medicationCOMPOSITION
Tirvox (Tirzepatide) solution for subcutaneous injection is supplied in multi-dose pre-filled pens delivering four (4) single doses of 0.6 mL each (2.4 mL total volume per pen) as per Innovator's Specifications:
• Each dose contains 2.5mg of Tirzepatide in 0.6ml solution
• Each multi-dose pre-filled pen contains 10mg of Tirzepatide in 2.4ml (4.17mg/ml)
• Each pen delivers 4 doses of 2.5mg
• Each dose contains 5mg of Tirzepatide in 0.6ml solution
• Each multi-dose pre-filled pen contains 20mg of Tirzepatide in 2.4ml (8.33mg/ml)
• Each pen delivers 4 doses of 5mg
• Each dose contains 7.5mg of Tirzepatide in 0.6ml solution
• Each multi-dose pre-filled pen contains 30mg of Tirzepatide in 2.4ml (12.5mg/ml)
• Each pen delivers 4 doses of 7.5mg
• Each dose contains 10mg of Tirzepatide in 0.6ml solution
• Each multi-dose pre-filled pen contains 40mg of Tirzepatide in 2.4ml (16.7mg/ml)
• Each pen delivers 4 doses of 10mg
• Each dose contains 12.5mg of Tirzepatide in 0.6ml solution
• Each multi-dose pre-filled pen contains 50mg of Tirzepatide in 2.4ml (20.8mg/ml)
• Each pen delivers 4 doses of 12.5mg
• Each dose contains 15mg of Tirzepatide in 0.6ml solution
• Each multi-dose pre-filled pen contains 60mg of Tirzepatide in 2.4ml (25mg/ml)
• Each pen delivers 4 doses of 15mg
| Dose per Delivery | Dose Volume | Total Pen Content | Concentration | Doses per Pen | Standard |
|---|---|---|---|---|---|
| 2.5 mg | 0.6 mL | 10 mg in 2.4 mL | 4.17 mg/mL | 4 Doses | Innovator's Specs |
| 5 mg | 0.6 mL | 20 mg in 2.4 mL | 8.33 mg/mL | 4 Doses | Innovator's Specs |
| 7.5 mg | 0.6 mL | 30 mg in 2.4 mL | 12.5 mg/mL | 4 Doses | Innovator's Specs |
| 10 mg | 0.6 mL | 40 mg in 2.4 mL | 16.7 mg/mL | 4 Doses | Innovator's Specs |
| 12.5 mg | 0.6 mL | 50 mg in 2.4 mL | 20.8 mg/mL | 4 Doses | Innovator's Specs |
| 15 mg | 0.6 mL | 60 mg in 2.4 mL | 25 mg/mL | 4 Doses | Innovator's Specs |
biotechDescription & Chemical Identity
Tirvox injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker.
scienceCLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
Tirzepatide is a GIP receptor and GLP-1 receptor agonist. It contains a C20 fatty diacid that enables albumin binding and prolongs the half-life. Tirzepatide selectively binds to and activates both the GIP and GLP-1 receptors, the targets for native GIP and GLP-1. Tirzepatide enhances first- and second-phase insulin secretion, and reduces glucagon levels, both in a glucose dependent manner.
PHARMACOKINETICS:
The pharmacokinetics of tirzepatide is similar between healthy subjects and patients with type 2 diabetes mellitus. Steady state plasma tirzepatide concentrations were achieved following 4 weeks of once weekly administration. Tirzepatide exposure increases in a dose-proportional manner.
Following subcutaneous administration, the time to maximum plasma concentration of tirzepatide ranges from 8 to 72 hours. The mean absolute bioavailability of tirzepatide following subcutaneous administration is 80%. Similar exposure was achieved with subcutaneous administration of tirzepatide in the abdomen, thigh, or upper arm.
The mean apparent steady-state volume of distribution of tirzepatide following subcutaneous administration in patients with type 2 diabetes mellitus is approximately 10.3 L. Tirzepatide is highly bound to plasma albumin (99%).
Tirzepatide is metabolized by proteolytic cleavage of the peptide backbone, beta-oxidation of the C20 fatty diacid and amide hydrolysis.
The primary excretion routes of tirzepatide metabolites are via urine and feces. Intact tirzepatide is not observed in urine or feces. The apparent population mean clearance of tirzepatide is 0.061 L/h with an elimination half-life of approximately 5 days.
Excipients: Sodium chloride, sodium phosphate dibasic heptahydrate, hydrochloric acid and sodium hydroxide (for pH adjustment to 6.5–7.5), and water for injections.
Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of:
• ≥30 kg/m² (Obesity), or
• ≥27 kg/m² (Overweight) with at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, cardiovascular disease).
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with insufficiently controlled type 2 diabetes mellitus:
• As monotherapy when metformin is considered inappropriate due to intolerance or contraindications.
• In combination with other medicinal products for the treatment of diabetes.
Indicated for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity, to significantly reduce apnea-hypopnea index (AHI) events with or without positive airway pressure (PAP) therapy.
Recommended Dose Escalation Schedule
To reduce gastrointestinal adverse effects, dosage escalation follows a 4-week step-wise titration approach:
- Administer once weekly, at any time of day, with or without food.
- The day of weekly administration can be changed if necessary, as long as the time between two doses is at least 3 days (>72 hours).
- If a dose is missed, administer as soon as possible within 4 days (96 hours) after the missed dose.
- If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day.
- Do not administer two doses within 3 days of each other.
Check the pen before using
Hold the Pen in up-right position.
Make sure the pen is not damaged and locked properly.
Make sure from the pen window that the medicine: is not frozen, is not cloudy, does not have particles.
مرحلہ ۱: پین کو سیدھا پکڑیں۔ اس بات کو یقینی بنائیں کہ پین خراب نہ ہو اور بند ہو۔ پین ونڈو سے دوا دیکھ کر یقینی بنائیں کہ منجمد نہ ہو، گدلا پن نہ ہو اور کوئی ذرات موجود نہ ہوں۔
All 4 Single-Dose Autoinjector Injection Steps At A Glance:
Keep out of reach of children. To be sold on prescription of a registered medical practitioner only.
Please read the contents carefully before use. This package insert is continually updated from time to time. Information based on approved Artwork LL-WF-260904A for Horizon Pharmaceuticals (Pvt) Ltd.