Ado-Trastuzumab Emtansine, Injection

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KEY POINTS

• This medicine is given by IV to treat HER-2 positive breast cancer.
• This medicine can harm the baby if you get pregnant.
• Keep all appointments for tests to see how this medicine affects you.
• You may get infections more easily when you are taking this medicine.
• This medicine can cause serious liver or heart problems. It may also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: ado-trastuzumab emtansine, injection; Kadcyla

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat HER-2 positive breast cancer that has spread and other cancer medicines have not been effective.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine, food, preservative, or dye
• Bleeding problems or if you take medicine to reduce the chance of blood clots forming
• Heart failure, a heart attack, or an irregular heartbeat
• Liver disease
• Lung problems
• Peripheral neuropathy (numbness, tingling, pain, or burning feelings in your feet or hands)

Tell your provider if you have recently had chemotherapy or radiation therapy. Also tell your provider if you have any kind of infection.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. Use an effective birth control method while you are taking this medicine and for 6 months after your last dose. If you become pregnant, contact your healthcare provider right away. Do not breast-feed during treatment with this medicine.

How do I use it?

Your healthcare provider will give you these infusions. You will receive your first dose over a period of 90 minutes. If you tolerate this dose, your doses will be given about every 3 weeks, over a period of 30 minutes. Your healthcare provider will tell you how often you will receive these infusions. You will be monitored closely while you are receiving this medicine. Be sure to keep all appointments for these infusions. If you miss an appointment, contact your healthcare provider right away.

What should I watch out for?

This medicine can cause serious or life-threatening liver problems. Contact your healthcare provider right away if you develop severe tiredness, stomach pain, nausea, vomiting, loss of appetite, dark urine, fever, headache, muscle or joint pain, severe itching, or yellowing of the whites of your eyes. These are signs of possible liver damage.

This medicine can cause serious heart problems. Contact your healthcare provider right away if you wake up at night with shortness of breath or if you have new or worsening shortness of breath, chest pain or irregular heartbeat, cough, sudden weight gain or swelling of the feet, ankles, or legs, or any unexplained swelling.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine can cause serious infusion reactions, especially during the first infusion. You will be monitored closely while receiving this medicine. This medicine can also cause severe allergic reactions. Tell your healthcare provider right away if you develop hives; itching; rash; tightness in your chest; or swelling of your lips, tongue, and throat.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

Tell your healthcare provider if you have numbness, tingling, or burning in the hands or feet while receiving this medicine. Your dose may need to be decreased or treatment stopped until your symptoms get better.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

Adults over the age of 65 may be at increased risk for side effects. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Waking up at night with shortness of breath or trouble breathing; new or worsening shortness of breath; swelling of the feet, ankles, or legs, or any unexplained swelling; sudden weight gain; numbness or tingling in arms or legs; trouble walking; unexplained fever; sore throat; severe tiredness or weakness; cough; fast, irregular, or pounding heartbeat; unusual bruising or bleeding; severe dizziness or fainting; redness, tenderness, skin irritation, pain or swelling at the infusion site; yellowing of eyes or skin; severe stomach pain, nausea or vomiting; light-colored bowel movements; dark urine.

Other: Diarrhea, nausea, vomiting, constipation, mild stomach pain, sores on your lips or mouth, loss of appetite, mild dizziness, tiredness, trouble sleeping, runny nose, mild joint or muscle pain, headache, dry eyes, dry mouth.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), and telithromycin (Ketek)
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and simeprevir (Olysio)
• Aprepitant (Emend)
• Cancer medicines such as abiraterone (Zytiga), ceritinib (Zykadia), cyclophosphamide (Cytoxan), dabrafenib (Tafinlar), daunorubicin (Cerubidine), doxorubicin (Doxil), enzalutamide (Xtandi), epirubicin (Ellence), idarubicin (Idamycin), imatinib (Gleevec), mitoxantrone (Novantrone), and paclitaxel (Abraxane, Taxol)
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Heart medicines such as diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), edoxaban (Savaysa), enoxaparin (Lovenox), heparin, rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Nefazodone
• Vaccines

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.