The first medication
approved by the FDA
to treat advanced
medullary thyroid
cancer (aMTC)

The first medication approved by the FDA to treat advanced medullary thyroid cancer (aMTC)

About CAPRELSA

What is CAPRELSA?

CAPRELSA is a prescription medication used to treat patients with medullary thyroid cancer (MTC) that cannot be removed by surgery or that has spread to other parts of the body, and in which the tumors are growing or causing symptoms. This type of MTC is typically called advanced medullary thyroid cancer (aMTC).

It takes a long time to get rid of CAPRELSA from your body and you may be at risk for side effects related to CAPRELSA after you have stopped your treatment.

How CAPRELSA works

CAPRELSA is a kinase inhibitor. A kinase is a kind of enzyme that can signal other molecules in a cell, including a cancer cell, to become active. CAPRELSA interferes with cell communication and may prevent tumor growth. It's also important to note that normal cells can be affected by your treatment with CAPRELSA, which could result in side effects.

 

  • CAPRELSA may

    Restrict

    tumor growth and the spread of cancer to other parts of the body
  • CAPRELSA may

    Slow

    down the growth of new blood vessels into tumors
  • CAPRELSA may

    Reduce

    the number of cancer cells or slow their rate of growth

Why consider CAPRELSA?

CAPRELSA was tested in one of the largest studies of patients with aMTC (the ZETA Study), which included a total of 331 men and women who were randomly put into 1 of 2 treatment groups. Group 1 took CAPRELSA by mouth once a day. Group 2 took placebo by mouth once a day.

ZETA Study=331 Patients with aMTC

group one
Group One
231 patients taking CAPRELSA
group two
Group Two
100 patients taking a PLACEBO

In the ZETA Study, CAPRELSA showed a 65% relative reduction in the risk of progression compared to placebo. This means taking CAPRELSA prolonged or extended progression-free survival (PFS). PFS is the amount of time a patient lives without the cancer progressing. At the time the PFS results were analyzed, 15% of patients had died and the data did not show that patients treated with CAPRELSA lived longer (overall survival) compared to patients treated with placebo.

CAPRELSA showed a 65% relative reduction in the risk of progression compared to placebo.

Important Safety Information, including Boxed WARNING, about CAPRELSA

CAPRELSA can cause a change in the electrical activity of your heart called QT prolongation, which can cause irregular heartbeats and that may lead to death. You should not take CAPRELSA if you have had a condition called long QT syndrome since birth.

Your health care provider should perform tests to check the levels of your blood potassium, calcium, magnesium, and thyroid-stimulating hormone (TSH) as well as the electrical activity of your heart, with a test called an electrocardiogram (ECG). These tests should be performed before starting CAPRELSA and regularly during CAPRELSA treatment.

Call your health care provider right away if you feel faint, light-headed, or feel your heart beating irregularly while taking CAPRELSA. These may be symptoms related to QT prolongation.

CAPRELSA may cause other serious side effects, including:

  • Serious skin reactions. CAPRELSA can cause a serious skin reaction, called Stevens-Johnson syndrome, or other serious skin reactions that may affect any part of your body. These serious skin reactions may be life threatening. Call your health care provider right away if you experience any of these symptoms: skin rash or acne; dry skin; itching; blisters on your skin; blisters or sores in your mouth; peeling of your skin; fever, muscle or joint aches; redness or swelling of your face, hands, or soles of your feet
  • Breathing problems (interstitial lung disease). CAPRELSA may cause a breathing problem called interstitial lung disease that can lead to death. Tell your health care provider right away if you experience sudden or worsening shortness of breath or cough
  • Stroke. Strokes have been reported in some people who have taken CAPRELSA and in some cases have caused death. Stop taking CAPRELSA and call your health care provider right away if you have symptoms of a stroke which may include: numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking, dizziness, loss of balance or coordination; sudden, severe headache
  • Bleeding. Bleeding can happen during your treatment with CAPRELSA. Tell your health care provider right away if you have severe bleeding while you are taking CAPRELSA
  • Heart failure. CAPRELSA can cause heart failure that can lead to death. You may have to stop taking CAPRELSA if you have heart failure. Heart failure may not be reversible after stopping CAPRELSA. Your health care provider should monitor you for signs and symptoms of heart failure
  • Diarrhea. Diarrhea is often a symptom of medullary thyroid cancer. CAPRELSA can also cause diarrhea or make diarrhea worse. Tell your health care provider right away if you develop diarrhea or your diarrhea gets worse
  • Thyroid hormones. You can have changes in your thyroid hormone when taking CAPRELSA. Your health care provider may need to adjust your thyroid medication while you are taking CAPRELSA
  • High blood pressure (hypertension). If you develop high blood pressure or your high blood pressure gets worse, your health care provider may lower your dose of CAPRELSA or tell you to stop taking CAPRELSA until your blood pressure is under control. Your health care provider may prescribe another medicine to control your high blood pressure
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome can happen while taking CAPRELSA. Call your health care provider right away if you have: headaches; seizures; confusion; changes in vision; problems thinking

Be sure to tell your health care provider about all your health conditions, including any heart problems. Also tell your health care provider about all the medicines you take, including prescription and and non-prescription medicines, vitamins, and herbal supplements. Do not take other medicines while taking CAPRELSA until you have talked with your health care provider or pharmacist.

Tell your health care provider if you are pregnant or plan to become pregnant. CAPRELSA can cause harm to your unborn baby.

CAPRELSA can make your skin sensitive to the sun, so you should limit exposure to the sun. While taking CAPRELSA and for 4 months after stopping your CAPRELSA treatment, use sun block and wear clothes that cover your skin, including your head, arms and legs when you go outdoors.

Use caution before driving or using machinery. Keep in mind that CAPRELSA may make you feel tired or weak, or cause blurred vision.

It takes a long time to get rid of CAPRELSA from your body and you may be at risk for side effects related to CAPRELSA after you have stopped your treatment.

Most Common Side Effects

The most common side effects of CAPRELSA include diarrhea (57%), rash (53%), acne (35%), nausea (33%), high blood pressure (33%), headache (26%), feeling tired (24%), upper respiratory tract infections (23%), loss of appetite (21%), and stomach (abdominal) pain (21%).

Approved Uses for CAPRELSA

CAPRELSA is a prescription medicine used to treat medullary thyroid cancer that cannot be removed by surgery or that has spread to other parts of the body, and the tumors are growing or causing symptoms. Because of the risks associated with CAPRELSA, your health care provider should carefully consider whether to prescribe CAPRELSA for you if your tumors are growing slowly or if you are not having symptoms.

Please read Prescribing Information, including Boxed WARNING.

Please read Medication Guide.

This information does not take the place of talking to your health care provider about your medical condition or treatment.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/safety/medwatch or call 1‑800‑FDA‑1088. You may also contact Sanofi Genzyme at 1-800-745-4447, option 2.