Drugs List

Therapeutic Indications

Uses

Seasonal allergic conjunctivitis treatment
Seasonal allergic rhinitis - treatment

Disease-modifying treatment of grass pollen induced rhinitis and conjunctivitis with clinically relevant symptoms and diagnosed with a positive skin prick test and/or specific IgE test to grass pollen.

Administration

Oral lyophilisate to be placed under the tongue, where it will disperse.

Contraindications

Children under 5 years
Immunopathological disorder
Oropharyngeal inflammation
Patients over 65 years
Malignant neoplasm
Severe asthma
Uncontrolled asthma

Precautions and Warnings

Children aged 5 to 18 years
Fish allergy
Asthma
Breastfeeding
Pregnancy

Contains fish-derived gelatine
Monitor patient for 20-30 minutes when first dose is taken
Advise patient to seek medical advice if asthma seems to be worsening
Advise pt to seek medical attention if diff. swallowing or breathing occurs
Systemic side effects may occur
Discontinue if rash with systemic, allergic or mucosal symptoms occurs
Stop treatment for 7 days in case of oral surgery, inc dental extraction
Temporarily discontinue in children with concomitant asthma until resolved
Advise patient not to swallow for 1 min or eat/drink for 5 mins after use
Advise patients of possible adverse reactions

In patients who have previously had a systemic reaction to grass pollen subcutaneous immunotherapy, the risk of experiencing a severe reaction with this medication may be increased. Initiation of the medication should be carefully considered and measures to treat reactions should be available.

In children with concomitant asthma and experiencing an acute upper respiratory tract infection this treatment should be temporarily discontinued until the infection has resolved.

If the patient experiences significant local adverse reactions from the treatment, anti-allergic medication (e.g. antihistamines) should be considered.

Vaccination may be given without interrupting treatment with this medication after medical evaluation of the general condition of the patient.

Pregnancy and Lactation

Pregnancy

The manufacturer notes that there is no experience of the use of this medicine in human pregnancy but animal studies have not indicated an increased risk to the foetus.

The manufacturer also notes that it is recommended that treatment with this medication should not be initiated during pregnancy. If pregnancy occurs during treatment, the treatment may continue after evaluation of the general condition (including lung function) of the patient and reactions to previous administration of the medication. In patients with pre-existing asthma, close supervision during pregnancy is recommended.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

The manufacturer notes that there is no experience of the use of this medicine in breastfeeding but no effects on the breastfed infant are anticipated.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Considered suitable or recommended by manufacturer? - The SPC notes that no effects on the breastfed infant are anticipated and that there is no clinical data available for the use of this medication during lactation.

Side Effects

Abdominal discomfort
Abdominal pain
Allergic reaction
Angioedema
Aphthous stomatitis
Asthma
Bronchospasm
Cheilitis
Chest discomfort
Chest pain
Conjunctival hyperaemia
Conjunctival irritation
Conjunctivitis
Cough
Decreased appetite
Diarrhoea
Dizziness
Dry mouth
Dry throat
Dysgeusia
Dyspepsia
Dysphagia
Dysphonia
Dyspnoea
Ear discomfort
Ear pain
Ear pruritus
Eczema
Epigastric discomfort
Erythema
Eyelid oedema
Facial oedema
Fatigue
Feeling hot
Flushing
Gastroesophageal reflux
Gingival disorder
Gingival oedema
Glossitis
Glossodynia
Headache
Increased lacrimation
Laryngitis
Lip blister
Lymphadenopathy
Malaise
Mouth swelling
Mouth ulcers
Nasal congestion
Nasal discomfort
Nasopharyngitis
Nausea
Ocular oedema
Ocular pruritus
Odynophagia
Oedema of the lips
Oral discomfort
Oral disorder
Oral hypoaesthesia
Oral mucosal blistering
Oral mucosal erythema
Oral pain
Oral paraesthesia
Oropharyngeal irritation
Oropharyngeal oedema
Oropharyngeal pain
Palatal oedema
Palpitations
Paraesthesia
Pharyngeal erythema
Pharyngeal oedema
Pharyngitis
Pruritus
Pyrexia
Rash
Rhinitis
Rhinorrhoea
Salivary gland disorders
Sensation of foreign body
Sneezing
Stomatitis
Throat irritation
Throat tightness
Tongue blistering
Tongue disorder
Tongue swelling
Tonsillar hypertrophy
Upper respiratory tract infection
Urticaria
Vomiting
Wheezing

Presentation

Oral lyophilisate formulation of standardised allergen extract of grass pollen from Timothy (Phleum pratense)

Drugs List

Therapeutic Indications

Uses

Seasonal allergic conjunctivitis treatment
Seasonal allergic rhinitis - treatment

Disease-modifying treatment of grass pollen induced rhinitis and conjunctivitis with clinically relevant symptoms and diagnosed with a positive skin prick test and/or specific IgE test to grass pollen.

Dosage

It is recommended that the first tablet is taken under medical supervision (20 to 30 minutes).

Clinical effect in the first grass pollen season is obtained if treatment is initiated at least 4 months prior to the expected start of the grass pollen season. If treatment is initiated 2 to 3 months before the season, some efficacy may be obtained. It is recommended to continue treatment with the medication for a period of 3 years.

Adults

Children

Administration

Oral lyophilisate to be placed under the tongue, where it will disperse.

Contraindications

Children under 5 years
Immunopathological disorder
Oropharyngeal inflammation
Patients over 65 years
Malignant neoplasm
Severe asthma
Uncontrolled asthma

Precautions and Warnings

Children aged 5 to 18 years
Fish allergy
Asthma
Breastfeeding
Pregnancy

Contains fish-derived gelatine
Monitor patient for 20-30 minutes when first dose is taken
Advise patient to seek medical advice if asthma seems to be worsening
Advise pt to seek medical attention if diff. swallowing or breathing occurs
Systemic side effects may occur
Discontinue if rash with systemic, allergic or mucosal symptoms occurs
Stop treatment for 7 days in case of oral surgery, inc dental extraction
Temporarily discontinue in children with concomitant asthma until resolved
Advise patient not to swallow for 1 min or eat/drink for 5 mins after use
Advise patients of possible adverse reactions

In patients who have previously had a systemic reaction to grass pollen subcutaneous immunotherapy, the risk of experiencing a severe reaction with this medication may be increased. Initiation of the medication should be carefully considered and measures to treat reactions should be available.

In children with concomitant asthma and experiencing an acute upper respiratory tract infection this treatment should be temporarily discontinued until the infection has resolved.

If the patient experiences significant local adverse reactions from the treatment, anti-allergic medication (e.g. antihistamines) should be considered.

Vaccination may be given without interrupting treatment with this medication after medical evaluation of the general condition of the patient.

Pregnancy and Lactation

Pregnancy

The manufacturer notes that there is no experience of the use of this medicine in human pregnancy but animal studies have not indicated an increased risk to the foetus.

The manufacturer also notes that it is recommended that treatment with this medication should not be initiated during pregnancy. If pregnancy occurs during treatment, the treatment may continue after evaluation of the general condition (including lung function) of the patient and reactions to previous administration of the medication. In patients with pre-existing asthma, close supervision during pregnancy is recommended.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

The manufacturer notes that there is no experience of the use of this medicine in breastfeeding but no effects on the breastfed infant are anticipated.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Considered suitable or recommended by manufacturer? - The SPC notes that no effects on the breastfed infant are anticipated and that there is no clinical data available for the use of this medication during lactation.

Side Effects

Abdominal discomfort
Abdominal pain
Allergic reaction
Angioedema
Aphthous stomatitis
Asthma
Bronchospasm
Cheilitis
Chest discomfort
Chest pain
Conjunctival hyperaemia
Conjunctival irritation
Conjunctivitis
Cough
Decreased appetite
Diarrhoea
Dizziness
Dry mouth
Dry throat
Dysgeusia
Dyspepsia
Dysphagia
Dysphonia
Dyspnoea
Ear discomfort
Ear pain
Ear pruritus
Eczema
Epigastric discomfort
Erythema
Eyelid oedema
Facial oedema
Fatigue
Feeling hot
Flushing
Gastroesophageal reflux
Gingival disorder
Gingival oedema
Glossitis
Glossodynia
Headache
Increased lacrimation
Laryngitis
Lip blister
Lymphadenopathy
Malaise
Mouth swelling
Mouth ulcers
Nasal congestion
Nasal discomfort
Nasopharyngitis
Nausea
Ocular oedema
Ocular pruritus
Odynophagia
Oedema of the lips
Oral discomfort
Oral disorder
Oral hypoaesthesia
Oral mucosal blistering
Oral mucosal erythema
Oral pain
Oral paraesthesia
Oropharyngeal irritation
Oropharyngeal oedema
Oropharyngeal pain
Palatal oedema
Palpitations
Paraesthesia
Pharyngeal erythema
Pharyngeal oedema
Pharyngitis
Pruritus
Pyrexia
Rash
Rhinitis
Rhinorrhoea
Salivary gland disorders
Sensation of foreign body
Sneezing
Stomatitis
Throat irritation
Throat tightness
Tongue blistering
Tongue disorder
Tongue swelling
Tonsillar hypertrophy
Upper respiratory tract infection
Urticaria
Vomiting
Wheezing

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: February 2013

Reference Sources

British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.

BNF for Children (2012-2013) Pharmaceutical Press, London.

Summary of Product Characteristics: Grazax 75,000 SQ-T oral lyophilisate. Alk-Abello Ltd. Revised 11-12.