In a 24-week study of initial therapy with JANUVIA at 100 mg/day in combination with pioglitazone at 30 mg/day (N=261)

• There were no adverse reactions reported (regardless of investigator assessment of causality) in ≥5% of patients and more commonly than in patients given pioglitazone alone (N=259)

In a 24-week, placebo-controlled clinical study of initial therapy with sitagliptin (100 mg) and metformin (1000 mg or 2000 mg per day [administered as sitagliptin 50 mg/metformin 500 mg or 1000 mg twice daily])

• Adverse experiences reported (regardless of investigator assessment of causality) in ≥5% of patients treated with sitagliptin plus metformin (n=372) and more commonly than in patients treated with metformin alone (n=364) were: upper respiratory tract infection (sitagliptin plus metformin, 6.2%; metformin, 5.2%) and headache (5.9%, 3.8%)
• The incidence of hypoglycemia was 1.6% in patients given sitagliptin in combination with metformin and 0.8% in patients given metformin alone

In a placebo-controlled clinical study of sitagliptin (100 mg) with metformin and rosiglitazone

• Adverse experiences reported (regardless of causality assessment) through the primary time point at week 18 in ≥5% of patients treated with sitagliptin (n=170) and more commonly than in patients treated with placebo (n=92) were: upper respiratory tract infection (JANUVIA, 5.9%; placebo, 5.4%) and nasopharyngitis (5.3%, 4.3%)
• Through week 54, the adverse experiences reported (regardless of causality assessment) in ≥5% of patients treated with sitagliptin and more commonly than in patients treated with placebo were: upper respiratory tract infection (JANUVIA, 16.5%; placebo, 6.5%), nasopharyngitis (10.6%, 9.8%), peripheral edema (8.8%, 5.4%), and headache (5.9%, 4.3%)

In a 24-week, placebo-controlled clinical study of JANUVIA (100 mg once daily) with glimepiride or glimepiride + metformin

• Adverse experiences reported regardless of causality assessment in ≥5% of patients treated with JANUVIA (n=222) and more commonly than in patients treated with placebo (n=219) were: hypoglycemia (JANUVIA, 12.2%; placebo, 1.8%), nasopharyngitis (6.3%, 4.6%), and headache (5.9%, 2.3%)
• As is typical with other antihyperglycemic agents, when JANUVIA was used in combination with a sulfonylurea or with insulin, medications known to cause hypoglycemia, the incidence of sulfonylurea- or insulin-induced hypoglycemia was increased over that of placebo
  • As a drug-related adverse reaction reported in ≥1% of patients treated with JANUVIA and more commonly than in patients treated with placebo, rates of hypoglycemia reported were 9.5% with JANUVIA and 0.9% with placebo
  • A lower dose of sulfonylurea or insulin may be considered to reduce the risk of sulfonylurea- or insulin-induced hypoglycemia

In a 24-week, placebo-controlled study of JANUVIA 100 mg once daily in combination with insulin (with or without metformin)

• The only adverse experience reported regardless of causality assessment in ≥5% of patients treated with JANUVIA (n=322) and more commonly than in patients treated with placebo (n= 319) was hypoglycemia (JANUVIA, 15.5%; placebo, 7.8%).
  

Postmarketing experience

• The following additional adverse reactions have been identified during postmarketing use of JANUVIA. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Hypersensitivity reactions include anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions, including Stevens-Johnson syndrome; upper respiratory tract infection; nasopharyngitis; pancreatitis

Before prescribing, please consult the Prescribing Information.

הידעת?
™JANUVIA פעם ביום מאפשרת אופציות טיפוליות גמישות למגוון רחב של חולים