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Ado-Trastuzumab Emtansine Injection 160 mg (TRASTUZUMAB EMTANSINE - INJECTION)

For treating cancer.

Brand Name(s): KADCYLA

Generic Name: Ado-Trastuzumab Emtansine

Instructions

This medicine is given as an IV injection into a vein.

This medicine should be given by a trained health care provider.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Your doctor may prescribe other medications to reduce side effects. Follow instructions carefully.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients with weak hearts may have worsening of symptoms. If you notice difficulty breathing, weight gain, or swelling of your legs or ankles, let your doctor know right away.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

Tell your doctor or nurse right away if any of these happen while the medicine is being given: feeling of heat or flushing, fever, chills, dizziness, fast or irregular heartbeat, or shortness of breath. The medicine may need to be stopped or given at a slower rate.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Do not breastfeed while on this medicine. You may safely start breastfeeding 7 months after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women of childbearing age should have a negative pregnancy test before starting this medicine.

Women must use reliable forms of birth control while taking this medicine and for 7 months after stopping to prevent pregnancy.

Men with a female partner who is of childbearing age must use reliable birth control during sexual activity while taking this medicine and for 4 months after stopping to prevent pregnancy.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • decreased appetite
  • constipation or diarrhea
  • mouth sores or irritation
  • nausea and vomiting
  • pain near injection site
  • stomach pain
  • changes in taste or unpleasant taste

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • bleeding or bruising
  • bone pain
  • wheezing or difficulty breathing
  • chest pain
  • cough that does not go away
  • coughing up blood or vomit that looks like coffee grounds
  • dizziness
  • swelling of the legs, feet, and hands
  • fainting
  • fever or chills
  • numbness or tingling in hands and feet
  • severe or persistent headache
  • fast or irregular heart beats
  • low blood pressure
  • pain, redness, swelling near injection
  • signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
  • shortness of breath
  • red, peeling or blistering skin
  • sore throat
  • bloody or dark, tarry stools
  • symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
  • sudden or unexplained weight gain

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.