Brand and Other Names:Januvia
Dosing & Uses
Dosage Forms & Strengths
Diabetes Mellitus, Type 2
100 mg PO qDay
- CrCl >50 mL/min: Dose adjustment not necessary
- CrCl 30-50 mL/min: 50 mg PO qDay
- CrCl <30 mL/min: 25 mg PO qDay
- ESRD: 25 mg PO qDay regardless of hemodialysis
- Mild to moderate impairment: Dose adjustment not necessary
- Severe impairment: Not studied
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Peripheral edema (2%)
Hypersensitivity reactions such as anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions (including Stevens-Johnson syndrome)
Hepatic enzyme elevations
Acute pancreatitis, including fatal and nonfatal hemorrhagic and necrotizing pancreatitis
Worsening renal function, including acute renal failure (sometimes requiring dialysis)
Severe and disabling arthralgia
Pain in extremity
Use with caution in hepatic impairment, or heart failure
Use with caution in renal failure; worsening of renal failure, including acute renal failure reported
Not for use in diabetic ketoacidosis patients; not effective
Not for use in type 1 diabetes mellitus; not effective
Combo treatment studied only with metformin and thiazolidinediones, not with insulin or sulfonylureas
Caution when coadministering with strong CYP3A4/5 inhibitors (may require dose adjustment)
May cause acute pancreatitis, including hemorrhagic and necrotizing pancreatitis; unknown if patients with history of pancreatitis are at increased risk
Concomitant use of insulin with secretagogues may increase risk of hypoglycemia
Angioedema reported with other dipeptidyl peptidase-4 (DPP-4) inhibitors; caution with history of angioedema
Severe and disabling arthralgia reported in patients taking DPP-4 inhibitors; consider as a possible cause for severe joint pain and discontinue drug if appropriate
Pregnancy & Lactation
Pregnancy category: B
Lactation: Not known whether excreted in breast milk: use caution
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
DPP-4 inhibitor; therefore, increases and prolongs incretin hormone activity, which is inactivated by DPP-4 enzyme
Incretins increase insulin release and synthesis from pancreatic beta cells and reduce glucagon secretion from pancreatic alpha cells
Peak plasma time: 1-4 hr
Protein bound: 38%
Vd: 198 L
Limited; primarily via CYP3A4 and CYP2C8
Half-life, terminal: 12.4 hr
Excretion: Urine (87%), feces (13%)
Take with or without food
Swallow tablet whole; do not chew, crush, or split
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