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Ado-trastuzumab Emtansine Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 18, 2024.

Applies to ado-trastuzumab emtansine: intravenous powder for solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (powder for solution)

Do not substitute ado-trastuzumab emtansine with or for trastuzumab.

Hepatotoxicity, liver failure, reductions in left ventricular ejection fraction, and death have occurred in ado-trastuzumab emtansine-treated patients.

Monitor hepatic function and left ventricular function before beginning treatment and before each dose.

Modify, hold, or discontinue treatment as necessary.

Exposure to ado-trastuzumab emtansine during pregnancy can result in embryo-fetal harm.

Advise patients of these risks and the need for effective contraception.

Precautions

It is very important that your doctor check your progress closely while receiving the medicine and at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for 7 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for 4 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

Check with your doctor right away if you have pain or tenderness in the upper right stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause heart failure. Your doctor may test your heart before and during treatment. Contact your doctor right away if you have chest pain, increased coughing, trouble breathing, rapid weight gain, or swelling in your ankles or legs. These could be symptoms of heart failure.

Tell your doctor right away if you are having shortness of breath, chest tightness, or any type of breathing problem while receiving this medicine. These could be symptoms of a serious lung problem.

Ado-trastuzumab emtansine may cause a serious infusion reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a fever, chills, chest pain, fast or uneven heartbeat, lightheadedness, dizziness, fainting, headache, rash, trouble breathing, or weakness while you receive the medicine or after the infusion.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Talk with your doctor before receiving this medicine if you plan to have children. Some men and women who receive this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects

Along with its needed effects, ado-trastuzumab emtansine 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 while taking ado-trastuzumab emtansine:

More common side effects

  • 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
  • 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
  • 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
  • seizures
  • slow or fast heartbeat
  • sore throat
  • stomach pain
  • 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
  • vomiting
  • weakness in the arms, hands, legs, or feet

Less common side effects

  • chest pain
  • dilated neck veins
  • extreme tiredness or weakness
  • general feeling of discomfort or illness
  • irregular breathing
  • skin rash
  • thickening of bronchial secretions

Rare side effects

  • dark urine
  • general feeling of tiredness or weakness
  • light-colored stools
  • stomach bloating
  • vomiting blood
  • yellow eyes or skin

Incidence not known

  • agitation
  • confusion
  • decreased awareness or responsiveness
  • depression
  • hostility
  • irritability
  • itching
  • joint pain, stiffness, or swelling
  • loss of consciousness
  • muscle twitching
  • severe sleepiness
  • stomach tenderness or cramps

Other side effects

Some side effects of ado-trastuzumab emtansine 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 side effects

  • belching
  • change in taste
  • constipation
  • diarrhea
  • difficulty with moving
  • heartburn
  • indigestion
  • lack or loss of strength
  • loss of taste
  • muscle stiffness
  • stomach discomfort or upset
  • swelling or inflammation of the mouth
  • trouble sleeping

Less common side effects

  • burning, dry, or itching eyes
  • discharge or excessive tearing
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

For healthcare professionals

Applies to ado-trastuzumab emtansine: intravenous powder for injection.

Cardiovascular adverse events

Dermatologic

Gastrointestinal

Genitourinary

Hematologic

Hepatic

Common (1% to 10%):

Hypersensitivity

Immunologic

Metabolic

Musculoskeletal

Nervous system

Ocular

Other

Psychiatric

Respiratory

Local

See also:

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics."

2. Cerner Multum, Inc. "Australian Product Information."

3. (2022) "Product Information. Kadcyla (ado-trastuzumab emtansine)." Genentech

Frequently asked questions

Further information

Ado-trastuzumab emtansine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.