Trastuzumab Intravenous

Trastuzumab injection is used to treat HER2-overexpressing new or metastatic (cancer that has spread) breast cancer. It can be used alone or with other cancer medicines (eg, carboplatin, cyclophosphamide, docetaxel, doxorubicin, paclitaxel).

Trastuzumab injection is also used in combination with cisplatin and capecitabine or 5-fluorouracil to treat HER2-overexpressing metastatic (cancer that has spread) stomach and gastroesophageal (stomach and esophagus) cancer.

Trastuzumab prevents the growth of some tumors that produce extra amounts of a certain substance known as the HER2 protein. It should only be used in patients whose tumors have been shown to produce extra amounts of this protein (HER2 overexpression).

Trastuzumab is a monoclonal antibody. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected by trastuzumab, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, such as a skin rash, may not be serious but may cause concern. Some effects do not occur until months or years after the medicine is used.

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

Medicines used to treat cancer are very strong and can have many side effects. Before receiving trastuzumab, 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 trastuzumab. It is given through a needle placed into one of your veins. It must be given slowly, so the needle should remain in place for at least 90 minutes.

Missed Dose

trastuzumab needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

It is very important that your doctor check your progress at regular visits to make sure that trastuzumab is working properly. Blood tests may be needed to check for unwanted effects.

Your doctor may test your heart before you start receiving trastuzumab injection and while you are getting treatments with trastuzumab. Contact your doctor right away if you experience any chest pain, increased coughing, trouble with breathing, a sudden difficulty with breathing at night, rapid weight gain, or abnormal swelling in your ankles or legs. These could be symptoms of a serious heart problem.

trastuzumab may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving trastuzumab.

Using trastuzumab while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy and for 7 months after the last dose of trastuzumab. If you think you have become pregnant while using the medicine, tell your doctor right away.

Serious lung or breathing problems may occur after you receive trastuzumab. Call your doctor right away if have changes in your breathing, chest tightness, or any type of breathing problem.

trastuzumab can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If this occurs, there are certain precautions you can take to reduce the risk of infection:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, a cough or hoarseness, lower back or side pain, or have painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.

See also Warning section.

Diarrhea, redness/irritation at injection (IV) site, muscle/joint/back pain, stomach/abdominal pain, trouble sleeping, nausea, vomiting, mouth sores, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: bone pain, increased coughing, swelling of the hands/ankles/feet, sudden unexplained weight gain, unusual tiredness, severe headache, tingling/numbness (e.g., in the hands, feet, leg), mental/mood changes, fast/pounding heartbeat, easy bruising/bleeding.

Get medical help right away if you have any very serious side effects, including: weakness on one side of the body, slurred speech, vision changes, confusion.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

This medication can sometimes cause a serious infusion (IV) reaction. Immediately tell your doctor of the following side effects that occur while this drug is being given or within 24 hours after your treatment is finished, such as chills, fever, flushing, nausea, headache, dizziness, fainting, rash, and weakness. (See also Warning section.)

Trastuzumab can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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 trastuzumab treatment, if possible, wait at least 7 months.