New medicines
Baraclude
Composition: Entecavir.
Presentation: Film-coated tablets.
Class: Guanosine nucleoside analogue.
Indications: Treatment of chronic hepatitis B virus (HBV) infection in
adults with compensated liver disease and evidence of active viral replication,
persistently elevated serum alanine aminotransferase levels and histological
evidence of active inflammation or fibrosis.
Dosage: For nucleoside-naive patients the recommended dose is 0.5mg once
daily with or without food. For lamivudine-refractory patients the recommended
dose is 1mg once daily, taken on an empty stomach (more than two hours
before or two hours after a meal).
Precautions: Dose adjustment is required in renal impairment (see SPC).
After initiating antiviral therapy, serum alanine aminotransferase may
increase in some patients as HBV DNA levels decline. Patients with cirrhosis
may be at higher risk for hepatic decompensation following hepatitis
exacerbation and should be monitored during therapy. Patients with decompensated
cirrhosis should be monitored for serious hepatic adverse events. Nucleoside
analogues should be used with caution for any patient with hepatomegaly,
hepatitis or other known risk factors for liver disease. Virological
response should be closely monitored in lamivudine-refractory subjects,
and appropriate resistance testing should be performed. Coadministration
of Baraclude with medicines that reduce renal function or compete for
active tubular secretion may increase serum concentrations of either
medicine.
Side effects: Common (>=1/100, <1/10) insomnia, headache (very
common in lamivudine-refractory patients), dizziness, somnolence, vomiting,
diarrhoea, nausea, dyspepsia, fatigue.
Legal category: POM.
Net price: 30 x 0.5mg, £378;
30 x 1mg, £378.
Contact details: Bristol-Myers Squibb Pharmaceuticals Ltd, Uxbridge Business
Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH. Telephone 01895 523000.
Exjade
Composition: Deferasirox.
Presentation: Dispersible tablets.
Class: Iron chelating agent.
Indications: Treatment of chronic iron overload due to frequent blood
transfusions (>=7ml/kg/month of packed red blood cells) in patients
with beta thalassaemia major aged six years and older; treatment of chronic
iron overload due to blood transfusions when desferrioxamine therapy
is contraindicated or inadequate in patients with other anaemias, patients
aged two to five years, or patients with beta thalassaemia major with
iron overload due to infrequent blood transfusions (<7ml/kg/month
of packed red blood cells).
Dosage: The recommended initial dose of Exjade is 20mg/kg
once daily, rounded to the nearest whole tablet size and taken on an
empty stomach.
An initial daily dose of 30mg/kg may be considered for patients who require
reduction of elevated body iron levels and who are also receiving more
than 14ml/kg/month of packed red blood cells. An initial daily dose of
10mg/kg may be considered for patients who do not require reduction of
body iron levels and who are also receiving less than 7ml/kg/month of
packed red blood cells, the patient’s response must be monitored
for efficacy. Serum ferritin should be monitored every month and dose
adjustments may be made every three to six months in steps of 5 to 10
mg/kg.
Contraindications: Patients with creatinine clearance <60ml/min; combination
with other iron chelator therapies.
Precautions: Daily doses above 30mg/kg are not recommended because of
limited experience. If serum ferritin falls consistently below 500µg/L
an interruption of treatment should be considered. During clinical trials,
dose-dependent increases in serum creatinine of >33 per cent on more
than two consecutive occasions, sometimes above the upper limit of the
normal range, occurred in about 36 per cent of patients. It is recommended
that serum creatinine be assessed in duplicate before initiating therapy
and serum creatinine, creatinine clearance and/or plasma cystatin C levels
should be monitored weekly in the first month after initiation or modification
of therapy with Exjade, and monthly thereafter. Particular attention
should be paid to monitoring patients who are receiving high doses of
Exjade and/or low rates of transfusion, and to patients who are concomitantly
receiving medicinal products that depress renal function. It is recommended
that liver function tests be performed every month. Exjade should be
used with caution in patients with hepatic impairment. Patients are recommended
not to take Exjade with aluminium-containing antacid preparations.
Side effects: Very common (>1/10) increased blood creatinine. Common
(>1/100, <1/10) headache, diarrhoea, constipation, vomiting, nausea,
abdominal pain, abdominal distension, dyspepsia, increased transaminases,
rash, pruritus, proteinuria.
Legal category: POM.
Net price: 28 x 125mg, £117.60; 28 x 250mg, £235.20; 28 x
500mg, £470.40.
Contact details: Novartis Pharmaceuticals UK Ltd, Frimley Business Park,
Frimley, Camberley, Surrey GU16 7SR. Telephone 01276 692255.
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