Description
Trastuzumab-dttb injection is used to treat HER2-overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer. It can be used alone after a previous treatment with an anthracycline medicine or with other cancer medicines (eg, carboplatin, cyclophosphamide, docetaxel, doxorubicin, paclitaxel).
Trastuzumab-dttb injection is also used alone to treat HER2-overexpressing metastatic (cancer that has spread) breast cancer in patients who have previously received one or more cancer treatments or as first-line treatment together with paclitaxel to treat HER2-overexpressing metastatic breast cancer.
Trastuzumab-dttb 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-dttb 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). Your doctor will test for the presence of this protein.
Trastuzumab-dttb 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-dttb, other effects will also occur. Some of these may be serious and must be reported to your doctor.
This medicine is to be given only by or under the direct 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-dttb 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-dttb 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 30 to 90 minutes.
Avoid using other cancer medicines (eg, anthracyclines) for up to 7 months after stopping treatment with trastuzumab-dttb injection. If you are receiving an anthracycline medicine, your doctor may need to check for heart problems regularly.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for 7 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.
Your doctor may test your heart before you start receiving trastuzumab-dttb 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.
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, 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:
- If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- 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.
- Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
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
- Black, tarry stools
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody urine
- body aches or pain
- chest pain
- chills
- cough
- decreased frequency or amount of urine
- diarrhea
- difficulty in breathing
- dilated neck veins
- dry mouth
- dryness or soreness of the throat
- ear congestion
- extreme tiredness or weakness
- fever
- general feeling of discomfort or illness
- headache
- hoarseness
- increased blood pressure
- increased cough
- increased thirst
- irregular breathing
- irregular heartbeat
- joint pain
- loss of appetite
- loss of voice
- lower back or side pain
- mood changes
- muscle pain or cramps
- nausea
- numbness or tingling in the hands, feet, or lips
- pain or tenderness around the eyes and cheekbones
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- rapid weight gain
- seizures
- shivering
- sneezing
- sore throat
- stuffy or runny nose
- sweating
- tender, swollen glands in the neck
- tightness in the chest
- trouble in swallowing
- trouble sleeping
- troubled breathing with exertion
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- voice changes
- vomiting
Less common
- Bladder pain
- blindness or vision changes
- blurred vision
- burning of the face or mouth
- burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
- cloudy urine
- clumsiness or unsteadiness
- dizziness
- fast, pounding, or irregular heartbeat or pulse
- frequent urge to urinate
- nervousness
- nosebleed
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- pounding in the ears
- slow heartbeat
- weakness in the hands or feet
Rare
- Decreased ability to exercise
- fainting
- hives, itching, skin rash
- irritation
- joint stiffness or swelling
- neck tenderness or swelling
- redness of the skin
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
- Back pain
- bone pain
- change in or loss of taste
- cracked lips
- depression
- difficulty in moving
- lack or loss of strength
- stomach pain
- swelling or inflammation of the mouth
- trouble sleeping
- weight decreased
Less common
- Belching
- heartburn
- indigestion
- muscle spasm
- stabbing pain
- stomach discomfort or upset
- upper stomach pain
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.
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