Drug Action
Necitumumab is a monoclonal antibody that binds to the epidermal growth factor receptor (EGFR).
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Drug reference
Necitumumab is a monoclonal antibody that binds to the epidermal growth factor receptor (EGFR).
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Locally advanced or metastatic epidermal growth factor receptor expressing squamous non-small-cell lung cancer, in patients who have not received previous chemotherapy (in combination with gemcitabine and cisplatin) (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: 800 mg once daily on days 1 and 8 of a 3-week cycle, for up to 6 cycles, patients whose disease has not progressed after combination therapy may continue with necitumumab monotherapy, for dose adjustments due to infusion-related reactions or skin reactions— consult product literature
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Cardiorespiratory disorders (no information available). history of thromboembolic events. patients may need pre-medication to minimise the development of infusion-related and skin reactions (consult product literature). risk factors for thromboembolic events CAUTIONS, FURTHER INFORMATION ▶Thromboembolic events Manufacturer advises that necitumumab should not be administered to patients with multiple risk factors for thromboembolic events unless the benefits outweigh the risks. Thromboprophylaxis should be considered after assessment of a patient’s risk factors.
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NICE decisions ▶Necitumumab for untreated advanced or metastatic squamous non-small-cell lung cancer (September 2016) NICE TA411 Necitumumab (Portrazza ®), in combination with gemcitabine and cisplatin, is not recommended within its marketing authorisation for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)- expressing squamous non-small-cell lung cancer that has not been treated with chemotherapy. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta411
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→Appendix 1: monoclonal antibodies
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▶Common or very common Conjunctivitis. dysuria. electrolyte imbalance. embolism and thrombosis. fever. haemorrhage. headache. hypersensitivity. hypomagnesaemia (severe). increased risk of infection. infusion related reaction. muscle spasms. oral disorders. skin reactions. taste altered. vomiting. weight decreased ▶Frequency not known Cardiac arrest. eyelash trichomegaly
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Manufacturer advises women of child-bearing potential should use effective contraception during and for 3 months after treatment.
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Manufacturer advises avoid unless potential benefit outweighs risk—limited information available. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid during treatment and for at least 4 months after the last dose—no information available.
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Manufacturer advises monitor patients during and following each infusion for signs of hypersensitivity and infusion-related reactions; monitor electrolytes (including magnesium, potassium and calcium) prior to each infusion and after completion of treatment, until within normal limits—correct any electrolyte disturbance promptly.
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Manufacturer advises necitumumab should be given under the supervision of an experienced specialist, in an environment where full resuscitation facilities and resources for the treatment of infusion-related reactions are immediately available. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator (2–8ºC); consult product literature for storage conditions after preparation of the infusion.
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There can be variation in the licensing of different medicines containing the same drug. Solution for infusion ELECTROLYTES: May contain Sodium ▶Portrazza (Eli Lilly and Company Ltd) A Necitumumab 16 mg per 1 ml Portrazza 800mg/50ml concentrate for solution for infusion vials | 1 vial P £1,450.00 (Hospital only)
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Manufacturer advises patients and their carers should be made aware of the symptoms of thromboembolism and advised to seek medical attention if they experience sudden breathlessness, chest pain, or swelling of a limb.
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800 mg once daily on days 1 and 8 of a 3-week
First-line fragment. Read the complete Indications and Dose section above.
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