The Pharmaceutical Journal
Vol 279 No 7478 p559
17 November 2007

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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
• Celsentri
SPC changes
• Elaprase
Products miscellany
• BeneFIX
• Florinef
• Prothiaden

New medicines

Celsentri

Composition: Maraviroc.

Presentation: Film-coated tablets.

Action: CCR5 antagonist.

Indications: Treatment-experienced adult patients in whom only CCR5-tropic HIV-1 is detectable, in combination with other antiretroviral medicines.

Dosage: 150mg, 300mg or 600mg twice a day depending on interactions with co-administered antiretroviral therapy and other medicines, as indicated in the product’s summary of product characteristics.

Precautions: Before taking Celsentri it must be confirmed that only CCR5-tropic HIV-1 is detectable (ie, CXCR4 or dual/mixed tropic virus not detected) using an adequately validated and sensitive detection method on a newly drawn blood sample.

Maraviroc is a substrate of cytochrome P450 3A4 — dosage adjustment is recommended when co-administered with medicines that induce or inhibit CYP3A4.

Dosage adjustment is required in renal impairment for patients who are also receiving potent inhibitors of CYP3A4.

Celsentri should be used with caution in patients with hepatic impairment, in patients with severe cardiovascular disease, and in patients with a history of postural hypotension (or taking medicines known to lower blood pressure).

CCR5 antagonists could potentially impair immune response to certain infections; this should be taken into account when treating infections such as active tuberculosis and invasive fungal infections.

Discontinuation of Celsentri should be considered in any patient with signs of acute hepatitis, particularly if hypersensitivity-type reaction is suspected.

Concomitant use of Celsentri with rifampicin plus efavirenz or with St John’s wort is not recommended.

Side effects: Very common (>=1/10) nausea. Common (>=1/100, <1/10) dizziness, paraesthesia, dysgeusia, somnolence, cough, vomiting, abdominal pain, abdominal distension, dyspepsia, constipation, rash, pruritus, muscle spasms, back pain, asthenia, insomnia, decreased weight, increased alanine aminotransferase, increased aspartate aminotransferase, increased gamma-glutamyltransferase.

Legal category: POM.

Net price:
60 x 150mg, £551.10
60 x 300mg, £551.10

Contact details: Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT13 9NJ (tel 01304 616161).

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SPC changes

Elaprase
Potentially life threatening anaphylactoid reactions have been observed in some patients treated with Elaprase (idursulfase; Shire), the product’s summary of product characteristics now states.

The SPC recommends that Elaprase infusion should be suspended immediately following a reaction. Late emergent symptoms and signs of anaphylactoid reactions have been observed as long as 24 hours after an initial reaction.

Patients who have experienced anaphylactoid reactions should be treated with caution when readministering Elaprase.

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Products miscellany

BeneFIX
BeneFIX (nonacog alfa recombinant coagulation factor IX; Wyeth) vials 250iu, 500iu and 1,000iu have been reformulated. The pack contents and appearance have changed, as have the product ordering codes. BeneFIX is also now available in a 2,000iu strength vial.
Net price: 1 x 2,000iu, £1,320.

Florinef
The appearance and storage requirements for Florinef (fludrocortisone acetate; Bristol-Myers Squibb) tablets 100µg have changed. The tablets are now white instead of pink and are now available in packs of 100 instead of 56 tablets.

Florinef tablets now need to be refrigerated (2–8C) at all times and the shelf life has increased from 12 to 24 months.
Net price: 100, £5.36.

Prothiaden
Prothiaden (dosulepin; Abbott) capsules 25mg are now available in 28-capsule packs. The 100- and 600-capsule pack sizes are no longer available.
Net price: 28, £1.70.

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