Drug Action
Trastuzumab emtansine is an antibody- drug conjugate that contains trastuzumab covalently linked to DM1, a cytotoxic microtubule inhibitor.
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Drug reference
Trastuzumab emtansine is an antibody- drug conjugate that contains trastuzumab covalently linked to DM1, a cytotoxic microtubule inhibitor.
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Monotherapy for the treatment of HER2-positive, unresectable, locally advanced or metastatic breast cancer, in adult patients who have previously received trastuzumab and a taxane separately or in combination (initiated by a specialist) | Monotherapy for the treatment of HER2-positive, unresectable, locally advanced or metastatic breast cancer, in adult patients who have developed disease recurrence during or within 6 months of completing adjuvant therapy (initiated by a specialist) ▶BY INTRAVENOUS INFUSION ▶Adult: (consult product literature or local protocols)
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Dyspnoea at rest—increased risk of pulmonary events. history of congestive heart failure. patients over 75 years. peripheral neuropathy (temporarily discontinue treatment—consult product literature). recent history of myocardial infarction. recent history of unstable angina. risk of left ventricular dysfunction—consult product literature for specific risks with trastuzumab treatment. serious arrhythmias
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When prescribing, dispensing or administering, check that this is the correct preparation— trastuzumab emtansine and trastuzumab are not interchangeable.
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NICE decisions ▶Trastuzumab emtansine for treating HER2-positive advanced breast cancer after trastuzumab and a taxane (updated November 2017) NICE TA458 Trastuzumab emtansine is recommended, within its marketing authorisation, as an option for treating human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced or metastatic breast cancer in adults who previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior therapy for locally advanced or metastatic disease or developed disease recurrence during or within 6 months of completing adjuvant therapy. Trastuzumab emtansine is recommended only if the manufacturer provides it with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/TA458 Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (April 2017) that trastuzumab emtansine (Kadcyla ®) is accepted for use Immune system and malignant disease within NHS Scotland as monotherapy for the treatment of patients with human epidermal growth factor type 2 (HER2)-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination, and have either received prior therapy for locally advanced or metastatic disease or developed disease recurrence during or within six months of completing adjuvant therapy. This advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower.
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→Appendix 1: monoclonal antibodies
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▶Common or very common Alopecia. anaemia. arthralgia. asthenia. chills. conjunctivitis. constipation. cough. diarrhoea. dizziness. dry eye. dry mouth. dyspnoea. Immune system and malignant disease excessive tearing. fever. gastrointestinal discomfort. haemorrhage. headache. hypersensitivity. hypertension. hypokalaemia. infusion related reaction. insomnia. left ventricular dysfunction. leucopenia. memory loss. musculoskeletal pain. myalgia. nail disorder. nausea. neutropenia. peripheral neuropathy. peripheral oedema. skin reactions. stomatitis. taste altered. thrombocytopenia. urinary tract infection. vision blurred. vomiting ▶Uncommon Hepatic disorders. nodular regenerative hyperplasia. pneumonitis
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Effective contraception must be used during and for 6 months after stopping treatment in women and men.
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Manufacturer advises avoid— oligohydramnios reported with trastuzumab. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid breast- feeding during and for 6 months after treatment.
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Manufacturer advises caution— consult product literature. Dose adjustments Manufacturer advises dose reduction according to liver function tests—consult product literature.
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No information available— manufacturer advises caution in severe impairment.
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▶Monitor hepatic function before each dose. ▶Monitor for signs and symptoms of neurotoxicity. ▶Monitor closely for infusion-related and hypersensitivity reactions. ▶Monitor platelet count before each dose and as clinically indicated (consult product literature for treatment modification in thrombocytopenia). ▶Test cardiac function before treatment and regularly during treatment—delay or discontinue treatment in cases of left ventricular dysfunction. ▶Monitor for dyspnoea, cough, fatigue and pulmonary infiltrates—discontinue if interstitial lung disease or pneumonitis confirmed (fatal cases reported).
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Resuscitation facilities should be available during administration of trastuzumab emtansine.
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There can be variation in the licensing of different medicines containing the same drug. Powder for solution for infusion ▶Kadcyla (Roche Products Ltd) Trastuzumab emtansine 100 mg Kadcyla 100mg powder for concentrate for solution for infusion vials | 1 vial P £1,641.01 Trastuzumab emtansine 160 mg Kadcyla 160mg powder for concentrate for solution for infusion vials | 1 vial P £2,625.62 Carcinoid syndrome ENZYME INHIBITORS
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(consult product literature or local protocols)
First-line fragment. Read the complete Indications and Dose section above.
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