New medicines
Grazax
Composition: Standardised grass pollen allergen extract from timothy
(Phleum pratense).
Presentation: Oral lyophilisate, 75,000 standardised quality units tablet
(SQ-T).
Class: Allergen extract.
Indications: Grass-pollen-induced rhinitis and conjunctivitis in adult
patients with clinically relevant symptoms and diagnosed with a positive
skin prick test and/or specific IgE test to grass pollen.
Dosage: One sublingual tablet daily.
Contraindications: Malignancy or systemic diseases affecting the immune
system; inflammatory conditions in the oral cavity with severe symptoms
such as oral lichen planus with ulcerations or severe oral mycosis; uncontrolled
or severe asthma.
Precautions: Food and beverage should not be taken for five minutes following
the dose. Grazax should only be initiated by physicians with experience
in treating allergic diseases and the first dose should be taken under
medical supervision. No efficacy data on treatment with Grazax beyond
one grass pollen season are available yet. Patients should stop taking
Grazax for seven days to allow healing following oral surgery, including
dental extractions. Local allergic reactions (primarily mild or moderate)
can be expected; treatment (eg, with antihistamines) should be considered
if the patient experiences significant local adverse reactions. If severe
systemic reactions, angioedema, difficulty swallowing, difficulty breathing,
changes in voice or feeling of fullness in the throat occur a physician
should be contacted immediately and Grazax should be discontinued permanently
or until otherwise advised by the physician. If patients with asthma
experience deterioration, treatment should be discontinued and evaluated.
Physicians should be aware that Grazax contains fish-derived gelatine
when initiating treatment for patients with severe fish allergy.
Side effects: Very common (>1/10) ear pruritus, throat irritation,
sneezing, mouth oedema, oral pruritus. Common (>1/100, <1/10) headache,
oral paraesthesia, eye pruritus, conjunctivitis, cough, asthma, pharyngitis,
rhinorrhoea, nasal congestion, nasal passage irritation, rhinitis, throat
tightness, oropharyngeal swelling, dyspepsia and nausea, oral hypoaesthesia
or discomfort, oral mucosal blistering, swollen tongue or glossodynia,
pruritus, fatigue.
Legal category: POM.
Net price: 30, £67.50.
Contact details: ALK-Abelló (UK) Ltd, 1 Tealgate, Hungerford,
Berkshire RG17 0YT (tel 01488 686016).
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The
Pharmaceutical Journal
Complan Shake is now available from Complan Foods in vanilla, strawberry
and chocolate flavours. Advisory Committee on Borderline Substances approved.
Net price: 4 x 57g, £3.26.