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Update 2 - Replacement stock available soon
13 December 2019
Mylan has advised the TGA that stock of the new batch of EpiPen Jr, which is being conditionally released as described below, is now in Australia.
The pens are now being labelled and packaged before being dispatched to wholesalers. They will be available for pharmacies to order from mid-next week (18 or 19 December 2019).
Mylan is writing to pharmacies to provide further information, including details on how to order the replacement products.
Update on shortage
5 December 2019
Mylan advised the TGA today, 5 December 2019, that stock of EpiPen Jr has run out in Australia. TGA is working with Mylan to confirm arrangements for supply of the new batch.
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.
TGA will provide additional information as it becomes available.
Safety advisory - conditional release of one batch to alleviate shortage
2 December 2019
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. The most up-to-date information about the current EpiPen Jr shortage is available on the Medicine Shortages Information Initiative (MSII) website.
The current shortage of EpiPen Jr has been caused by this manufacturing issue and is currently expected to continue until 31 January 2020. The information on the MSII webpage is provided by sponsors and may be updated by a sponsor at any time.
Information for consumers
People requiring an EpiPen Jr 150 mcg adrenaline (epinephrine) auto-injector should contact their local pharmacy.
The Australasian Society of Clinical Immunology and Allergy (ASCIA) has also provided information about the shortage on its website, including advice for schools and early childhood education/care centres and information about expired pens.
The risk from not having adrenaline available to treat anaphylaxis is high and people with responsibility for potentially affected children should familiarise themselves with the full range of advice provided by ASCIA.
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.
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.