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Erbitux is a brand name for Cetuximab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)- expressing, RAS wild-type metastatic colorectal cancer • in combination with irinotecan-based chemotherapy, • in first-line in combination with FOLFOX, • as a single agent in patients who have failed oxaliplatin- and…
Verbatim from this product's EMA label. Tap a section to expand.
Erbitux must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products. Close monitoring is required during the infusion and for at least 1 hour after the end of the infusion. Availability of resuscitation equipment must be ensured.
Posology Prior to the first infusion, patients must receive premedication with an antihistamine and a corticosteroid at least 1 hour prior to administration of cetuximab. This premedication is recommended prior to all subsequent infusions.
1). Evidence of wild-type RAS (KRAS and NRAS) status is required before initiating treatment with Erbitux. 1). Erbitux may be administered in a weekly or every other week dose regimen. Weekly dose regimen Erbitux is administered once a week.
The initial dose is 400 mg cetuximab per m2 body surface area (BSA). All subsequent weekly doses are 250 mg/m2 each. Biweekly dose regimen Erbitux is administered once every other week. Each dose is 500 mg cetuximab per m2 body surface area.
For the dosage or recommended dose modifications of concomitantly used chemotherapeutic agents, refer to the product information for these medicinal products. They must not be administered earlier than 1 hour after the end of the cetuximab infusion.
It is recommended that cetuximab treatment be continued until progression of the underlying disease. Squamous cell cancer of the head and neck In combination with radiation therapy In patients with locally advanced squamous cell cancer of the head and neck, cetuximab is used concomitantly with radiation therapy.
It is recommended to start cetuximab therapy one week before radiation therapy and to continue cetuximab therapy until the end of the radiation therapy period. Erbitux is administered once a week. The initial dose is 400 mg cetuximab per m2 body surface area (BSA).
All subsequent weekly doses are 250 mg/m2 each. 1). Chemotherapy must not be administered earlier than 1 hour after the end of the cetuximab infusion. Erbitux may be administered in a weekly or every other week dose regimen. Weekly dose regimen Erbitux is administered once a week.
The initial dose is 400 mg cetuximab per m2 body surface area (BSA). All subsequent weekly doses are 250 mg/m2 each. Biweekly dose regimen Erbitux is administered once every other week. Each dose is 500 mg cetuximab per m2 body surface area.
The main undesirable effects of cetuximab are skin reactions, which occur in more than 80% of patients, hypomagnesaemia which occurs in more than 10% of patients and infusion-related reactions, which occur with mild to moderate symptoms in more than 10% of patients and with severe symptoms in more than 1% of patients.
The following definitions apply to the frequency terminology used hereafter:
Very common ( 1/10) Common ( 1/100 to < 1/10) Uncommon ( 1/1 000 to < 1/100) Rare ( 1/10 000 to < 1/1 000) Very rare (< 1/10 000) Frequency not known (cannot be estimated from the available data) An asterisk (*) indicates that additional information on the respective undesirable effect is provided below the table.
4). 4); anorexia which may lead to weight decrease. 9 Nervous system disorders Common: Headache.
Frequency not known:
Aseptic meningitis.
Eye disorders Common:
Conjunctivitis.
Uncommon:
Blepharitis; keratitis.
Vascular disorders Uncommon:
Deep vein thrombosis. 4).
Gastrointestinal disorders Common:
Diarrhoea; nausea; vomiting.
Hepatobiliary disorders Very common:
Increase in liver enzyme levels (ASAT, ALAT, AP).
Skin and subcutaneous tissue disorders Very common:
Skin reactions*.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infusion-related, including anaphylactic, reactions Severe infusion-related reactions, including anaphylactic reactions, may commonly occur, in some cases with fatal outcome.
Occurrence of a severe infusion-related reaction requires immediate and permanent discontinuation of cetuximab therapy and may necessitate emergency treatment. Some of these reactions may be anaphylactic or anaphylactoid in nature or represent a cytokine release syndrome (CRS).
Symptoms may occur during the first infusion and for up to several hours afterwards or with subsequent infusions. It is recommended to warn patients of the possibility of such a late onset and instruct them to contact their physician if symptoms or signs of an infusion-related reaction occur.
Symptoms may include bronchospasm, urticaria, increase or decrease in blood pressure, loss of consciousness or shock. In rare cases, angina pectoris, myocardial infarction or cardiac arrest have been observed. g. due to preformed IgE antibodies cross-reacting with cetuximab.
These reactions are commonly associated with bronchospasm and urticaria. They can occur despite the use of premedication. 5 The risk for anaphylactic reactions is much increased in patients with a history of allergy to red meat or tick bites or positive results of tests for IgE antibodies against cetuximab (α-1-3-galactose).
In these patients cetuximab should be administered only after a careful assessment of benefit/risk, including alternative treatments, and only under close supervision of well trained personnel with resuscitation equipment ready. The first dose should be administered slowly whilst all vital signs are closely monitored for at least two hours.
If during the first infusion, an infusion-related reaction occurs within the first 15 minutes, the infusion should be stopped. A careful benefit/risk assessment should be undertaken including consideration whether the patient may have preformed IgE antibodies before a subsequent infusion is given.
Erbitux is contraindicated in patients with known severe (grade 3 or 4) hypersensitivity reactions to cetuximab. 4). Before initiation of combination treatment, contraindications for concomitantly used chemotherapeutic agents or radiation therapy must be considered.
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4). 4). No dose adjustment is required in older people, but the experience is limited in patients 75 years of age and above. Paediatric population There is no relevant use of cetuximab in the paediatric population for the granted indications.
6). 4). The recommended infusion period is 120 minutes. For subsequent cetuximab administration the infusion rate must not exceed 10 mg/min. If initial infusion is well tolerated the recommended infusion period for weekly dose regimen of 250 mg/m2 is 60 minutes and recommended infusion period for biweekly dose regimen of 500 mg/m2 is 120 minutes.
Very rare:
Stevens-Johnson syndrome/toxic epidermal necrolysis. Frequency not known:Superinfection of skin lesions*. 4); mucositis, in some cases severe. Mucositis may lead to epistaxis. 4); fatigue. Additional information Overall, no clinically relevant difference between genders was observed.
g. paronychia). Approximately 15% of the skin reactions are severe, including single cases of skin necrosis. The majority of skin reactions develop within the first three weeks of therapy. 4). g. with S. g. cellulitis, erysipelas, or, potentially with fatal outcome, staphylococcal scalded skin syndrome, necrotising fasciitis or sepsis.
10 Combination treatment When cetuximab is used in combination with chemotherapeutic agents, also refer to their respective product information. 4). In combination with fluoropyrimidines, the frequency of cardiac ischaemia including myocardial infarction and congestive heart failure as well as the frequency of hand-foot syndrome (palmar-plantar erythrodysaesthesia) were increased compared to that with fluoropyrimidines.
In combination with local radiation therapy of the head and neck area, additional undesirable effects were those typical of radiation therapy (such as mucositis, radiation dermatitis, dysphagia or leukopenia, mainly presenting as lymphocytopenia).
In a randomised controlled clinical study with 424 patients, reporting rates of severe acute radiation dermatitis and mucositis as well as of late radiation-therapy-related events were slightly higher in patients receiving radiation therapy in combination with cetuximab than in those receiving radiation therapy alone.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
If an infusion-related reaction develops later during the infusion or at a subsequent infusion further management will depend on its severity: a) Grade 1: continue slow infusion under close supervision b) Grade 2: continue slow infusion and immediately administer treatment for symptoms c) Grade 3 and 4: stop infusion immediately, treat symptoms vigorously and contraindicate further use of cetuximab A cytokine release syndrome (CRS) typically occurs within one hour after infusion and is less commonly associated with bronchospasm and urticaria.
CRS is normally most severe in relation to the first infusion. Mild or moderate infusion-related reactions are very common comprising symptoms such as fever, chills, dizziness, or dyspnoea that occur in a close temporal relationship mainly to the first cetuximab infusion.
If the patient experiences a mild or moderate infusion-related reaction, the infusion rate may be decreased. It is recommended to maintain this lower infusion rate in all subsequent infusions. A close monitoring of patients, particularly during the first administration, is required.
Special attention is recommended for patients with reduced performance status and pre-existing cardio- pulmonary disease. Respiratory disorders Cases of interstitial lung disease (ILD), including fatal cases, have been reported, with the majority of patients from the Japanese population.
Confounding or contributing factors, such as concomitant chemotherapy known to be associated with ILD, and pre-existing pulmonary diseases were frequent in fatal cases. Such patients should be closely monitored. In the event of symptoms (such as dyspnoea, cough, fever) or radiographic findings suggestive of ILD, prompt diagnostic investigation should occur.
If interstitial lung disease is diagnosed, cetuximab must be discontinued and the patient be treated appropriately. Skin reactions Main adverse reactions of cetuximab are skin reactions which may become severe, especially in combination with chemotherapy.
8). 6 Skin reactions are very common and treatment interruption or discontinuation may be required. According to clinical practice guidelines prophylactic use of oral tetracyclines (6 - 8 weeks) and topical application of 1% hydrocortisone cream with moisturiser should be considered.
Medium to high-potency topical corticosteroids or oral tetracyclines have been used for the treatment of skin reactions. If a patient experiences an intolerable or severe skin reaction ( grade 3; Common Terminology Criteria for Adverse Events, CTCAE), cetuximab therapy must be interrupted.
Treatment may only be resumed if the reaction has resolved to grade 2. If the severe skin reaction occurred for the first time, treatment may be resumed without any change in dose level. With the second and third occurrences of severe skin reactions, cetuximab therapy must again be interrupted.
If the reaction has resolved to grade 2 treatment may only be resumed with a dose reduction of 20% (200 mg/m² BSA in the weekly dosing regimen, 400 mg/m² BSA in the biweekly dosing regimen) after the second occurrence and with a dose reduction of 40% (150 mg/m² BSA in the weekly dosing regimen, 300 mg/m² BSA in the biweekly dosing regimen) after the third occurrence.
If severe skin reactions occur a fourth time or do not resolve to grade 2 during interruption of treatment, permanent discontinuation of cetuximab treatment is required. Electrolyte disturbances Progressively decreasing serum magnesium levels occur frequently and may lead […]