help ensure sterility and prevent blocked needles. Do not reuse or share needles with another person. You may give other people a serious infection or get a serious infection from them.

7. Push the capped needle straight onto the pen and twist the needle on until it is tight.

8. Pull off the outer needle cap. Do not throw it away.

9. Make sure you prime your pen before setting your dose. Turn the dose selector to select the priming symbol. Hold the pen with the needle pointing up. Tap the top of the pen gently a few times to let any air bubbles rise to the top. Hold the pen with the needle pointing up. Press and hold in the dose button until the dose counter shows “0”. The “0” must line up with the dose pointer. A drop of Xultrophy 100/3.6 should be seen at the needle tip. If you don't see the drop, repeat priming steps or change the needle and repeat priming steps.

10. Turn the dose selector to select the dose you need to inject. The dose pointer should line up with your dose.

• If you select the wrong dose, you can turn the dose selector forwards or backwards to the correct dose.
• The even numbers are printed on the dial.
• The odd numbers are shown as lines.

11. The Xultophy 100/3.6 pen scale will show you how much Xultophy 100/3.6 is left in your pen.

• Turn the dose selector until it stops. The dose counter will line up with the dose that is left in your pen. If the dose counter shows 50, there is a dose of at least 50 units left in your pen
• If the dose counter shows between 10 and 50, the number shown in the dose counter is the total units left in your pen.
• If there is not enough Xultophy 100/3.6 left in your pen for a full dose, do not use it. Use a new Xultophy 100/3.6 pen.

12. Giving your injection:

• Inject your Xultophy 100/3.6 exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
• Xultophy 100/3.6 can be injected under the skin (subcutaneously) of your stomach area (abdomen), upper legs (thighs) or upper arms.
• Change (rotate) your injection sites within the area you choose for each dose. Do not use the same injection site for each injection.
• Choose your injection site and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose.
• Insert the needle into your skin.Press and hold down the dose button until the dose counter shows “0”. The “0” must line up with the dose pointer. You may hear or feel a click. Keep the needle in your skin after the dose counter has returned to “0” and slowly count to 6. 
• Pull the needle out of your skin

13. Carefully remove the needle from the pen after each use and throw it away. Do not recap the needle. Recapping the needle can lead to needle stick injury. If you do not have a sharps container, follow the steps below:

• Carefully slip the needle into the outer needle cap. Safely remove the needle and throw it away as soon as you can.

• Do not store the pen with the needle attached. Storing without the needle attached helps prevent leaking, blocking of the needle, and air from

entering the pen.

14. Replace the pen cap by pushing it straight on.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose range of Xultophy is 16 to 50 units in a single injection (with each unit of insulin degludec, the pen also delivers 0.036 mg of liraglutide). The units can be increased by 1 unit at a time. The dose equals the number of units shown in the dose counter.

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 take too much Xultophy 100/3.6, it can cause severe nausea and vomiting.

If you take too Xultophy 100/3.6, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Before use:

• Store unused Xultophy 100/3.6 pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze Xultophy 100/3.6. Do not use Xultophy 100/3.6 if it has been frozen.
• Unused pens may be used until the expiration date printed on the label, if kept in the refrigerator.
• If Xultophy 100/3.6 is stored outside of refrigeration prior to first use, it should be used or thrown away within 21 days.
• Store the pens in the carton they come in to keep them clean and protected from light.

Pen in use:

• Store the pen you are currently using out of the refrigerator below 86°F (30°C) or in a refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze Xultophy 100/3.6. Do not use Xultophy 100/3.6 if it has been frozen.
• Keep Xultophy 100/3.6 away from heat or light.
• The Xultophy 100/3.6 pen you are using should be thrown away after 21 days, even if it still has Xultophy 100/3.6 left in it and the expiration date has not passed.

Keep Xultophy 100/3.6 pens and needles out of the reach of children.

Always use a new needle for each injection.

Warning: risk of thyroid c-cell tumors

In studies with rats and mice, liraglutide, one of the components of Xultophy 100/3.6, 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. 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.

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.