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424323009

Refrigerated Storage

ElapraseShire

Shire
Elaprase
2mg/ml vial concentrate for solution for infusion

Takeda (now part of Shire) has conducted internal stability studies to evaluate the impact of temperature excursions on agalsidase alfa vials (Shire Internal Data). Results indicate there is no impact on the product stability or original shelf life of agalsidase alfa during a single temperature excursion of:

-2˚C to <2˚C for up to 20 days
>8˚C to ≤27˚C for up to 45 days

This is subject to the product being stored at the licensed storage conditions for the remaining period of time. These studies suggested that the quality attributes of the product would be expected to be maintained until expiration date.
Please note, stability data at Shire is continually monitored and subject to change. Please contact Shire on a case by case basis for any temperature excursions.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Contact Shire in all cases where deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

No.
Yes - when exposed to temperatures stated above.
19 November 2020
London MI Service

New Medicines

Elaprase ITMucopolysaccharidosis II (MPS II - Hunter syndrome);long-term treatment of mild-to-moderate disease in paediatric patients. Used in conjunction with IV idursulfase. Intrathecal formulation.

Information

Elaprase IT
New formulation
Takeda
Takeda

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Yes

Category

Enzyme replacement therapy. Patients receive 10mg intrathecal injections of idursulfase-IT once monthly.
The incidence of Hunter syndrome in Europe is estimated to be 1 in 166,000 live births, and prevalence has previously been estimated at between 1 and 9 per 100,000 population [1].
Mucopolysaccharidosis II (MPS II - Hunter syndrome);long-term treatment of mild-to-moderate disease in paediatric patients. Used in conjunction with IV idursulfase. Intrathecal formulation.
Intrathecal

Further information

Yes
To be confirmed

Evidence based evaluations