New medicines
Xolair
Composition: Omalizumab 150mg.
Presentation: Powder and solvent for solution for injection.
Action: Humanised monoclonal antibody that selectively binds to human
immunoglobulin E.
Indication: Add-on therapy to improve asthma control in adult and adolescent
patients with severe persistent allergic asthma who have a positive skin
test or in vitro reactivity to a perennial aeroallergen and who have
reduced lung function as well as frequent daytime symptoms or night-time
awakenings and who have documented severe asthma exacerbations despite
daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
It should only be considered in patients with convincing IgE mediated
asthma.
Dosage: Dose is determined by baseline IgE and body weight. Maximum recommended
dose is 375mg by subcutaneous injection every two weeks.
Precautions: Xolair is not indicated for the treatment of acute exacerbations
of asthma. It has not been studied in patients with hyperimmunoglobulin
E syndrome or allergic bronchopulmonary aspergillosis or for the prevention
of anaphylactic reactions. Caution should be exercised in patients with
autoimmune diseases, immune complex-mediated conditions or pre-existing
renal or hepatic impairment, and in patients at high risk of helminth
infections. Abrupt discontinuation of systemic or inhaled corticosteroids
after initiation of Xolair is not recommended. Patients with diabetes,
glucose-galactose malabsorption syndrome, fructose intolerance or sucrase-isomaltase
deficiency should be advised that Xolair contains 108mg of sucrose.
Side effects: Common (>1/100; <1/10) headache, injection site reactions.
Legal category: POM.
Net price: £256.15.
Contact details: Novartis, Frimley Business Park, Frimley, Surrey GU16
7SR. Telephone 01276 698370.
Aptivus
Composition: Tipranavir 250mg.
Presentation: soft capsule.
Class: Protease inhibitor.
Indications: Co-administration with low dose ritonavir for combination
antiretroviral treatment of HIV-1 infection in highly pretreated patients
with virus resistant to multiple protease inhibitors.
Dosage: 500mg, co-administered with 200mg ritonavir, twice daily, with
food.
Contraindications: Moderate or severe hepatic impairment, co-administration
with rifampicin ,or herbal preparations containing St John’s wort
or active substances that are highly dependent on CYP3A for clearance,
including antiarrhythmics, antihistamines, ergot derivatives, gastrointestinal
motility agents, neuroleptics, sedatives or hypnotics and HMG-CoA reductase
inhibitors. Co-administration with drugs dependent on CYP2D6 for clearance,
such as flecainide and propafenone, is also contraindicated.
Precautions: Monitoring of hepatic tests should be done before initiation
of therapy, after two, four and eight weeks, and every eight to 12 weeks
thereafter.
Side effects: Very common (>1/10) diarrhoea, nausea. Common (>1/100, <1/10)
hypertriglycridaemia, hyperlipidaemia, anorexia, headache, vomiting,
flatulence, abdominal distension, abdominal pain, loose stools, dyspepsia,
rash, pruritis, fatigue.
Legal category: POM
Net price: 120 capsules, £490,
Contact details: Boehringer Ingelheim, Ellesfield Avenue, Bracknell,
Berkshire RG12 8YS. Telephone 01344 424600.
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The
Pharmaceutical Journal
Enshake, a powdered shake drink (600Kcal, 16g protein when reconstituted
with whole milk) has been launched by Abbott. Net price, six sachets, £10.92.