TIRZEPAT

Metabolic & Weight Management

TIRZEPAT is a modern pharmaceutical-grade injectable peptide developed in the United States for medical and professional use. It is intended for the management of carbohydrate metabolism disorders and body weight control in adults.

When TIRZEPAT is selected:

• In type 2 diabetes mellitus to improve glycemic control

• In overweight or obesity

• In metabolic syndrome

• To reduce appetite and support correction of eating behavior

• When long-term stabilization of blood glucose levels is required

Mechanism of action:

TIRZEPAT simultaneously activates both GIP and GLP-1 receptors, resulting in:

• Glucose-dependent enhancement of insulin secretion

• Reduction of glucagon secretion

• Delayed gastric emptying

• Decreased hunger sensation and increased satiety

Due to albumin binding, the elimination half-life is approximately 5 days, allowing for once-weekly administration.

Clinical effects:

• Improved blood glucose control

• Reduced appetite and caloric intake

• Decreased body weight through reduced energy consumption

• Stabilization of metabolic parameters

• Potential positive effects on lipid profile and blood pressure

Clinical trials demonstrate significant body weight reduction (up to approximately 11 kg greater compared with GLP-1–based therapies over 26 weeks at higher doses).

Pharmaceutical quality:

• Synthetic peptide with a precisely defined molecular structure

• Selective dual action on GIP and GLP-1 receptors

• High active ingredient purity

• Stable injectable formulation

• Manufactured in compliance with GMP standards

Dosage form:

Lyophilized white or off-white powder for preparation of a solution for injection.

After reconstitution, a clear, colorless solution free of visible particles is obtained.

Packaging:

• 1 vial × 10 mg

• 2 vials × 10 mg

Storage conditions:

After reconstitution, store refrigerated at 2–8°C (36–46°F) and use within 30 days.

Do not freeze.

Administration:

Reconstitution: Add 1.0 mL of bacteriostatic water → final concentration 10 mg/mL.

Weekly range: 2.5–15 mg once weekly (gradual dose escalation over 4-week intervals).

Measurement reference: At a concentration of 10 mg/mL, 1 unit (0.01 mL) = 0.1 mg (100 mcg) using a U-100 insulin syringe.

Dosage & Titration:

Recommended gradual weekly dose-escalation approach:

Initiation: 2.5 mg once weekly for 4 weeks to establish baseline tolerance.

Escalation: Increase by 2.5 mg every 4 weeks as tolerated.

Maintenance: 5–15 mg weekly depending on clinical response and tolerability.

Frequency: Once weekly (subcutaneous injection).

Timing: Administer on the same day each week at any time of day; rotate injection sites to minimize local irritation.

Laboratory Verification:

Certificate of Analysis (CoA):

BioRegen:

Manufacturer:

American Pharmaceutical, Inc.

Ohio, USA