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Kadcyla (trastuzumab emtansine) – Conditions or restrictions regarding supply and use - L01XC14

Updated on site: 08-Oct-2017

Medication nameKadcyla
ATC CodeL01XC14
Substancetrastuzumab emtansine
ManufacturerRoche Registration Ltd

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

Lonza Ltd.

Lonzastrasse

CH-3930 Visp

Switzerland

Name and address of the manufacturer responsible for batch release

Roche Pharma AG

Emil-Barell-Strasse 1

D-79639 Grenzach-Whylen

Germany

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web- portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

At the request of the European Medicines Agency;

Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

Additional risk minimisation measures

The MAH shall agree the content and format of the Kadcyla educational material and a communication plan with the National Competent Authority in the Member State before Kadcyla is launched in each Member State.

The MAH shall ensure that in parallel to the launch of Kadcyla, all health care professionals who may prescribe, dispense or administer Kadcyla and/or Herceptin are provided with a health care professional (HCP) educational pack. This HCP educational pack shall consist of the following:

Kadcyla SPC

Health care professional information

The HCP information shall contain the following key messages:

1.Kadcyla and Herceptin are two very different products with different active substances never to be used interchangeably. Kadcyla is NOT a generic version of Herceptin and has different properties, indications and dose.

2.Kadcyla is an antibody-drug conjugate containing humanized anti-HER2 IgG1 antibody trastuzumab and DM1, a microtubule-inhibitory maytansinoid.

3.Do not substitute or combine Kadcyla with or for Herceptin

4.Do not administer Kadcyla in combination with chemotherapy

5.Do not administer Kadcyla at doses greater than 3.6 mg/kg once every 3 weeks

6.If a prescription for Kadcyla is written electronically, it is important to ensure that the medication prescribed is trastuzumab emtansine and not trastuzumab.

7.Both the invented name Kadcyla and its full non-proprietary name (trastuzumab emtansine) should be used and confirmed when prescribing, preparing the infusion solution and administering Kadcyla to patients. It must be verified that the non-proprietary name is trastuzumab emtansine.

8.In order to prevent medication errors it is important to review the Summary of Product Characteristics and to check the outer carton and vial labels to ensure that the medicinal product being prepared and administered is Kadcyla and not Herceptin.

9.Description of the key differences between Kadcyla and Herceptin in relation to indication, dose, administration and packaging differences.

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