Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about GRAZAX®. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking GRAZAX® against the benefits this medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What GRAZAX® is used for

GRAZAX® contains an allergen extract of grass pollen. It comes in a tablet form which is intended to be absorbed by the body by placing it under the tongue.

GRAZAX® is used to treat grass pollen allergies that are characterised by rhinitis (sneezing, runny or itchy nose, nasal congestion) and allergic conjunctivitis (itchy eyes) in adults and children 5 years or older.

GRAZAX® works by increasing your immunological tolerance to grass pollen, thereby reducing the severity of your allergic reactions over time.

Before starting treatment, the doctor will check if GRAZAX® is suitable for you by performing the appropriate blood and/or skin prick tests.

GRAZAX® is only available with a doctor’s prescription.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is not expected to affect your ability to drive a car or operate machinery.

Before you take GRAZAX®

When you must not take it

Do not take GRAZAX® if:

• you have an allergy to any of the ‘Other ingredients’ listed at the end of this leaflet
• you have an illness which affects your immune system or have cancer
• you have severe asthma (as assessed by your doctor).
• you have recently had a tooth taken out, had other forms of mouth surgery, or have ulcers or infections in the mouth (refer to Before you start to take it).

Do not take the medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

Before you start to take it

Tell your doctor if you:

• have an allergy to any of the ‘Other ingredients’ listed at the end of this leaflet
• are being treated for depression or Parkinson’s disease
• have previously been treated for grass pollen allergies and had a severe allergic reaction
• have asthma and a chest infection. Your doctor may recommend delaying the start of your treatment until you are better
• have recently had a tooth taken out, had other forms of mouth surgery, are planning to have any form of mouth surgery, or have ulcers or infections in the mouth. Your doctor may delay or stop your treatment until your condition has resolved
• are recovering or are in remission from an illness which affects your immune system
• have an inflamed oesophagus
• are pregnant or intend to become pregnant during treatment.
• are breast-feeding or intend to breast-feed during treatment

Taking other medicines

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

Some medicines and GRAZAX® may interfere with each other.

Ask your doctor for more information on medicines to be careful of or avoid while taking GRAZAX®

How to take GRAZAX®

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions in this leaflet, ask your doctor or pharmacist for help.

How much to take

The recommended dose of GRAZAX® is one tablet per day. Each tablet contains 75,000 SQ-T standardised allergen extract of grass pollen from Timothy grass (Phleum pratense).

Always follow the instructions given to you by your doctor or pharmacist.

How to take it

Make sure your hands are clean and dry before handling the medicine. Follow the instructions below when taking GRAZAX®:

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 (refer to Side effects).

When to take it

Take the medicine as prescribed by your doctor.

Take your medicine at about the same time each day. It will also help you to remember when to take it.

Do not consume food or drink for 5 minutes after taking this medicine. Food can interfere with the absorption of this medicine.

How long to take it

Continue taking the medicine for as long as your doctor tells you to.

Do not stop taking the medicine until your doctor tells you – even if you feel better.

If you forget to take it

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 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 take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 1126) for advice, or go to Accident and Emergency at the nearest hospital if you think that you or anyone else may have taken too much GRAZAX®. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using GRAZAX®

Things you must do

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

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

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 (refer to Side effects).

Tell your doctor if you feel the treatment is not helping your condition.

Things you must not do

Do not use GRAZAX® 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 give this medicine to children under 5 years of age.

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.

Side effects

Tell your doctor or pharmacist if you have any unpleasant effects while taking GRAZAX® even if you do not think the effect is connected with this medicine.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need to seek medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

• Sensation of rapid forceful or irregular beating of the heart or chest discomfort
• Tonsil enlargement
• Tiredness
• Altered taste
• Pain in the throat, mouth, lips, stomach, or ears
• Numbness of the throat, mouth or tongue
• Itching of the mouth, lips ears, eyes, nose or skin
• Prickling sensation, or discomfort in the mouth or tongue
• Swelling of the mouth, tongue, lips, throat, eyes, or ears
• Dry throat or mouth
• Redness of the eyes, mouth, tongue, throat or skin
• Blistering or ulcers of the mouth or lips.
• Rash
• Prickling sensation of the skin
• Stomach pain, discomfort or indigestion, or pain when swallowing
• Diarrhoea, vomiting or feeling sick (nausea)
• Irritation of the throat
• Discomfort in the ears
• Increased tear or saliva flow and runny nose
• Sneezing

Tell your doctor as soon as possible if you notice any of the following:

• Tightness in the throat
• Heartburn
• Shortness of breath
• Coughing
• Hoarseness
• Sensation of something stuck in the throat
• Pain or difficulty when swallowing

In most cases these reactions are only temporary.

If any of the following happen, stop taking GRAZAX® and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

• Worsening of existing asthma
• Rapid swelling of face, mouth or throat
• Difficulties in swallowing or breathing
• Voice changing
• Hives
• Severe discomfort.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After using GRAZAX®

Storage

Store the blister pack in the carton to protect the tablets from light.

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

Do not store GRAZAX®, or any other medicine, in the bathroom or near a sink. Do not leave it in the car on hot days. Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking the tablets, or the tablets have passed their expiry date, ask your pharmacist what to do with any GRAZAX® that is left over.

Product description

What GRAZAX® looks like

GRAZAX® tablets are white to off-white with an imprint on one side. The tablets are individually packed in blister foils.

The following pack sizes are available: 10, 30, 90 or 100 tablets.

Not all pack sizes may be marketed.

Ingredients

Active ingredients

Each GRAZAX® tablet contains 75,000 SQ-T standardised allergen extract of grass pollen from Timothy grass (Phleum pratense) as the active ingredient.

Other ingredients

The tablet also contains:

• gelatine (from fish)
• mannitol
• sodium hydroxide.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Distributor

GRAZAX® is distributed in Australia by:

Seqirus (Australia) Pty Ltd
ABN: 66 120 398 067
63 Poplar Rd
Parkville 3052
Victoria

Australian Registration Number

AUST R 267955

This leaflet was prepared in 17 February 2020

GRAZAX® is a registered trademark of ALK-Abello A/S used under license

Published by MIMS June 2020

1 Name of Medicine

Phleum pratense.

2 Qualitative and Quantitative Composition

Grazax sublingual tablets contain 75,000 SQ-T standardised allergen extract of Timothy grass pollen (Phleum pratense) which is a temperate grass.
SQ-T is the dose unit for Grazax. SQ is a method for standardisation on biological potency, major allergen content and complexity of the allergen extract.
Grazax sublingual tablets 75,000 SQ-T also contains gelatine (fish), mannitol and sodium hydroxide.

3 Pharmaceutical Form

Grazax 75,000 SQ-T is supplied as white to off-white freeze-dried debossed tablets.

4 Clinical Particulars

4.1 Therapeutic Indications

Grazax is indicated for disease modifying treatment of grass pollen (Phleum pratense or allergens cross reacting with P. pratense) induced allergic rhinitis with or without conjunctivitis in adults, adolescents and children above the age of 5 years.

4.2 Dose and Method of Administration

Treatment with Grazax should be initiated by a clinician with experience in treatment of allergies. Patients should have a confirmed clinical history and diagnosis by a positive test of grass pollen sensitisation to Phleum pratense or cross reacting allergens (specific IgE and/or skin prick test) prior to treatment.
The recommended dose is one sublingual tablet (75,000 SQ-T) 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. Management of specific allergy symptoms should be discussed prior to initiation of treatment.
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.
For clinical effect in the grass pollen season, treatment should be initiated at least 16 weeks before the grass pollen season and continued daily. If treatment is initiated 2-3 months before the grass pollen season some efficacy may also be obtained.
For long-term efficacy and disease modification treatment should be continued daily for 3 consecutive years. Also see Section 5.1 Pharmacodynamic Properties, Clinical trials.
Efficacy data is available for 3 years of treatment and 2 years of follow-up in adults. No data on treatment with Grazax in children beyond 1 grass pollen season is available (see Section 5.1 Pharmacodynamic Properties, Clinical trials). If no improvement is observed during the first year of treatment with Grazax there is no indication for continuing treatment.
Grazax is not recommended for use in patients below 5 years of age due to insufficient data on safety and efficacy in this population (see Section 4.4 Special Warnings and Precautions for Use).

4.3 Contraindications

Grazax is contraindicated:
in patients with a known hypersensitivity to the any of the excipients;
in adult patients with uncontrolled asthma or FEV₁ < 70% of predicted value (after adequate pharmacological treatment) at initiation of treatment;
in paediatric patients with uncontrolled asthma or FEV₁ < 80% of predicted value (after adequate pharmacological treatment) at initiation of treatment;
in patients with malignant or systemic disease affecting the immune system e.g. autoimmune diseases, immune complex diseases or immune deficiency diseases;
in patients with acute severe oral inflammation or oral wounds (see Section 4.4 Special Warnings and Precautions for Use);
in patients who have experienced a severe asthma exacerbation within the last 3 months.

4.4 Special Warnings and Precautions for Use

In patients with asthma and experiencing an acute respiratory tract infection, initiation of Grazax treatment should be postponed until the infection has resolved.
If patients with concomitant asthma experience symptoms and signs indicating asthma deterioration, treatment should be discontinued and medical attention must be sought immediately in order to evaluate the continuation of treatment.
When treated with Grazax the patient is exposed to the allergen that causes the allergic symptoms. Therefore, mild or moderate local allergic reactions are to be expected during the treatment period (see Section 4.8 Adverse Effects (Undesirable Effects)). The use of anti-allergic medication (e.g. antihistamines) could be considered at clinician's discretion for any potential significant local adverse reactions to Grazax.
Treatment with Grazax should be discontinued immediately and urgent medical attention sought in cases of serious anaphylactic reactions including anaphylactic shock, angioedema, difficulty in swallowing, difficulty in breathing, changes in voice, hypotension or feeling of fullness in the throat.
Initiation of Grazax in patients who have previously had a systemic reaction to subcutaneous grass allergen immunotherapy should be carefully considered, and measures to treat any potential adverse reactions should be available.
Serious anaphylactic reactions may be treated with adrenaline. The effects of adrenaline may be potentiated in patients treated with tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) and/or COMT inhibitors with possible fatal consequences. This should be taken into consideration prior to initiating allergy immunotherapy. The effects of adrenaline may be reduced in patients treated with beta-blockers. Patient with cardiac disease may be at increased risk in case of severe systemic allergic reactions.
In patients with severe oral inflammation (e.g. oral lichen planus, mouth ulcers or thrush), oral wounds or following oral surgery, including dental extraction, or following tooth loss, initiation of Grazax treatment should be postponed and any ongoing treatment should be temporarily interrupted to allow healing of the oral cavity.
Isolated cases of eosinophilic esophagitis have been reported in association with Grazax treatment. In patients with severe or persisting gastro-esophageal symptoms such as dysphagia or dyspepsia, discontinuation of treatment with Grazax should be considered.
The efficacy and safety of Grazax for the treatment of allergy induced by sub-tropical grasses has not been assessed in the submitted studies.

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. Vaccination may be given without interrupting treatment with Grazax after medical evaluation of the general condition of the patient.
Concomitant therapy with symptomatic anti-allergic agents (e.g. antihistamines, corticosteroids and/or mast cell stabilisers) may increase the tolerance level of the patient to immunotherapy.
There are no data available on possible risks of simultaneous immunotherapy with other marketed allergy immunotherapy products.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

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

4.8 Adverse Effects (Undesirable Effects)

Subjects taking Grazax should primarily expect mild to moderate local allergic reactions to occur early in therapy that tend to subside spontaneously within 1 to 7 days. For the majority of events, the reaction should be expected to start within 5 minutes after intake of Grazax 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).
In a pooled analysis of all subjects in the Grazax clinical development program, 76% of subjects administered Grazax reported a treatment emergent adverse event (TEAE). This was similar compared to those subjects administered placebo (73%).
The majority of subjects in the pooled Grazax studies reported 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 (SOC) in Table 1.
The most common TEAEs in subjects administered Grazax included oral pruritus, throat irritation, and ear pruritus (reported by 32%, 20% and 11% of subjects (Table 1)).
Adverse reactions reported in clinical trials with frequencies < 5% 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).

Immune system disorders.

Nervous system disorders.

Eye disorders.

Cardiac disorders.

Ear and labyrinth disorders.

Respiratory, thoracic and mediastinal disorders.

Gastrointestinal disorders.

Skin and subcutaneous tissue disorders.

General disorders and administration site conditions.

Post marketing experience.

Reporting suspected adverse effects.

4.9 Overdose

If doses higher than the recommended daily dose are taken, the risk of undesirable effects, including systemic side effects or severe local adverse reactions, may increase. In case of severe reaction such as angioedema, difficulty in swallowing, difficulty in breathing, changes in voice, or feeling of fullness in the throat, immediate medical evaluation is needed.
In the event of an overdose, the adverse effects should be treated symptomatically.
Contact the Poisons Information Centre on 131 126 for advice on overdosage management.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Adults.

Paediatrics.

5.2 Pharmacokinetic Properties

No clinical studies investigating the pharmacokinetic profile and metabolism of Grazax 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

Store Grazax 75,000 SQ-T sublingual tablet below 25°C. Protect from light.

6.5 Nature and Contents of Container

Packs contain 10, 30, 90 and 100 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 talking 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