Timothy-grass pollen oral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral lyophilisate formulation of standardised allergen extract of grass pollen from Timothy (Phleum pratense)
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.
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.
1 tablet daily
For treatment of children, doctors should be experienced in treating allergic diseases in children and the patients should be carefully selected considering the expected level of efficacy in the age group.
No data on treatment with this medication in children beyond one grass pollen season is available.
Children 5 years and over
1 tablet daily
Oral lyophilisate to be placed under the tongue, where it will disperse.
Children under 5 years
Patients over 65 years
Precautions and Warnings
Children aged 5 to 18 years
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
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 ).
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.
Oedema of the lips
Oral mucosal blistering
Oral mucosal erythema
Salivary gland disorders
Sensation of foreign body
Upper respiratory tract infection
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 ).
Last Full Review Date: February 2013
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.
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