EpiPen® Jr out of stock in Australia - 4 Dec 2019

ASCIA and Allergy & Anaphylaxis Australia (A&AA) have been notified that there will be no available EpiPen® Jr stock from  5 December 2019.

See notice from Mylan Australia here.

Australia has no EpiPen® Jr stock, therefore, those that are newly diagnosed and those who use their last EpiPen® Jr will not be able to purchase an EpiPen® Jr device until stock arrives from the US on the 17 December or soon after.

The Therapeutic Goods Administration (TGA) released a statement earlier this week saying they had approved EpiPen® Jr stock that was contaminated with a very small dose of a medication called pralidoxime and this stock is due to arrive in Australia on the 17 December or soon after. The TGA have reviewed safety data provided by Mylan Australia on the contaminated EpiPen® Jr batch and determined the risk of not having adrenaline (epinephrine) available to treat anaphylaxis is far greater than the risk of being exposed to a very small amount of pralidoxime. Please see https://www.tga.gov.au/alert/epipen-jr  The conditional release applies to batch number 9KC652.

Allergen avoidance

In light of the above EpiPen® Jr no stock information, we encourage parents of children that should have an EpiPen® Jr but do not, to be even more careful* about exposure to the allergen they are allergic to, whether it be food, insects or another trigger.

*Ideas on how you can be even more careful during the EpiPen® Jr no stock period include:

For Schools and early childhood education/care (ECEC) centres see this helpful information.

General advice:

  • Be aware of how far you are from a hospital
  • Reconsider travel/activities away from medical help/hospital locations
  • Always have a mobile phone that is sufficiently charged
  • Still carry an ASCIA Action Plan with you in case of emergency

For food allergy:

  • Prepare food at home
  • Use fresh ingredients for meals if possible
  • READ ALL INGREDIENTS EVERY TIME
  • Try not to eat out – take food for child that has been prepared at home
  • Make treat foods to take to social occasions/Christmas parties
  • Be aware of high risk foods that often have variations that contain your child’s food allergen/s
  • Avoid foods that have any precautionary allergen statement such as “May contain…”
  • Supervise children around food at all times. Ensure one adult is responsible for the supervision of the child then hand over to another responsible adult, especially when eating away from home
  • Consider not consuming alcohol as this can diminish the level of supervision provided
  • Have your child eat safer food prepared at home before going out
  • Teach your child to only eat food prepared by mum and dad at all times
  • Have food in a labelled lunch box your child recognises, for any outings
  • Always take extra food when leaving the house
  • If desperate and caught without any food, choose foods that are more likely to be safe (e.g. packet of crisps you have eaten before after you check the ingredients) or a piece of fruit

For insect sting allergy:

  • Always wear shoes
  • Wear long pants and long sleeve shirts that are not brightly coloured
  • Avoid grass and gardens, for example play on concrete and decking
  • Avoid playing near bins
  • Keep sweet drinks inside in open cups/closed cups with straws, not cans that stinging insects can crawl into without you knowing
  • Drive with car windows closed

Emergency treatment if you do not have an EpiPen®

If you have no access to adrenaline call an ambulance early if there are signs of an allergic reaction and you are uncertain if there are signs of anaphylaxis.

Always follow your ASCIA Action Plan and keep the child in laying position or sitting on the ground/lap with legs outstretched in front of them (not dangling) while an ambulance is called.

Babies/children should not be held upright or be stood up/walked as this can cause a drop in blood pressure.

During this period of critical shortage of EpiPen ®Jr, ASCIA recommends:

Prescribing of adrenaline autoinjectors

Clinicians should continue to provide prescriptions for EpiPen® Jr according to current ASCIA recommendations www.allergy.org.au/hp/anaphylaxis/adrenaline-autoinjector-prescription

While 2 EpiPen® Jr autoinjectors are usually prescribed please advise parents/carers that only ONE EpiPen® Jr will be dispensed to each patient during this time until Australia has normal stock levels.

ASCIA does not recommend prescribing adrenaline ampoules in place of adrenaline autoinjectors due to the significant risk of overdose.

Can a higher dose of adrenaline be given to a young child if no EpiPen ®Jr is available?

In Australia and New Zealand, there are currently two doses of adrenaline autoinjectors available:

  • EpiPen®(300mcg) is usually prescribed for children over 20 kg and adults.
  • EpiPen® Jr (150mcg) is usually prescribed for children 7.5*-20 kg.

*Whilst 10-20kg was the previous weight guide for a 150mcg adrenaline autoinjector device, a 150mcg device may now also be prescribed for an infant weighting 7.5-10kg by health professionals who have made a considered assessment. Use of a 150mcg device for treatment of infants weighing 7.5kg or more poses less risk, particularly when used without medical training, than use of an adrenaline via ampoule and syringe.

A general guide to adrenaline autoinjector dose: 

  • Children under 7.5kg are not usually prescribed an adrenaline autoinjector. If anaphylaxis is suspected only a 150mcg device should be given. Higher dose adrenaline autoinjectors should NOT be administered to children under 7.5kg.
  • In children weighing 7.5-20kg, a 150mcg adrenaline autoinjector should be used. However, if only a 300mcg device is available, this should be used in preference to not using one at all.

Dispensing of adrenaline autoinjectors

Please note that supply of EpiPen® 300mcg adrenaline (epinephrine) autoinjectors is NOT affected. 

Mylan, the supplier of EpiPen® in Australia and New Zealand, has set up the following process to ensure those at risk of a potentially life-threatening allergic reaction (anaphylaxis) have access to the emergency treatment they may need:

  • Parents/carers requiring an EpiPen® Jr are to contact their local pharmacy.
  • Pharmacies can then contact the Mylan Customer Support team on 1800 274 276 or the EpiPen® Customer Service Toll Free hotline on 1800 931 625 or This email address is being protected from spambots. You need JavaScript enabled to view it.to obtain instructions on how to access EpiPen® Jr once the batch of EpiPen® Jr autoinjectors arrives on or soon after the 17th December 2019.
  • It is likely that only ONEEpiPen® Jr will be dispensed to each patient once the batch 9KC652 arrives from the US.

Optimal storage of EpiPen®s

EpiPen®s should be stored between 15 and 25 degrees Celsius and out of direct sunlight. As temperatures in Australia far exceed 25 ͦC individuals need to be aware of where they keep/place their EpiPen®/s. If an EpiPen® is kept in hot locations for extended periods it is likely to be less effective if it has expired. Always try to keep EpiPen®s in a cooler location out of direct sunlight during the summer months. Never store the EpiPen® in the car and if going camping or to the beach consider purchasing a temperature control device through A&AA’s online shop.

Use of an expired EpiPen®

Patients with an EpiPen® Jr that has recently expired, should keep and use this EpiPen® Jr in an emergency according to instructions on the ASCIA Action Plan. Whilst the use of an expired EpiPen® Jr adrenaline autoinjector is not ideal, research suggests that recently expired devices retain potency. Therefore, if no other EpiPen® Jr autoinjector is available, use of a recently expired EpiPen® Jr autoinjector to treat anaphylaxis is advised, as stated on the ASCIA website www.allergy.org.au/hp/anaphylaxis/adrenaline-autoinjector-storage-expiry-and-disposal

When to call emergency services 000 (triple zero)

We recommend calling 000 if an individual has any signs of anaphylaxis (severe allergic reaction) after using an EpiPen (in date or expired) if available.

Again, if you have no access to adrenaline call an ambulance early if there are signs of an allergic reaction and you are uncertain if there are signs of anaphylaxis.

Always follow your ASCIA Action Plan and keep child in laying position or sitting on the ground/lap with legs outstretched in front of them (not dangling) as an ambulance is called.

Babies/children should not be held upright or be stood up/walked as this can cause a drop in blood pressure.

Schools and early childhood education/care (ECEC) centres

We also request that schools and early childhood education/care (ECEC) centres take into account the current supply issues, by not requesting additional EpiPen® Jr devices to be brought to the school or ECEC centre for each child at risk of anaphylaxis, and to limit the replacement of general use devices at this time. Parents should be able to bring EpiPen® Jr devices to and from school/ECEC each day with the child.

Parents and carers requiring documentation for schools and ECEC during the out of stock period can use the ASCIA document ASCIA EpiPen Jr Out of Stock ECEC December 2019 available at www.allergy.org.au/hp/anaphylaxis/epipen-jr-out-of-stock

We thank you in advance for your consideration of others at this challenging time.

Content updated 5 December 2019

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IN AN EMERGENCY

If you are having an allergic reaction follow advice on your ASCIA Action Plan.

If in doubt, give the Anapen® or EpiPen®.

Do not call us for emergency advice.

If you do not have an ASCIA Action Plan and/or an Anapen® or EpiPen® call triple zero (000) for an ambulance.