KADCYLA for HER2+ early breast cancer

Is KADCYLA right for me? Learn about the potential benefits and risks.

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.

If your doctor is considering KADCYLA for you for early breast cancer, your treatment plan may look like this:

Where is KADCYLA in your treatment plan?

After neoadjuvant treatment and surgery, a pathologist checks to see if any cancer cells are present in the breast tissue or any lymph nodes that the surgeon removed. If cancer cells are found in any of the removed tissue, this is called residual disease. If you have HER2+ early breast cancer and residual disease, your doctor may choose KADCYLA for you. Talk to your healthcare team about the potential benefits and risks of KADCYLA.

How well did KADCYLA work when given after surgery?

KADCYLA significantly lowered the chance of cancer coming back compared to Herceptin.

In a clinical study of 1,486 people with HER2+ early breast cancer who had residual disease after taking neoadjuvant medicine including a taxane and Herceptin and surgery,

Three years after people started the study:

How effective is KADCYLA?

Side effects that may occur with KADCYLA

KADCYLA can cause serious side effects including severe liver problems and heart problems. Receiving KADCYLA during pregnancy can result in the death of an unborn baby and birth defects.

Additional possible serious side effects of KADCYLA include:
- Lung problems
- Infusion-related reactions
- Serious bleeding
- Low platelet count
- Nerve damage
- Skin reactions around the infusion site

See additional information on these side effects below or talk to your doctor.

Taking KADCYLA

Understand how KADCYLA is given for early breast cancer.

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Financial Resources

If you need help paying for KADCYLA, there may be options to help.

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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.