The new batches for all strengths (50/100/200/250mcg) have been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and will be supplied from July 2021 “for several months”.
Chiesi had already released a temporary batch of 100mcg inhalers in May 2020 to ease the increase in demand experienced in the early stages of the COVID-19 pandemic.
While those Clenil inhalers had a different coloured actuator and cap (beige and yellow respectively), the new ones will be in “familiar” colours (see image above), the manufacturer said.
The new inhalers will still contain beclometasone, which means no change to the way prescriptions are written, or the way in which patients manage their asthma is required, Chiesi said.
New batches of Clenil have no dose indicator
The additional batches will not include a dose indicator on any strength of Clenil, the manufacturer said.
Although these differences do not affect the safety profile (adverse effects) of the medicines, Chiesi recommends patients and caregivers have increased vigilance for when they may need a new inhaler and check the dosage on the labelling of the outer packaging and canister.
On their part, healthcare professionals should advise patients that this inhaler does not contain a dose indicator, but that the medicine and the inhaler are the same, Chiesi said.
Tom Delahoyde, managing director of Chiesi UK, explained that the manufacturer plans on reintroducing inhalers with dose indicators in a few months’ time.
“We have worked hard over the last few months to ensure that stock levels exceed demand, and we expect to reintroduce all strengths of Clenil inhalers with both standard coloured actuators and dose indicators back into the supply chain in several months,” Mr Delahoyde said.
GSK: No releases of extra batches required
GlaxoSmithKline (GSK), one of the UK’s leading manufacturers of inhalers, said its products continue to be available across the country.
“We have no current requirement to release additional batches and we continue to regularly monitor our stocks and safety stocks. This is to ensure we continue to deliver our promise to patients with respiratory diseases,” a spokesperson for GSK told C+D.
C+D has reached out to Novartis about supply issues.