Safety First!

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Important Safety Information

Who is KADCYLA for?

KADCYLA is approved 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.

Important Safety Information

What is the most important safety information I should know about KADCYLA?

KADCYLA is not the same medicine as trastuzumab (Herceptin).

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 greater than 5 lb in less than 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 are exposed to KADCYLA during pregnancy or become pregnant within 7 months of your last dose of KADCYLA, contact your healthcare provider right away; you are also encouraged to enroll in the MotHER Pregnancy Registry by calling 1-800-690-67201-800-690-6720 or visiting http://www.motherpregnancyregistry.com/
  • You are also encouraged to report exposure to KADCYLA during pregnancy, or if you become pregnant within 7 months of your last dose to Genentech by calling 1-888-835-25551-888-835-2555
  • If you are a mother who is breastfeeding, you should talk with your doctor about either stopping breastfeeding or stopping 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?

Not all people have serious side effects; however, side effects with KADCYLA treatment are common. It is important to know what side effects may happen and what symptoms you should watch for.

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. Life-threatening bleeding may also happen with KADCYLA, even when blood thinners are not also being taken

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

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

How will my doctor know if KADCYLA is right for me?

You must have a HER2 test to determine if your cancer is HER2-positive before taking KADCYLA, because benefit has been shown only in patients whose tumors are HER2-positive.

What are the most common side effects of KADCYLA?

The most common severe side effects of KADCYLA are:

  • Low platelet count
  • Liver problems
  • Low levels of red blood cells
  • Nerve problems
  • Low levels of potassium in the blood
  • Tiredness

The most common side effects seen in people taking KADCYLA were:

  • 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 1-888-835-25551-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-10881-800-FDA-1088.

Please see KADCYLA full Prescribing Information, including Most Important Safety Information, for additional Important Safety Information.

What other types of support are there?

KADCYLA Patient Support Line

Talk to expert nurses who can answer your questions about KADCYLA

Call 1 (855) KADCYLA1 (855) KADCYLA (1-855-523-29521-855-523-2952) to talk to registered oncology nurses

When you have important questions about KADCYLA treatment or need additional support, call the KADCYLA Patient Support Line. Registered oncology nurses are available to answer questions and provide information about KADCYLA. Genentech cannot provide medical advice.

Nurses are immediately available (9 am-9 pm, Monday-Friday) or on-call (Saturday-Sunday). If your call is answered by voicemail, leave a message and a nurse will return your call. Be sure to say your full name and phone number on the message.

We're here to help you understand your treatment

Nurses are available to answer your treatment questions, including:

  • How KADCYLA is designed to work
  • The potential benefits and risks of KADCYLA
  • Side effects of KADCYLA
  • What to expect from KADCYLA treatment
  • Finding reimbursement help for KADCYLA

Every nurse on the team:

  • Is a registered nurse who specializes in cancer
  • Has about 20 years of experience
  • Is knowledgeable about KADCYLA treatment

The information you receive from the KADCYLA Patient Support Line is not meant to replace the advice of your healthcare team. Genentech will not provide medical advice regarding your medical condition or treatment.

Who is KADCYLA for?

KADCYLA Kadcyla GlossaryKadcyla Glossary is approved 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.

KADCYLA (ado-trastuzumab emtansine)

Hear it pronounced

Important Safety Information

What is the most important safety information I should know about KADCYLA?

KADCYLA is not the same medicine as trastuzumab (Herceptin).

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 greater than 5 lb in less than 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 are exposed to KADCYLA during pregnancy or become pregnant within 7 months of your last dose of KADCYLA, contact your healthcare provider right away; you are also encouraged to enroll in the MotHER Pregnancy Registry by calling 1-800-690-67201-800-690-6720 or visiting http://www.motherpregnancyregistry.com/
  • You are also encouraged to report exposure to KADCYLA during pregnancy, or if you become pregnant within 7 months of your last dose to Genentech by calling 1-888-835-25551-888-835-2555
  • If you are a mother who is breastfeeding, you should talk with your doctor about either stopping breastfeeding or stopping 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?

Not all people have serious side effects; however, side effects with KADCYLA treatment are common. It is important to know what side effects may happen and what symptoms you should watch for.

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. Life-threatening bleeding may also happen with KADCYLA, even when blood thinners are not also being taken

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

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

How will my doctor know if KADCYLA is right for me?

You must have a HER2 test to determine if your cancer is HER2-positive before taking KADCYLA, because benefit has been shown only in patients whose tumors are HER2-positive.

What are the most common side effects of KADCYLA?

The most common severe side effects of KADCYLA are:

  • Low platelet count
  • Liver problems
  • Low levels of red blood cells
  • Nerve problems
  • Low levels of potassium in the blood
  • Tiredness

The most common side effects seen in people taking KADCYLA were:

  • 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 1-888-835-25551-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-10881-800-FDA-1088.

Please see KADCYLA full Prescribing Information, including Most Important Safety Information, for additional Important Safety Information.