Trastuzumab can result in subclinical and clinical cardiac failure, with the greatest risk and severity upon concurrent administration with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue trastuzumab in patients receiving adjuvant therapy and withhold trastuzumab for a clinically significant decrease in left ventricular function. Serious and fatal infusion reactions and pulmonary toxicity may occur during or within 24 hours after administration. Discontinue trastuzumab if signs of anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome are noted. Exposure during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception .
Trastuzumab is used to treat new cases of breast cancer or disease that has spread to other parts of the body. It may prevent the growth of some breast tumors that produce extra amounts of a certain substance known as the HER2 protein. Trastuzumab should only be used in patients whose breast tumors have been shown to produce extra amounts of this protein. It can be used alone or with other cancer medicines (chemotherapy) such as doxorubicin, cyclophosphamide, paclitaxel, docetaxel, and carboplatin.
Trastuzumab is also used in combination with cisplatin and capecitabine or 5-fluorouracil to treat malignant tumor of the stomach and esophagogastric (esophagus and stomach) cancer, metastatic, 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.
Before you begin treatment with trastuzumab, you and your doctor should talk about the benefits this medicine will do as well as the risks of using it.
This medicine is to be administered only by or under the immediate supervision of your doctor.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, trastuzumab is used in certain patients with the following medical conditions:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of trastuzumab in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of trastuzumab in the elderly. However, elderly patients are more likely to have age-related heart problems, which may require caution in patients receiving trastuzumab.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
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.
A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.
Trastuzumab must be given slowly, so the IV tube must remain in place for at least 90 minutes.
It is very important that your doctor check your progress 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.
Your doctor may test your heart before you start receiving trastuzumab and while you are getting treatments with this medicine. 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 serious heart problems.
Using this medicine while you are pregnant may cause very serious birth defects. Use an effective form of birth control to keep from getting pregnant during therapy and for 7 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
Trastuzumab may cause a serious infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a fever, chills, chest pain, lightheadedness, dizziness, fainting, headache, rash, pain, nausea, vomiting, trouble with 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, which increases the chance of getting an infection. If this occurs, there are certain precautions you can take to reduce the risk of infection:
This medicine may cause lung disease or breathing problems. Tell your doctor right away if you are having shortness of breath, chest tightness, or any type of breathing problem while receiving this medicine.
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:
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:
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.