Prescription products / SPC change / Discontinued products / Products miscellany / Supply issues

Tarceva
Composition: Erlotinib.
Presentation: Film-coated tablet.
Class: tyrosine kinase inhibitor.
Indications: Treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
Dosage: 150mg daily taken at least one hour before or two hours after food. When dose adjustment is necessary, reduce in 50mg steps.
Precautions: Use in patients with severe hepatic impairment or severe renal impairment is not recommended. Use in children is not recommended. Concomitant treatment with CYP3A4 inducers and inhibitors should be avoided. Smokers should be advised to stop smoking since plasma concentration of erlotinib could be reduced. Interstitial lung disease has been reported uncommonly and patients who develop acute onset of new or progressive unexplained pulmonary symptoms, such as dyspnoea, cough or fever should be evaluated for interstitial lung disease. Caution should be exercised when using antacids, proton pump inhibitors and H2 antagonists with erlotinib.
Side effects: Very common (>1/10) infection, anorexia, conjunctivitis, keratoconjunctivitis sicca, dyspnoea, cough, diarrhoea, nausea, vomiting, stomatatis, abdominal pain, rash, pruritis, dry skin, fatigue. Common (>1/100) gastrointestinal bleeding, liver function test abnormalities, keratitis.
Legal category: POM
Net price: 30 x 150mg £1,631.53, 30 x 100mg £1,324.14.
Contact details: Roche, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY. Telephone 0800 328 1629.

Apidra
Composition: Insulin glulisine.
Presentation: Solution for injection containing 100U insulin glulisine per ml.
Class: Human insulin analogue.
Indications: Treatment of adult patients with diabetes mellitus.
Dosage: Given shortly before (0–15 mins) or soon after meals. Apidra should be used with an intermediate or long acting insulin or basal insulin analogue and can be used with oral hypoglycaemics. Dosage should be adjusted according to individual requirements.
Apidra can be given by subcutaneous injection or by continuous subcutaneous pump infusion.
Precautions: Medical supervision and monitoring recommended when transferring from other insulins.
Side effects: Hypoglycaemia, injection site reactions and local hypersensitivity.
Legal category: POM.
Net price: 10ml vial £17.27, 5 x 3ml cartridges £29.45.
Contact details: Aventis Pharma, 1 Onslow Street, Guildford, Surrey GU1 4YS. Telephone 01483 505515.

Prescription Products

BuTrans
BuTrans (buprenorphine) transdermal patches are now available from Napp. They are licensed for the treatment of severe opioid-responsive pain conditions, which are not adequately responding to non-opioid analgesics. There are three patch strengths available, delivering 5µg/hour, 10µg/hour and 20µg/hour. The patches should be changed every seventh day. Net price 5µg/hour, 2 patches £9, 10µg/hour, 4 patches £32.72, 20µg/hour, 4 patches £59.59. Legal category: POM CD (schedule 3).

SPC changes

Glivec
The summary of product characteristics for Glivec (imatinib; Novartis) has been updated. It now states that it can be used at a dose of 800mg in patients with metastatic or unresectable gastrointestinal stromal tumours, whose disease has progressed on or not responded to 400mg or 600mg. The dose should be administered as 400mg twice a day. See SPC.

Humira
Humira (adalimumab; Abbott) is now indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. It is also now indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. The recommended dose for both indications is 40mg adalimumab every other week as a single dose by subcutaneous injection. See SPC.

Topamax
Topamax (topiramate; Janssen-Cilag) is now indicated for the prevention of migraine headache. The summary of product characteristics states that it should be considered for adults who experience three or more migraine attacks per month or frequent migraine attacks that significantly interfere with their daily routine. It should be initiated at a dose of 25mg nightly for one week. Dosage can then be increased in increments of 25mg per day at one-weekly intervals. The maximum recommended dose is 100mg daily in two divided doses. Its initiation should be restricted to specialist care and treatment should be managed under specialist supervision or shared care arrangements. See SPC.

Zoton
Zoton (lansoprazole; Wyeth) is now additionally indicated for the eradication of Helicobacter pylori from the upper gastrointestinal tract when used in combination with appropriate antibiotics in patients with ulcer-like dyspepsia leading to the prevention of symptom recurrence. See SPC.

Discontinued products

Monocor
Monocor (bisoprolol fumarate; Wyeth) tablets 10mg have been discontinued. Monocor tablets 5mg remain available. Further information from Wyeth customer service department on 0845 8505544.

Products miscellany

Vicks First Defence
Vicks First Defence, a micro gel nasal spray, is now available from Procter & Gamble. Recommended retail price, 15ml £6.99. Legal category: medical device class 1.

Optium Plus
Optium Plus glucose test strips for use with Optium Xceed advanced diabetes management system are now available from Abbott Diabetes Care. Net price 50 strips £15.57.

Zydol
Zydol (tramadol; Grünenthal) capsules 50mg will now carry a black Grünenthal logo on the body of the capsules. There are no other changes to the product or packaging.