Information intended for healthcare professionals only.
This formulary decision guide was developed from content provided by Glenmark Pharmaceuticals Europe Ltd in a format developed by Guidelines in Practice.
- Soprobec is a generic CFC-free beclometasone dipropionate launched in the UK as an alternative to Clenil® Modulite®
- Soprobec provides dosing equivalence to Clenil® Modulite®, at 25% lower acquisition cost1,2
- Soprobec offers the same range of doses as Clenil® Modulite® in an equivalent device.3
Soprobec (beclometasone dipropionate) pMDI
- Soprobec is an inhaled corticosteroid indicated for the prophylactic management of mild, moderate, or severe asthma, in adults or children.4–7
- Soprobec is available in four doses: 50 (PIP 4098620), 100 (PIP 4098638), 200 (PIP 4098646), and 250 mcg (PIP 4098653)4–7
- Starting dose should be adjusted to severity of disease until control is achieved, and then titrated to the lowest dose at which control of asthma is maintained4–7
- In adults, the usual starting dose is 200 mcg twice daily4–7
- In children, the usual starting dose is 100 mcg twice daily4–7
- See the Summary of Product Characteristics4–7 for additional dosage information.
- Soprobec is for inhalation use only4–7
- The Volumatic™ spacer device may be used by patients with difficulty in synchronising aerosol actuation with inspiration of breath4–7
- When administered to children and adolescents ≤15 years, Soprobec should always be administered using the Volumatic™ spacer device4–7
- Correct administration is essential for successful therapy.
- Soprobec is supplied in an alumnium canister fitted with a metering valve, an actuator, and a dust cap (component colours are different depending on the dosage)4–7
- Each inhaler delivers 200 actuations4–7
- The design and functioning of the inhaler are equivalent to those of Clenil® Modulite®.3
- Soprobec (see pricing overleaf) could provide acquisition cost savings of 25% compared to the existing standard of care2,8
|Potential cost savings with Soprobec8|
|Current annual cost to NHS for beclometasone dipropionate prescriptions||£56 million|
|Potential annual acquisition cost savings to NHS using Soprobec versus Clenil® Modulite®||£12-13 million|
|Potential annual acquisition cost savings to a local health economy when prescribing Soprobec versus Clenil® Modulite®||typical savings £100,000|
- Formulation studies confirmed the pharmaceutical equivalence of Soprobec to the reference product for 50, 100, 200, and 250 mcg per actuation.1
pMDI=pressurised meter dose inhaler
- Glenmark Pharmaceuticals Europe Ltd data on file. Bioequivalence.
- Monthly Index of Medical Specialities website. MIMS online. www.mims.co.uk/drugs/respiratory-system/asthma-copd/clenil-modulite (accessed February 2019).
- Glenmark Pharmaceuticals Europe Ltd data on File. Device specifications.
- Glenmark Pharmaceuticals Europe Ltd. Soprobec 50 micrograms per actuation pressurised inhalation solution–summary of product characteristics. December 2018. www.medicines.org.uk/emc/product/9806/smpc
- Glenmark Pharmaceuticas Europe Ltd. Soprobec 100 micrograms per actuation pressurised inhalation solution–summary of product characteristics. December 2018. www.medicines.org.uk/emc/product/9816/smpc
- Glenmark Pharmaceuticals Europe Ltd. Soprobec 200 micrograms per actuation pressurised inhalation solution–summary of product characteristics. December 2018. www.medicines.org.uk/emc/product/9817/smpc
- Glenmark Pharmaceuticals Europe Ltd. Soprobec 250 micrograms per actuation pressurised inhalation solution–summary of product characteristics. December 2018. www.medicines.org.uk/emc/product/9818/smpc
- Glenmark Pharmaceuticals Europe Ltd data on file. Soprobec cost comparison.
Clenil Modulite is a registered trademark of Chiesi Limited.
Volumatic™ is a registered trademark of GlaxoSmithKline UK Ltd.
Date of preparation: March 2019