New medicines
Champix
 Composition: Varenicline. Presentation: Film-coated tablets.
Class: Nicotinic acetylcholine receptor partial agonist.
Indication: Smoking cessation in adults.
Dosage: A one-week titration (0.5mg once daily for days 1–3 and
0.5mg twice daily for days 4–7), followed by 1mg Champix twice
daily. Dosing should start one or two weeks before the date patients
have set to stop smoking. Patients should be treated with Champix for
12 weeks. An additional course of 12 weeks may be considered.
Contraindications: Patients under 18 years of age.
Precautions: Physiological changes resulting from smoking cessation,
with or without treatment with Champix, may alter the pharmacokinetics
or pharmacodynamics of some medicinal products for which dosage adjustment
may be necessary. Smoking cessation may result in an increase in plasma
levels of CYP1A2 substrates. At the end of treatment, discontinuation
of Champix has been associated with an increase in irritability, urge
to smoke, depression and insomnia.
Side effects: Very common (>=1/10) abnormal dreams,
insomnia, headache, nausea. Common (>=1/100, <1/10) increased
appetite, somnolence, dizziness, dysgeusia, vomiting, constipation, diarrhoea,
abdominal distension,
stomach discomfort, dyspepsia, flatulence, dry mouth, fatigue.
Legal category: POM.
Net price: Treatment initiation pack (11 x 0.5mg tablets and 14 x 1mg
tablets), £27.30; maintenance pack (28 x 1mg tablets), £27.30;
maintenance pack (56 x 1mg tablets), £54.60.
Contact details: Pfizer, Ramsgate Road, Sandwich, Kent
CT13 9NJ (tel 01304 616161).
Sprycel
Composition: Dasatinib.
Presentation: Film-coated tablets.
Class: Protein kinase inhibitor.
Indication: Treatment of adults with chronic, accelerated or blast phase
chronic myeloid leukaemia (CML) with resistance or intolerance to prior
therapy including imatinib mesilate. Treatment of adults with Philadelphia
chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) and lymphoid
blast CML with resistance or intolerance to prior therapy.
Dosage: 70mg twice daily administered orally in the morning and in the
evening.
Contraindications: Patients under 18 years of age.
Precautions: Coadministration of a potent CYP3A4 inhibitor or inducer
is not recommended. Caution is warranted when Sprycel is coadministered
with CYP3A4 substrates of narrow therapeutic index. H2 blockers and proton
pump inhibitors are not recommended and aluminium hydroxide or magnesium
hydroxide products should be administered up to two hours before, or
two hours following, the administration of dasatinib. Caution is recommended
with administering Sprycel to patients with moderate to severe hepatic
impairment. Treatment with Sprycel is associated with anaemia, neutropenia
and thrombocytopenia. Complete blood counts should be performed weekly
for the first two months and then monthly thereafter, or as clinically
indicated. Caution should be exercised if patients are required to take
anticoagulants or medicinal products that inhibit platelet function.
Patients who develop symptoms suggestive of pleural effusion such as
dyspnoea or dry cough should be evaluated by chest X-ray. Sprycel should
be administered with caution to patients who have or may develop prolongation
of QTc interval. Hypokalaemia or hypomagnesaemia should be corrected
before Sprycel administration. Patients with rare hereditary problems
of galactose intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption should not take Sprycel.
Side effects: Very common (>=1/10) anorexia, haemorrhage, pleural
effusion, dyspnoea, vomiting, headache, diarrhoea, nausea, skin rash,
musculoskeletal pain, superficial oedema, fatigue, pyrexia, asthenia.
Common (>=1/100, <1/10) infection, dizziness, neuropathy, cough,
abdominal pain, abdominal distension, mucosal inflammation, arthralgia,
myalgia, pain, pruritus, alopecia.
Legal category: POM.
Net price: 56 x 70mg tablets, £2,432.85; 56 x 50mg tablets, £2,432.85;
56 x 20mg tablets, £1,216.43.
Contact details: Bristol-Myers Squibb, Uxbridge Business Park, Sanderson
Road, Uxbridge
UB8 1DH (tel 01895 523000).
Correction
The Champix (varenicline) 56-tablet maintenance pack contains 0.5mg tablets and not 1mg tablets.
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