Januvia (Sitagliptin)
Dosage & administration
The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food. (
The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.
Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.73 m2. (
Assess renal function prior to initiation of JANUVIA and periodically thereafter.
For patients with an estimated glomerular filtration rate [eGFR] greater than or equal to 45 mL/min/1.73 m2to less than 90 mL/min/1.73 m2, no dosage adjustment for JANUVIA is required.
For patients with moderate renal impairment (eGFR greater than or equal to 30 mL/min/1.73 m2to less than 45 mL/min/1.73 m2), the dose of JANUVIA is 50 mg once daily.
For patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25 mg once daily. JANUVIA may be administered without regard to the timing of dialysis.
| eGFR greater than or equal to 30 mL/min/1.73 m2 to less than 45 mL/min/1.73 m2 | eGFR less than 30 mL/min/1.73 m2 (including patients with end stage renal disease [ESRD] on dialysis) |
| 50 mg once daily | 25 mg once daily |
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Januvia prescribing information
JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food. (
The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.
Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.73 m2. (
Assess renal function prior to initiation of JANUVIA and periodically thereafter.
For patients with an estimated glomerular filtration rate [eGFR] greater than or equal to 45 mL/min/1.73 m2to less than 90 mL/min/1.73 m2, no dosage adjustment for JANUVIA is required.
For patients with moderate renal impairment (eGFR greater than or equal to 30 mL/min/1.73 m2to less than 45 mL/min/1.73 m2), the dose of JANUVIA is 50 mg once daily.
For patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25 mg once daily. JANUVIA may be administered without regard to the timing of dialysis.
| eGFR greater than or equal to 30 mL/min/1.73 m2 to less than 45 mL/min/1.73 m2 | eGFR less than 30 mL/min/1.73 m2 (including patients with end stage renal disease [ESRD] on dialysis) |
| 50 mg once daily | 25 mg once daily |
- 100 mg tablets are beige, round, film-coated tablets with "277" on one side.
- 50 mg tablets are light beige, round, film-coated tablets with "112" on one side.
- 25 mg tablets are pink, round, film-coated tablets with "221" on one side.
The limited available data with JANUVIA in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy
Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity.
In embryo-fetal development studies, sitagliptin administered to pregnant rats and rabbits during organogenesis (gestation day 6 to 20) did not adversely affect developmental outcomes at oral doses up to 250 mg/kg (30-times the 100 mg clinical dose) and 125 mg/kg (20-times the 100 mg clinical dose), respectively, based on AUC. Higher doses in rats associated with maternal toxicity increased the incidence of rib malformations in offspring at 1000 mg/kg, or approximately 100-times the clinical dose, based on AUC. Placental transfer of sitagliptin was observed in pregnant rats and rabbits.
Sitagliptin administered to female rats from gestation day 6 to lactation day 21 caused no functional or behavioral toxicity in offspring of rats at doses up to 1000 mg/kg.
The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a Hemoglobin A1c >7% and has been reported to be as high as 20-25% in women with a Hemoglobin A1c >10%. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.
There have been postmarketing reports of serious hypersensitivity reactions in patients treated with JANUVIA. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset of these reactions occurred within the first 3 months after initiation of treatment with JANUVIA, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue JANUVIA, assess for other potential causes for the event, and institute alternative treatment for diabetes.
Angioedema has also been reported with other DPP-4 inhibitors. Use caution in a patient with a history of angioedema with another DPP-4 inhibitor because it is unknown whether such patients will be predisposed to angioedema with JANUVIA.
Additional adverse reactions have been identified during postapproval use of JANUVIA as monotherapy and/or in combination with other antihyperglycemic agents. 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 including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions including Stevens-Johnson syndrome; hepatic enzyme elevations; acute pancreatitis, including fatal and non-fatal hemorrhagic and necrotizing pancreatitis
- Pancreatitis:There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue JANUVIA. ()
5.1 PancreatitisThere have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking JANUVIA. After initiation of JANUVIA, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, JANUVIA should promptly be discontinued and appropriate management should be initiated. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUVIA.
- Heart failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of JANUVIA in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. ()
5.2 Heart FailureAn association between dipeptidyl peptidase-4 (DPP-4) inhibitor treatment and heart failure has been observed in cardiovascular outcomes trials for two other members of the DPP-4 inhibitor class. These trials evaluated patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease.
Consider the risks and benefits of JANUVIA prior to initiating treatment in patients at risk for heart failure, such as those with a prior history of heart failure and a history of renal impairment, and observe these patients for signs and symptoms of heart failure during therapy. Advise patients of the characteristic symptoms of heart failure and to immediately report such symptoms. If heart failure develops, evaluate and manage according to current standards of care and consider discontinuation of JANUVIA.
- Acute Renal Failure:Has been reported postmarketing, sometimes requiring dialysis. Assessment of renal function is recommended prior to initiating JANUVIA and periodically thereafter. ()
5.3 Acute Renal FailureThere have been postmarketing reports of worsening renal function, including acute renal failure, sometimes requiring dialysis. A subset of these reports involved patients with renal impairment, some of whom were prescribed inappropriate doses of sitagliptin. A return to baseline levels of renal impairment has been observed with supportive treatment and discontinuation of potentially causative agents. Consideration can be given to cautiously reinitiating JANUVIA if another etiology is deemed likely to have precipitated the acute worsening of renal function.
Assessment of renal function is recommended prior to initiating JANUVIA and periodically thereafter. A dosage adjustment is recommended in patients with moderate or severe renal impairment and in patients with ESRD requiring hemodialysis or peritoneal dialysis.
[See Dosage and Administration (2.2); Use in Specific Populations (8.6).] - Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues:Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Lower dose of insulin or insulin secretagogue may be required. (,
5.4 Hypoglycemia with Concomitant Use with Insulin or Insulin SecretagoguesWhen JANUVIA was used in combination with insulin or insulin secretagogues (e.g., sulfonylurea), medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo used in combination with a sulfonylurea or with insulin.
[See Adverse Reactions (6.1).]Therefore, a lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.[See Drug Interactions (7.1).])7.1 Insulin Secretagogues or InsulinCoadministration of JANUVIA with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
[See Warnings and Precautions (5.4).] - Hypersensitivity Reactions:There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with JANUVIA such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Promptly stop JANUVIA, assess for other potential causes, institute appropriate monitoring and treatment. (,
5.5 Hypersensitivity ReactionsThere have been postmarketing reports of serious hypersensitivity reactions in patients treated with JANUVIA. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset of these reactions occurred within the first 3 months after initiation of treatment with JANUVIA, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue JANUVIA, assess for other potential causes for the event, and institute alternative treatment for diabetes.
[See Adverse Reactions (6.2).]Angioedema has also been reported with other DPP-4 inhibitors. Use caution in a patient with a history of angioedema with another DPP-4 inhibitor because it is unknown whether such patients will be predisposed to angioedema with JANUVIA.
)6.2 Postmarketing ExperienceAdditional adverse reactions have been identified during postapproval use of JANUVIA as monotherapy and/or in combination with other antihyperglycemic agents. 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 including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions including Stevens-Johnson syndrome; hepatic enzyme elevations; acute pancreatitis, including fatal and non-fatal hemorrhagic and necrotizing pancreatitis
[see Indications and Usage (1)]; worsening renal function, including acute renal failure (sometimes requiring dialysis), and tubulointerstitial nephritis; severe and disabling arthralgia;bullous pemphigoid;constipation; vomiting; headache; myalgia; pain in extremity; back pain; pruritus; mouth ulceration; stomatitis; rhabdomyolysis. - Severe and Disabling Arthralgia:Has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate. ()
5.6 Severe and Disabling ArthralgiaThere have been postmarketing reports of severe and disabling arthralgia in patients taking DPP-4 inhibitors. The time to onset of symptoms following initiation of drug therapy varied from one day to years. Patients experienced relief of symptoms upon discontinuation of the medication. A subset of patients experienced a recurrence of symptoms when restarting the same drug or a different DPP-4 inhibitor. Consider DPP-4 inhibitors as a possible cause for severe joint pain and discontinue drug if appropriate.
- Bullous Pemphigoid:There have been postmarketing reports requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue JANUVIA. ()
5.7 Bullous PemphigoidPostmarketing cases of bullous pemphigoid requiring hospitalization have been reported with DPP-4 inhibitor use. In reported cases, patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of the DPP-4 inhibitor. Tell patients to report development of blisters or erosions while receiving JANUVIA. If bullous pemphigoid is suspected, JANUVIA should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment.