Trastuzumab (Intravenous route)
- Powder for Solution
Warnings:Intravenous route(Powder for Solution)
Trastuzumab can result in subclinical and clinical cardiac failure, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue trastuzumab for cardiomyopathy. Serious and fatal infusion reactions and pulmonary toxicity may occur. Discontinue trastuzumab for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Exposure during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death .
Uses of This Medicine:
Trastuzumab is a monoclonal antibody. It is used to treat new cases of breast cancer or disease that has spread to other parts of the body. Trastuzumab 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 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:
- Breast cancer, HER2-overexpressing disease, primary treatment in combination with chemotherapy, before surgery.
Before Using This Medicine:
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.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
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.
- Daunorubicin Citrate Liposome
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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:
- Heart disease (e.g., cardiomyopathy, heart failure) or
- Heart rhythm problems (e.g., arrhythmia) or
- Hypertension (high blood pressure) or
- Lung disease (e.g., interstitial pneumonitis, pulmonary fibrosis)—Use with caution. May make these conditions worse.
- Infection—May decrease your body's ability to fight infection.
Proper Use of This Medicine:
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.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for any 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 (e.g., decreased amniotic fluid, bone problems). Use an effective form of birth control to keep from getting pregnant during treatment and for 6 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients receiving this medicine.
Trastuzumab may cause a serious side effect called an 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 within a few hours after you receive it.
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:
- 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.
- 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.
Tell your doctor right away if you are having shortness of breath, chest tightness, or any type of breathing problem while receiving this medicine.
Cancer medicines can cause nausea or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.
Side Effects of This Medicine:
- More common
- fever or chills
- muscle aches
- nausea or vomiting
- shortness of breath
- skin rash
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
- Less common
- Bloody nose
- difficult or labored breathing
- ear congestion or pain
- fast or irregular heartbeat
- general feeling of discomfort or illness
- head congestion
- hoarseness or other voice changes
- increased cough
- joint pain
- loss of appetite
- nasal congestion
- pain or tenderness around the eyes and cheekbones
- swelling of the feet or lower legs
- tightness in the chest
- trouble with sleeping
- Blue lips and fingernails
- blurred vision
- chest pain
- cough or hoarseness, accompanied by fever or chills
- faintness or lightheadedness when getting up suddenly from a lying or sitting position suddenly
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, feet, or sex organs
- lower back or side pain, accompanied by fever or chills
- painful or difficult urination, accompanied by fever or chills
- pale skin
- redness of the skin
- trouble with breathing
- Incidence not known
- Black, tarry stools
- bloody or cloudy urine
- sores, ulcers, or white spots in the mouth
- unusual bleeding or bruising
- weight gain
- More common
- Less common
- Numbness or tingling of the hands or feet
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.
Last Updated: 11/4/2014