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

Taking CAPRELSA

Dosing

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.

CAPRELSA is a tablet that you take by mouth once a day, with or without food. It comes in 100-mg and 300-mg tablets. The recommended daily dose for CAPRELSA is a single 300-mg tablet. Your doctor may reduce your dosage strength to 200 mg (two 100-mg tablets) and then to 100 mg. Your doctor will prescribe the dosage strength that’s right for you.

  • pill
    Single Tablet
    Starting Dose
    (Tablet not actual size)
  • calendar
    Once a Day
    Anytime
  • food
    With Or
    Without Food

During treatment with CAPRELSA, your health care provider should check your blood and heart for side effects, and check your blood pressure regularly.

Always take CAPRELSA exactly as your doctor prescribes and keep the following guidelines in mind:

  • CAPRELSA may be taken with or without food
  • Swallow CAPRELSA tablet(s) whole with water once a day as directed by your health care provider
    • If you have difficulty swallowing, talk to your health care provider about an alternative method for taking CAPRELSA
  • Do not change your dose or stop taking CAPRELSA unless directed by your health care provider
  • Do NOT crush or chew CAPRELSA tablets
  • If CAPRELSA tablets are accidentally crushed, contact with skin should be avoided
    • If contact occurs, wash affected areas well with water

If You Miss a Dose

  • If your next dose is in less than 12 hours, take your next dose at the normal time. Do not make up for the missed dose
  • If your next dose is in 12 hours or more, take the missed dose as soon as you remember. Take the next dose at the normal time

If You Take Too Much CAPRELSA

  • Call your health care provider right away

What should you avoid while taking CAPRELSA?

  • Limit exposure to the sun. CAPRELSA can make your skin sensitive 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 CAPRELSA may make you feel tired, weak, or cause blurred vision.

Side effects

CAPRELSA may cause serious side effects, including

  • QT Prolongation: See "The Most Important Information about CAPRELSA"
  • 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 and may need to be treated in a hospital. 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 [ILD]): CAPRELSA may cause a breathing problem called ILD. This can lead to death. Tell your health care provider right away if you have sudden or worsening shortness of breath or cough
  • Stroke: Strokes have been reported in some people who have taken CAPRELSA. In some cases strokes have caused death. Stop taking CAPRELSA and call your health care provider right away if you have symptoms of a stroke. Symptoms 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 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 (MTC). CAPRELSA can also cause diarrhea or make diarrhea worse. Your health care provider should check your blood levels to monitor your electrolytes more frequently if you have diarrhea
  • Thyroid hormone changes: You can have changes in your thyroid hormone when taking CAPRELSA. Your health care provider should monitor your thyroid hormone levels 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 RPLS can happen while taking CAPRELSA. Call your health care provider right away if you have
    • Headaches
    • Seizures
    • Confusion
    • Changes in vision
    • Problems thinking

Common side effects in 231 patients treated with CAPRELSA in the ZETA clinical trial

side effects

These are not all the possible side effects of CAPRELSA. For more information, ask your health care provider.

Tell your health care provider about any potential side effects you may be experiencing.

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.

How should you store CAPRELSA?

  • Store CAPRELSA tablets at 59°F to 86°F (15°C to 30°C).
  • Safely throw away medicine that is out of date or that you no longer need. Ask your pharmacist how to safely throw away CAPRELSA tablets.

Keep CAPRELSA and all medicines out of the reach of children.

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 serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, 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.