Omari12.5 mg

Omari is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

• Established use: As monotherapy or in combination with other antidiabetic agents (such as metformin, sulfonylureas, or insulin) when diet and exercise alone, or existing therapy, do not provide adequate glycemic control.
• Distinguishing feature: Omari is notable for once-weekly oral dosing, owing to its long plasma half-life, which may support adherence compared with once-daily agents in the same class.
• Not indicated for: Omari is not indicated for the treatment of type 1 diabetes mellitus or for diabetic ketoacidosis, as it is not effective in these settings.

Each film-coated tablet of Omarigliptin typically contains Omarigliptin equivalent to 25 mg or 12.5 mg of the free base, along with standard pharmaceutical excipients used for tablet formulation. Exact strengths and excipients may vary by manufacturer; refer to the specific product label for details.

Omari is an orally administered, highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor belonging to the "gliptin" class of antidiabetic medicines. It was developed with a long elimination half-life that allows for once-weekly dosing, distinguishing it from most other DPP-4 inhibitors, which are typically dosed once daily.

Omari is used in the management of type 2 diabetes mellitus, generally as part of a broader treatment plan that includes diet, exercise, and, where appropriate, other antidiabetic medications.

Omari belongs to the Dipeptidyl Peptidase-4 (DPP-4) Inhibitor class of oral antidiabetic agents (also known as "gliptins").

Omarigliptin works by inhibiting the enzyme dipeptidyl peptidase-4 (DPP-4), which is responsible for the rapid degradation of the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).

• By inhibiting DPP-4, Omarigliptin increases circulating levels of active incretin hormones.
• This leads to glucose-dependent increases in insulin secretion from pancreatic beta cells and a decrease in glucagon secretion from alpha cells.
• The overall effect is improved glycemic control with a low intrinsic risk of hypoglycemia when used as monotherapy.
• Omarigliptin has a long plasma half-life (reported to be in the range of several days), which is the pharmacologic basis for its once-weekly dosing regimen.

Omari tablets are taken orally, once weekly, on the same day each week, with or without food. The day of weekly administration can be changed if necessary, as long as the next dose is taken at least 3 days after the previous dose. Tablets should be swallowed whole with water and should not be crushed or chewed unless specifically directed by a physician.

Omari has a relatively low potential for clinically significant drug interactions, as it is not extensively metabolized by the cytochrome P450 system. However, the following interactions are clinically relevant:

• Sulfonylureas and insulin: Concomitant use with Omari increases the risk of hypoglycemia; a lower dose of the sulfonylurea or insulin may be required.
• Other antidiabetic agents: Combination with other glucose-lowering drugs may have additive glucose-lowering effects, requiring monitoring of blood glucose.
• P-glycoprotein/transporter-affecting drugs: Since Omari is a substrate of certain drug transporters, strong inhibitors or inducers of these pathways could theoretically alter Omari exposure; clinical significance is generally limited but caution is advised.

Patients should inform their physician of all medicines they are taking, including over-the-counter drugs and herbal supplements, before starting Omari.

Most patients tolerate Omari well. Reported side effects include:

Common

• Nasopharyngitis (common cold-like symptoms)
• Headache
• Upper respiratory tract infection
• Hypoglycemia (mainly when Omari is used together with a sulfonylurea or insulin)

Less Common / Serious

• Acute pancreatitis (see Precautions and Warnings)
• Severe and disabling joint pain (arthralgia), a recognized class effect of DPP-4 inhibitors
• Hypersensitivity reactions, including angioedema, urticaria, and rarely severe skin reactions
• Bullous pemphigoid (a blistering skin condition), reported with DPP-4 inhibitors as a class

Patients should seek medical attention promptly if they experience severe abdominal pain, signs of an allergic reaction, severe joint pain, or unusual skin blistering.

Pregnancy: Data on the use of Omari in pregnant women are limited. Omari should be used during pregnancy only if clearly needed and if the potential benefit to the mother justifies the potential risk to the fetus. As uncontrolled diabetes during pregnancy carries risks to both mother and baby, insulin is generally the preferred agent for glycemic control in pregnancy; a physician should be consulted before use of Omari in this setting.

Lactation: It is not known whether Omari passes into human breast milk. Because many drugs are excreted in breast milk and the effects on a nursing infant are unknown, a decision should be made by a physician whether to discontinue breastfeeding or discontinue Omari, taking into account the benefit of breastfeeding and the mother's clinical need for the drug.

The following precautions should be observed with Omari:

• Pancreatitis: Cases of acute pancreatitis have been reported with DPP-4 inhibitors as a class. Patients should be observed for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back, with or without vomiting). If pancreatitis is suspected, Omari should be discontinued promptly.
• Heart failure: Some drugs in the DPP-4 inhibitor class have been associated with an increased risk of hospitalization for heart failure. Caution is advised in patients with known risk factors for heart failure, and patients should be monitored for signs and symptoms such as unusual shortness of breath or swelling.
• Severe joint pain: Severe and sometimes disabling joint pain has been reported with DPP-4 inhibitors as a class. Onset can occur from one day to years after starting treatment. If this occurs, the physician should evaluate for other causes and consider discontinuing Omari.
• Hypoglycemia: When used with a sulfonylurea or insulin, the risk of hypoglycemia is increased; a lower dose of the sulfonylurea or insulin may be needed (see Interactions).
• Hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylaxis, angioedema, and severe skin reactions, have been reported with DPP-4 inhibitors. If a serious hypersensitivity reaction is suspected, Omari should be discontinued and alternative treatment considered (see Contraindications).
• Not for type 1 diabetes or diabetic ketoacidosis: Omari is not a substitute for insulin in patients who require insulin and should not be used to treat type 1 diabetes mellitus or diabetic ketoacidosis.
• Renal impairment: Dose adjustment is required in moderate-to-severe renal impairment (see Dosage and Administration).

There is limited clinical experience with overdose of Omari. In the event of a suspected overdose, the patient should seek immediate medical attention or contact a poison control center/emergency services. Management should include standard supportive measures as clinically indicated, including monitoring of blood glucose for hypoglycemia, along with monitoring of vital signs and clinical status. There is no specific antidote for Omari overdose; hemodialysis has not been well studied for this purpose and its usefulness in overdose is unclear.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Renal Impairment

Dose adjustment of Omari is recommended in patients with moderate-to-severe renal impairment or end-stage renal disease (see Dosage and Administration). Renal function should be assessed before starting Omari and periodically thereafter.

Hepatic Impairment

No specific dose adjustment is generally required in mild-to-moderate hepatic impairment; data in severe hepatic impairment are limited, and Omari should be used with caution in such patients.

Elderly

No overall dose adjustment is required based on age alone; however, elderly patients are more likely to have reduced renal function, which should be taken into account (see Renal Impairment above).

Pediatric Use

Safety and efficacy of Omari in patients under 18 years of age have not been established (see Pediatric Uses).

Omari is generally used as a long-term, chronic treatment for type 2 diabetes mellitus, alongside diet and exercise. The duration of treatment should be determined by the treating physician based on ongoing glycemic control (e.g., HbA1c), tolerability, and the patient's overall diabetes management plan. Treatment should not be stopped or changed without medical advice.

Dipeptidyl Peptidase-4 (DPP-4) Inhibitor; Oral Antidiabetic Agent (Gliptin class)

Omarigliptin selectively and reversibly inhibits the enzyme DPP-4, thereby slowing the breakdown of the incretin hormones GLP-1 and GIP. This increases their circulating active concentrations, resulting in glucose-dependent stimulation of insulin release and suppression of glucagon secretion, which together lower blood glucose levels without a high intrinsic risk of hypoglycemia.

The safety and efficacy of Omari have not been established in pediatric patients (below 18 years of age). Omari is therefore not recommended for use in children or adolescents until further clinical data become available. Use in this population should only occur under close specialist supervision if considered necessary by a physician.