Indications and clinical use

Monotherapy: Trajenta® is indicated for use as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus for whom metformin is inappropriate due to contraindications or intolerance.

Add-on combination: Trajenta® is indicated for use in adult patients with type 2 diabetes mellitus to improve glycemic control in combination with: metformin, sulfonylurea (with or without metformin), metformin and empagliflozin, basal insulin (with or without metformin), when the therapy alone listed above, along with diet and exercise, does not provide adequate glycemic control.

No dosage adjustment is required based on age, however, greater sensitivity in some older individuals cannot be ruled out.

Safety and effectiveness has not been established in pediatric patients (<18 years of age), therefore Trajenta® should not be used in this patient population.

Contraindications

Patients with diabetic ketoacidosis or with type 1 diabetes mellitus

Relevant warnings and precautions

  • An association between DPP-4i treatment and heart failure was observed in cardiovascular outcomes trials for two other members of the DPP-4i class
  • Hypoglycemia: caution when used in combination with a sulfonylurea or insulin
  • Loss of glycemic control may occur in periods of stress
  • Use with strong inducers of P-gp or CYP3A4 (blood glucose monitoring recommended)
  • Not recommended in patients with severe hepatic impairment
  • Monitor for signs and symptoms of pancreatitis
  • Clinical trial/post-marketing reports of serious hypersensitivity reactions
  • Immunocompromised patients (consider monitoring lymphocyte count)
  • Monitor blood glucose and HbA1c levels periodically
  • Assess hepatic function before starting treatment and periodically thereafter
  • Use with caution in patients with end-stage renal disease (ESRD) and those on dialysis
  • No studies on the effect on human fertility have been conducted
  • Ulcerative and necrotic skin lesions (monitoring for skin disorders is recommended)
  • Cases of bullous pemphigoid
  • Not recommended in pregnant and nursing women

For more information

Please refer to the Product Monograph at www.TrajentaPM.ca for important information relating to adverse events, drug interactions, dosing and conditions of clinical use. The Product Monograph is also available by calling 1-800-263-5103 ext. 84633.