KADCYLA 160 mg ( ADO-TRASTUZUMAB ) IV INFUSION VIAL

WHAT IS ADO-TRASTUZUMAB EMTANSINE (KADCYLA)?
Ado-trastuzumab emtansine is used to treat a HER2-positive breast cancer. This medicine is used both for early breast cancer and for breast cancer that has spread to other parts of the body (metastatic).

Ado-trastuzumab emtansine is usually given after other treatments have failed.

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

Ado-trastuzumab emtansine may also be used for purposes not listed in this medication guide.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF ADO-TRASTUZUMAB EMTANSINE (KADCYLA)?
Get emergency medical help if you have signs of an allergic reaction: 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;
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;
heart problems--swelling in your lower legs, rapid weight gain, feeling short of breath, cough, fast or pounding heartbeat, dizziness, feeling like you might pass out;
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 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.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ADO-TRASTUZUMAB EMTANSINE (KADCYLA)?
Do not use if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment.

This medicine can cause serious side effects on your liver or heart. Call your doctor at once if you have upper stomach pain, loss of appetite, dark urine, yellowing of your skin or eyes, shortness of breath, cough, swelling, rapid weight gain, fast or pounding heartbeats, dizziness, or if you feel like you might pass out.

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