Taking CAPRELSA

Dosing

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.
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. It is not known if CAPRELSA is safe and effective in children.

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.

• 
  Single Tablet
  Starting Dose
  (Tablet not actual size)
• 
  Once a Day
  Anytime
• 
  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.

Take CAPRELSA exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking CAPRELSA unless your healthcare provider tells you to.

• CAPRELSA may be taken with or without food
• Swallow CAPRELSA tablet(s) whole with water
• Do NOT crush CAPRELSA tablets. If CAPRELSA tablets are accidentally crushed, contact with skin should be avoided. If contact occurs, wash affected areas well with water. If CAPRELSA tablets are accidentally crushed, contact with skin should be avoided
• If you cannot swallow CAPRELSA tablets whole:
• place your dose of CAPRELSA in a glass that contains 2 ounces of noncarbonated water (no other liquids should be used).
• stir the CAPRELSA tablet(s) and water mixture for about 10 minutes or until the tablet(s) are in very small pieces (the tablets will not completely dissolve).
• swallow CAPRELSA and water mixture right away if any CAPRELSA and water mixture remains in the glass,
• if any CAPRELSA and water mixture remains in the glass, mix with an additional 4 ounces of noncarbonated water and swallow the mixture to make sure that you take your full dose of CAPRELSA.

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

During treatment with CAPRELSA, your healthcare provider should

• check your blood and heart for side effects.
• check your blood pressure regularly

What should you avoid while taking CAPRELSA?

• Limit exposure to the sun. CAPRELSA can make your skin sensitive to the sun. During treatment with CAPRELSA and for at least 4 months after stopping treatment with CAPRELSA 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 or cause blurred vision.

Side effects

CAPRELSA may cause serious side effects, including

• QT Prolongation: See "What is the most important information I should know about CAPRELSA"

• Severe skin reactions. CAPRELSA can cause severe skin reactions that can lead to death, such as toxic epidermal necrolysis and Stevens-Johnson syndrome, or other serious skin reactions that may affect any part of your body. These severe skin reactions may be life threatening and you may need to be treated in a hospital. Call your healthcare provider right away if you experience any of these symptoms.
• skin rash or acne
• dry skin
• itching
• blisters on your skin
• redness or swelling of your face, hands, or soles of your feet
• blisters or sores in your mouth
• peeling of your skin
• fever
• muscle or joint aches

• 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 that does not go away (persistent), or fever

• 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: CAPRELSA can cause serious bleeding that can lead to death. 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 common with CAPRELSA and can be severe. Your healthcare provider should check your blood levels to monitor your electrolytes more frequently if you have diarrhea. Tell your healthcare provider if you develop diarrhea during treatment with CAPRELSA.

• Thyroid hormone: 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
• seizures
• headaches
• changes in vision
• confusion
• problems thinking

• Kidney problems: CAPRELSA may cause problems with your kidneys including kidney failure
• Wound healing problems: Wounds may not heal properly during CAPRELSA treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with CAPRELSA
• You should stop taking CAPRELSA at least 1 month before planned surgery.
• Your healthcare provider should tell you when you may start taking CAPRELSA again after surgery.

The most common side effects of CAPRELSA include:

• rash
• acne
• high blood pressure
• nausea
• headache
• upper respiratory tract infections
• decreased appetite
• stomach-area (abdominal) pain

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

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.

How should you store CAPRELSA?

• Store CAPRELSA tablets at room temperature between 68°F and 77°F (20°C and 25°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 may cause other serious side effects, including:

• Severe skin reactions. CAPRELSA can cause severe skin reactions that can lead to death, such as toxic epidermal necrolysis and Stevens-Johnson syndrome, or other serious skin reactions that may affect any part of your body. These severe skin reactions may be life threatening and you 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; ; redness or swelling of your face, hands, or soles of your feet; blisters or sores in your mouth; peeling of your skin; fever; muscle or joint aches.
• 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, cough that does not go away (persistent) or fever.
• 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. CAPRELSA can cause serious bleeding that can lead to death. 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 common with CAPRELSA and can be severe. Tell your health care provider right away if you develop diarrhea during treatment with CAPRELSA.
• 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: seizures; headaches; changes in vision; confusion; problems thinking.
• Kidney problems. CAPRELSA may cause problems with your kidneys, including kidney failure.
• Wound healing problems. Wounds may not heal properly during CAPRELSA treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with CAPRELSA.

The most common side effects of CAPRELSA include rash, acne, high blood pressure, nausea, headache, upper respiratory tract infections, decreased appetite, and stomach-area (abdominal) pain.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CAPRELSA.

Before you take CAPRELSA, 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 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.

Females who are able to become pregnant: Tell your health care provider if you are pregnant or plan to become pregnant. CAPRELSA can cause harm to your unborn baby. Your healthcare provider should do a pregnancy test before you begin treatment with CAPRELSA. You should use effective birth control during your treatment with CAPRELSA and for at least 4 months after your last dose of CAPRELSA.

What should I avoid while taking CAPRELSA?

Limit exposure to the sun. CAPRELSA can make your skin sensitive to the sun. During treatment with CAPRELSA and for at least 4 months after stopping treatment with CAPRELSA, 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.

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. 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. It is not known if CAPRELSA is safe and effective in children.

Please see full Prescribing Information, including Boxed WARNING and Medication Guide

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

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. You may report side effects to the FDA at 1-800-FDA-1088.