Omnitida 7.5 BioActive — Vial, 30 mg / 2 mL
For healthcare professionals and trade partners. Prescription-only medicine. Information on this page is not intended for the general public.
Overview
Omnitida 7.5 BioActive is a sterile solution of tirzepatide supplied in a 2 mL vial containing 30 mg (equivalent to 7.5 mg per 0.5 mL). In the titration schedule 7.5 mg is used in weeks 9–12. The vial format is intended primarily for use by medical staff: each dose is drawn with a sterile syringe, which is not included.
Tirzepatide is a GIP and GLP-1 receptor agonist: a 39-amino-acid modified peptide with a C20 fatty diacid moiety that enables albumin binding and prolongs the half-life to about 5 days, allowing once-weekly dosing. It selectively binds to and activates both GIP and GLP-1 receptors and enhances first- and second-phase insulin secretion while reducing glucagon levels, both in a glucose-dependent manner.
Indications
- Adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus
- Chronic weight management in adults with obesity (BMI ≥ 30 kg/m²)
- Adults with overweight (BMI ≥ 27 kg/m²) and at least one weight-related comorbidity: hypertension, cardiovascular disease, type 2 diabetes, dyslipidaemia or obstructive sleep apnoea
Contraindications
- Known hypersensitivity to tirzepatide or any other component of the product
- Personal or family history of medullary thyroid carcinoma (MTC)
- Multiple endocrine neoplasia syndrome type 2 (MEN 2)
Limitations of use: not studied in patients with a history of pancreatitis; not indicated in type 1 diabetes mellitus. Safety and effectiveness below 18 years of age have not been established.
Dosing & administration
Start with 2.5 mg once weekly — this dose is for treatment initiation, not for glycaemic control. After 4 weeks increase to 5 mg; further increases are in 2.5 mg steps after at least 4 weeks on the current dose. Maintenance dose is 5, 10 or 15 mg once weekly, selected by response and tolerability; 15 mg is the maximum.
- 2.5 mg Weeks 1–4 · starting dose Available
- 5 mg Weeks 5–8 Not in this form
- 7.5 mg Weeks 9–12 This product
- 10 mg Weeks 13–16 Not in this form
- 12.5 mg Weeks 17–20 Not in this form
- 15 mg Weeks 21+ · maximum dose Available
Injection sites
Abdomen (at least 5 cm from the navel), front of the upper thigh or outer upper arm. Rotate sites with each dose, 2–3 cm from the previous injection.
Timing
Once weekly, at any time of day, with or without meals.
Missed dose
Give as soon as possible within 4 days (96 h). After 4 days skip it and resume the usual schedule. The weekly day can be changed if at least 3 days (72 h) separate two doses.
Preparation
Inspect visually before use — do not use if particles or discolouration are present. Do not dilute and do not mix with other solutions. With insulin: separate injections, never mixed; the same body region is acceptable, but not adjacent.
Drawing the dose
Intended for use by medical staff. Draw the dose with a sterile syringe (U-100 scale: 1 unit = 0.01 mL). Use each needle once. Do not leave an opened vial outside the refrigerator.
Safety
The most common side effects are nausea, diarrhoea, decreased appetite, vomiting, constipation, dyspepsia and abdominal pain.
Pregnancy and lactation. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. In lactation, weigh the benefits of breastfeeding against the clinical need and potential effects on the infant.
Interactions. Tirzepatide delays gastric emptying and may affect absorption of oral medicines — monitor drugs with a narrow therapeutic index (e.g. warfarin). Patients on oral hormonal contraceptives should switch to a non-oral method or add a barrier method for 4 weeks after initiation and after each dose escalation.
Overdose. Supportive treatment according to clinical signs; observation may be needed given the half-life of about 5 days.
Full information: package leaflet.
Specifications
| Active substance (INN) | Tirzepatide |
|---|---|
| ATC code | A10BX16 |
| Pharmaceutical form | Sterile solution for injection, vial |
| Concentration | 30 mg / 2 mL (15 mg/mL) |
| Equivalent dose volume | 7.5 mg in 0.5 mL |
| Fill volume | 2 mL |
| Route of administration | Subcutaneous |
| Dosing frequency | Once weekly |
| Pack size | 1 vial |
| Syringes / needles | Not included |
| Legal status | Prescription-only medicine (POM) |
| Manufacturer | Biotech Laboratorium LTD, London, UK |
Storage
Refrigerate
Store at +2 °C to +8 °C, away from the freezer compartment.
Do not freeze
Do not use a product that has been frozen.
Protect from light
Keep in the original carton until use.
Check before use
Do not use after expiry or if the solution is discoloured or cloudy. It should be clear to slightly yellowish, free of particles. Keep out of the reach and sight of children.
May be transported at temperatures not exceeding 30 °C for up to 30 days. After opening store at +2 °C to +8 °C and do not leave the vial outside the refrigerator.
Pack contents
- 1 vial, 2 mL sterile solution (30 mg tirzepatide)
- Package leaflet
- Syringes not included — purchase separately (e.g. U-100 insulin syringe)
Other strengths & forms
Supplying distributors, pharmacy chains and clinics
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Omnitida BioActive is a prescription-only medicine. It must be sold or administered only on the prescription of a registered physician. Always refer to the package leaflet before prescribing. Manufactured by Biotech Laboratorium LTD, London, UK.