Generic name: Ado-Trastuzumab Emtansine

Kadcyla™ is the trade name for ado-trastuzumab emtansine. In some cases, health care professionals may use the trade name Kadcyla™ when referring to the generic drug name ado-trastuzumab emtansine.

Drug type: Kadcyla™ is an Anti-HER2 monoclonal antibody combined with a microtubular inhibitor. (For more detail, see "How this drug works" section below).

What Kadcyla Is Used For:

Kadcyla™ is used as a single agent to treat HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:

• Received prior therapy for metastatic disease, or
• Developed disease recurrence during or within 6 months of completely adjuvant therapy

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Kadcyla Is Given:

• Kadcyla™ is given through an infusion into a vein (intravenous, IV)

The amount of Kadcyla™ that you will receive depends on many factors, including your weight, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule.

Side Effects:

Important things to remember about the side effects of Kadcyla™:

• Most people will not experience all of the Kadcyla™ side effects listed.
• Kadcyla™ side effects are often predictable in terms of their onset, duration, and severity.
• Kadcyla™ side effects will improve after therapy is complete.
• Kadcyla™ side effects may be quite manageable. There may be options to minimize or prevent the side effects of Kadcyla™.

The following side effects are common (occurring in greater than 30%) for patients taking Kadcyla™:

• Increased liver enzymes (AST, ALT)
• Decreased platelet count
• Decreased red blood cells
• Nausea
• Decreased white blood cells
• Fatigue
• Musculoskeletal pain (joint and muscle pain)
• Decreased potassium

These are less common (occurring in 10-29%) side effects for patients receivingKadcyla™:

• Headache
• Constipation
• Diarrhea
• Nose bleeds
• Peripheral neuropathy (numbness or tingling in hands or feet)
• Vomiting
• Fever
• Abdominal pain
• Cough
• Weakness
• Increased bilirubin
• Dry mouth
• Mouth sores
• Insomnia (trouble sleeping)
• Shortness of breath
• Rash
• Dizziness

Not all side effects are listed above. Side effects that are very rare -- occurring in less than about 10 percent of patients -- are not all listed here. But you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night and go to the emergency room, if you should experience any of the following symptoms:

• Fever of 100.4º F (38º C) or higher, chills (possible signs of infection)
• Trouble breathing, bad cough, swelling of the ankles/legs, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness
• Chest pain or pressure

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Signs of infection: Fever, chills, very bad sore throat, ear or sinus pain, cough with or without sputum, pain with passing urine, wounds that will not heal
• Yellowing of the eyes or skin
• Dark urine
• Right-sided abdominal pain
• Nausea (interferes with ability to eat and unrelieved with prescribed medication)
• Vomiting (vomiting more than 4-5 times in a 24 hour period)
• Diarrhea (4-6 episodes in a 24-hour period)
• Dizziness or lightheadedness
• Bad headache
• Unusual bleeding or bruising
• Extreme fatigue (unable to carry on self-care activities)
• Muscle weakness
• Mouth sores (painful redness, swelling or ulcers)

Always inform your health care provider if you experience any unusual symptoms

Some severe but rare possible side effects of Kadcyla™ include:

• Liver problems (liver failure)
• Heart-decrease in left ventricular ejection fraction (LVEF)

Precautions:

Before starting Kadcyla™ treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).

Do not receive any kind of immunization or vaccination without your doctor’s approval while taking Kadcyla™.

Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (Kadcyla™ may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.)

For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking Kadcyla™. Barrier methods of contraception, such as condoms, are recommended. Verify pregnancy status prior to treatment initiation. Effective contraception should be used during therapy and for 6 months after treatment.

Do not breast feed while taking Kadcyla™.

Self-Care Tips:

Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.

You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.

Wash your hands often.

To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1 teaspoon of baking soda mixed with 8 ounces of water.

Use an electric razor and a soft toothbrush to minimize bleeding.

Avoid contact sports or activities that could cause injury.

To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.

Follow regimen of anti-diarrhea medication as prescribed by your health care professional.

Eat foods that may help reduce diarrhea (see managing side effects - diarrhea).

Acetaminophen or ibuprofen may help relieve discomfort from fever, headache and/or generalized aches and pains. However, be sure to talk with your doctor before taking it.

Avoid sun exposure. Wear SPF 15 (or higher) sun block and protective clothing.

In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.

Get plenty of rest.

Maintain good nutrition.

Remain active as you are able. Gentle exercise is encouraged such as a daily walk.

If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

Lab work to check blood counts and liver/kidney functions will be checked regularly by your health care professional while you are taking Kadcyla™, to monitor side effects and check your response to therapy.

HER2 expression must be present for initiation of Kadcyla™ (either as 3+ IHC [Dako Herceptest™] or FISH amplification ratio >2 [Dako HER2 FISH pharmDx™ test]).

Negative pregnancy test prior to initiation.

Cardiac studies to assess Left Ventricular Ejection Fraction (LVEF) may be ordered.

How Kadcyla Works:

Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.

Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.

There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies. Antiangiogenesis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.

Kadcyla™ has the component of an antibody type of targeted therapy. Antibodies are an integral part of the body’s immune system. Normally the body creates antibodies in response to an antigen (such as a protein or a germ) that has entered the body. The antibodies attach to the antigen in order to mark it for destruction by the immune system. To make anti-cancer antibodies in the laboratory, scientists analyze specific antigens on the surface of cancer cells (the targets). Then using animal and human proteins, they create a specific antibody that will attach to the target antigen on the cancer cells. When given to a patient, these antibodies will attach to matching antigens like a key fits a lock. Since antibodies target only specific cells, they may cause less toxicity to healthy cells. Monoclonal antibody therapy is usually only given for cancers in which antigens and the respective antibodies have been identified already.

Kadcyla™ is a monoclonal antibody which targets the surface of the cells human epidermal growth factor receptor 2 protein (HER2) on the cancer cell, interfering with HER2 causing cancer cell death. Kadcyla™ incorporates the HER2 targeted actions of trastuzumab with the microtubule inhibitor DM1 (a maytansine derivative). This allows for selective delivery into HER2 overexpressing cells, resulting in cell arrest and death.

Research continues to identify which cancers may be best treated with targeted therapy and to identify additional targets for more types of cancer.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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