ZITUVIO

SITAGLIPTIN

Manufacturer: Zydus Pharmaceuticals (USA) Inc.

Score: 141.0

Quick Summary

JANUVIA (SITAGLIPTIN) is a dipeptidyl peptidase-4 (DPP-4) inhibitor used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It works by slowing the inactivation of incretin hormones, increasing insulin release, and decreasing glucagon levels in a glucose-dependent manner. The recommended dose is 100 mg once daily, which can be taken with or without food. Dosage adjustments are recommended for patients with renal impairment. JANUVIA has been associated with several adverse reactions, including upper respiratory tract infection, nasopharyngitis, and headache. It is contraindicated in patients with a history of serious hypersensitivity reactions to sitagliptin and should not be used in patients with type 1 diabetes or a history of pancreatitis.

Key Clinical Findings and Indications

JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
JANUVIA slows the inactivation of incretin hormones, increasing insulin release and decreasing glucagon levels in a glucose-dependent manner
JANUVIA has been shown to be effective in improving glycemic control in patients with type 2 diabetes mellitus

Important Safety Information

Warning

JANUVIA should not be used in patients with type 1 diabetes or a history of pancreatitis

Contraindications

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

Adverse Reactions

Upper respiratory tract infection
Nasopharyngitis
Headache
Hypoglycemia

Dosing Recommendations

General Guidance

Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.73 m^2

Type 2 diabetes mellitus

Adult Dose

100 mg once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

The limited available data with JANUVIA in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage

Nursing Mothers

No information available

Pediatric Use

The safety and effectiveness of JANUVIA have not been established in pediatric patients

Geriatric Use

Of the total number of subjects in pre-approval clinical safety and efficacy studies of JANUVIA, 725 patients were 65 years and over, while 61 patients were 75 years and over