Melitide®


(Liraglutide)

What is it?

What is Melitide®?

Melitide® contains liraglutide, an analog of human glucagon-like peptide-1 (GLP-1) and acts as a GLP-1 receptor agonist. Melitide® multidose pen is an injectable prescription medicine.

Indications

What is Melitide® used for?

Melitide® (liraglutide) is used:

  • Along with diet and exercise to lower blood sugar (glucose) in adults and children who are 10 years of age and older with type 2 diabetes mellitus
  • To reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease.

Contraindications

Who should not use Melitide®?

Do not use Melitide® if:

  • You or any of your family have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • You are allergic to liraglutide or any of the ingredients in Melitide®.

Melitide® is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.

It is not known if Melitide® can be used with mealtime insulin.

It is not known if Melitide® is safe and effective to lower blood sugar in children under 10 years of age.

Important information

What should I tell my health care provider before using Melitide®?

Before using Melitide®, tell your health care provider if you:

  • Have or have had problems with your pancreas, kidneys, or liver.
  • Have any other medical conditions or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
  • Are pregnant or breastfeeding or plan to become pregnant or breastfeed.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.

How should I use Melitide®?

  • Do not mix insulin and Melitide® together in the same injection.
  • You may give an injection of Melitide® and insulin in the same body area (such as your stomach area), but not right next to each other.
  • Do not share your Melitide® pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Side Effects

What are the possible side effects of Melitide®?

The most common side effects of Melitide® may include nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.

Melitide® may cause serious side effects, including:

  • Possible thyroid tumors, including cancer. Tell your health care 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. In studies with rats and mice, liraglutide caused thyroid tumors, including thyroid cancer. It is not known if liraglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
  • Inflammation of your pancreas (pancreatitis). Stop using Melitide® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
  • Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Melitide® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. In children who are 10 years of age and older, the risk for low blood sugar may be higher with Melitide® regardless of use with another medicine that can also lower blood sugar. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
  • Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse.
  • Serious allergic reactions. Stop using Melitide® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or a very rapid heartbeat.
  • Gallbladder problems. Gallbladder problems have happened in some people who take liraglutide. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include pain in the right or middle upper stomach area, fever, nausea and vomiting, or your skin or the white part of your eyes turns yellow.

Storage

Storage

Melitide® should be stored in a refrigerator between 2ºC to 8ºC. Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze Melitide® and do not use Melitide® if it has been frozen. Keep the pen cap on when not in use. Melitide® should be protected from excessive heat and sunlight. Always remove and safely discard the needle after each injection and store the Melitide® pen without an injection needle attached. This will reduce the potential for contamination, infection, and leakage while also ensuring dosing accuracy.

 

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