Dulaglutide Injection

  • Medicine name- Aplevant
  • API- Dulaglutide
  • Pack Size-  single-dose pen
  • Strength- 0.75 mg and 1.5 mg
  • Manufactured By: Lupin Ltd
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Description

Dulaglutide injection is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated:

  • As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 
  • To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. Limitations of Use: 
  • Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in these patients. 
  • Not for treatment of type 1 diabetes mellitus. 
  • Not recommended in patients with severe gastrointestinal disease, including severe gastroparesis.

Dosage and Side Effects

  • Initiate at 0.75 mg subcutaneously once weekly. Increase the dose to 1.5 mg once weekly for additional glycemic control.
  • If additional glycemic control is needed, increase the dose to 3 mg once weekly after at least 4 weeks on the 1.5 mg dose. 
  • If additional glycemic control is needed, increase to the maximum dose of 4.5 mg once weekly after at least 4 weeks on the 3 mg dose. 
  • If a dose is missed, administer the missed dose as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose.
  • Administer once weekly at any time of day with or without food. 
  • Inject subcutaneously in the abdomen, thigh, or upper arm.

Dulaglutide common side effects are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.

Warning and Precautions

Thyroid C-cell Tumors: See Boxed Warning. 

  • Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
  •  Hypoglycemia: When Dulaglutide is used with an insulin secretagogue or insulin, consider lowering the dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia.
  • Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) have occurred. Discontinue Dulaglutide and promptly seek medical advice. 
  • Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. 
  • Severe Gastrointestinal Disease: Use may be associated with gastrointestinal adverse reactions, sometimes severe. Has not been studied in patients with severe gastrointestinal disease and is not recommended in these patients. 
  • Diabetic Retinopathy Complications: Have been reported in a cardiovascular outcomes trial. Monitor patients with a history of diabetic retinopathy.

FAQ's

Is dulaglutide approved by the FDA?

The FDA approved the drug Dulaglutide in 2014.

What is the warning for dulaglutide?

  • Thyroid C-cell Tumors: See Boxed Warning. 
  • Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed. 
  • Hypoglycemia: When Dulaglutide is used with an insulin secretagogue or insulin, consider lowering the dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia. 
  • Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) have occurred. Discontinue Dulaglutide and promptly seek medical advice.

How is Dulaglutide administered?

Dulaglutide solution supplied in single-dose pens for subcutaneous administration.