Description
Ado-trastuzumab emtansine injection is used to treat HER2-positive metastatic breast cancer (cancer that has spread) in patients who have previously received other medicines (eg, trastuzumab, taxane medicine) that did not work well or whose cancer has returned during or within 6 months of completing treatment. It is also used as additional treatment in patients with HER2-positive early breast cancer who have cancer left after a taxane medicine and trastuzumab-based treatment.
HER2 protein is produced by some breast tumors. Ado-trastuzumab emtansine interferes with the growth of this protein which also prevents tumor growth. The tumor cells will then be destroyed by the body.
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 ado-trastuzumab emtansine 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 ado-trastuzumab emtansine injection in the elderly.
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.
- Atazanavir
- Boceprevir
- Clarithromycin
- Cobicistat
- Conivaptan
- Idelalisib
- Indinavir
- Itraconazole
- Ketoconazole
- Lopinavir
- Nefazodone
- Nelfinavir
- Posaconazole
- Ritonavir
- Saquinavir
- Telaprevir
- Telithromycin
- Tipranavir
- Voriconazole
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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
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:
- Bleeding problems or
- Heart failure, history of or
- Interstitial lung disease or
- Liver disease or
- Peripheral neuropathy (nerve disorder) or
- Pneumonitis (lung disease) or
- Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.
- Kidney disease, severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
- Liver disease, severe—Use has not been studied in patients with this condition.
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 in a medical facility. It is given through a needle placed into one of your veins. The medicine must be given slowly, so the needle will have to stay in place for at least 30 to 90 minutes. The injection is usually given once every 3 weeks.
Precautions
It is very important that your doctor check your progress closely while receiving the medicine and 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.
Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for 7 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for 4 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.
Check with your doctor right away if you have pain or tenderness in the upper right stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause heart failure. Your doctor may test your heart before and during treatment. Contact your doctor right away if you have chest pain, increased coughing, trouble breathing, rapid weight gain, or swelling in your ankles or legs. These could be symptoms of heart failure.
Tell your doctor right away if you are having shortness of breath, chest tightness, or any type of breathing problem while receiving this medicine. These could be symptoms of a serious lung problem.
Ado-trastuzumab emtansine may cause a serious infusion reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a fever, chills, chest pain, fast or uneven heartbeat, lightheadedness, dizziness, fainting, headache, rash, trouble 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, 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 the 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.
Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.
Talk with your doctor before receiving this medicine if you plan to have children. Some men and women who receive this medicine have become infertile (unable to have children).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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
- bladder pain
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- blurred vision
- burning, numbness, tingling, or painful sensations
- chills
- cough
- decreased urine
- difficult or labored breathing
- difficult, burning, or painful urination
- dizziness
- dry mouth
- fever
- frequent urge to urinate
- headache
- increased thirst
- irregular heartbeat
- loss of appetite
- lower back or side pain
- mood changes
- muscle pain or cramps
- nausea
- nervousness
- nosebleeds
- numbness or tingling in the hands, feet, or lips
- pale skin
- pinpoint red spots on the skin
- pounding in the ears
- rapid weight gain
- seizures
- slow or fast heartbeat
- sore throat
- stomach pain
- tightness in the chest
- troubled breathing with exertion
- ulcers, sores, or white spots in the mouth
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
- weakness in the arms, hands, legs, or feet
Less common
- Chest pain
- dilated neck veins
- extreme tiredness or weakness
- general feeling of discomfort or illness
- irregular breathing
- skin rash
- thickening of bronchial secretions
Rare
- Dark urine
- general feeling of tiredness or weakness
- light-colored stools
- stomach bloating
- vomiting blood
- yellow eyes or skin
Incidence not known
- Agitation
- confusion
- decreased awareness or responsiveness
- depression
- hostility
- irritability
- itching
- joint pain, stiffness, or swelling
- loss of consciousness
- muscle twitching
- severe sleepiness
- stomach tenderness or cramps
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
- Belching
- change in taste
- constipation
- diarrhea
- difficulty with moving
- heartburn
- indigestion
- lack or loss of strength
- loss of taste
- muscle stiffness
- stomach discomfort or upset
- swelling or inflammation of the mouth
- trouble sleeping
Less common
- Burning, dry, or itching eyes
- discharge or excessive tearing
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
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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