The Pharmaceutical Journal
Vol 280 No 7485 p47
19 January 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
• Isentress
Prescription Products
• Diovan
• Fostair
• Ionsys
• Lyrica
• Risperidone
• Sumatriptan
SPC changes
• Enbrel
• Humira
• Sporanox
• Taxotere
• Zyprexa
Discontinued products
• FemTab Sequi
Supply issues
• Kenalog

New medicines

Isentress

Composition: Raltegravir.

Presentation: Film-coated tablet.

Action: Integrase strand transfer inhibitor.

Indications: Treatment of HIV-1 infection in treatment-experienced adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy, used in combination with other antiretroviral medicinal products.

Dosage: 400mg twice daily with or without food.

Precautions: Isentress should be used with caution for elderly people.

Safety and efficacy of Isentress have not been established for patients below 16 years of age.

Isentress should be used with caution for patients with severe hepatic impairment.

Patients with pre-existing liver dysfunction including chronic hepatitis are at increased risk of liver function abnormalities during combination antiretroviral therapy and should be monitored accordingly. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment should be considered.

Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.

Cases of osteonecrosis have been reported particularly in patients with advanced HIV disease or long-term exposure to combination antiretroviral therapy.

Rifampicin reduces plasma levels of raltegravir; if co-administration with rifampicin is unavoidable a doubling of the dose of Isentress could be considered.

Side effects: Common (>=1/100 to <1/10) dizziness, vertigo, abdominal pain, flatulence, constipation, pruritus, acquired lipodystrophy, hyperhidrosis, arthralgia, fatigue, asthenia.

Legal category: POM.

Net price: 60 x 400mg, £647.29.

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

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Prescription Products

Diovan
Diovan (valsartan) is now available from Novartis in 320mg capsules. Additionally, Diovan 80mg and 160mg capsules are now available in 98-capsule packs and Diovan 40mg capsules are available in 28-capsule packs; packs of seven 40mg capsules are being phased out.
Net price:
28 x 40mg, £16.44
98 x 80mg, £57.54
98 x 160mg, £75.81
28 x 320mg, £38.80
98 x 320mg, £83.30
Legal category: POM.

Fostair
Fostair (beclometasone dipropionate 100µg, formoterol fumerate 6µg) pressurised inhalation solution (120-dose) is now available from Trinity-Chiesi.
Net price: 1 inhaler, £29.32
Legal category: POM.

Ionsys
Ionsys (fentanyl) iontophoretic transdermal system delivering 80 x 40µg doses are now available from Janssen-Cilag.
Net price: 1, £62
Legal category: CD (schedule 2).

Lyrica
Lyrica (pregabalin) is now available from Pfizer in 225mg capsules.
Net price: 56, £64.40
Legal category: POM.

Risperidone
Risperidone film-coated tablets are now available from Teva UK in six strengths.
Net price:
20 x 0.5mg, £6.71
60 x 1mg, £11.03
60 x 2mg, £65.26
60 x 3mg, £95.96
60 x 4mg, £126.67
28 x 6mg, £89.57
Legal category: POM.

Sumatriptan
Sumatriptan tablets are now available from Pliva in two strengths.
Net price:
6 x 50mg, £17.62
6 x 100mg, £35.24
Legal category: POM.

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SPC changes

Enbrel
In clinical studies, concurrent administration of abatacept and Enbrel (etanercept; Wyeth) resulted in increased incidences of serious adverse events, the summary of product characteristics for Enbrel now states.

The SPC warns that this combination has not demonstrated increased clinical benefit and that its use is not recommended. The product’s shelf life has increased from 18 months to two years.

Humira
Humira (adalimumab; Abbott) now has an additional indication for the treatment of moderate to severe chronic plaque psoriasis in adult patients who fail to respond to, have a contraindication to, or are intolerant to, other systemic therapy, including ciclosporin, methotrexate or PUVA. The summary of product characteristics for Humira has been updated accordingly.

Sporanox
Co-administration of nisoldipine and bepridil with Sporanox (itraconzole; Janssen-Cilag) oral solution and Sporanox IV is now contraindicated in the summaries of product characteristics for both products.

Additionally, the SPCs’ special warnings sections now state that reports of heart failure were more frequent with daily doses of 400mg than with lower total daily doses.

Taxotere
The head and neck cancer indication for Taxotere (docetaxel; Sanofi-Aventis) has been updated in the product’s summary of product characteristics to read:

“Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.”

Zyprexa
Fatigue has been added to the list of common side effects in the summary of product characteristics for Zyprexa (olanzapine; Lilly).

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Discontinued products

FemTab Sequi
FemTab Sequi (estradiol valerate 2mg; estradiol valerate/levonorgestrel 2mg/75µg) tablets, 3 x 28 pack, have been discontinued by Merck Serono.

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Supply issues

Kenalog
Bristol-Myers Squibb is experiencing difficulties supplying Kenalog (triamcinolone acetonide) pre-filled syringes 1 x 1ml and vials 5 x 1ml.

Customer services on 01244 586250.

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