Class: Biological Therapy
Generic Name: ado-trastuzumab emtansine
Trade Name: Kadcyla®
For which conditions is Kadcyla approved for? Kadcyla is indicated as a single agent for the treatment of patients with HER2-positive, metastatic breast cancer who previously received Herceptin® (trastuzumab) and a taxane, separately or in combination. In order to receive Kadcyla, patients should have either received prior therapy for metastatic disease or developed disease recurrence during or within six months of completing adjuvant therapy.
What is the mechanism of action? Kadcyla is part of a class of drugs called antibody-drug conjugates, which consist of an antibody attached to a toxic chemotherapy. Kadcyla combines Herceptin and a chemotherapy drug (emtansine or DM1) that interferes with cancer cell growth. Kadcyla delivers Herceptin and DM1 directly to HER2-positive cells and limits exposure of the rest of the body to chemotherapy.
How is Kadcyla typically given (administered)? Kadcyla is given as an intravenous infusion every three weeks until disease progression or unacceptable toxicity.
How are patients typically monitored? Patients receiving Kadcyla must be monitored for:
- Liver damage and failure. This includes monitoring liver function before beginning treatment and before each dose.
- The ability of the heart’s left ventricle to pump out blood (left ventricular ejection fraction [LVEF]). A patient’s LVEF should be measured before beginning treatment.
- Lung damage and lung disorders. Treatment should be stopped if lung damage is detected.
- Infusion-site reactions.
- Thrombocytopenia (low platelet count). Monitor platelet counts before each dose.
- Neurotoxicity (damage to the nervous system), including peripheral neuropathy.
What are the common (occur in 30% or more of patients) side effects of treatment with Kadcyla?
- Musculoskeletal pain
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Kadcyla?
- Stomatitis (inflammation inside the mouth)
- Dry mouth
- Abdominal pain
- Asthenia (weakness, lack of energy, loss of strength)
- Increased transaminases
- Hypokalemia (low blood potassium levels)
- Muscle pain
- Joint pain
- Peripheral neuropathy (weakness, numbness, and pain; usually in hands and feet)
- Shortness of breath or breathlessness
- Nose bleed
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
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Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects? Follow your dosing schedule for Kadcyla and discuss with your healthcare providers all health conditions and concerns and medications you are taking (over the counter and prescription).
Are there any special precautions patients should be aware of before starting treatment? Kadcyla can harm an unborn baby. Women of childbearing age should use effective contraception while receiving treatment and for six months following the last dose of Kadcyla. Nursing mothers should not nurse while receiving Kadcyla**.** Women who are exposed to Kadcyla during pregnancy are encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720.
When should patients notify their physician?
- If you experience any side effects that bother you or don’t go away.
- If you experience symptoms of liver damage, such as nausea, vomiting, abdominal pain, jaundice, dark urine, generalized itching, and anorexia.
- If you experience new onset or worsening shortness of breath, cough, swelling of the ankles or legs, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness, or loss of consciousness.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy, or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition, or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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