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.

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.

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.

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.

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.

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.