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UK-RES-2101606 August 2021
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Last updated: 17th June 2021
Prescribing Information

Chiesi announces release of additional batches for all strengths of Clenil® Modulite® (beclometasone) using the standard colours of the inhaler actuators with no dose indicator

As Chiesi continues to experience increased demand for inhalers, in order for all strengths of Clenil (beclometasone; 50/100/200/250mcg) to be available to patients in actuators using the standard colours, new additional batches of all strengths (with no indicator) will be released into the UK supply chain following authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA). These inhalers are likely to come into circulation from July 2021 for several months and will provide patients reassurance as the colour of their inhalers will be familiar.

For further information of concerned batch numbers, please visit the Chiesi UK website: https://www.chiesi.uk.com/supply-of-chiesi-products

What can you and your patient expect with the additional batches of Clenil?

  • These inhalers contain the same medication as before, beclometasone, and therefore require no change to either the way prescriptions are written, or the way patients manage their asthma.
  • The medicine is provided in the same inhaler device (pressurised metered dose inhaler; pMDI).
  • The only difference in the new additional batches is the lack of dose indicator on any strength of Clenil (50/100/200/250mcg)
    • Please note that the previous Clenil 100mcg inhalers with no dose indicator (supplied since May 2020), where the colour of the plastic actuator and protective cap were beige and yellow respectively, may still be in the supply chain (Figure 1). From July 2021, all strengths will be replaced by new batches where the actuator and cap will revert back to the standard colours but without a dose indicator (Figure 2).
  • These differences have no effect on the safety profile (adverse effects) of the medicines, however, patients should have increased vigilance for when they may need a new inhaler and should confirm the dosage on the labelling of the outer packaging and canister.
  • Clenil 100mcg inhaler batch-specific variation

    Figure 1
    Clenil 100mcg inhaler subject to the batches supplied since May 2020 (to be discontinued)

  • Clenil 100mcg inhaler from a regular batch

    Figure 2
    Clenil 50/100/200/250mcg inhalers subject to the new batches available from July 2021 with no dose indicators

  • The batches will be released with previously authorised packaging i.e. the carton, label, and leaflet without the dose indicator information.

If dispensing this product, healthcare professionals should:

  • Advise patients/caregivers that this inhaler does not contain a dose indicator but that the medicine and the inhaler are the same.
  • Advise patients/caregivers to check the dosage on the labelling on the package and the canister.
  • As usual, recommend that patients keep track of when they start to use their inhaler; each Clenil inhaler (irrespective of batch or strength) contains 200 doses of medication so if a patient is taking two puffs of their inhaler twice a day, this means the inhaler will last for over a month.
  • Clarify to patients and caregivers that all strengths of Clenil can be used with a volumetric spacer.
  • Remind your patients to clean their inhaler once a week as usual, referring to the package leaflet for cleaning instructions.

Adverse Event Reporting

Please continue to report suspected adverse drug reactions (ADRs) to the MHRA through the Yellow Card Scheme. Report on the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Adverse events should also be reported to Chiesi Limited on 0800 009 2329, or at pv.uk@chiesi.com.

Further Information

Please contact Medical Information (medinfo.UK@chiesi.com) should you have any further questions or require additional information.

UK-CLE-2100037 September 2021

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UK-RES-2101574 August 2021

INTENDED FOR UK HEALTHCARE PROFESSIONALS ONLY
Clenil® Beclometasone pMDI logo with devices

Clenil 50mcg and 100mcg licensed for adults and children,
Clenil 200mcg and 250mcg licensed for adults only

Clenil 50mcg and 100mcg licensed for adults and children,
Clenil 200mcg and 250mcg licensed for adults only

Clenil 50mcg and 100mcg
licensed for adults and children, 
Clenil 200mcg and 250mcg
licensed for adults only

Overview
Dosing & Device

Costing

Data

Prescribing Information

General Resources

Clenil® Data Summary1-4

Clenil (Beclometasone dipropionate) is a pro-drug with weak glucocorticoid receptor binding affinity. It is extensively hydrolysed via esterase enzymes to the active metabolite beclometasone-17-monopropionate (B-17-MP), which has potent topical anti-inflammatory activity.

Absorption when administered via inhalation by a pMDI

Systemic absorption of unchanged beclometasone dipropionate (BDP) occurs through the lungs. There is negligible oral absorption of the swallowed dose of unchanged BDP. Prior to absorption there is extensive conversion of BDP to its active metabolite B-17-MP. The systemic absorption of B-17-MP arises from both lung deposition (36%) and oral absorption of the swallowed dose (26%). The absolute bioavailability following inhalation is approximately 2% and 62% of the nominal dose for unchanged BDP and B-17-MP, respectively. BDP is absorbed rapidly with peak plasma concentrations observed (tmax) at 0.3 hours. B-17-MP appears more slowly with a tmax of 1 hour. There is an approximately linear increase in systemic exposure with increasing inhaled dose. When administered orally the bioavailability of BDP is negligible but pre-systemic conversion to B-17-MP results in 41% of the dose being absorbed as B-17-MP.

Distribution

The tissue distribution at steady-state for BDP is moderate (20 L) but more extensive for B-17-MP (424 L). Plasma protein binding is moderately high (87%).

Biotransformation

BDP is cleared very rapidly from the systemic circulation, by metabolism mediated via esterase enzymes that are found in most tissues. The main product of metabolism is the active metabolite (B-17-MP). Minor inactive metabolites, beclometasone-21-monopropionate (B-21-MP) and beclometasone (BOH), are also formed but these contribute little to the systemic exposure.

Elimination

The elimination of BDP and B-17-MP are characterised by high plasma clearance (150 L/hour and 120 L/hour) with corresponding terminal elimination half-lives of 0.5 hours and 2.7 hours. Following oral administration of tritiated BDP, approximately 60% of the dose was excreted in the faeces within 96 hours mainly as free and conjugated polar metabolites. Approximately 12% of the dose was excreted as free and conjugated polar metabolites in the urine. The renal clearance of BDP and its metabolites is negligible.

Preclinical safety data

Preclinical safety studies indicate that beclometasone dipropionate shows negligible systemic toxicity when administered by inhalation.

The non-CFC propellant HFA-134a has been shown to have no toxic effect at very high vapour concentrations, far in excess of those likely to be experienced by patients, in a wide range of animal species exposed daily for periods of up to two years.

For additional information to share with your patients who have been prescribed Clenil, please visit our Clenil patient and carer site.
References:
1. Clenil Modulite 50 micrograms Summary of Product Characteristics. Chiesi Limited.
2. Clenil Modulite 100 micrograms Summary of Product Characteristics. Chiesi Limited.
3. Clenil Modulite 200 micrograms Summary of Product Characteristics. Chiesi Limited.
4. Clenil Modulite 250 micrograms Summary of Product Characteristics. Chiesi Limited.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Chiesi Limited on 0800 0092329 (UK) or PV.UK@Chiesi.com.