SUMMARY CMI

ACARIZAX^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using ACARIZAX^®?

ACARIZAX^®contains the active ingredient standardised allergen extract from house dust mites, American house dust mite (Dermatophagoides farinae) and European house dust mite (Dermatophagoides pteronyssinus).

ACARIZAX^® is for the treatment of house dust mite allergy that is characterised by rhinitis (sneezing, runny or itchy nose, nasal congestion) in adults and adolescents aged 12 years and above. It is also for the treatment of house dust mite related allergic asthma in adults.

For more information, see Section 1. Why am I using ACARIZAX^®? in the full CMI.

2. What should I know before I use ACARIZAX^®?

Do not use if you have ever had an allergic reaction to ACARIZAX^® or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use ACARIZAX^®? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ACARIZAX^® and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use ACARIZAX^®?

The recommended dose of ACARIZAX^® is one tablet per day.

More instructions can be found in Section 4. How do I use ACARIZAX^®? in the full CMI.

5. What should I know while using ACARIZAX^®?

For more information, see Section 5. What should I know while using ACARIZAX^®? in the full CMI.

6. Are there any side effects?

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

ACARIZAX^® (a-kari-zaks)

Active ingredient(s): American house dust mite extract and European house dust mite extract

Consumer Medicine Information (CMI)

This leaflet provides important information about using ACARIZAX^®. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using ACARIZAX^®.

Where to find information in this leaflet:

1. Why am I using ACARIZAX^®?
2. What should I know before I use ACARIZAX^®?
3. What if I am taking other medicines?
4. How do I use ACARIZAX^®?
5. What should I know while using ACARIZAX^®?
6. Are there any side effects?
7. Product details

1. Why am I using ACARIZAX^®?

ACARIZAX^® contains the active ingredients, standardised allergen extract from house dust mites Dermatophagoides farinae and Dermatophagoides pteronyssinus.

ACARIZAX^® is for the treatment of house dust mite allergy that is characterised by rhinitis (sneezing, runny or itchy nose, nasal congestion) in adults and adolescents aged 12 years and above. It is also for the treatment of house dust mite related allergic asthma in adults.

2. What should I know before I use ACARIZAX^®?

Warnings

Do not use ACARIZAX^® if:

• you are allergic to standardised allergen extract from house dust mites Dermatophagoides farinae and Dermatophagoides pteronyssinus, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.
• you have poor lung function (as assessed by your doctor)
• your asthma has worsened over the last 3 months (as assessed by your doctor)
• you have asthma as well as an ongoing airway infection such as a cold or chest infection on the day you are to take the first dose of ACARIZAX^®. Your doctor may recommend delaying the start of your treatment until your cold or infection is better.
• you have an illness which affects your immune system or have cancer
• you have recently lost or had a tooth taken out had other forms of mouth surgery, have ulcers, wounds, or infections in the mouth (see 2. What should I know before I use ACARIZAX^®?
• Do not take the medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering

Check with your doctor if you:

• have any other medical conditions
• take any medicines for any other condition
• are being treated for depression, asthma, Parkinson's disease or have a heart condition such as high blood pressure or an irregular heartbeat (see 3. What if I am taking other medicines?
• have previously been treated for house dust mite allergy and had a severe allergic reaction, have recently lost or had a tooth taken out, had other forms of mouth surgery, are planning to have any form of mouth surgery, have ulcers, wounds or infections in the mouth. Your doctor may delay or stop your treatment until your condition has resolved.
• recovering or are in remission from an illness which affects your immune system
• have an inflamed oesophagus
• are taking steroids

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with ACARIZAX^® and affect how it works.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect, or could be affected by ACARIZAX^®.

4. How do I use ACARIZAX^®?

How much to take / use

• The recommended dose of ACARIZAX^® is one tablet per day.
• Always follow the instructions given to you by your doctor or pharmacist.

When to take / use ACARIZAX^®

ACARIZAX^® should be taken at about the same time each day.

Taking it at the same time each day will help you get the best effect. It will also help you to remember when to take it.

Do not consume food and drink for 5 minutes after taking this medicine.

Food can interfere with the absorption of this medicine.

How to take ACARIZAX^®

Make sure your hands are clean and dry before handling the medicine.

Follow the instructions below when taking ACARIZAX^®:

Figure 1: Tear off the strip marked with triangles at the top of the pack.

Figure 2: Tear a square off the pack along the dotted lines.

Figure 3: To remove the tablet, fold back the marked corner of the foil and then pull it off. Do not force the tablet through the foil - as it breaks easily.

Figure 4: Remove the tablet carefully from the foil and place it under your tongue immediately.

Figure 5: Keep the tablet under your tongue until it has dissolved. Do not swallow for 1 minute. Do not eat or drink for at least 5 minutes after taking the tablet.

Your doctor should give you the first tablet under medical supervision and then monitor you for 30 minutes. This gives you the opportunity to discuss any possible side effects with your doctor (6. Are there any side effects?).

If you forget to use ACARIZAX^®

If you forget to take a dose, take it later in the day.

Do not take a double dose to make up for the dose you missed.

If you have not taken ACARIZAX^® for more than 7 days contact your doctor before taking ACARIZAX^® again.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you use too much ACARIZAX^®

If you think that you have used too much ACARIZAX^®, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using ACARIZAX^®?

Things you should do

If you are about to be started on any new medicine, inform your doctor or pharmacist that you are taking ACARIZAX^®.

Remind any doctor, dentist or pharmacist you visit that you are using ACARIZAX^®.

If you become pregnant while taking this medicine, tell your doctor immediately.

You can expect some mild to moderate localised allergic reactions during your treatment. In most cases these reactions are only temporary. However, if you think these are severe, talk to your doctor to see if you need any anti-allergic medicines such as antihistamines (see 6. Are there any side effects?) Tell your doctor if you feel the treatment is not helping your condition.

Things you should not do

• Do not stop taking your medicine without checking with your doctor. If you stop taking it suddenly, your condition may worsen or you may have unwanted side effects.
• Do not use ACARIZAX^® to treat any other conditions unless your doctor tells you to.
• Do not give this medicine to anyone else even if they have the same conditions as you.
• Do not take this medicine if you are below 12 years of age.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how ACARIZAX^® affects you.

ACARIZAX^® may cause dizziness in some people.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

Follow the instructions on the carton on how to take care of your medicine properly.

Keep it in a cool dry place where the temperature stays below 25°C.

Store the blister pack in the carton to protect the tablets from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects that you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What ACARIZAX^® contains

Do not take this medicine if you are allergic to any of these ingredients.

What ACARIZAX^® looks like

ACARIZAX^® tablets are white to off-white with an imprint on one side. The tablets are individually packed in blister foils (AUST R 250392).

The following pack sizes are available: 10, 30 or 90 tablets. Not all pack sizes may be marketed.

Who distributes ACARIZAX^®

Seqirus Pty Ltd
ABN: 26 160 735 035
63 Poplar Road, Parkville VIC 3052 Australia
Telephone: 1800 642 865
www.seqirus.com.au

This leaflet was prepared in August 2022.

ACARIZAX^® is a registered trademark of ALK-Abelló A/S used under license

Published by MIMS October 2022

1 Name of Medicine

American house dust mite extract and European house dust mite extract.

2 Qualitative and Quantitative Composition

Acarizax is allergy immunotherapy.
Acarizax sublingual tablets contain 12 SQ-HDM standardised allergen extract from the house dust mites (HDM) Dermatophagoides farinae and Dermatophagoides pteronyssinus.
The unit SQ-HDM has been defined to measure the potency of Acarizax and is based on a standardised amount of allergens from each species. Each tablet contains 6 SQ-HDM D. farinae and 6 SQ-HDM of D. pteronyssinus for a total of 12 SQ-HDM.
Acarizax sublingual tablets, 12 SQ-HDM also contains gelatin (fish), mannitol and sodium hydroxide.

3 Pharmaceutical Form

Acarizax 12 SQ-HDM is supplied as white to off-white freeze-dried debossed sublingual tablets.

4 Clinical Particulars

4.1 Therapeutic Indications

Allergic rhinitis.

Allergic asthma.

4.2 Dose and Method of Administration

Treatment with Acarizax should be initiated by a clinician with experience in treatment of allergies. Patients should have a confirmed clinical history and a positive test of house dust mite sensitization (specific IgE and/or skin prick test) prior to treatment.
The recommended dose for patients 12 years and above is one sublingual tablet (12 SQ-HDM) daily.
It is recommended that the first sublingual tablet is taken under medical supervision and that the patient is monitored for 30 minutes, to enable discussion and possible treatment of any immediate side effects. Also see Section 4.4 Special Warnings and Precautions for Use.
The sublingual tablet should be taken with dry fingers from the blister unit immediately after opening the blister and placed under the tongue, where it will disperse. Swallowing should be avoided for approximately 1 minute. Food and beverage should not be consumed for the following 5 minutes.
Onset of the clinical effect is to be expected 8-14 weeks after initiation of treatment. If no improvement is observed during the first year of treatment with Acarizax there is no indication for continuing treatment.
Refer to treatment guidelines for recommendations on the duration of patient treatment. International treatment guidelines refer to a treatment period of 3 years for allergy immunotherapy to achieve disease modification. Efficacy data is available for 18 months of treatment with Acarizax from the clinical trial MT-04 (MITRA) conducted in adults with HDM allergic asthma. Long-term efficacy has not been established.
Acarizax is not recommended for use in patients below 18 years of age for allergic asthma and below 12 years of age for allergic rhinitis due to insufficient data on safety and efficacy in these populations. Also see Section 5.1 Pharmacodynamic Properties, Clinical trials.
If treatment with Acarizax is interrupted for a period of up to 7 days, treatment can be resumed by the patient. If treatment is interrupted for more than 7 days, it is recommended to seek medical advice before continuing treatment.

4.3 Contraindications

Acarizax is contraindicated in patients:
with a known hypersensitivity to any of the excipients;
with FEV₁ < 70% of predicted value (after adequate pharmacological treatment) at initiation of treatment;
who have experienced a severe asthma exacerbation within the last 3 months;
with asthma and experiencing an acute respiratory tract infection, initiation of Acarizax treatment should be postponed until the infection has resolved;
with active or poorly controlled autoimmune diseases, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic disease with current disease relevance;
with acute severe oral inflammation or oral wounds (see Section 4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

Asthma.

Local allergic reactions.

Severe systemic allergic reactions.

Oral inflammation.

Eosinophilic oesophagitis.

Autoimmune diseases in remission.

Use in the elderly.

Paediatric use.

Effect on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction trials have been conducted in humans and no potential drug interactions have been identified from any source.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Treatment with Acarizax has no or negligible influence on the ability to drive or use machines.

4.8 Adverse Effects (Undesirable Effects)

Subjects taking Acarizax should primarily expect mild to moderate local allergic reactions to occur within the first few days and subsiding again with continued treatment (1-3 months) (see Section 4.4 Special Warnings and Precautions for Use). For the majority of events, the reaction is expected to start within 5 minutes after intake of Acarizax on each day of occurrence and abate after minutes to hours. More severe oropharyngeal allergic reactions may occur (see Section 4.4 Special Warnings and Precautions for Use).
Isolated cases of severe acute worsening of asthma symptoms have been reported. Patients with known risk factors should not initiate treatment with Acarizax (see Section 4.3 Contraindications).
In the pooled safety analysis of adult and adolescent subjects in the Acarizax clinical development program, 85% of subjects administered Acarizax reported at least 1 treatment emergent adverse event (TEAE). This was higher when compared with the placebo group (69%).
The majority of subjects in all treatment groups in the pooled analysis experienced TEAEs that were mild to moderate in intensity.
The most frequently reported TEAEs (defined as those occurring in ≥ 5% of subjects in any active group) are summarised by system organ class in Table 1.
The most common TEAEs included oral pruritus, throat irritation, ear pruritus and nasopharyngitis (reported by 34%, 33%, 23% and 20% of subjects (Table 1)).
No overall difference in safety was observed between the adult and adolescent population.
In the pooled phase II/III adult studies, time to onset from first administration for oral pruritus, throat irritation and oedema mouth was typically fast (median onset 2 minutes, 2 minutes and 1 minute after first administration, respectively). Also see Section 4.4 Special Warnings and Precautions for Use.
Adverse reactions in adult and adolescent patients with HDM allergic rhinitis and/or allergic asthma reported in clinical trials with < 5% frequencies are listed below.
Adverse reactions are divided into groups according to the MedDRA convention frequencies: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).

Infections and infestations.

Immune system disorders.

Nervous system disorders.

Eye disorders.

Ear and labyrinth disorders.

Cardiac disorders.

Respiratory, thoracic and mediastinal disorders.

Gastrointestinal disorders.

Skin and subcutaneous tissue disorders.

General disorders and administration site conditions.

Postmarketing experience.

Respiratory, thoracic and mediastinal disorders.

Gastrointestinal disorders.

Immune system disorders.

Reporting suspected adverse effects.

4.9 Overdose

There have been no cases of overdosage reported.
If doses higher than the recommended daily dose are taken, the risk of undesirable effects, including systemic allergic reactions or severe local allergic reactions, may increase. In case of severe reactions such as angioedema, difficulty in swallowing, difficulty in breathing, changes in voice, or feeling of fullness in the throat, immediate medical evaluation is needed. These reactions should be treated with relevant symptomatic medication.
In the event of an overdose, the adverse effects should be treated symptomatically.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Allergic asthma.

Allergic rhinitis.

Allergic rhinitis.

5.2 Pharmacokinetic Properties

No clinical studies investigating the pharmacokinetic profile and metabolism of Acarizax have been conducted. The effect of allergy immunotherapy is mediated through immunological mechanisms, and there is limited information available on the pharmacokinetic properties.
The active molecules of an allergen extract are composed primarily of proteins. For sublingually administered allergy immunotherapy (SLIT) products, studies have shown that no passive absorption of the allergen through the oral mucosa occurs. Evidence points towards the allergen being taken up through the oral mucosa by dendritic cells, in particular Langerhans cells. Allergen which is not absorbed in this manner is expected to be hydrolysed to amino acids and small polypeptides in the lumen of the gastrointestinal tract.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition for the complete list of excipients.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Acarizax 12 SQ-HDM sublingual tablet has a shelf life of 48 months when stored below 25°C. Protect from light.

6.5 Nature and Contents of Container

Packs contain 10, 30 and 90 sublingual tablets supplied in aluminium blister foils.
Not all pack sizes may be available.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine, S4.

Summary Table of Changes