New medicines
Revlimid
Composition: Lenalidomide.
Presentation: Hard capsule.
Action: Anti-neoplastic, anti-angiogenic, pro-erythropoietic and immunomodulatory
Indications: In combination with dexamethasone for the treatment of multiple
myeloma in patients who have received at least one prior therapy.
Dosage: Capsules should be taken at the same time each day. The recommended
starting dose is 25mg once daily on days 1–21 of repeated 28-day
cycles. Dose adjustments are recommended to manage grade 3 or 4 neutropenia
or thrombocytopenia, or other grade 3 or 4 toxicity judged to be related
to lenalidomide.
Contraindications: Patients under 18 years of age. Pregnant women. Women
of childbearing age (unless all the pregnancy prevention programme conditions
outlined in the summary of product characteristics are met). Patients
with Lapp lactase deficiency or glucose-galactose malabsorption.
Precautions: For elderly patients and those with impaired renal function,
care should be taken in dose selection and renal function should be monitored.
Dose adjustments should be made based on patients’ renal function.
Erythropoietic agents (or other agents that may increase the risk of
thrombosis, such as hormone replacement therapy) should be used with
caution in multiple myeloma patients receiving lenalidomide with dexamethsaone.
A haemoglobin concentration above 13g/dl should lead to discontinuation
of erythropoietic agents. Patients and physicians should be alert to
signs and symptoms of thromboembolism. Patients should seek medical care
if they develop symptoms such as shortness of breath, chest pain, or
arm or leg swelling. Prophylactic antithrombotic medicines should be
recommended, especially in patients with additional thrombotic risk factors.
Patients should be advised to report febrile episodes promptly. Patients
and physicians should be alert to signs and symptoms of bleeding, including
petechiae and epistaxes. A complete blood cell count should be performed
at baseline, every week for the first eight weeks of treatment and monthly
thereafter to monitor for cytopenias. Co-administration of lenalidomide
with other myelosuppressive agents should be undertaken with caution.
Side effects: Very common (>1/10) neutropenia, thrombocytopenia, anaemia,
constipation, diarrhoea, nausea, weight change, rash, muscle cramp, muscle
weakness, fatigue, asthenia, peripheral oedema, insomnia.
Legal category: POM.
Net price: 21 x 5mg, £3,570; 21 x 10mg, £3,780; 21 x 15mg, £3,969;
21 x 25mg, £4,368.
Contact details: Celgene, 8 The Square, Stockley Park, Uxbridge, Middlesex
UB11 1FW (tel 08448 010045).
Sebivo
Composition: Telbivudine.
Presentation: Film-coated tablet.
Class: Thymidine nucleoside analogue.
Indications: Treatment of chronic hepatitis B in adult patients with
compensated liver disease and evidence of viral replication, persistently
elevated serum alanine aminotransferase levels and histological evidence
of active inflammation or fibrosis.
Dosage: 600mg once daily.
Precautions: Adjustment of the dosage interval is required in renal impairment.
After initiating antiviral therapy, serum alanine aminotransferase may
increase in some patients as hepatitis B virus DNA levels decline. Patients
with cirrhosis may be at higher risk for hepatic decompensation and hepatitis
exacerbation, and should be monitored during therapy. Sebivo is not indicated
for patients with decompensated cirrhosis. Exacerbations of hepatitis
have been reported in patients who have stopped treatment, and hepatic
function should therefore be monitored for at least six months after
discontinuation. Nucleoside analogues should be used with caution for
any patient with hepatomegaly, hepatitis or other known risk factors
for liver disease. Evidence does not support the use of telbivudine monotherapy
for patients with established lamivudine-resistant hepatitis B infection.
Side effects: Common (>1/100, <1/10) dizziness, headache, cough,
diarrhoea, nausea, abdominal pain, rash, fatigue, increased blood amylase,
increased blood lipase, increased blood creatine phosphokinase, increased
blood alanine aminotransferase.
Legal category: POM.
Net price: 28 x 600mg, £290.33.
Contact details: Novartis Pharmaceuticals UK Ltd, Frimley Business Park,
Frimley, Surrey GU16 7SR (tel 01276 698370).
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