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PJ Online homeThe Pharmaceutical Journal
Vol 273 No 7327 p781
27 November 2004

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    New medicines Prescription Products SPC changes

New medicines

Composition: Pemetrexed (as pemetrexed disodium).
Presentation: Powder for concentrate for solution for infusion.
Class: Folic acid analogues.
Indications: In combination with cisplatin for the treatment of chemotherapy-naive patients with unresectable malignant pleural mesothelioma. Monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy.
Dosage: 500mg/m2 administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle. For malignant pleural mesothelioma the recommended dose of cisplatin to be used in combination with pemetrexed is 75mg/m2 infused over two hours approximately 30 minutes after the completion of the pemetrexed infusion on the first day of each 21-day cycle.
Precautions: Patients should be monitored for myelosupression during therapy. Patients should take folic acid and vitamin B12 to reduce treatment-related toxicity.
Contraindications: Concomitant yellow fever vaccination. Breasting must be discontinued during therapy.
Side effects: Very common (>= 10 per cent) include decreased haemoglobin, leucocytes and neutrophils or granulocytes, nausea, vomiting, fatigue and rash.
Legal category: POM
Net price: 500mg vial £800.
Contact details: Alimta will be available from 29 November. Because it is a specialised hospital product, supply will only be available direct from the manufacturer at Eli Lilly and company, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL. Tel 01256 315000.

AngioxComposition: Bivalirudin.
Presentation: Powder for concentrate for solution for injection or infusion.
Class: Antithrombotic agent.
Indications: Anticoagulation in patients undergoing percutaneous coronary intervention.
Dosage: Intravenous bolus of 0.75mg/kg followed immediately by an intravenous infusion at a rate of 1.75mg/kg/hour for at least the duration of the procedure. The infusion may be continued for up to four hours post-PCI as clinically warranted.
Major precautions: Angiox should not be administered intramuscularly. Patients must be observed carefully for symptoms and signs of bleeding during treatment. Preparations should be made to deal with allergic-type hypersensitivity reactions which have been reported uncommonly in clinical trials.
Contraindications: Patients with: active bleeding or increased risk of bleeding because of haemostasis disorders or irreversible coagulation disorders; severe uncontrolled hypertension and subacute bacterial endocarditis; severe renal impairment or patients who are dialysis-dependent.
Side effects: Include major and minor bleeding. See SPC.
Legal category: POM
Net price: 10 x 250mg vials £3,100.
Contact details: Nycomed UK,
The Magdalen Centre, Oxford Science Park, Oxford, OX4 4GA.
Tel 01865 784500.

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Prescription Products

Ceftazidime injection
Ceftazidime powder for injection is now available from Genus Pharmaceuticals; net price, 1 vial, 500mg £4.48, 1g £8.95, 2g £17.90. Legal category: POM

Mirtazapine tablets
Mirtazapine tablets 30mg are now available from PLIVA; net price, 28 £20.49. Legal category: POM

Moxonidine tablets
Moxonidine tablets are now available from Genus Pharmaceuticals; net price, 200µg 28 £9.95, 300µg 28 £11.95, 400µg 28 £12.95. Legal category: POM

Telzir suspension
Telzir (fosamprenavir calcium) oral suspension 50mg/ml is now available from GlaxoSmithKline; net price, 225ml £78.83. Legal category: POM.

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SPC changes

Taxotere (docetaxel) is now additionally indicated for the treatment of patients with hormone refractory metastatic prostate cancer in combination with prednisolone or prednisone (Aventis). The recommended dose for this indication is 75mg/m2. Oral prednisolone or prednisone 5mg twice daily should be administered continuously. The recommended premedication regimen is oral dexamethasone 8mg taken 12 hours, three hours and one hour before the docetaxel infusion. The summary of product characteristics has been updated with clinical trial data supporting this indication. See SPC.

Climaval and Climagest
The summaries of product characteristics for Climaval (estradiol valerate) tablets and Climagest (estradiol valerate and norethisterone) tablets now state that for the initiation and continuation of treatment of postmenopausal symptoms the lowest effective dose for the shortest duration should be used (Novartis). The section on the risk of breast cancer has been revised following results from the Women’s Health Initiative Study and the Million Woman Study, and additional guidance on coronary artery disease and cognitive function has been included. The undesirable effects section has also been updated. See SPC.

The summary of product characteristics for Viread (tenofovir disoproxil) now states that there have been reports of a high rate of virological failure and of emergence of resistance at an early stage when tenofovir disoproxil fumarate is combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen (Gilead Sciences). See SPC.

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Citation: Electronicjuice URI: 20013492

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