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PJ Online homeThe Pharmaceutical Journal
Vol 280 No 7502 p591
17 May 2008

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Products

Accessing SPCs
The summaries of product characteristics and patient information leaflets for medicines licensed in the UK are available online

    New medicines Prescription Products SPC changes

New medicines

Ivemend

Composition: Fosaprepitant.

Presentation: Powder for solution for infusion.

Class: Anti-emetic; prodrug of aprepitant.

Indications: Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy, or associated with moderately emetogenic cancer chemotherapy, given as part of a combination anti-emetic regimen.

Dosage: Ivemend (115mg) may be substituted for aprepitant (125mg) prior to chemotherapy, on day 1 only of the chemotherapy induced nausea and vomiting regimen, as an infusion administered over 15 minutes.

Contraindications: Co-administration with pimozide, terfenadine, astemizole or cisapride.

Precautions: Ivemend should be used with caution for patients with moderate or severe hepatic insufficiency.

Ivemend (and oral aprepitant) should be used with caution in patients receiving medicines that are metabolised primarily through CYP3A4.

Concomitant administration with irinotecan should be approached with extra caution as the combination might result in increased toxicity.

Concomitant use of fosaprepitant with ergot alkaloid derivatives, which are CYP3A4 substrates, may result in elevated plasma concentrations of these medicinal products; caution is advised due to the potential risk of ergot-related toxicity.

In patients on chronic warfarin therapy, international normalised ratio should be monitored closely for two weeks after a three-day regimen of fosaprepitant followed by oral aprepitant (and throughout ongoing treatment with oral aprepitant).

Non-hormonal contraception should be used if required during treatment with fosaprepitant or aprepitant and for two months following the last dose of aprepitant.

Concomitant administration of fosaprepitant with medicinal products that strongly induce CYP3A4 activity, including St John’s Wort, should be avoided.

Concomitant administration of fosaprepitant with medicinal products that inhibit CYP3A4 activity should be approached cautiously as the combination results in increased plasma concentrations of aprepitant.

Corticosteroid doses need to be adjusted when administered with fosaprepitant/aprepitant (as per standard anti-emetic regimens that include aprepitant). Ivemend should not be given as a bolus injection, but should always be diluted and given as a slow intravenous infusion.

Ivemend should not be administered intramuscularly or subcutaneously. Mild injection site thrombosis has been observed at higher doses. If signs or symptoms of local irritation occur, the injection or infusion should be terminated and restarted in another vein.

Side effects: Common (>=1/100 to <1/10) headache, dizziness, hiccups, constipation, diarrhoea, dyspepsia, eructation, anorexia, asthaenia/fatigue, increased aspartate aminotransferase and increased alanine aminotransferase.

Legal category: POM.

Net price: 115mg vial, £20.55.

Contact details: Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU (tel 01992 467272).

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Prescription Products

Retacrit
Retacrit (epoetin zeta) solution for injection in prefilled syringe is now available from Hospira.

Net price:
6 x 1,000iu/0.3ml, £33.94
6 x 2,000iu/0.6ml, £67.88
6 x 3,000iu/0.9ml, £101.82
6 x 4,000iu/0.4ml, £135.76
6 x 5,000iu/0.5ml, £169.70
6 x 6,000iu/0.6ml, £203.63
6 x 8,000iu/0.8ml, £271.52
6 x 10,000iu/1ml, £339.39
1 x 40,000iu/1ml, £226.26

Legal category: POM

Reyataz
Reyataz (atazanavir) is now available from Bristol-Myers Squibb in 300mg capsules.

Net price: 30 x 300mg, £315.69
Legal category: POM

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SPC changes

Accessing SPCs
The summaries of product characteristics and patient information leaflets for medicines licensed in the UK are available online

Lyrica
Information about hypersensitivity reactions and visual field defects has been added to the summary of product characteristics for Lyrica (pregabalin; Pfizer).

Nexavar
The summary of product characteristics for Nexavar (sorafenib; Bayer) now includes the following warning: “Gastrointestinal perforation is an uncommon event and has been reported in less than 1 per cent of patients taking sorafenib. In some cases this was not associated with apparent intra-abdominal tumour. Sorafenib therapy should be discontinued.”

Reminyl
Hypertension has been added to the lists of common undesirable effects in the summaries of product characteristics for Reminyl (galantamine; Shire) tablets, Reminyl oral solution and Reminyl XL capsules.

The SPC for Reminyl XL now says about switching to Reminyl XL from Reminyl tablets or oral solution: “It is recommended that the same total daily dose of galantamine is administered to patients. Patients switching to the once-daily regimen should take their last dose of Reminyl tablets or oral solution in the evening and start Reminyl XL prolonged release capsules once daily the following morning.”

Viread
Viread (tenofovir disoproxil; Gilead) has a new indication for treatment of chronic hepatitis B in adults with compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase levels and histological evidence of active inflammation or fibrosis. The summary of product characteristics has been updated accordingly.

Zevalin
Zevalin (ibritumomab tiuxetan; Bayer) is now indicated as consolidation therapy after remission induction for previously untreated patients with follicular lymphoma, the product’s summary of product characteristics now states. The benefit of Zevalin following treatment with rituxumab plus chemotherapy has not been established, the SPC adds.

New details have been added to the special warnings section, including:

  • information regarding blood cell counts for patients receiving Zevalin
  • a warning that patients should not receive growth factor treatment for two weeks either side of the Zevalin regimen
  • a statement that no data are available for patients with CNS-lymphoma
  • a warning that patients should be closely monitored for signs of extravasation during injection

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