Kadcyla (ado-trastuzumab emtansine) is used to treat people with HER2-positive breast cancer who’ve previously received cancer therapy. It can be used for early breast cancer after surgery and for breast cancer that’s spread to other parts of the body (metastatic). Kadcyla is a targeted anticancer medication known as an antibody-drug conjugate (ADC). It’s given by a healthcare professional as an infusion through the vein once every 3 weeks. This medication commonly causes side effects like nausea, fatigue, headache, and muscle or joint pain.
Metastatic HER2-positive breast cancer in people who’ve already had treatment with Herceptin (trastuzumab) and a taxane
HER2-positive early breast cancer after surgery in people who still have cancerous tissue after treatment with Herceptin (trastuzumab) and a taxane
Kadcyla is a type of targeted therapy called an antibody-drug conjugate (ADC). It’s made up of a few parts that work together to find and kill breast cancer cells.
Ado-trastuzumab, or trastuzumab, is a monoclonal antibody. It finds and attaches to a specific protein on the surface of cells called HER2. Kadcyla uses trastuzumab to find cancer cells with large amounts of HER2 on them.
Once Kadcyla reaches and enters into the cancer cell, the medication breaks apart so the chemotherapy part called DM1 can work. DM1 is a microtubule inhibitor. It blocks cells from using their microtubules, an important component of cells for normal structure and functioning. By blocking cells from using their microtubules, Kadcyla prevents the cancer cell from growing and eventually kills it.
Source: DailyMed
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
decreased urine
difficult or labored breathing
difficult, burning, or painful urination
dizziness
frequent urge to urinate
headache
increased thirst
irregular heartbeat
loss of appetite
lower back or side pain
mood changes
muscle pain or cramps
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
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
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
hostility
irritability
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
difficulty with moving
indigestion
lack or loss of strength
loss of taste
muscle stiffness
stomach discomfort or upset
swelling or inflammation of the mouth
trouble sleeping
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.
Given as an infusion once every 3 weeks, over either 30 or 90 minutes
Given just by itself (not taken alongside other cancer treatments)
Recommended option for HER2-positive early breast cancer that has some cancerous tissue remaining after initial treatment
An option for metastatic HER2-positive breast cancer when other treatments haven’t worked well
Must stay at the center for some time after each infusion to make sure you’re tolerating the medication well
Can cause nausea; fatigue; and muscle, bone, or joint pain
Not safe to take during pregnancy or while breastfeeding
Plan plenty of time for your Kadcyla infusion appointments. Your first infusion will take about 90 minutes. Afterwards, you’ll need to stay at the center for at least 90 more minutes so your care team can check for any reactions to the medication. If the first infusion goes smoothly, your next infusions will take 30 minutes, and then you’ll stay at the center for at least 30 more minutes for monitoring.
It can help to bring a blanket, a book, and other things to help pass the time and make you feel more comfortable during your each of your Kadcyla infusion visits.
Be sure to look out for infusion-related reactions, even though they aren’t very common. Your care team will also watch for these reactions during and after your Kadcyla infusion. Tell your care team right away if you notice any sign of an infusion reaction, such as throat tightness, trouble breathing, fever, chills, flushing, dizziness, or chest pain. Your care team can help manage these symptoms.
Call your care team if you notice any redness, pain, swelling, or blistering near your IV site. Kadcyla might irritate the area where you have the IV placed, especially if some medication leaks out of the vein to the tissue around it. Your care team might recommend a warm or cold compress or medications to help relieve the irritation. Your infusion might get paused if this happens while you’re receiving Kadcyla.
Make sure to get any blood tests or imaging done in a timely manner as instructed by your care team so they can check that Kadcyla is safe for you. For example, it’s important to have heart imaging done because the medication can affect how well your heart pumps blood and lead to symptoms of heart failure (e.g., shortness of breath, chest pain, swelling, sudden weight gain).
Talk with your care team first before starting any new medications, supplements, or herbal products to check that they’re safe to take with Kadcyla. Drug interactions with Kadcyla can make your cancer medication work less well or put you at risk for side effects. For example, taking the antibiotic clarithromycin with Kadcyla can raise your risk for side effects from the cancer medication (like liver injury or nerve pain).
Kadcyla can harm an unborn baby if it’s given during pregnancy. If you or your partner can get pregnant and is sexually active, use birth control during treatment. Continue using birth control for 4 months after the last dose if you’re male and for 7 months after stopping treatment if you’re female. Tell your oncologist right away if you or your partner becomes pregnant. Also report the pregnancy to Genentech (the manufacturer) by calling 1-888-835-2555 to help them track medication safety.
Avoid breastfeeding while you’re getting treated with Kadcyla and for 7 months after your last dose. Based on how the medication works, it’s possible for Kadcyla to cause serious side effects to your breastfed baby. Speak with a healthcare professional about other options to feed your baby.
Kadcyla can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Liver problems | Taking other medications that can harm the liver
Kadcyla can potentially harm your liver. In very rare situations, it’s possible for this liver damage to be serious or even fatal.
You might not feel any symptoms when your liver is having problems, but your oncology care team can see signs of liver damage from your blood test results. This is why you’ll need to get blood tests done to check your liver before each Kadcyla infusion. Tell your treatment team if you have more noticeable symptoms of liver damage, like pain on the right side of the stomach, yellowing of the eyes or skin, or dark urine.
If your oncologist suspects that you have liver damage, you might need to take a break from Kadcyla. Once your liver test results return to normal, you might be able to restart the medication at a lower dose.
Kadcyla can raise the risk of developing new or worsened left-sided heart failure. It can affect how well your heart pumps blood through your body. Make sure your oncology care team knows about your health conditions, especially any heart problems you've had.
Your oncologist will check your heart function through imaging using an echocardiogram (echo) or a MUGA scan. You’ll need to get imaging done before you start Kadcyla and also periodically during treatment. Tell your care team if you have any signs or symptoms of heart failure, including shortness of breath, dry cough, irregular heartbeats, chest pain, or sudden weight gain, while you’re taking this medication.
Kadcyla can harm an unborn baby if it’s given during pregnancy. If you’re able to have children, your oncologist will ask you to do a pregnancy test before you start Kadcyla to make sure it’s safe to take the medication.
If you or your partner can become pregnant and you’re sexually active, use birth control while you’re taking Kadcyla. For females, continue to use birth control for another 7 months after you stop the medication. And for males, keep using birth control, such as condoms during sex, after your last dose. Let your oncology care team know right away if you or your partner becomes pregnant while you’re taking Kadcyla.
Risk factors: Shortness of breath when you’re at rest
Although rare, some people who’ve taken Kadcyla had serious and sometimes fatal lung problems, including inflammation of the lungs and fluid buildup in the lungs. Tell your oncology care team if you have difficulty breathing, cough, or fatigue during your treatment.
Risk factors: Getting your first Kadcyla infusion
It’s possible to feel unwell during your Kadcyla infusion. These symptoms are called infusion reactions and can include fever, chills, trouble breathing, fast heartbeat, or feeling flushed, dizzy, or lightheaded. Infusion-related reactions are usually mild and tolerable, but they can be serious in rare cases.
Tell your treatment team right away if you experience any throat tightness, trouble breathing, fast heartbeat, fever, chills, hives, flushing, dizziness, or chest pain. They’ll pause the infusion and manage your symptoms. Depending on how severe the reaction is, your care team will decide whether to continue the infusion at a slower speed once you’re feeling better or have you take a break from treatment. In general, your symptoms should get better over the course of several hours to a day.
Risk factors: Taking blood thinners or antiplatelets | Low platelets
During clinical studies, some people experienced bleeding while they were taking Kadcyla. The bleeding can happen anywhere in the body and, though rarely, can even be fatal. You might be at risk if you have a low platelet count or if you’re taking other medications that can cause bleeds.
Contact your healthcare team if you have bleeding that’s hard to stop. Also call your care team if you notice symptoms of bleeding on the inside of your body, such as feeling lightheaded, having black or bloody stools, coughing up blood, or vomiting up coffee ground-like bits. Your treatment will probably get paused if you have serious bleeding.
Kadcyla can cause your body to make fewer platelets, the blood cells that help your blood clot to stop bleeding. Having low amounts of platelets can put you at risk for bleeding. This can be anything from easy bruising and easily getting nose bleeds or gum bleeds to more life-threatening situations.
You’ll have your blood drawn before each Kadcyla infusion to make sure that the medication is safe to take. If your platelet levels are too low, your team will adjust your treatment schedule. They might also lower your Kadcyla dose.
Kadcyla can sometimes cause discomfort, pain, numbness, and tingling in the hands and feet (peripheral neuropathy). Usually, these symptoms are mild. But let your treatment team know if they’re disrupting your daily activities.
Your treatment team can recommend medications to help with these nerve problems. Your oncologist might also lower the Kadcyla dose or give you a longer break between infusions to help relieve your side effects. And if you continue to experience nerve problems with Kadcyla, your oncologist might consider switching you to a different medication.
Your treatment team will calculate your specific Kadcyla dose based on your weight (kg). The recommended dose is 3.6 mg/kg as an infusion through the vein once every 3 weeks.
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.
Metastatic HER2-positive breast cancer in people who’ve already had treatment with Herceptin (trastuzumab) and a taxane
HER2-positive early breast cancer after surgery in people who still have cancerous tissue after treatment with Herceptin (trastuzumab) and a taxane
Advanced or metastatic HER2-positive or HER2-low breast cancer, after previous anti-HER2 treatment has stopped working
Advanced or metastatic non-small cell lung cancer with HER2 mutations, after previous treatment
Advanced or metastatic HER2-positive stomach cancer, after previous treatment with Herceptin (trastuzumab)
Advanced or metastatic HER2-positive esophageal cancer, after previous treatment with Herceptin (trastuzumab)
Advanced or metastatic HER2-positive solid tumors, after previous treatment
HER2-positive, breast cancers - IV and SQ injections
HER2-positive, metastatic stomach cancer - IV injection only
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