Omnitida 2.5 BioActive — Pre-filled Pen, 2.5 mg
For healthcare professionals and trade partners. Prescription-only medicine. Information on this page is not intended for the general public.
Overview
Omnitida 2.5 BioActive is a disposable pre-filled pen containing 10 mg of tirzepatide in 2 mL, delivering four weekly doses of 2.5 mg in 0.5 mL. It is the starting dose, used in weeks 1–4 for treatment initiation, and is not intended for glycaemic control. Needles and alcohol wipes are included, so the pen is suitable for self-administration at home under a physician’s supervision.
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 This product
- 5 mg Weeks 5–8 Available
- 7.5 mg Weeks 9–12 Not in this form
- 10 mg Weeks 13–16 Available
- 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.
Pen preparation
Before first use of each new pen, attach a new needle and prime: dial the first mark and press until a drop appears. Use a new sterile needle for every injection.
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 | Solution for injection in pre-filled pen (disposable) |
| Strength per dose | 2.5 mg in 0.5 mL |
| Total content per pen | 10 mg in 2 mL |
| Number of doses | 4 |
| Route of administration | Subcutaneous |
| Dosing frequency | Once weekly |
| Pack size | 1 pre-filled pen |
| 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.
Take the pen out of the refrigerator 15–30 minutes before injection.
Pack contents
- 1 pre-filled pen (4 × 2.5 mg doses)
- 4 needles — one per dose
- Alcohol wipes
- Package leaflet
Other strengths & forms
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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.