Xultophy

Generic name: Insulin Degludec And Liraglutide
Drug class: Antidiabetic combinations

Usage of Xultophy

Xultophy is an injection pen containing a combination of insulin degludec and liraglutide. Insulin degludec is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours.

Liraglutide is similar to a hormone that occurs naturally in the body and helps control blood sugar, insulin levels, and digestion.

Xultophy is used to lower blood sugar in adults with type 2 diabetes mellitus. This medicine should be used together with diet and exercise.

Xultophy is usually given when your blood sugar levels have not been well controlled by using other medications.

Xultophy is not for people with type 1 diabetes.

Xultophy side effects

Get emergency medical help if you have signs of an allergic reaction to Xultophy: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

severe nausea and vomiting;

shortness of breath (even with mild exertion);

swelling in your feet or ankles, rapid weight gain;

signs of pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

kidney problems - little or no urination, painful or difficult urination; or

low potassium level - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Xultophy side effects include:

nausea, diarrhea;

headache; or

cold symptoms such as stuffy or runny nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Xultophy

You should not use Xultophy if you are allergic to insulin or liraglutide. Do not use this medicine during an episode of low blood sugar, or if you have:

multiple endocrine neoplasia type 2 (tumors in your glands);

a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer);

diabetic ketoacidosis (call your doctor for treatment); or

a condition for which you use liraglutide (Saxenda, Victoza) or a medicine like liraglutide (albiglutide, dulaglutide, exenatide, lixisenatide, Adlyxin, Byetta, Bydureon, Tanzeum, Trulicity).

To make sure Xultophy is safe for you, tell your doctor if you have ever had:

pancreatitis;

kidney or liver disease;

stomach problems causing slow digestion;

alcoholism;

gallstones; or

if you also use a meal-time insulin.

In animal studies, liraglutide caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people using regular doses. Ask your doctor about your risk.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using insulin if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

Xultophy is not approved for use by anyone younger than 18 years old.

Relate drugs

How to use Xultophy

Usual Adult Dose of Xultophy for Diabetes Type 2:

Basal Insulin or GLP-1 Receptor Agonist Naive: Initial dose: 10 units suBCutaneously once a day Currently receiving a Basal Insulin or GLP-1 Receptor Agonist -Discontinue therapy with basal insulin and/or liraglutide Initial dose: 16 units subcutaneously once a day TITRATION: Adjust dose up or down in increments of 2 units every 3 to 4 days based on individual metabolic needs, blood glucose monitoring, and glycemic goal until desired fasting plasma glucose is achieved Maximum daily dose: 50 units (insulin degludec 50 units; liraglutide 1.8 mg) Comments: -Dosing is provided as insulin degludec units; the liraglutide component dose for each unit of insulin degludec is displayed on a dosing table in the package labeling; 10 units of insulin degludec provides 0.36 mg of liraglutide. -To minimize the risk of hypoglycemia or hyperglycemia, additional titration may be necessary with changes in physical activity, food intake, during acute illness, or with use of concomitant medications. -This combination drug is not recommended as first-line therapy because of the uncertainty of rodent C-cell tumor finding to humans. -The combination drug has not been studied in combination with prandial insulin. Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Warnings

You should not use Xultophy if you have multiple endocrine neoplasia type 2 (tumors in your glands), a personal or family history of medullary thyroid cancer, insulin-dependent diabetes, or if you are having an episode of low blood sugar or diabetic ketoacidosis.

In animal studies, liraglutide caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people.

Call your doctor at once if you have signs of a thyroid tumor, such as swelling or a lump in your neck, trouble swallowing, a hoarse voice, or shortness of breath.

What other drugs will affect Xultophy

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of Xultophy. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Disclaimer

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