The Pharmaceutical Journal
Vol 280 No 7486 p79
26 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
• Vectibix

Recall Metwest Pharmaceuticals simvastatin tablets 10mg

New medicines

Vectibix

Composition: Panitumumab.

Presentation: Concentrate for solution for infusion.

Class: Monoclonal antibody.

Indications: EGFR-expressing metastatic colorectal carcinoma with the non-mutated (wild-type) KRAS gene after failure of chemotherapy regimen containing fluoropyrimidine, oxaliplatin, and irinotecan.

Dosage: 6mg/kg bodyweight once every two weeks.

Contraindications: Patients less than 18 years of age. Patients with interstitial pneumonitis or pulmonary fibrosis.

Precautions: If a patient develops severe or intolerable dermatologic reactions, Vectibix should be withheld until reactions improve; patients should be monitored for inflammatory or infectious sequelae and appropriate treatment promptly initiated.

Patients should wear sunscreen and hats, and limit sun exposure, if they experience rash or dermatological toxicities while receiving Vectibix.

In the event of acute onset or worsening of pulmonary symptoms, Vectibix treatment should be interrupted and an investigation of symptoms undertaken.

If pneumonitis or lung infiltrates are diagnosed, Vectibix should be discontinued and the patient treated.

Patients should be monitored for hypomagnesaemia and accompanying hypocalcaemia every two weeks during Vectibix treatment and eight weeks after the completion of treatment.

Administration of Vectibix in combination with bolus 5-fluorouracil, leucovorin and irinotecan or in combination with bevacizumab-containing chemotherapy regimens should be avoided.

Side effects:
Very common (>=1/10)

• diarrhoea
• dry skin
• erythema
• fatigue
• paronychia
• pruritus
• rash
• skin exfoliation
• skin fissures

Common (>=1/100, <1/10)

• alopecia
• conjunctivitis
• cough
• dehydration
• dry eye
• dry mouth
• dyspnoea
• eye pruritus
• growth of eyelashes
• headache
• hypertrichosis
• hypocalcaemia
• hypokalaemia
• hypomagnesaemia
• increased lacrimation
• infusion reactions (pyrexia, chills)
• mucosal inflammation
• nasal dryness
• nausea
• ocular hyperaemia
• onycholysis
• stomatitis
• vomiting

Legal category: POM.

Net price: 1 x 100mg/5ml vial, £299.

Contact details: Amgen Ltd, 240 Cambridge Science Park, Milton Road, Cambridge CB4 0WD (tel 01223 420305).

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