Consumer medicine information

Alustal

Allergen extracts

BRAND INFORMATION

Brand name

Alustal House Dust Mites Extract

Active ingredient

Allergen extracts

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Alustal.

What is in this leaflet

This leaflet answers some common questions about Alustal allergen extracts.

It does not contain all of 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 giving you Alustal allergen extracts against the expected benefits it will have for you.

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

What Alustal is used for

Alustal belongs to a group of medicines called anti-allergy preparations and is used in the treatment of seasonal or perennial rhinitis, conjunctivitis and rhino-conjunctivitis with or without associated asthma.

Alustal is given as a subcutaneous treatment and this is often referred to as SIT (Subcutaneous Immunotherapy Treatment)

How it works:

A list of allergen available in Australia and New Zealand is provided at the end of this leaflet. The exact type will depend on your allergy and what your doctor identifies as the cause of your allergy. The aim of treatment with allergen extracts is to prevent the more severe allergic reactions you experience.

Alustal works by slowly increasing your tolerance to specific allergens and decreases the severity of your allergic reactions.

The injection is specifically designed according to individual patient needs. Alustal helps to increase your tolerance to allergens and may decrease the severity of your allergic reactions.

Ask your doctor if you have any questions why Alustal has been prescribed for you.

Alustal is not addictive. This medicine is available only with a doctor’s prescription and administered under a doctor’s supervision.

Before you are given Alustal

When you must not be given Alustal

Do not start Alustal treatment if:

  • You have unstable asthma, severe immunodeficiency, malignant disease, or autoimmune disease. Injection should be avoided if you have bleeding tendency.
  • You are currently receiving treatment with beta-blockers (often in medicines for blood pressure or heart conditions), as you may be unresponsive to the usual doses of adrenaline used to treat anaphylactic reactions.
  • You have problems with your kidneys - renal insufficiency - as this may increase the risk of accumulation of aluminium from aluminium hydroxide preparations (as for any aluminium hydroxide vaccine) into tissues (central nervous system, bones)
  • The package shows signs of tampering.
  • The expiry date (EXP) printed on the pack has passed.

If you receive injections of this medicine after the expiry date has passed, it may not work as well.

It is not advisable to use SIT during pregnancy: pregnancy is not considered as a contraindication to the continuation of immunotherapy but treatment should not be started during pregnancy. If a patient becomes pregnant during initial treatment, stop injections; if a patient becomes pregnant during maintenance therapy, treatment may continue if well tolerated.

There is no data available on the excretion of allergen extracts in human milk or any effect on breast-fed infants.

If you are not sure if you should be taking Alustal, talk to your doctor

Before you start your treatment with Alustal:

Tell your doctor if:

You have any other health problems, especially the following:

  • Asthma or other respiratory problems.
  • You have, or have previously had, a serious immunological disease.
  • You have a bleeding tendency.
  • You have an autoimmune disease. Your doctor will decide if the risk from allergen exposure is greater than the risk of exacerbating the autoimmune disease.
  • You have acute fever, uncontrolled allergic symptoms and recent exacerbation of asthma. Your doctor can decide to delay treatment.

If you have not told your doctor about any of the above, tell him/her before you start treatment with Alustal

Taking other medicines

  • Tell your doctor if you are taking any other medicines, including any that you have bought from a pharmacy, supermarket or health food shop.
  • Some medicines may interfere with Alustal. These medicines include:

Beta-blockers (blood pressure or heart medications), including topically administered beta-blockers, are known interfere with treatment of anaphylactic reactions. They may make you less responsive to the usual doses of epinephrine (adrenaline) used to treat anaphylactic reactions.

Your doctor will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking any of the Alustal.

Ask your doctor or pharmacist if you are not sure if your medicine is one of the ones listed above.

How Alustal is given

How much is given

Your treatment schedule will include:

Initial treatment and maintenance treatment:

Your doctor will tell you how much medicine will be given during each treatment.

  • Normally initial treatment will be weekly injections lasting for approximately 14 weeks. This will be of the allergen that you are allergic to in increasing concentrations up to the highest dose you can tolerate.
  • Maintenance treatment will be of monthly injections of the highest concentration that you can tolerate comfortably.

Where two different courses are being given concurrently, the two extracts must never be mixed within the same syringe. Injections of the two extracts may be given at the same visit, but in separate arms. However mixtures of allergens may have been prescribed for you by your Doctor, these will already be mixed and given in a single injection. But the doctor may need to give more than one injection if you are being treated for more than one allergy.

How Alustal is given

Alustal is given as an injection under the skin (subcutaneously) It is not injected into a blood vessel or intramuscularly.

How long to have it Alustal for

Treatment or maintenance should continue for 3 to 5 years depending on the severity of the allergy and response to treatment.

If you miss a dose:
If you miss a dose, talk to your doctor and arrange another visit as soon as possible.

If you are given too much (overdose)

Overdose is unlikely because your doctor will give you this medicine by injection. If you think that you may have been given too much Alustal, immediately tell your doctor or go to Accident and Emergency at your nearest hospital. Symptoms such as:

  • generalized rash,
  • itching,
  • swelling of lips, face, tongue or other parts of the body,
  • shortness of breath, respiratory or cardiac distress (including asthma),
  • seizures,

may occur. If you have any concerns, ask your doctor.

While you are receiving Alustal

Things you must do

Tell all doctors, dentists and pharmacists who are treating you, that you are receiving Alustal.

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

Keep all of your appointments with your doctor so that your progress can be checked. It is important to have your follow-up doses of Alustal at the appropriate times to make sure the immunotherapy has the best chance of working.

Things you must not do

It is recommended to avoid any activity that may increase blood flow through the injection site such as strenuous exercise, hot baths, sauna, application of local heat or rubbing, for the remainder of the day.

Things to be careful of

  • You must avoid strenuous activity for the remainder of the day
  • You must wait in the doctor’s waiting room for at least 30 minutes following your Alustal injection. The majority of serious reactions will begin within 30 minutes after an injection. Patients should be instructed to seek medical advice immediately if symptoms develop after leaving the clinic. The more rapidly symptoms begin, the more severe they are likely to be and the more rapidly treatment measures should begin.
  • Alustal is presumed to be unlikely to produce an effect on the ability to drive or use machinery.

Side effects

Alustal allergen extracts helps most people with allergies but they may have unwanted side effects in a few people.

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

Contact your doctor or nurse immediately if symptoms of an allergic reaction occur.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are receiving Alustal.

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

Of these, the more serious effects can include

  • generalized rash,
  • itching,
  • swelling of lips, face, tongue or other parts of the body,
  • shortness of breath or tightness (including asthma)
  • seizures

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the above:

Serious side effects are rare. This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist to answer any questions you may have and to explain anything you do not understand on this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using Alustal

Storage

Alustal is usually stored in the doctor’s surgery. However, if you need to store it:

  • Keep it where children cannot reach it
  • Keep it in the original pack
  • Keep it in the refrigerator (between 2° to 8°C). Do not freeze.

Disposal

Your doctor will dispose of any unfinished medicine if the vials have passed their expiry date.

Product description

What Alustal looks like

Each 5mL vial contains specific allergen extract(s) in suspension and are available in various concentrations for many different allergens. Your Doctor will choose the correct allergen to treat your allergy. Other ingredients in all allergen suspensions include aluminium hydroxide hydrate, sodium chloride, phenol, mannitol and water for injections.

Alustal presentation

Initial treatment set: 3 vials, each vial containing either 0.1, 1.0 and 10.0 IR/mL or IC/mL.

Maintenance set: a single vial containing 10.0 IR/mL or IC/mL.

Available Concentrations:

Vial containing 5 mL of suspension.

Yellow cap: 0.1 IR/mL or 0.1 IC/mL

Green cap: 1.0 IR/mL or 1.0 IC/mL

Blue cap: 10.0 IR/mL or 10.0 IC/mL
(IR/mL is the Index of Reactivity per mL)
(IC/mL is the Index of Concentration per mL)

Ingredients

Alustal products contain either a single allergen extract or a combination of allergen extracts within the mite or pollen group of allergens.

ALUSTAL is prepared from freeze-dried allergen extracts adsorbed onto aluminium hydroxide gel. The freeze-dried allergen extracts are prepared by ammonium bicarbonate extraction of the allergen source materials e.g. pollen, mites. Specific allergen(s) are selected by the physician for Specific Immunotherapy Treatment (SIT) for the individual patient.

Sponsor

NAME AND ADDRESS OF THE SPONSOR

Sponsor in Australia:

Stallergenes Australia Pty Ltd
Suite 2408
4 Daydream St.,
Warriewood, NSW 2102
Ph: 1800 824 166

Sponsor in New Zealand:

Stallergenes Greer New Zealand Limited
Level 1, 24 Manukau Road,
Epsom, Auckland 1023
New Zealand
Ph: 0800 824 166

Date of preparation:
16 June 2021

Published by MIMS February 2022

BRAND INFORMATION

Brand name

Alustal House Dust Mites Extract

Active ingredient

Allergen extracts

Schedule

S4

 

1 Name of Medicine

Alustal House Dust Mites Extract (American (D. farinae) and European (D. pteronyssinus) House dust mite allergen extracts).

2 Qualitative and Quantitative Composition

Alustal is prepared from freeze dried allergen extracts adsorbed onto aluminium hydroxide gel. The freeze dried allergen extracts are prepared by ammonium bicarbonate extraction of the allergen source materials, e.g. pollen, mites. Specific allergen(s) are selected by the physician for specific immunotherapy treatment (SIT) for the individual patient.
Each 5 mL vial contains specific allergen extract(s) in suspension and are available in various concentrations. Different concentrations are identified by different coloured caps on the vials.
Yellow cap: 0.1 IR/mL or 0.1 IC/mL.
Green cap: 1.0 IR/mL or 1.0 IC/mL.
Blue cap: 10.0 IR/mL or 10.0 IC/mL.

IR (index of reactivity).

An allergen extract is said to have a titre of 100 IR/mL if, in a prick test performed using a Stallerpoint in 30 subjects sensitised to the allergen in question, it produces a wheal measuring 7 mm in diameter (geometric mean). Skin reactivity in these subjects is simultaneously demonstrated by a positive response to a prick test with codeine phosphate 9% or histamine dihydrochloride 10 mg/mL.

IC (index of concentration).

An allergen extract has an index of concentration of 100 IC/mL when its manufacturing parameters lead to the same dilution ratio as those of standardized extracts at 100 IR/mL from the same family, taken as a reference.
When the family does not contain any standardized reference extract, the value 100 IC/mL corresponds to an extract where the dilution ratio is established according to medical experience.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Suspension for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Alustal treatment is indicated for patients with type 1 allergy (Gell and Coombs classification), particularly presenting as seasonal or perennial rhinitis, conjunctivitis, rhinoconjunctivitis with or without associated asthma.

4.2 Dose and Method of Administration

Important note.

Care should always be taken to ensure that the correct dosage schedule is used.
Treatment is given in two phases: initial treatment at escalating dosage (weekly injections);
maintenance treatment at constant dosage (monthly injections).

Before each injection.

The expiry date on the vial should be checked.
It should be confirmed that the vial to be used is the same as that prescribed (composition, patient's name, concentration). The vial should be shaken gently before the quantity to be injected is withdrawn.
The normal rules of asepsis should be observed.
Disposable 1 mL 'tuberculin' syringes with 1/100 graduations should be used.
The injection should be precisely the required dose.
The dosage for children is the same as for adults. Because of the smaller size of children larger volumes of solution may produce excessive discomfort. Therefore, in order to achieve the total dose required, the volume of the dose may need to be divided into more than one injection.
Dosage does not vary with age, but must be adjusted to the reactivity of the individual patient.

1. Initial treatment: escalation of dosage.

The product is injected exclusively by the deep subcutaneous route, at progressively escalating dosage, at a rate of one injection per week up to the maximum tolerated, according to the following treatment schedule (Table 1).

Important note.

This treatment schedule is a guideline only. It must be modified depending on the patient's condition and any reactions that occur. Ideally, SIT with pollen allergens should begin before pollen season.

2. Maintenance treatment: constant dose.

(Maintenance: 1 vial 10 IR/mL or IC/mL (blue cap)). The highest tolerated dose (max 0.8 mL) in the initial treatment course is then repeated at interval of two weeks, then monthly or at longer intervals, not exceeding 6 weeks, between successive injections. If the interval is longer, the dose should be readjusted. It should be remembered that the above treatment schedule is a guideline only. It must be modified depending on the patient's condition and any reactions that occur. When changing vials for a patient on maintenance therapy, the first dose of the new vial should be 50% of the last dose (i.e. last dose given at 0.8 mL of 10.0 IR/mL, new vial dose should be 0.4 mL of 10.0 IR/mL; then followed by regular monthly doses of 0.8 mL). For pollen allergens, it may be necessary to reduce the maintenance dosage by half during pollen season but only if reactions occur.

Important note.

Administer maintenance therapy only after treatment with the initial allergen set has been completed and within 6 weeks of the previous final dose.

Duration of treatment.

As a general rule, SIT with Alustal should be continued for between 3 and 5 years.
Refer to the Patient Verification table provided at the end of the manufacturer's PI.

4.3 Contraindications

Do not give SIT to patients with unstable asthma, severe immunodeficiency, malignant disease or autoimmune disease. SIT is contraindicated for patients on treatment with beta-blockers. Any injections including SIT should be avoided in patients with a bleeding tendency.

4.4 Special Warnings and Precautions for Use

Before starting SIT, patients should have their symptoms controlled, if necessary, by administration of adequate symptomatic treatment.
1. Immunotherapy should only be administered by trained personnel familiar with the recognition of early signs of allergic reactions and competent in the management of systemic reactions. A medical practitioner should always be on the premises where immunotherapy is administered. Before giving an SIT injection, the practitioner should ensure that an emergency kit is immediately available containing aqueous epinephrine hydrochloride (adrenaline) 1:1000, equipment for administering oxygen, equipment for administering intravenous fluids, oral airway, an injectable corticosteroid, an injectable antihistamine, vasopressor, stethoscope and sphygmomanometer, tourniquets, syringes, hypodermic and large bore needles.
2. Shake vial gently before withdrawing dose.
3. Proper aseptic precautions should be taken during withdrawal of dose including swabbing of bungs with a suitable antiseptic.
4. The injection should be postponed if the patient has a cold, influenza or febrile illness.
5. Absolute accuracy of dosage is essential. Double check both the vial strength and amount drawn up every time.
6. Inject slowly using deep subcutaneous route. Always pull back syringe plunger before injecting to ensure needle is not in a blood vessel. Do not inject into a blood vessel or intramuscularly.
7. Patients should be kept under medical observation for at least 30 minutes after treatment.
The majority of serious reactions will begin within 30 minutes after an injection. Patients must be instructed to avoid any activity that may increase blood flow through the injection site, e.g. strenuous exercise, hot baths, sauna, application of local heat or rubbing, for the remainder of the day. Patients should be instructed to seek medical advice immediately if symptoms develop after leaving the clinic. The more rapidly symptoms begin, the more severe they are likely to be and the more rapidly treatment measures should begin.
8. Special care should be taken in the treatment of patients with asthma as they may be more susceptible to severe adverse reactions. Patients with asthma must be supervised by a specialist with expertise and experience with the administration of immunotherapy to those with asthma. Before considering immunotherapy for patients with asthma, establish serial baseline lung function values. If there has been a recent exacerbation of asthma, as assessed clinically and/or by measurement of peak expiratory flow rate (PEFR), treatment should be halted and restarted after symptomatic improvement.
9. In many patients with asthma, lung function is worst in the morning and, therefore, in such patients it may be preferable to give the injection in the afternoon.
Always ask the patient and record any local or systemic reaction that occurred after leaving the clinic after the previous injection. If necessary, adjust the dose of the next injection appropriately.

Use in renal impairment.

Risk of accumulation of aluminium from aluminium hydroxide preparations (as for any aluminium hydroxide vaccine) into tissues (central nervous system, bones) should be kept in mind, especially in case of renal insufficiency.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The interactions of this medicine with other medicines and other forms of interactions were not assessed as part of its registration.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
It is not advisable to use SIT during pregnancy: pregnancy is not considered as a contraindication to the continuation of immunotherapy but treatment should not be started during pregnancy. If a patient becomes pregnant during initial treatment, stop injections; if a patient becomes pregnant during maintenance therapy, treatment may continue if well tolerated. There is no data available on the excretion of allergen extracts in human milk or any effect on breast-fed infants.
 No data available.

4.7 Effects on Ability to Drive and Use Machines

Alustal is presumed to be unlikely to produce an effect on the ability to drive or use machinery.

4.8 Adverse Effects (Undesirable Effects)

See Tables 2 and 3.
As with all forms of hyposensitisation therapy, local and/or systemic reactions may occur. Injections of Alustal may be associated with some itching and redness at the injection site. Prolonged pain or pain radiating up the arm is usually the result of intramuscular injection. The tolerated dose is not necessarily constant, but may vary over time, depending on the individual's specific reactivity and environment.

Management of adverse reactions.

Local reactions.

Skin reactions due to aluminium hydroxide have been reported. Some regress spontaneously, while others, much more rarely, can progress to the formation of subcutaneous nodules. Local reactions (> 2 to 3 cm in diameter) with erythema, oedema and pruritus are relatively common, and do not invariably necessitate modification of the treatment schedule. However, they may still act as a reminder that caution is required.
A major local reaction (≥ 5 cm in diameter) should be treated with an oral antihistamine. Supervision of the patient should be extended, reduce the next dose to that previously tolerated. If necessary, increase the subsequent doses by smaller increments. Another dose should never be given until all local reaction resulting from the previous dose has disappeared.
Discontinue injections if reaction size increases.

Other reactions.

Immediate type reactions.

A patient experiencing asthma after an injection must be observed until stable.
If an asthma attack occurs after an injection, bronchodilators must be used, if necessary together with a parenteral corticosteroid.
Systemic reactions (pruritus, giant urticaria or angioedema) should be treated by intramuscular injection of 0.5 to 1 mL of 1/1000 epinephrine (adrenaline), if necessary together with an intravenous corticosteroid. In view of the possibility of progression to shock, intensive and prolonged monitoring in a hospital setting is required.
Laryngeal dyspnoea should also be treated with intramuscular injection of epinephrine (adrenaline); admission to hospital is advisable.
In case of anaphylactic shock, the treatment should be administered as in an emergency and the patient should be admitted to a specialised unit (see Anaphylaxis, below).

Severe delayed reactions.

A serum sickness type of reaction may occur, with arthralgia, myalgia, urticarial rashes, nausea, lymphadenopathy and fever. This is extremely rare, however, SIT should be discontinued if any of these occur.

Anaphylaxis.

Anaphylactic shock consists of some of the following: widespread urticaria, angioedema of the face and glottis, pallor, cough, wheezing, bronchospasm, faintness and hypotension, bradycardia, hyperemesis, shock.
i. Lay patient flat and elevate the legs. Treat immediately.
ii. Give 0.5 mL 1/1000 epinephrine (adrenaline) intramuscularly near the injection site at once. If necessary, repeat 1/1000 epinephrine (adrenaline) intramuscularly at 3-5 minute intervals to a maximum of 2.0 mL in 15 minutes.
iii. Ensure maintenance of adequate airway.
iv. Give antihistamine.
v. If necessary use full supportive measures such as, intravenous saline or plasma expanders for hypotension, oxygen, external cardiac massage.
vi. If bronchospasm is severe, isoprenaline sulphate or salbutamol inhaler may also be used and, if necessary, 10-20 mL of Aminophylline Injection BP by slow intravenous injection at a rate of 2 mL/minute.
vii. A parenteral steroid such as 200-600 mg Hydrocortisone Injection BP, intravenously, may help to prevent persistent bronchospasm.
viii. Patients experiencing an anaphylaxis reaction should be admitted to hospital for close monitoring for at least 24 hours.
Stop treatment in patients with severe reactions.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

See Section 4.4 Special Warnings and Precautions for Use.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: V (various); C1 allergy (desensitization); P1 allergens and antigens.
ATC classification: V01.
The following biological changes have been demonstrated:
Appearance of specific antibodies (IgG) which act as blocking antibodies;
Reduction of specific plasma IgE levels in some cases;
Change in the behaviour of cells involved in allergic reaction;
Favourable change in TH2 and TH1 lymphocyte activities, leading to the production of cytokines (decrease in IL-4 and increase in IFNγ) that regulate IgE production.
At the same time specific immunotherapy stimulates an immune response which is maintained over long periods by immunological memory.
SIT acts directly upon the patient's immune system, providing lasting hyposensitisation and preventing progression of the allergy to more severe forms.
SIT is more effective if treatment is initiated at an early age. Thus, in children SIT may be started from the age of 5 years. It should be administered to children or young adults as soon as it is justified by the severity of the allergic symptoms. When immunotherapy is contemplated for very young children, consultation with a specialist paediatric immunologist/ allergist is essential. The physician who administers the injections should be able to treat a systemic reaction appropriately. In adults aged over 50 years, SIT remains indicated in cases of recent sensitisation.

Mechanism of action.

The precise mechanism of SIT is not known.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Aluminium hydroxide hydrate, sodium chloride, phenol, mannitol and water for injections.

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 at 2-8°C. (Refrigerate. Do not freeze.)
The vial may be stored for up to 6 months opened. Do not use after the expiry date.

6.5 Nature and Contents of Container

Initial treatment set: 3 vials, each vial containing either 0.1, 1.0 and 10.0 IR/mL or IC/mL.
Maintenance: a single vial containing 10.0 IR/mL or IC/mL.
Available Concentrations: vial containing 5 mL of suspension.
Yellow cap: 0.1 IR/mL or 0.1 IC/mL.
Green cap: 1.0 IR/mL or 1.0 IC/mL.
Blue cap: 10.0 IR/mL or 10.0 IC/mL.
The ARTG details for the Alustal HDM are:
Alustal House Dust Mites Extract Initial Treatment: European house dust mite and American house dust mite injection suspension vial composite pack - AUST R 132725.
Alustal House Dust Mites Extract Maintenance: European house dust mite and American house dust mite 10.0 IR/mL injection suspension vial - AUST R 132680.
See Table 4.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

No data available.

CAS number.

No data available.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine - S4.

Summary Table of Changes