Ado-Trastuzumab Emtansine (AY-doh tras-TOOZ-oo-mab em-TAN-seen)

Treats breast cancer.

Brand Name(s):

Kadcyla

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. The medicine must be given slowly, so the needle will have to stay in place for at least 30 to 90 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how ado-trastuzumab works. Tell your doctor if you are using any of the following:
  • Atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole
  • Blood thinner (including warfarin)

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Female patients should use an effective form of birth control during treatment and for 7 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for 4 months after the last dose.
• Do not breastfeed during treatment with this medicine and for 7 months after the last dose.
• Tell your doctor if you have liver disease, kidney disease, heart disease, lung disease, heart failure, or bleeding problems.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may cause the following problems:
  • Liver problems
  • Lung problems
  • New or worsening heart failure
  • Infusion reactions
  • Increased risk of bleeding problems
  • Brain or nerve problems, including peripheral neuropathy
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, cough, uneven heartbeat
• Chills, fever, fast heartbeat, warmth or redness of the skin
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Dizziness, lightheadedness, or fainting
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Pain, redness, itching, burning, swelling, or a lump under your skin where the needle is placed
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness, nosebleeds

If you notice these less serious side effects, talk with your doctor:

• Constipation, mild nausea or vomiting
• Headache
• Muscle, joint, or bone pain
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088