Safety Profile

Contraindications

ProzalanD is contraindicated in patients with hypersensitivity to ProzalanD or any of its excipients.

Warnings and Precautions

• Dosage adjustment and monitoring: Monitor blood glucose in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment of concomitant anti-diabetic treatment.
• Administration: Do not dilute or mix with any other insulin or solution. Do not administer subcutaneously via an insulin pump, intramuscularly, or intravenously because severe hypoglycemia can occur. Needles, insulin pens, or syringes should never be shared.
• Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin therapy and may be life-threatening. When a GLP-1 receptor agonist is used in combination with ProzalanD, the ProzalanD dose may need to be lowered or more conservatively titrated to minimize the risk of hypoglycemia.
• Hypersensitivity and allergic reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including ProzalanD.
• Renal and hepatic Impairment: Careful glucose monitoring and dose adjustments of insulin, including ProzalanD, may be necessary in patients with renal or hepatic impairment.
• Drug Interactions: Some medications may alter insulin requirements and subsequently increase the risk for hypoglycemia or hyperglycemia.
• Fluid retention and heart failure with concomitant use of PPAR-gamma agonists: Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including ProzalanD. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered.

Adverse Reactions

• Adverse reactions associated with ProzalanD include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, rash, pruritus, and if taken with GLP-1 receptor agonist, diarrhea.

Use in Specific Populations

• ProzalanD has not been studied in children with type 2 diabetes or in children with type 1 diabetes who are younger than 2 years of age.
• The background risk of birth defects, pregnancy loss, or other adverse events that exists for all pregnancies is increased in pregnancies complicated by hyperglycemia.

Whether these observed weight results represent true effects of ProzalanD and other therapies are not known since the trial was not blinded, and the protocol (eg, diet and exercise instructions and monitoring) was not specifically directed at exploring hypotheses related to weight effects of the treatments evaluated. The clinical significance of these observed effects has not been established.