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PRESCRIBING INFORMATION - UK AND
intolerable or severe skin reaction (≥ grade 3 CTCAE). Only resume if reaction resolves to grade 2. With second or third instances of severe skin reactions, resume at lower dose (200 mg/m2, then 150 mg/m2). A Please refer to the Summary of Product
fourth occurrence of severe skin reaction, or failure to resolve to grade 2 Characteristics for further information
during interruption, necessitates permanent discontinuation of Erbitux. Determine serum electrolyte levels (e.g. magnesium, potassium, Erbitux 5 mg/ml solution for infusion
calcium) prior to, and periodically during Erbitux treatment and replete cetuximab.
as appropriate. In combination with platinum-based chemotherapy, Presentation: Glass vial containing 20 ml or 100 ml of Erbitux
severe leukopenia or neutropenia may occur, leading to infectious solution for infusion at a concentration of 5 mg/ml. complications such as febrile neutropenia, pneumonia and sepsis. Total: 100 mg or 500 mg Erbitux per vial. Careful monitoring is recommended in such patients, particularly in Indications: Treatment of Epidermal Growth Factor Receptor-
those who experience skin lesions, mucositis or diarrhoea. An increased expressing, RAS wild-type metastatic colorectal cancer (mCRC) frequency of severe and sometimes fatal cardiovascular events and in combination with irinotecan-based chemotherapy; in first-line in treatment emergent deaths has been observed in non-small cell lung combination with FOLFOX (oxaliplatin, 5-FU and folinic acid) or cancer, SCCHN and colorectal carcinoma patients. In some studies as a single agent in patients who have failed oxaliplatin- and (non-small cell lung cancer) association of these with age ≥ 65 years irinotecan-based therapy and who are intolerant to irinotecan. has been observed. When prescribing, take into account the Treatment of squamous cell cancer of the head and neck cardiovascular and performance status of the patient and concomitant (SCCHN) in combination with radiation therapy for locally administration of cardiotoxic compounds such as fluoropyrimidines. advanced disease or in combination with platinum-based Do not use Erbitux in colorectal cancer patients whose tumours have chemotherapy for recurrent and/or metastatic disease. RAS mutations or for whom RAS tumour status is unknown. Dosage and administration: Administer Erbitux once a week.
Promptly refer patients with symptoms of keratitis to an Adults: Initial dose: 400 mg/m2 infused over 120 min. Subsequent ophthalmology specialist. If ulcerative keratitis is confirmed, interrupt weekly doses: 250 mg/m2 infused over 60 min. Older people: no or discontinue Erbitux. Consider the benefits/risks of continuing dose adjustment required, but experience limited in patients older treatment if keratitis is diagnosed. Use Erbitux with caution in than 75 years. Children: safety and efficacy have not been patients with a history of keratitis, ulcerative keratitis or severe dry established. Administration must be supervised by a physician eye. Contact lens use is a risk factor for keratitis and ulceration. experienced in antineoplastic medicinal products. Administer Only use in pregnancy if potential benefit justifies potential risk to intravenously with infusion pump, gravity drip or syringe pump foetus. Breast feeding is not recommended during Erbitux treatment using a separate infusion line. Do not exceed an infusion rate of or for up to 2 months after last infusion. 10 mg/min. Premedicate first infusion with an antihistamine and a Side effects: Very common: skin reactions (acne-like rash; pruritus;
corticosteroid. Premedication recommended for all subsequent dry skin; desquamation; hypertrichosis; nail disorders); infusions. Flush line with sterile 0.9% NaCl at end of infusion. hypomagnesaemia; increase in liver enzyme levels; mild or moderate Closely monitor patient throughout infusion and for at least infusion-related reactions (fever; chills; dizziness; dyspnoea); 1 hour afterwards. Resuscitation equipment must be available. mucositis, in some cases severe,which may lead to epistaxis. mCRC: Evidence of wild-type RAS status is required before Common: headache; diarrhoea; nausea; vomiting; severe infusion- initiating treatment. Mutational status should be determined by an related reactions (bronchospasm; urticaria; increase or decrease in experienced laboratory using validated test methods for detection blood pressure; loss of consciousness; shock; rarely: angina of KRAS and NRAS (exons 2, 3 and 4). Refer to product pectoris; myocardial infarction; cardiac arrest); conjunctivitis; fatigue; information for concomitantly used chemotherapeutic agents for dehydration normally secondary to diarrhoea or mucositis; dosage. Administer Erbitux first and do not administer hypocalcaemia; anorexia which may lead to weight decrease. concomitantly used chemotherapeutic agents earlier than 1 hour Uncommon: blepharitis; keratitis; pulmonary embolism; DVT, after end of Erbitux infusion. Continue treatment until disease interstitial lung disease. Very rare: Stevens-Johnson syndrome/toxic progression. Locally advanced SCCHN: start Erbitux one week epidermal necrolysis. Unknown frequency: superinfection of skin before radiation therapy and continue treatment until the end of the radiation therapy period. Recurrent/metastatic SCCHN: use in Refer to product information of concomitantly used chemotherapeutic combination with platinum-based chemotherapy followed by agents for side effects. In combination with fluoropyrimidines, the Erbitux as maintenance therapy until disease progression. Do not frequency of cardiac ischaemia and hand-foot syndrome was administer chemotherapy earlier than 1 hour after the end of increased compared to that with fluoropyrimidines. In combination with capecitabine and oxaliplatin (XELOX) the frequency of severe Contraindications: Severe (grade 3 or 4) hypersensitivity to
Erbitux. In combination with oxaliplatin-containing chemotherapy In combination with platinum-based chemotherapy, the frequency of in patients with mutant RAS mCRC or for whom RAS mCRC severe leukopenia or neutropenia may be increased, leading to a status is unknown. Consider contraindications to concomitantly higher rate of infectious complications such as febrile neutropenia, used chemotherapeutic agents or radiation therapy. pneumonia and sepsis compared with platinum-based chemotherapy Precautions: Decrease infusion rate if mild or moderate infusion-
related reaction occurs and use lower rate in all subsequent Prescribers should consult the summary of product characteristics in infusions. Warn patients of possible delayed-onset severe infusion-related reactions. Discontinue infusion immediately and Legal category: POM. Basic NHS price: One vial of
permanently in the event of a severe infusion-related reaction– 100 mg/20 ml: £178.10. One vial of 500 mg/100 ml: £890.50. emergency treatment may be required. Closely monitor patients with reduced performance status and pre-existing Marketing Authorisation Holder and Numbers:
cardiopulmonary disease. Cases of interstitial lung disease have Merck KGaA, Darmstadt, Germany; EU/1/04/281/003, 005. been reported, with most patients being from the Japanese population. Discontinue Erbitux if this is diagnosed. For further information, including price queries, contact: UK:
Skin reactions are very common. Consider prophylaxis with oral Merck Serono Ltd, Bedfont Cross, Stanwell Road, Feltham, tetracyclines (6-8 weeks) and topical 1% hydrocortisone cream with Middlesex, TW14 8NX, UK Tel: 020 8818 7373. moisturiser. Skin reactions may become severe, especially in Republic of Ireland: Merck Serono, 4045 Kingswood Road,
combination with chemotherapy. The risk of secondary infections is Citywest Business Campus, Dublin 24. Tel: 01 4687590. increased and cases of staphylococcal scalded skin syndrome, necrotising fasciitis and sepsis, in some cases with fatal outcome, Date of preparation: November 2013.
have been reported. Interrupt treatment if patient experiences an Job Bag No: ERB13-0189
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard. In the Republic of Ireland information can be found at
www.imb.ie. Adverse events should also be reported to Merck Serono Limited –
Tel: +44(0)20 8818 7373 or email: [email protected]

FIRE-3 RAS wt - ECC Abstract.pdf

Source: http://merckseronojanuary2014.co.uk/New-PI-Jan-2014.pdf