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PRESCRIBING INFORMATION - KADCYLA

PRESCRIBING INFORMATION:
Kadcyla ®
(trastuzumab emtansine)

Please refer to Summary of Product Characteristics prior to use of Kadcyla.

100 mg powder for concentrate for solution for infusion, 160 mg powder for concentrate for solution for infusion.

Indications: Treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have received prior therapy for locally advanced or metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy.

Dosage and Administration: Patients should have HER2-positive tumour status, scored as 3 + by immunohistochemistry or a ratio of ≥ 2.0 by in situ hybridization. Kadcyla should be administered by a healthcare professional at a dose of 3.6 mg/kg bodyweight as an intravenous (IV) infusion every 3 weeks (21 day cycle). Kadcyla should not be mixed with glucose. Use of 0.22 micron in-line polyethersulfone (PES) filter is required for the infusion when the concentrate for infusion is diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion. Initial dose should be administered as 90 minute IV infusion, followed by 90 minutes of observation for infusion-related reactions (IRR). If well tolerated, subsequent doses may be administered as 30 minute infusions, followed by 30 minutes of observation. If a dose is missed, it should be administered as soon as possible; the dosing schedule adjusted to maintain a 3-week cycle. To prevent medication errors check vial labels to ensure the medicinal product being prepared and administered is Kadcyla (trastuzumab emtansine) and not Herceptin (trastuzumab).

Contraindications: Hypersensitivity to Kadcyla or any excipients.

Precautions: Management of symptomatic adverse reactions may require temporary interruption, dose reduction, or treatment discontinuation; patients should be monitored closely for these adverse reactions. These symptomatic adverse reactions may include IRR, increased transaminases, hyperbilirubinemia, decreased left ventricular ejection fraction (LVEF), peripheral neuropathy, interstitial lung disease (ILD), including pneumonitis, nodular regenerative hyperplasia, or hypersensitivity reactions. Refer to Summary of Product Characteristics for management of adverse reactions. Patients with thrombocytopenia and patients on anti-coagulant treatment should be monitored closely, and platelet counts in all patients monitored prior to each dose. Cases of bleeding events with a fatal outcome have been observed. Standard cardiac function testing should be performed prior to initiation and at regular intervals. Liver function should be monitored prior to initiation of treatment and each dose. Patients with baseline elevation of ALT may be predisposed to liver injury with a higher risk of a Grade 3-5 hepatic event or liver function test increase. Patients with dyspnoea at rest due to complications of advanced malignancy and co‑morbidities may be at increased risk of pulmonary events.

Drug Interactions: No formal interaction studies have been performed. In vitro metabolism studies suggest that concomitant use of strong CYP3A4 and CYP3A5 inhibitors should be avoided. If not possible, consider a delay in administration of Kadcyla until the CYP3A4 inhibitor has cleared. If Kadcyla treatment cannot be delayed, patients should be closely monitored.

Pregnancy and Lactation: Women of childbearing potential should use effective contraception during Kadcyla treatment and for 6 months following the final dose. The use of Kadcyla in pregnant and breast feeding women is not advised. Women may breast feed 6 months after concluding treatment. Women who become pregnant must immediately contact their doctor.

Adverse reactions: The most common serious adverse drug reactions seen in clinical trials with Kadcyla were pyrexia, thrombocytopenia, vomiting, abdominal pain, nausea, constipation, diarrhoea, dyspnoea and pneumonitis. Very common reactions: urinary tract infection, thrombocytopenia, anaemia, hypokalaemia, insomnia, peripheral neuropathy, headache, dizziness, haemorrhage, epistaxis, cough, dyspnea, stomatitis, diarrhoea, vomiting, nausea, constipation, dry mouth, abdominal pain, rash, musculoskeletal pain, arthralgia, myalgia, fatigue, pyrexia, asthenia, chills, transaminases increased. Common reactions: neutropenia, leucopoenia, drug hypersensitivity, dysgeusia, memory impairment, dry eye, conjunctivitis, vision blurred, lacrimation increased, left ventricular dysfunction, hypertension, dyspepsia, gingival bleeding, pruritus, alopecia, nail disorder, palmar-plantar erythrodysaesthesia syndrome, urticaria, peripheral oedema, blood alkaline phosphatase increased, infusion related reactions. Uncommon reactions: Pneumonitis (ILD), hepatotoxicity, hepatic failure, nodular regenerative hyperplasia, portal hypertension, injection site extravasation. Laboratory abnormalities: Both hepatic and haematological abnormalities were observed in patients treated with Kadcyla.

Legal Category: POM

Presentation, Basic NHS Cost and Marketing Authorisation Number: Kadcyla (trastuzumab emtansine) one 100mg glass vial - £1641.01. EU/1/13/885/001.

Kadcyla (trastuzumab emtansine) one 160mg glass vial - £2625.62. EU/1/13/885/002.

 

Marketing Authorisation Holder: Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

Kadcyla is a registered trade mark

RXUKMEDI00154(1)                         Date of Preparation: November 2013

This medicinal product is subject to additional monitoring. 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. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing welwyn.uk_dsc@roche.com or calling +44(0)1707 367554.