Q: What is Xultophy used for?

Xultophy is used to treat type 2 diabetes mellitus .

Q: What are the active ingredients in Xultophy?

The active ingredients in Xultophy are insulin degludec and liraglutide .

Q: What are the side effects of Xultophy?

Common side effects of Xultophy may include: Nausea Diarrhea Low blood sugar Always consult with a healthcare professional about potential side effects.

Q: What is the dosage of Xultophy and how do I take it?

How to Use Xultophy is administered as an injection under the skin (subcutaneously) once per day. It can be taken at any time of day, with or without food, but it should be used at approximately the same time each day. Common injection sites include the abdomen, the thigh, or the upper arm. It is important to rotate the injection site within the chosen area for each dose to reduce the risk of developing skin lumps or thickened skin at the injection site. Administration Tips Always check the medication before use; the liquid should be clear and colorless. Do not use the medication if it is cloudy or contains particles. Use a new needle for every injection to prevent contamination, infection, and needle blockage. Never share your injection pen with another person, even if the needle has been changed, as this can spread bloodborne pathogens. Missed Dose If you miss a dose of Xultophy, skip the missed dose and take your next scheduled dose the following day at your usual time. Do not take an extra dose or increase your dose to make up for a missed one. If you miss more than three consecutive days of doses, contact your healthcare provider for instructions on how to restart the medication.

Q: Is Xultophy safe during pregnancy and breastfeeding?

Pregnancy It is not known if Xultophy will harm an unborn baby, as there are no adequate and well-controlled studies in pregnant women. Research involving liraglutide, one of the active ingredients in Xultophy, has shown evidence of fetal harm in animal studies, including reduced growth and physical abnormalities. However, animal studies for the other ingredient, insulin degludec, did not show adverse effects on fetal development. Poorly controlled diabetes during pregnancy increases the risk of complications for both the mother and the fetus, such as birth defects, pregnancy-induced high blood pressure, and stillbirth. If you are pregnant or planning to become pregnant, talk to your healthcare provider about the best way to manage your blood sugar levels. Breastfeeding It is unknown whether Xultophy passes into human breast milk or if it has any effect on a nursing infant or milk production. In animal studies, both insulin degludec and liraglutide were found in the milk of lactating rats. Because the risks to a human infant are not established, you should consult with your doctor to determine if you should continue using this medication while breastfeeding.

Q: What is the FDA approval status of Xultophy?

FDA Approval and Indications Xultophy was approved by the U.S. Food and Drug Administration (FDA) in November 2016. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Boxed Warning The medication carries a boxed warning because one of its active ingredients, liraglutide, has been shown to cause thyroid C-cell tumors in animal studies. It is unknown whether it causes these tumors in humans. Patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) should not use this medication. Safety Monitoring The FDA has monitored potential safety signals associated with Xultophy through the FDA Adverse Event Reporting System (FAERS): Medication Errors: In early 2018, the FDA identified potential signals related to medication errors, including receiving the wrong drug or dose. Gastrointestinal Issues: In 2020, the FDA evaluated reports of ileus (a condition where the muscles of the intestines do not allow food to pass through, resulting in a blockage) associated with GLP-1 receptor agonists like the liraglutide component in Xultophy.

Question 1

What is Xultophy?

Accepted Answer

Xultophy is a medication that combines a long-acting basal insulin with a glucagon-like peptide-1 (GLP-1) receptor agonist. The two active ingredients are insulin degludec and liraglutide.

The insulin component provides a steady level of basal insulin, while the GLP-1 receptor agonist helps the body release its own insulin more effectively. Together, these components work to maintain more consistent glucose levels through multiple physiological pathways.

Question 2

What is Xultophy used for?

Accepted Answer

Xultophy is used to treat type 2 diabetes mellitus.

Question 3

How does Xultophy work?

Accepted Answer

How Xultophy Works

Xultophy contains two active ingredients that work together to control blood sugar: insulin degludec and liraglutide.

Insulin Degludec

Insulin degludec is a long-acting (basal) insulin. It works by replacing the insulin that the body would normally produce. Its primary functions include:

Helping cells in the muscles and fat take in sugar from the bloodstream to use as energy.
Reducing the amount of sugar the liver produces and releases into the blood.

Because it is long-acting, it provides a steady level of insulin in the body for an extended period.

Liraglutide

Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. It mimics a natural hormone in the body to manage blood sugar in several ways:

Increasing insulin release: It signals the pancreas to release more insulin, but only when blood sugar levels are high.
Lowering glucagon: It reduces the secretion of glucagon, a hormone that tells the liver to release stored sugar.
Slowing digestion: It slows down the speed at which food leaves the stomach, which helps prevent blood sugar from rising too quickly after a meal.

Question 4

What are the active ingredients in Xultophy?

Accepted Answer

The active ingredients in Xultophy are insulin degludec and liraglutide.

Question 5

What are the side effects of Xultophy?

Accepted Answer

Common side effects of Xultophy may include:

Nausea
Diarrhea
Low blood sugar

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Xultophy?

Accepted Answer

Xultophy belongs to the combination of long-acting insulin and GLP-1 receptor agonist drug class.

Question 7

What is the dosage of Xultophy and how do I take it?

Accepted Answer

How to Use

Xultophy is administered as an injection under the skin (subcutaneously) once per day. It can be taken at any time of day, with or without food, but it should be used at approximately the same time each day.

Common injection sites include the abdomen, the thigh, or the upper arm. It is important to rotate the injection site within the chosen area for each dose to reduce the risk of developing skin lumps or thickened skin at the injection site.

Administration Tips

Always check the medication before use; the liquid should be clear and colorless. Do not use the medication if it is cloudy or contains particles.
Use a new needle for every injection to prevent contamination, infection, and needle blockage.
Never share your injection pen with another person, even if the needle has been changed, as this can spread bloodborne pathogens.

Missed Dose

If you miss a dose of Xultophy, skip the missed dose and take your next scheduled dose the following day at your usual time. Do not take an extra dose or increase your dose to make up for a missed one. If you miss more than three consecutive days of doses, contact your healthcare provider for instructions on how to restart the medication.

Question 8

Is Xultophy safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

It is not known if Xultophy will harm an unborn baby, as there are no adequate and well-controlled studies in pregnant women. Research involving liraglutide, one of the active ingredients in Xultophy, has shown evidence of fetal harm in animal studies, including reduced growth and physical abnormalities. However, animal studies for the other ingredient, insulin degludec, did not show adverse effects on fetal development.

Poorly controlled diabetes during pregnancy increases the risk of complications for both the mother and the fetus, such as birth defects, pregnancy-induced high blood pressure, and stillbirth. If you are pregnant or planning to become pregnant, talk to your healthcare provider about the best way to manage your blood sugar levels.

Breastfeeding

It is unknown whether Xultophy passes into human breast milk or if it has any effect on a nursing infant or milk production. In animal studies, both insulin degludec and liraglutide were found in the milk of lactating rats. Because the risks to a human infant are not established, you should consult with your doctor to determine if you should continue using this medication while breastfeeding.

Question 9

What forms and strengths does Xultophy come in?

Accepted Answer

Xultophy is supplied as a clear, colorless solution for subcutaneous injection. It is available in the following format:

Pre-filled Pen: A disposable, multi-dose delivery device designed for use by an individual patient.

The medication is administered by injection into the fatty layer under the skin of the thigh, upper arm, or abdomen.

Question 10

What is the FDA approval status of Xultophy?

Accepted Answer

FDA Approval and Indications

Xultophy was approved by the U.S. Food and Drug Administration (FDA) in November 2016. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Boxed Warning

The medication carries a boxed warning because one of its active ingredients, liraglutide, has been shown to cause thyroid C-cell tumors in animal studies. It is unknown whether it causes these tumors in humans. Patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) should not use this medication.

Safety Monitoring

The FDA has monitored potential safety signals associated with Xultophy through the FDA Adverse Event Reporting System (FAERS):

Medication Errors: In early 2018, the FDA identified potential signals related to medication errors, including receiving the wrong drug or dose.
Gastrointestinal Issues: In 2020, the FDA evaluated reports of ileus (a condition where the muscles of the intestines do not allow food to pass through, resulting in a blockage) associated with GLP-1 receptor agonists like the liraglutide component in Xultophy.

Question 11

What should I know about Xultophy and cost?

Accepted Answer

Insurance and Medicare Coverage

Most commercial insurance plans and many Medicare Part D plans provide coverage for Xultophy. However, because it is a brand-name combination drug, it is often placed on a higher formulary tier, which can lead to higher copayments. Some plans may also require prior authorization from a healthcare provider before they will cover the medication.

Manufacturer Assistance

The manufacturer of Xultophy may offer financial assistance to help reduce costs for eligible patients. This often includes savings cards for those with commercial insurance or patient assistance programs for individuals who meet specific income requirements and lack adequate insurance coverage.

Generic Availability

There is currently no generic version of Xultophy available in the United States. Brand-name medications typically maintain higher prices until their patent protections expire and the FDA approves generic alternatives.

Pharmacy Pricing

The retail price of Xultophy can vary significantly between different pharmacies. Patients may find different prices at local retail pharmacies compared to mail-order services or large warehouse clubs.

Xultophy

📋Overview

How It Works

Uses

Active Ingredients

Common Side Effects

Warnings & Precautions

Dosage

Pregnancy & Breastfeeding

Frequently Asked Questions

📚References

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