Frequently asked questions about KADCYLA for early breast cancer

Get answers to frequently asked questions about KADCYLA, including questions about the treatment experience and financial assistance.

About KADCYLA FAQs

KADCYLA is the first HER2-targeted treatment of its kind. It is made up of two cancer-fighting agents in one drug:

The monoclonal antibody trastuzumab (the same antibody in Herceptin®)
A chemotherapy

When you take KADCYLA, you are getting both a HER2-targeted treatment and a chemotherapy, at the same time.

KADCYLA is a prescription medicine used as an adjuvant (after surgery) treatment for HER2-positive early breast cancer if you have taken neoadjuvant (before surgery) treatment including a taxane and trastuzumab (Herceptin^®) and there is any amount of cancer remaining in the tissue removed during surgery. You are selected for therapy based on an FDA-approved test for KADCYLA.

If you received neoadjuvant treatment for HER2+ early breast cancer, and that treatment included a taxane and trastuzumab, and there was cancer remaining in the tissue removed during surgery, talk to your doctor to determine if KADCYLA is right for you.

For HER2+ early breast cancer, KADCYLA is given once every 3 weeks for 14 rounds of infusion—sometimes called “cycles”—unless the cancer comes back or side effects cause the treatment to be stopped sooner. Treatment with KADCYLA typically would last less than a year.

KADCYLA can cause severe liver problems that can be life-threatening. KADCYLA may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). Receiving KADCYLA during pregnancy can result in the death of an unborn baby and birth defects.

Other possible serious side effects include:

Lung problems
Infusion-related reactions
Serious bleeding
Low platelet count
Nerve damage
Skin reactions around the infusion site

Learn more about side effects and talk to your doctor about any side effects you experience.

The most common side effects in people taking KADCYLA for early breast cancer are tiredness, nausea, liver problems, pain that affects the bones, muscles, ligaments, and tendons, bleeding, low platelet count, headache, weakness, numbness, and pain in the hands and feet, and joint pain.

Learn more about side effects and talk to your doctor about any side effects you experience.

Infusion FAQs

If you haven't started treatment with KADCYLA yet, you may be wondering what a treatment day might look like. KADCYLA is given as an intravenous (IV) infusion in your doctor’s office, at a hospital, or at an infusion center. Your first infusion of KADCYLA takes 90 minutes. If prior infusions are well tolerated, all other infusions take 30 minutes.

Your healthcare team will wait at least 90 minutes after the first infusion, and at least 30 minutes after each following infusion, to check for any reactions. If side effects occur, they may adjust, delay, or stop your treatment.

Wear a comfortable top with no sleeves or sleeves that are easy to roll up
Pack items that will help you feel more comfortable, such as a blanket, a book, or earbuds
Schedule an early appointment to stop treatment-day nerves from building up
If you are feeling a little overwhelmed, to calm yourself down, try taking a deep breath while you count to 7, then exhaling slowly while counting to 7. Repeat this 5 times.

Financial support FAQs

Financial assistance options for KADCYLA include the Genentech Oncology Co-pay Assistance Program, independent co-pay assistance foundations, and the Genentech Patient Foundation.

To find the financial support program that may be right for you, answer a few questions with the financial support tool, which will guide you through the application process and any next steps.

Next: Helpful links & downloads

Who is KADCYLA for?

Early Breast Cancer

KADCYLA is a prescription medicine used as an adjuvant (after surgery) treatment for HER2-positive early breast cancer when the patient has taken neoadjuvant (before surgery) treatment including a taxane and trastuzumab (Herceptin^®) and there is cancer remaining in the tissue removed during surgery.

Patients are selected for therapy based on an FDA-approved test for KADCYLA.

Metastatic Breast Cancer

KADCYLA is a prescription medicine used to treat HER2-positive breast cancer that has spread to other parts of the body (metastatic breast cancer) after prior treatment with trastuzumab (Herceptin^®) and a taxane. Prior treatment could have been for the initial treatment of breast cancer or for the treatment of cancer that had spread to other parts of the body.

Patients are selected for therapy based on an FDA-approved test for KADCYLA.

Important Safety Information

What is the most Important Safety Information I should know about KADCYLA?

Liver problems

KADCYLA may cause severe liver problems that can be life-threatening. Symptoms of liver problems may include vomiting, nausea, eating disorder (anorexia), yellowing of the skin (jaundice), stomach pain, dark urine, or itching

Heart problems

KADCYLA may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). Symptoms may include swelling of the ankles or legs, shortness of breath, cough, rapid weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness, or irregular heartbeat

Pregnancy

Receiving KADCYLA during pregnancy can result in the death of an unborn baby and birth defects. Birth control should be used while you receive KADCYLA and for 7 months after your last dose of KADCYLA
If you think you may be pregnant, you should contact your healthcare provider immediately
If you are exposed to KADCYLA during pregnancy or if you become pregnant within 7 months following your last dose of KADCYLA, you are encouraged to report KADCYLA exposure to Genentech by calling 1-888-835-2555
If you are a male patient with a female partner that could become pregnant, birth control should be used during treatment and for 4 months following your last dose of KADCYLA
You should not breastfeed during treatment and for 7 months after the last dose of KADCYLA

Contact your doctor right away if you experience symptoms associated with these side effects.

What are the additional possible serious side effects of KADCYLA?

Lung problems

KADCYLA may cause lung problems, including inflammation of the lung tissue, which can be life-threatening. Signs of lung problems may include trouble breathing, cough, tiredness, and fluid in the lungs

Infusion-related reactions

Symptoms of an infusion-related reaction may include one or more of the following: the skin getting hot or red (flushing), chills, fever, trouble breathing, low blood pressure, wheezing, tightening of the muscles in the chest around the airways, or a fast heartbeat. Your doctor will monitor you for infusion-related reactions

Serious bleeding

KADCYLA can cause life-threatening bleeding. Taking KADCYLA with other medications used to thin your blood (antiplatelet) or prevent blood clots (anticoagulation) can increase your risk of bleeding. Your doctor should provide additional monitoring if you are taking one of these other drugs while on KADCYLA. Even when blood thinners are not also being taken, life-threatening bleeding may occur with KADCYLA

Low platelet count

Low platelet count may happen during treatment with KADCYLA. Platelets help your blood to clot. Signs of low platelets may include easy bruising, bleeding, and prolonged bleeding from cuts. In mild cases there may not be any symptoms

Nerve damage

Symptoms may include numbness and tingling, burning or sharp pain, sensitivity to touch, lack of coordination, muscle weakness, or loss of muscle function. Your doctor will monitor you for symptoms of nerve damage

Skin reactions around the infusion site

KADCYLA may leak from the vein or needle and cause reactions such as redness, tenderness, skin irritation, or pain or swelling at the infusion site. If this happens, it is more likely to happen within 24 hours of the infusion

What are the most common side effects of KADCYLA?

The most common side effects in people taking KADCYLA for early breast cancer are:

Tiredness
Nausea
Liver problems
Pain that affects the bones, muscles, ligaments, and tendons
Bleeding
Low platelet count
Headache
Weakness, numbness, and pain in the hands and feet
Joint pain

The most common side effects seen in people taking KADCYLA for metastatic breast cancer are:

Tiredness
Nausea
Pain that affects the bones, muscles, ligaments, and tendons
Bleeding
Low platelet count
Headache
Liver problems
Constipation
Nosebleeds

You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Talk to a healthcare professional for more information about the benefits and risks of KADCYLA.

Please see full Prescribing Information for Important Safety Information, including most serious side effects.

If you cannot afford your medication, visit genentech-access.com/patient for financial assistance information.

This image shows a normal cell with a normal amount of HER2, in which cells grow and divide normally; and a HER2+ cancer cell with too much HER2, in which cells grow and divide faster.
This image shows lymph nodes to which breast cancer can spread, such as those around or near the collarbone, in the armpits, and near the breastbone.
Overview
This image shows what your treatment plan may look like.

Details
1. Diagnosis
2. Neoadjuvant treatment
3. Surgery
4. Adjuvant treatment
  1. If SOME cancer cells are present in the tissue removed (known as residual disease), you may start on KADCYLA
  2. If NO cancer cells are present in the tissue removed, you do not have residual disease. KADCYLA is not approved for this use, but you may receive other treatment options.
Overview
This image provides information about neoadjuvant and adjuvant treatment.

Details
Neoadjuvant treatment (before surgery)
One of the goals of neoadjuvant treatment is to help reduce or get rid of cancer cells before surgery.

Adjuvant treatment (after surgery)
Adjuvant treatment is given with the intent to kill any cancer cells left behind after surgery.
Overview
This image shows what happened three years after people started the study.

Details
Three years after people started the study:
- Eighty-eight percent of the 743 people who received KADCYLA were still cancer free, compared to 77% of the 743 people who received Herceptin
- The chance of cancer coming back was lowered by 50% for people who received KADCYLA compared to people who received Herceptin
At this time of this data review, it was too early in the study to determine if people lived longer with KADCYLA. However, people in the study will continue to be followed and evaluated.
This image shows that 1 infusion of KADCYLA is given every 3 weeks for 14 cycles.
This image shows that the first infusion of KADCYLA takes 90 minutes. If prior infusions were well tolerated, all other infusions take 30 minutes.

Your healthcare team will wait at least 90 minutes after the first infusion, and at least 30 minutes after each following infusion, to check for any reactions. If side effects occur, they may adjust, delay, or stop your treatment.

Wait 3 weeks between infusions.

This image shows a normal cell with a normal amount of HER2, in which cells grow and divide normally; and a HER2+ cancer cell with too much HER2, in which cells grow and divide faster.
This image shows that 1 infusion of KADCYLA is given every 3 weeks.
This image shows that the first infusion of KADCYLA takes 90 minutes. If prior infusions were well tolerated, all other infusions take 30 minutes.

Your healthcare team will wait at least 90 minutes after the first infusion, and at least 30 minutes after each following infusion, to check for any reactions. If side effects occur, they may adjust, delay, or stop your treatment.

Wait 3 weeks between infusions.