Pregnancy Complications from Herceptin, PERJETA, and KADCYLA

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What is the MotHER Pregnancy Registry?

What is the MotHER Pregnancy Registry?

The MotHER Pregnancy Registry* was established for women who have taken Herceptin® (trastuzumab), PERJETA® (pertuzumab), or KADCYLA® (ado-trastuzumab emtansine) for breast cancer during pregnancy or within seven months of becoming pregnant. The goal is to learn about the health of these women and their babies.

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*The MotHER Pregnancy Registry is sponsored by Genentech, Inc.

Who is Herceptin for?

Adjuvant Breast Cancer

Herceptin is approved for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2+ and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high risk feature.* Herceptin can be used in several different ways:

  • As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as "AC→TH"
  • With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as "TCH"
  • Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy)

*High risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

Metastatic Breast Cancer

Herceptin has 2 approved uses in metastatic breast cancer:

  • Herceptin in combination with the chemotherapy drug paclitaxel is approved for the first line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer
  • Herceptin alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease

Important Patient Safety Information

Possible Serious Side Effects With HERCEPTIN

Not all people have serious side effects, but side effects with HERCEPTIN therapy are common.

Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur.

HERCEPTIN is not for everyone. Be sure to contact your doctor if you are experiencing any of the following:

HEART PROBLEMS

These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both HERCEPTIN and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. Your doctor will check for signs of heart problems before, during, and after treatment with HERCEPTIN.


INFUSION REACTIONS, including:

  • Fever and chills
  • Feeling sick to your stomach (nausea)
  • Throwing up (vomiting)
  • Pain (in some cases at tumor sites)
  • Headache
  • Dizziness
  • Shortness of breath

These signs usually happen within 24 hours after receiving HERCEPTIN.

Be sure to contact your doctor if you:

Are BREAST-FEEDING OR PREGNANT
HERCEPTIN may harm a nursing child or an unborn baby.

Are PLANNING TO BECOME PREGNANT
Taking HERCEPTIN could result in death of an unborn baby or birth defects.

If you stop treatment with HERCEPTIN, you should keep using birth control for at least 7 months before trying to become pregnant. If you are exposed to HERCEPTIN during pregnancy or within 7 months of becoming pregnant, you are encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720.

Have any signs of SEVERE LUNG PROBLEMS, including

  • Severe shortness of breath
  • Fluid in or around the lungs
  • Weakening of the valve between the heart and the lungs
  • Not enough oxygen in the body
  • Swelling of the lungs
  • Scarring of the lungs

Your doctor may check for signs of severe lung problems when he or she examines you.

Have LOW WHITE BLOOD CELL COUNTS

Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving HERCEPTIN plus chemotherapy than in patients receiving chemotherapy alone.

Your doctor may check for signs of low white blood cell counts when he or she examines you.

Other Important Information

Before taking HERCEPTIN, you must have a HER2 test to determine if your cancer is HER2-positive. This is because the benefit of treatment with HERCEPTIN has been shown only in patients whose tumors are HER2-postive.

Side Effects Seen Most Often With HERCEPTIN

Some patients receiving HERCEPTIN for breast cancer had the following side effects:

  • Fever
  • Feeling sick to your stomach (nausea)
  • Throwing up (vomiting)
  • Infusion reactions
  • Diarrhea
  • Infections
  • Increased cough
  • Headache
  • Feeling tired
  • Shortness of breath
  • Rash
  • Low white and red blood cell counts
  • Muscle pain

You should contact your doctor immediately if you have any of the side effects listed above.

You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1 (888) 835-2555.

Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information including Boxed WARNINGS.

What does PERJETA treat?

PERJETA® (pertuzumab) is approved for use in combination with Herceptin® (trastuzumab) and docetaxel in people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.

Important Safety Information

What should I know about side effects with PERJETA?

  • Not all people have serious side effects; however, side effects with PERJETA therapy are common. It is important to know what side effects may happen and what symptoms you should watch for
  • Your doctor may stop treatment if serious side effects happen. Be sure to contact your healthcare team right away if you have questions or are worried about any side effects

What are the most serious side effects?

  • PERJETA may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure).

  • Your doctor may run tests to monitor your heart function before and during treatment with PERJETA
  • Based on test results your doctor may hold or discontinue treatment with PERJETA
 

Receiving PERJETA during pregnancy can result in the death of an unborn baby and birth defects.

  • Birth control should be used while receiving PERJETA and for 7 months after your last dose of PERJETA. If you are a mother who is breastfeeding, you should talk with your doctor about either stopping breastfeeding or stopping PERJETA
  • If you think you may be pregnant, you should contact your healthcare provider immediately

If you are exposed to PERJETA during pregnancy, or become pregnant while receiving PERJETA or within 7 months following the last dose of PERJETA in combination with Herceptin, you are encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720.

What are other possible serious side effects?

  • PERJETA should not be used in patients who are allergic to pertuzumab or to any of the ingredients in PERJETA
  • Infusion-related reactions: PERJETA is a medicine that is delivered into a vein through a needle. This process can cause reactions known as infusion-related reactions. The most common infusion-related reactions when receiving PERJETA, Herceptin, and docetaxel were feeling tired, abnormal or altered taste, allergic reactions, muscle pain, and vomiting. The most common infusion-related reactions when receiving PERJETA alone were fever, chills, feeling tired, headache, weakness, allergic reactions, and vomiting
  • Severe allergic reactions: Some people receiving PERJETA may have severe allergic reactions, called hypersensitivity reactions or anaphylaxis. This reaction may be severe, may happen quickly, and may affect many areas of the body

How will my doctor and I know if PERJETA is right for me?

PERJETA has only been shown to work in people with HER2-positive breast cancer. You must have a HER2 test to know if your breast cancer is HER2-positive before receiving an anti-HER2 treatment, such as PERJETA.

What are the most common side effects?

The most common side effects of PERJETA when given with Herceptin and docetaxel for treatment of breast cancer that has spread to other parts of the body (metastatic) are:

  • Diarrhea
  • Hair loss
  • Low levels of white blood cells with or without a fever
  • Nausea
  • Feeling tired
  • Rash
  • Damage to the nerves (numbness, tingling, pain in hands/feet)

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

Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information including most serious side effects.

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 lbs 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 1-800-690-6720
  • 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 1-888-835-2555
  • 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?

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 side effects seen in people taking KADCYLA 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.

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

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