Xultophy, illustration of injection pen form (not a photo of the actual pack)

Illustrative image.

Xultophy

Insulin Degludec And Liraglutide

Prescription required

$370.00

5 pen

BrandBranded medicine· By Novo Nordisk

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FDA boxed warningRisk of thyroid c-cell tumors

Liraglutide, one of the components of XULTOPHY 100/3.6, causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether XULTOPHY 100/3.6 causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.

XULTOPHY 100/3.6 is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of XULTOPHY 100/3.6 and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with XULTOPHY 100/3.6.

Liraglutide, one of the components of XULTOPHY 100/3.6, causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether XULTOPHY 100/3.6 causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.

XULTOPHY 100/3.6 is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors.

Read this with the rest of the clinical information

About Xultophy

Overview

Xultophy is a prefilled injection pen containing insulin degludec, a long-acting insulin, and liraglutide, a GLP-1 receptor agonist. It is used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes. The two ingredients help lower blood sugar by helping the body use glucose, reducing glucose production by the liver, increasing insulin release when blood sugar is elevated, and slowing stomach emptying.

What it treats

Used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes.

Safety information

Side effects

Common side effects include inflammation of the nose and throat, headache, nausea, diarrhea, upper respiratory tract infections and increased levels of lipase, a digestive enzyme. Hives have also been reported with liraglutide. Serious side effects warrant prompt medical attention. These include inflammation of the pancreas, low blood sugar, kidney injury due to dehydration, severe stomach or bowel problems, gallbladder disease and low potassium levels. Low blood sugar and low potassium can be life-threatening. Severe allergic reactions can also be life-threatening and may involve swelling, difficulty breathing, low blood pressure or shock. Stop using Xultophy and seek emergency medical help if a severe allergic reaction occurs. Seek urgent help for severe low blood sugar. The label also warns about the risk of thyroid C-cell tumors. Fluid retention and heart failure can occur when insulin is used with medicines called thiazolidinediones (TZDs). Inhalation of stomach contents into the lungs has been reported during general anesthesia or deep sedation in people receiving GLP-1 receptor agonists. Tell your healthcare team you use Xultophy before any planned surgery or procedure.

FDA boxed warning

Risk of thyroid c-cell tumors

Liraglutide, one of the components of XULTOPHY 100/3.6, causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether XULTOPHY 100/3.6 causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.

XULTOPHY 100/3.6 is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of XULTOPHY 100/3.6 and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with XULTOPHY 100/3.6.

Liraglutide, one of the components of XULTOPHY 100/3.6, causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether XULTOPHY 100/3.6 causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.

XULTOPHY 100/3.6 is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors.

A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.

When to call your doctor

- Seek immediate medical attention for a lump in your neck, trouble swallowing or breathing, or hoarseness that does not go away. - Seek immediate medical attention for signs of a severe allergic reaction, such as swelling of the face or throat, wheezing, or difficulty breathing.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

Do not use Xultophy if you or anyone in your family has had medullary thyroid carcinoma (MTC), if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or if you are allergic to insulin degludec, liraglutide or any other ingredient. Do not use it during an episode of low blood sugar (hypoglycemia). Xultophy is not recommended for people with severe gastroparesis (severely delayed stomach emptying). During pregnancy, it should be used only if the potential benefit justifies the potential risk to the fetus. It must not be used with other GLP-1 receptor agonists. Conditions requiring caution include kidney or liver impairment, difficulty recognising low blood sugar, and a risk of low potassium. Low blood sugar and low potassium can be life-threatening. Changes to insulin treatment require close medical supervision and more frequent blood sugar checks. Closer monitoring may also be needed when other medicines, meal patterns or physical activity change. Other serious risks include inflammation of the pancreas, severe digestive side effects, dehydration-related kidney injury, gallbladder disease and severe allergic reactions. Stop using Xultophy if pancreatitis or an allergic reaction is suspected and seek medical care. Taking Xultophy with thiazolidinediones (TZDs) can cause fluid retention and heart failure. Tell your healthcare team before any planned surgery or procedure, as stomach contents entering the lungs during general anesthesia or deep sedation have been reported with GLP-1 receptor agonists. Never share a Xultophy pen, even if the needle is changed, and check the label before each injection to avoid medicine mix-ups.

Interactions

Tell your doctor about medicines that affect blood sugar. Your doctor may need to adjust your Xultophy treatment and monitor your blood sugar closely. Beta-blockers, clonidine, guanethidine and reserpine can reduce or hide the warning signs of low blood sugar. Xultophy slows stomach emptying, which may affect how medicines taken by mouth are absorbed. Discuss your oral medicines with your doctor.

Using Xultophy

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store in the original carton to protect it from light. Check the pack for whether it must be refrigerated before first use and how long it may be kept at room temperature afterwards. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label XULTOPHY 100/3.6 (INSULIN DEGLUDEC AND LIRAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK] (DailyMed, retrieved 19 September 2026).

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