When was Kadcyla approved by the EMA?
The European Commission granted a marketing authorisation valid throughout the European Union for Kadcyla on 15 November 2013.
Who manufactures Kadcyla?
Genentech: Kadcyla® (ado-trastuzumab emtansine) – Information for Patients.
What drugs are in Kadcyla?
KADCYLA is the first HER2-targeted treatment of its kind. It is made up of two cancer-fighting agents in one drug: The monoclonal antibody trastuzumab (the same antibody in Herceptin®) A chemotherapy.
How long does it take to administer Kadcyla?
First infusion: Administer infusion over 90 minutes. Observe patients during the infusion and for at least 90 minutes following the initial dose for fever, chills, or other infusion-related reactions [see WARNINGS AND PRECAUTIONS]. Subsequent infusions: Administer over 30 minutes if prior infusions were well tolerated.
Is Kadcyla a chemo?
Kadcyla is a combination of Herceptin and a chemo drug that work together to keep cancer cells from growing. It’s already approved by the US Food and Drug Administration to treat women with HER2 positive breast cancer that has metastacized (spread).
Does Kadcyla cause hair loss?
Like most cancer medicines, both Kadcyla and Perjeta can cause side effects. Common side effects of Perjeta include: hair loss.
Is there hair loss with Kadcyla?
Of great significance to women is that there is no hair loss associated with Kadcyla. Many women with secondary disease have experienced chemotherapy-related hair loss on more than one occasion, and can become disheartened at the thought of another round of demoralising baldness.
How bad is Kadcyla?
KADCYLA may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). Receiving KADCYLA during pregnancy can result in the death of an unborn baby and birth defects. Other possible serious side effects include: Lung problems.
Is Kadcyla considered chemotherapy?
What Is Kadcyla? Kadcyla (ado-trastuzumab emtansine) is a new class of chemotherapy drug called an antibody-drug conjugate used to treat breast cancer.
Does KADCYLA cause hair loss?
When should I stop KADCYLA?
Permanently discontinue treatment with KADCYLA in patients diagnosed with ILD or pneumonitis. For patients with radiation pneumonitis in the adjuvant setting, KADCYLA should be permanently discontinued for Grade ≥ 3 or for Grade 2 not responding to standard treatment.
Do you lose hair with Kadcyla?
Hair loss usually starts after your first or second treatment. It is almost always temporary, and your hair will usually grow back after treatment finishes.
Is there a risk management plan for Kadcyla?
A risk management plan has been developed to ensure that Kadcyla is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kadcyla, including the appropriate precautions to be followed by healthcare professionals and patients.
How is Kadcyla used in the treatment of breast cancer?
Kadcyla, as a single agent, is indicated for the 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 either: Received prior therapy for locally advanced or metastatic disease, or
Is the medicine Kadcyla authorised for use in the EU?
This medicine is authorised for use in the European Union. This is a summary of the European public assessment report (EPAR) for Kadcyla. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
How does trastuzumab emtansine work in Kadcyla?
How does Kadcyla work? The active substance in Kadcyla, trastuzumab emtansine, is made up of two active components which are linked together: Trastuzumab, a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the protein HER2, which is found in large quantities on the surface of some cancer cells.