ASCIA issues recommendation following EpiPen Jr out-of-stock dilemma

Mylan advised the TGA on 5 December 2019 that stock of EpiPen Jr has run out in Australia and is expected to continue until 31 January 2020. TGA is working with Mylan to confirm arrangements for supply of the new batch.

As a result of the well publicised shortages, ASCIA (Australasian Society of Clinical Immunology and Allergy) has issued a recommendation that all remaining stock in pharmacies should be provided to newly diagnosed infants and children weighing 7.5-20kg, and those who have used their EpiPen Jr and have no other dose available. 

Conditional release of one batch to alleviate shortage

Due to the critical nature of the ongoing EpiPen Jr shortage, the TGA is allowing one batch to be supplied that has not met all the required quality specifications. The conditional release applies to batch number 9KC652.

This batch is not yet available in Australia. The TGA is working with the sponsor on details of its supply and will publish updated information as it becomes available.

EpiPen Jr adrenaline autoinjectors are used for the emergency treatment of anaphylaxis in children and can be life-saving.

Several batches of Epipen Jr have been found to be affected by very low-level contamination with another medicine, pralidoxime. This was caused by a manufacturing issue between production batches of different products. The manufacturer has taken action to prevent the issue for future batches.

Pralidoxime is used to treat people who have been poisoned by pest-control chemicals and its safety profile has been well established in humans.

In the situations in which EpiPen Jr is used, administration of adrenaline can be life-saving. The risk from not having adrenaline available to treat anaphylaxis is far greater than the risk of being exposed to a very small amount of pralidoxime.

EpiPen Jr supplies are currently critically constrained in Australia and other countries. The release of the affected batch (no: 9KC652) will go some way towards meeting continuing patient demand.

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Information for health professionals

Testing of the batch to be supplied in Australia indicates that each pen would contain less than 1 microgram (mcg) pralidoxime.

An Epipen Jr delivers 150 mcg adrenaline in 0.3 ml. While each pen is single-use only, in some situations there is a possibility that patients may use more than one Epipen Jr, although they are unlikely to use more than two at one time. The amount of pralidoxime that a patient would be exposed to, in a case where two doses are administered, would not exceed 2 mcg.

The maximum amount of pralidoxime detected in the EpiPen Jr products is less than 0.1% of the recommended therapeutic dose indicated for organophosphate poisoning in children and is not expected to cause adverse effects. While not expected to occur, known potential side effects of pralidoxime include dizziness, blurred vision, double vision, impaired ability to focus when looking from near to far objects, headache, drowsiness, nausea, rapid heart rate, rapid breathing and muscular weakness.

A ‘Dear Healthcare Professional’ letter, with content to be approved by the TGA, will be provided to every pharmacy supplied with the contaminated batch (9KC652) providing further information.

TGA has been working closely with healthcare professional and consumer allergy groups. Advice for healthcare professionals, parents and carers about management during the shortage period is available on the following websites: Australasian Society of Clinical Immunology and Allergy (ASCIA) and Allergy and Anaphylaxis Australia.

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