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Frequently Asked Questions about ALLERJECT

What is ALLERJECT?

ALLERJECT is for the emergency treatment of serious allergic reactions (anaphylaxis) and is intended for people who are at risk and for people with a history of serious allergic reactions (anaphylaxis).1

What is ALLERJECT used for?

ALLERJECT is for the emergency treatment of serious allergic reactions (anaphylaxis) and is intended for people who are at risk and for people with a history of serious allergic reactions (anaphylaxis).

ALLERJECT should be used immediately to treat yourself or your child when experiencing a severe allergic reaction. This is emergency treatment. It does not replace seeing a doctor or going to the hospital. After injection, seek immediate medical attention.

Talk to your doctor or pharmacist to discuss treatment options for anaphylaxis and whether ALLERJECT is right for you. Always read and follow the patient information leaflet that comes with your ALLERJECT device.1

What is anaphylaxis?

Anaphylaxis is a severe and life-threatening type of allergic reaction.* It can be triggered by foods (e.g., peanuts, shellfish), insect stings, certain medications, latex or other allergens. Anaphylaxis can also be triggered by exercise. Sometimes, there is no way to tell what triggered an anaphylactic reaction.1

* ALLERJECT is not indicated to prevent death associated with anaphylaxis.

How common is anaphylaxis?

One to 2% of the general population is estimated to be at risk for anaphylaxis from food allergies and insect stings, with a lower reported prevalence for drugs and latex. People with asthma are at particular risk.1

Is ALLERJECT bioequivalent to EpiPen®?

In Canada, ALLERJECT and EpiPen contain the same amount of active ingredient. You are encouraged to speak with your doctor to learn about treatment options and determine if ALLERJECT is right for you.1,3

Is ALLERJECT the same as AUVI-Q?

The 0.15 mg and 0.3 mg ALLERJECT auto‑injectors contain the same drug and device components as AUVI-Q auto‑injectors. The only difference between the two auto‑injectors is the product labelling; for example, ALLERJECT has a hold time of 5 seconds while AUVI-Q has a hold time of 2 seconds. Additionally, ALLERJECT is available in French while AUVI-Q is not.2

Do I need a prescription for ALLERJECT? Or can I get ALLERJECT directly from my pharmacist?

ALLERJECT has been designated as an ethical drug under the Canadian Food and Drug Regulations. An ethical drug does not require a prescription; however, different provinces and territories, as well as insurance providers, may require a prescription. Consumers should contact their pharmacist or healthcare provider for information on how to obtain ALLERJECT.

How is ALLERJECT manufactured?

ALLERJECT is manufactured on a 100% automated robotic production line with over 100 automated quality checks on each ALLERJECT device, helping to ensure a streamlined and consistent production process. The automated robotic production line helps us produce a consistent, high-quality product, and uses specially calibrated sensors and vision inspection systems to help ensure each component is assembled into ALLERJECT with precision. Every component built into each ALLERJECT has a unique identifier and is tracked throughout the manufacturing process.2

How long is the battery life of ALLERJECT?

The batteries provide sufficient power for the electronic prompt system to be turned on and off once a week for 3 years.2

If the battery dies, is ALLERJECT still able to deliver the appropriate dosage?

Yes, the electronic components of ALLERJECT function independently of the drug delivery mechanism. This means that even if the battery does not work, epinephrine will still be delivered.1

How does ALLERJECT work?

Once the safety guard is removed and the black base is depressed, one end of the needle extends outside of the device into the patient’s thigh while the other end punctures the cartridge to deliver the dose of epinephrine.2

What dosage strengths are currently available for ALLERJECT?

ALLERJECT is currently available in two dosages: 0.15 mg (for patients 15–30 kg) and 0.3 mg (for patients 30 kg or more).1

What are the contraindications associated with ALLERJECT?

There are no absolute contraindications to the use of epinephrine in a life-threatening allergic situation. However, it is important to tell your doctor or pharmacist about any medical conditions or medications you take prior to using ALLERJECT.1

What are the warnings and precautions associated with ALLERJECT?

For warnings and precautions associated with ALLERJECT, please read our Indication and Safety Information section.

How do I get a trainer for ALLERJECT?

You can sign up to order a free trainer device, or you can talk to your healthcare provider or pharmacist.

How do I know that ALLERJECT has been used?

Following use, the LED lights will blink red, the black base will lock into place and the voice instruction system will say that ALLERJECT has been used. Additionally, in used devices the viewing window will no longer be completely clear.1

Will ALLERJECT say “injection complete” even if it is used improperly?

The “injection complete” voice instruction indicates only that the medication in ALLERJECT has been dispensed. It is not an indicator of whether the device has been used properly. ALLERJECT has both audio and visual cues that provide guidance on proper usage. As a reminder, patients should always seek immediate medical attention following an epinephrine injection whether or not they’ve used the device properly. Make sure to inform the healthcare provider of the location if an accidental injection has occurred.

Can ALLERJECT be reused?

No. ALLERJECT is a single-use epinephrine auto‑injector. After use, patients will need to obtain a new ALLERJECT. Until patients dispose of their used ALLERJECT, the interactive voice instruction system will remind them that it has been used each time the outer case is removed.1

Can I replace the red safety guard on the active ALLERJECT device?

The red safety guard CANNOT be replaced once it has been removed. Only remove the red safety guard when ready to use ALLERJECT for an allergic emergency. Please note the active ALLERJECT should not be used for training purposes. Instead, the trainer for ALLERJECT should be used to practice.

Once the red safety guard has been removed, even if removed in error, please obtain a replacement ALLERJECT.1

In the event of an anaphylactic reaction, can patients/caregivers bypass voice instructions to receive immediate treatment?

Yes, ALLERJECT allows users to move ahead without waiting for the voice-guided instructions. The voice instructions will keep up with the user. Conversely, if a patient needs more time, the voice instructions will repeat twice until the user performs the step or replaces the outer case.2

Is ALLERJECT available in languages other than English?

At this time, ALLERJECT is available in English and French.1

How should I dispose of ALLERJECT?

Patients or caregivers should take used or expired ALLERJECT back to their healthcare providers for proper disposal (never discard ALLERJECT in the regular trash).

Will ALLERJECT work if exposed to water or rain?

Yes, ALLERJECT will work even if exposed to water or rain.2 Although water may affect the voice prompt system, ALLERJECT will still inject a dose of epinephrine if used according to the instructions on the label, even if the voice prompts are not working.1

Will ALLERJECT work if completely immersed in water?

There is no data available regarding the total immersion of ALLERJECT in water such as dropping it in the bathtub, toilet, pool or ocean, or putting it through the washing machine. If it is known or suspected that ALLERJECT has been immersed in water, then ALLERJECT should not be used and should be disposed of properly. A new ALLERJECT auto‑injector should be obtained.2

Is ALLERJECT light sensitive?

The epinephrine in ALLERJECT is light sensitive. ALLERJECT should be stored in the outer case provided to protect it from light.1 Once the auto-injector’s outer case is removed, the epinephrine solution is exposed to light through the viewing window. ALLERJECT has been tested to demonstrate that the device stored in the outer case adequately protects the drug product from fluorescent and UV light exposure.2

What is the expiration dating for ALLERJECT?

The expiration dating for ALLERJECT will vary depending on when the product is dispensed from your pharmacy. Retail pharmacies control store inventory and thus the product dating may vary by pharmacy store location. Please reach out to the pharmacy where you filled your ALLERJECT prescription with any questions.2

Can ALLERJECT be refrigerated or frozen?

No, ALLERJECT should not be refrigerated or frozen.1

Can I store ALLERJECT in my car?

Do not expose ALLERJECT to extreme heat or extreme cold. Do NOT store ALLERJECT in a vehicle glove box.1

Can ALLERJECT be used at high altitudes?

While passenger and luggage compartments in aircraft are pressurized, altitude function testing demonstrated that the device functions correctly (delivers a dose of medication) at altitudes up to 3,048 metres.2

Can ALLERJECT go through the scanners at airport security checkpoints?

ALLERJECT has been tested to demonstrate that there is no significant effect on the product caused by exposure to x-rays such as from travelling through airport security.2

What if I drop ALLERJECT or otherwise damage it?

ALLERJECT has been designed to withstand normal physical impacts such as dropping. However, if there is any doubt about the functionality of the ALLERJECT, another prescription should be filled.2

Does ALLERJECT contain any animal derivatives?

No. The formulated drug product does not contain and is not derived from animal, vegetable, or human origin, nor does it come in contact with any other materials of animal, vegetable, or human origin during its manufacture.2

Does ALLERJECT contain latex?

No. ALLERJECT contains no latex in components, materials, or associated packaging that are human contacting, nor are they derived from latex.1

Can people with a sulfite allergy use ALLERJECT?

This product contains sodium metabisulfite, a substance which may cause allergic-type reactions including anaphylactic symptoms or mild to severe asthmatic episodes in certain susceptible persons.

Nevertheless, epinephrine is the drug of choice for serious allergic reactions and the presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations, even if you are sulfite-sensitive. Please talk to your doctor or pharmacist about any medical conditions/medications you are taking prior to using ALLERJECT.1

References: 1. ALLERJECT Product Monograph. kaléo, Inc. November 21, 2019. 2. Data on file. 3. EPIPEN Product Monograph. Dey Pharma, L.P. March 13, 2012.