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JANUVIA (SITAGLIPTIN): PRESCRIBING INFORMATION

DESCRIPTION

Januvia tablets contain Sitagliptin Phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme.

Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate.

The empirical formula is C16H15F6N5OxH3PO4xH2O and the molecular weight is 523.32.

Sitagliptin Phosphate Monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate.

Each film-coated tablet of Januvia contains 32.13, 64.25, or 128.5 mg of Sitagliptin Phosphate Monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: anhydrous dibasic calcium phosphate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, red iron oxide, titanium dioxide, and yellow iron oxide.


INDICATIONS AND USAGE

Monotherapy and Combination Therapy

Januvia (Sitagliptin Phosphate) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Important Limitations of Use

Januvia (Sitagliptin) should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

Januvia has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using this medication.


DOSAGE AND ADMINISTRATION

Januvia dosage and administration


DOSAGE FORMS AND STRENGTHS

  • 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.


    CONTRAINDICATIONS

    History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.


    WARNINGS AND PRECAUTIONS

    Januvia warnings and precautions


    ADVERSE REACTIONS

    Januvia adverse reactions


    DRUG INTERACTIONS

    Digoxin

    There was a slight increase in the area under the curve (AUC, 11%) and mean peak drug concentration (Cmax, 18%) of digoxin with the co-administration of 100 mg sitagliptin for 10 days. Patients receiving digoxin should be monitored appropriately. No dosage adjustment of digoxin or Januvia (Sitagliptin Phosphate) is recommended.


    USE IN SPECIFIC POPULATIONS

    Januvia use in specific populations


    OVERDOSAGE

    During controlled clinical trials in healthy subjects, single doses of up to 800 mg Januvia (Sitagliptin) were administered. Maximal mean increases in QTc of 8.0 msec were observed in one study at a dose of 800 mg Januvia, a mean effect that is not considered clinically important. There is no experience with doses above 800 mg in clinical studies. In Phase I multiple-dose studies, there were no dose-related clinical adverse reactions observed with this medication with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for up to 28 days.

    In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as dictated by the patient's clinical status.

    Sitagliptin is modestly dialyzable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis.


    CLINICAL PHARMACOLOGY

    Januvia clinical pharmacology

    Januvia drug interactions


    NONCLINICAL TOXICOLOGY

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    A two-year carcinogenicity study was conducted in male and female rats given oral doses of sitagliptin of 50, 150, and 500 mg / kg per day. There was an increased incidence of combined liver adenoma/carcinoma in males and females and of liver carcinoma in females at 500 mg / kg. This dose results in exposures approximately 60 times the human exposure at the maximum recommended daily adult human dose (MRHD) of 100 mg per day based on AUC comparisons. Liver tumors were not observed at 150 mg / kg, approximately 20 times the human exposure at the MRHD. A two-year carcinogenicity study was conducted in male and female mice given oral doses of sitagliptin of 50, 125, 250, and 500 mg / kg per day. There was no increase in the incidence of tumors in any organ up to 500 mg / kg, approximately 70 times human exposure at the MRHD. Sitagliptin was not mutagenic or clastogenic with or without metabolic activation in the Ames bacterial mutagenicity assay, a Chinese hamster ovary (CHO) chromosome aberration assay, an in vitro cytogenetics assay in CHO, an in vitro rat hepatocyte DNA alkaline elution assay, and an in vivo micronucleus assay.

    In rat fertility studies with oral gavage doses of 125, 250, and 1000 mg / kg, males were treated for 4 weeks prior to mating, during mating, up to scheduled termination (approximately 8 weeks total) and females were treated 2 weeks prior to mating through gestation day 7. No adverse effect on fertility was observed at 125 mg / kg (approximately 12 times human exposure at the MRHD of 100 mg per day based on AUC comparisons). At higher doses, nondose-related increased resorptions in females were observed (approximately 25 and 100 times human exposure at the MRHD based on AUC comparison).


    CLINICAL STUDIES

    Januvia clinical studies


    HOW SUPPLIED / STORAGE AND HANDLING

    Tablets Januvia, 25 mg, are pink, round, film-coated tablets with "221" on one side. They are supplied as follows: unit-of-use bottles of 30, 90; unit dose blister packages of 100.
    Tablets Januvia, 50 mg, are light beige, round, film-coated tablets with "112" on one side. They are supplied as follows: unit-of-use bottles of 30, 90; unit dose blister packages of 100.
    Tablets Januvia, 100 mg, are beige, round, film-coated tablets with "277" on one side. They are supplied as follows: unit-of-use bottles of 30, 90; unit dose blister packages of 100; bottles of 500, 1000

    Storage

    Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F), [see USP Controlled Room Temperature].

    Manufactured and distributed by Merck pharmaceutical company and its divisions.

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