Ado-trastuzumab emtansine Intravenous

Name: Ado-trastuzumab emtansine Intravenous

Uses For ado-trastuzumab emtansine

Ado-trastuzumab emtansine injection is used to treat HER2-positive metastatic breast cancer (cancer that has spread to other parts of the body) in patients who have already received other medicines that did not work well. HER2 protein is produced by some breast tumors. Ado-trastuzumab emtansine interferes with the growth of this protein which also prevents tumor growth. The tumor cells will then be destroyed by the body.

ado-trastuzumab emtansine is to be given only by or under the immediate supervision of your doctor.

Proper Use of ado-trastuzumab emtansine

Medicines used to treat cancer are very strong and can have many side effects. Before receiving ado-trastuzumab emtansine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A doctor or other trained health professional will give you ado-trastuzumab emtansine while you are in a hospital or cancer treatment center. ado-trastuzumab emtansine is given through a needle placed in a vein. It is usually given once every 3 weeks.

ado-trastuzumab emtansine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Black, tarry stools
  • bladder pain
  • bleeding gums
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • blurred vision
  • burning, numbness, tingling, or painful sensations
  • chills
  • convulsions
  • cough
  • decreased urine
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • dizziness
  • dry mouth
  • fever
  • frequent urge to urinate
  • headache
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • lower back or side pain
  • mood changes
  • muscle pain or cramps
  • nausea or vomiting
  • nervousness
  • nosebleeds
  • numbness or tingling in the hands, feet, or lips
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • rapid weight gain
  • slow or fast heartbeat
  • sore throat
  • tightness in the chest
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • weakness in the arms, hands, legs, or feet
Less common
  • Chest pain
  • dilated neck veins
  • extreme fatigue
  • general feeling of discomfort or illness
  • irregular breathing
  • irregular heartbeat
  • skin rash
  • thickening of bronchial secretions
Rare
  • Dark-colored urine
  • general feeling of tiredness or weakness
  • light-colored stools
  • stomach bloating or pain
  • vomiting blood
  • yellow eyes or skin
Incidence not known
  • Abdominal or stomach tenderness
  • itching

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • change in taste
  • constipation
  • diarrhea
  • difficulty with moving
  • heartburn
  • indigestion
  • lack or loss of strength
  • loss of taste
  • muscle pain or stiffness
  • pain in the joints
  • stomach discomfort or upset
  • swelling or inflammation of the mouth
  • trouble sleeping
Less common
  • Burning, dry, or itching eyes
  • discharge or excessive tearing
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Precautions

See also Warning section.

Before taking ado-trastuzumab emtansine, tell your doctor or pharmacist if you are allergic to it; or to other mouse protein medications; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous cancer treatments (including radiation therapy to the chest), current infection, heart disease, high blood pressure, lung problems, previous severe reaction to monoclonal antibody treatment, liver disease (including a rare liver condition called nodular regenerative hyperplasia).

Ado-trastuzumab emtansine can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially heart problems (such as heart failure).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using ado-trastuzumab. Ado-trastuzumab may harm an unborn baby. Women should ask about reliable forms of birth control while using this medication and for 7 months after stopping treatment. Men should ask about reliable forms of birth control while using this medication and for 4 months after stopping treatment. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 7 months after the last dose. Consult your doctor before breast-feeding.

Interactions

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If you will be using an anthracycline (such as doxorubicin) after stopping ado-trastuzumab emtansine treatment, if possible, wait at least 7 months.

Other medications can affect the removal of ado-trastuzumab emtansine from your body, which may affect how ado-trastuzumab emtansine works. Examples include azole antifungals (such as itraconazole, ketoconazole), clarithromycin, HIV protease inhibitors (such as atazanavir, ritonavir), nefazodone, telithromycin, among others.

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