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.

View prescribing information here

Key points

  • 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

 

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Drug name

Soprobec (beclometasone dipropionate) pMDI

Indication

  • Soprobec is an inhaled corticosteroid indicated for the prophylactic management of mild, moderate, or severe asthma, in adults or children.4–7

Dosage

  • 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.

Administration

  • 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.

Device

  • 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 inhalers picture

Budgetary implications

  • 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

Equivalence studies

  • Formulation studies confirmed the pharmaceutical equivalence of Soprobec to the reference product for 50, 100, 200, and 250 mcg per actuation.1

Abbreviations

pMDI=pressurised meter dose inhaler

References

  1. Glenmark Pharmaceuticals Europe Ltd data on file. Bioequivalence.
  2. Monthly Index of Medical Specialities website. MIMS online. www.mims.co.uk/drugs/respiratory-system/asthma-copd/clenil-modulite (accessed February 2019).
  3. Glenmark Pharmaceuticals Europe Ltd data on File. Device specifications.
  4. Glenmark Pharmaceuticals Europe Ltd. Soprobec 50 micrograms per actuation pressurised inhalation solutionsummary of product characteristics. December 2018. www.medicines.org.uk/emc/product/9806/smpc
  5. Glenmark Pharmaceuticas Europe Ltd. Soprobec 100 micrograms per actuation pressurised inhalation solutionsummary of product characteristics. December 2018. www.medicines.org.uk/emc/product/9816/smpc
  6. Glenmark Pharmaceuticals Europe Ltd. Soprobec 200 micrograms per actuation pressurised inhalation solutionsummary of product characteristics. December 2018. www.medicines.org.uk/emc/product/9817/smpc
  7. Glenmark Pharmaceuticals Europe Ltd. Soprobec 250 micrograms per actuation pressurised inhalation solutionsummary of product characteristics. December 2018. www.medicines.org.uk/emc/product/9818/smpc
  8. 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.

PP-UK-SOP-0003

Date of preparation: March 2019