Description
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.
This medicine is to be given only by or under the immediate supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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:
Allergies
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of trastuzumab injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of trastuzumab injection in the elderly. However, elderly patients are more likely to have age-related heart problems, which may require caution in patients receiving this medicine.
Breastfeeding
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.
Drug Interactions
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
- Daunorubicin Citrate Liposome
- Daunorubicin Liposome
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Epirubicin
- Idarubicin
- Pirarubicin
- Pixantrone
- Valrubicin
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.
- Warfarin
Other Interactions
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 (eg, cardiomyopathy, heart failure) or
- Heart rhythm problems (eg, arrhythmia) or
- Hypertension (high blood pressure) or
- Lung disease (eg, interstitial pneumonitis, pulmonary fibrosis)—Use with caution. May make these conditions worse.
- Infection—May decrease your body's ability to fight infection.
Proper Use
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. 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
This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine 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 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 a serious heart problem.
This medicine 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 this medicine.
Using this medicine 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 this medicine. 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 this medicine. Call your doctor right away if have changes in your breathing, chest tightness, or any type of breathing problem.
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.
- 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.
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
- Dizziness
- fever or chills
- headache
- muscle aches
- nausea or vomiting
- skin rash
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Less common
- Bloody nose
- cough
- diarrhea
- 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
- shivering
- sneezing
- sweating
- swelling of the feet or lower legs
- tightness in the chest
- trouble with sleeping
- vomiting
Rare
- Blue lips and fingernails
- blurred vision
- chest pain
- confusion
- cough or hoarseness, accompanied by fever or chills
- faintness or lightheadedness when suddenly getting up from a lying or sitting position
- itching
- 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
Incidence not known
- Black, tarry stools
- bloody or cloudy urine
- sores, ulcers, or white spots in the mouth
- unusual bleeding or bruising
- weight gain
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
- Difficulty in moving
- metallic taste in the tongue
- muscle pain or stiffness
- pain
- weight loss
Less common
- Numbness or tingling of the hands or feet
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.
CON-XXXXXXXX
