New medicines / Prescription products / Discontinued products / Supply issues / SPC changes / Products miscellany

Composition: Sunitinib maleate.

Presentation: hard capsules.

Class: Protein-tyrosine kinase inhibitor.

Indications: Treatment of unresectable or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance; treatment of advanced or metastatic renal cell carcinoma (MRCC) after failure of interferon alfa or interleukin-2 therapy.

Dosage: One 50mg dose orally, taken daily for four consecutive weeks, followed by a two-week rest period to complete a six-week cycle. Dose modifications in 12.5mg steps may be applied based on individual safety and tolerability. The daily dose should not, however, exceed 87.5mg nor should it be decreased below 37.5mg.

Precautions: Co-administration with potent CYP3A4 inducers, such as rifampin, and with potent CYP3A4 inhibitors, such as ketoconazole, should be avoided. Serious, sometimes fatal, gastrointestinal complications, including gastrointestinal perforation, have occurred rarely in patients with intra-abdominal malignancies treated with Sutent.

Side effects: Adverse reactions reported in GIST studies: very common (>1/10) anaemia, dysgeusia, headache, hypertension, diarrhoea, nausea, stomatitis, vomiting, dyspepsia, abdominal pain, skin discolouration, palmar-plantar erythrodysaesthesia syndrome, rash, fatigue/asthenia, mucosal inflammation; common (>1/100) neutropenia, thrombocytopenia, hypothyroidism, anorexia, epistasis, chromaturia, glossodynia, constipation, oral pain, flatulence, dry mouth, gastro-oesophageal reflux disease, hair colour changes, dry skin, pain in extremities, arthralgia, myalgia, oedema.

Adverse reactions report in MRCC studies: Very common (>1/10) neutropenia, anorexia, dysgeusia, headache, hypertension, diarrhoea, nausea, stomatitis, dyspepsia, vomiting, constipation, glossodynia, abdominal pain, skin discolouration, rash, hair colour changes, palmar-plantar erythrodysaesthesia syndrome, dry skin, erythema, pain in extremities fatigue/asthenia, muscosal inflammation, blister; common (>1/100) anaemia, thrombocytopenia, leucopenia, increased lacrimation, dehydration, decreased appetite, dizziness, paraesthesia, epistaxis, dyspnoea, flatulence, abdominal distension, dry mouth, alopecia, exfoliative dermatitis, periorbital oedema, myalgia.

Legal category: POM.

Net price: 30 x 12.5mg, £885; 30 x 25mg, £1,770; 30 x 50mg, £3,540.

Contact details: Pfizer, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS.
Telephone 01304 616161.

Prescription Products

Exubera Exubera
Exubera (human insulin) pre-dispensed inhalation powder is now available from Pfizer.

Net price: 90 x 1mg blisters, £25.19; 90 x 3mg blisters, £62.28; inhaler kit (assembled insulin release unit [IRU] and chamber, 1 spare chamber and 6 spare IRUs), £52.68; 6 IRUs, £9.10; 1 chamber, £10.11. Legal category: POM.

Humatrope
Humatrope (somatropin) reconstituted cartridges will be available from Eli Lilly from 12 August. Net price: 1 x 6mg, £137.25; 1 x 12mg, £274.50;
1 x 24, £549.00. Legal category:POM.

SPC changes

Menjugate Kit
The summary of product characteristics for the Menjugate Kit (meningococcal group C oligosaccharide conjugate vaccine [adsorbed]; Sanofi Pasteur) has been updated to allow concomitant administration of pneumoccal conjugate vaccine. See SPC.

Revatio
The summary of product characteristics for Revatio (sildenafil citrate; Pfizer) has been updated to include an additional contraindication and further information in the special warnings and precautions for use section. The SPC now states that Revatio is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (regardless of whether this episode was in connection or not with previous phosphodiesterase type 5 [PDE5] inhibitor exposure). It also now states that visual defects and cases of non-arteritic anterior ischaemic optic neuropathy have been reported in connection with taking sildenafil and other PDE5 inhibitors, and that patients should be advised that, in cases of sudden visual defect, they should stop taking Revatio and consult a physician immediately. See SPC.

Discontinued products

Floxapen
GlaxoSmithKline is discontinuing Floxapen (flucloxacillin) 10 x 1g, 10 x 500mg and 10 x 250mg vials. Further information on 0800 221441.

Supply issues

Pfizer short-dated products
Pfizer currently only has stock of Inspra (eplerenone) 28 x 50mg tablets and Synarel (nafarelin) 30-dose nasal spray (4ml) dated 1 February 2007. The company is asking pharmacists to accept this stock until fresh supplies are available. This short-dated stock will be supplied on a sale-or-return basis. Further information is available from customer services on 01304 645262.

Products miscellany

Micotil
Following concerns about the safety of the veterinary medicinal product Micotil (tilmicosin, propylene glycol; Eli Lilly), additional safety warnings have been added to its labelling and that it is now recommended that Micotil only be administered to animals by veterinary surgeons.

The additional safety warnings state: “Injection of this drug in humans can be fatal — exercise extreme caution to avoid accidental self-injection and follow the administration instructions and the guidance below precisely. This product should only be administered by a veterinary surgeon. Never carry a syringe loaded with Micotil 300 with the needle attached. The needle should be connected to the syringe only when filling the syringe or administering the injection. Keep the needle and syringe separate at all other times. Do not use automatic injection equipment. Ensure that animals are properly restrained, including those in the vicinity. Do not work alone using Micotil. In case of human injection seek immediate medical attention and take this vial or the package leaflet with you. Apply a cold pack (not ice directly) to the injection site.”