Kadcyla is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Kadcyla is used to treat HER2-positive breast cancer.

Kadcyla is used both for early breast cancer and for breast cancer that has spread to other parts of the body (metastatic).

Kadcyla is usually given after other cancer medications have been tried without success.

Kadcyla should not be used in place of Herceptin (trastuzumab).

Do not use Kadcyla if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

You may need to have a negative pregnancy test before starting this treatment.

Kadcyla can harm your liver. Call your doctor at once if you have upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Before you receive each Kadcyla injection, your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Kadcyla is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take 30 to 90 minutes to complete.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when Kadcyla is injected.

Kadcyla is usually given once every 3 weeks. Your doctor will determine how long to treat you.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

Usual Adult Dose for Breast Cancer:

3.6 mg/kg IV every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity
Maximum dose: 3.6 mg/kg IV every 3 weeks

Comments:
-Administer the first infusion over 90 minutes. Subsequent infusions may be administered over 30 minutes as tolerated.
-Observe patients during and for at least 90 minutes following the initial dose for fever, chills, or other infusion-related reactions.
-Patients should have a HER2 positive tumor status confirmed prior to starting therapy.
-Do not substitute trastuzumab emtansine for or with trastuzumab.
-If a planned dose is delayed or missed, it should be administered as soon as possible; do not wait until the next planned cycle.

Use: As a single agent, for HER2-positive, metastatic breast cancer in patients 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 completing adjuvant therapy

You should not use Kadcyla if you are allergic to ado-trastuzumab emtansine.

Do not use Kadcyla if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 7 months after your last dose.

Tell your doctor if you become pregnant during treatment.

To make sure Kadcyla is safe for you, tell your doctor if you have ever had:

• heart problems;

• liver disease (especially hepatitis B or C);

• bleeding or blood clotting disorder such as hemophilia; or

• asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder.

You should not breast-feed while using this medicine.

Call your doctor for instructions if you miss an appointment for your Kadcyla injection.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Ado-trastuzumab emtansine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Get emergency medical help if you have signs of an allergic reaction to Kadcyla: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel cold, light-headed, feverish or sweaty, or have chest tightness, rapid heartbeats, or trouble breathing.

Call your doctor at once if you have:

• easy bruising, unusual bleeding, purple or red spots under your skin;

• coughing up blood or vomit that looks like coffee grounds;

• bloody or tarry stools;

• chest pain, wheezing, dry cough, feeling short of breath;

• unusual tiredness, feeling light-headed;

• pale skin, cold hands and feet;

• numbness, tingling, or burning pain in your hands or feet;

• sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;

• liver problems - loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or

• signs of tumor cell breakdown - confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Kadcyla side effects may include:

• easy bruising or bleeding (especially nosebleeds);

• nausea, constipation;

• joint or muscle pain;

• headache; or

• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with ado-trastuzumab emtansine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.