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 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.