Starting 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.

After you and your doctor have decided that CAPRELSA is the right treatment choice for you, your doctor will write a prescription.

Filling your prescription

Because of the risks associated with CAPRELSA, it is only available through a restricted distribution program with Biologics,  Inc., a specialty pharmacy. You cannot fill your CAPRELSA prescription at your regular pharmacy.

Your doctor will send your CAPRELSA prescription to the Biologics pharmacy team. They will fill the prescription and mail your CAPRELSA directly to you.

To contact the Biologics pharmacy team 24/7, call 1-800-850-4306.

Learn more about our patient support services for CAPRELSA

The CAPRELSA Welcome Kit

What is the most important information I should know 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 healthcare 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). You should have these tests:

• Before starting CAPRELSA
• Regularly during CAPRELSA treatment:
• 2 to 4 weeks after starting CAPRELSA
• 8 to 12 weeks after starting CAPRELSA
• every 3 months thereafter
• if your healthcare provider changes your dose of CAPRELSA
• if you start taking medicine that causes QT prolongation
• as instructed by your healthcare provider

Your healthcare provider may stop your CAPRELSA treatment for a while and restart you at a lower dose if you have QT prolongation.

Call your healthcare 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. .

Who should not take CAPRELSA?

Do not take CAPRELSA if you have had QT prolongation.

What should you tell your health care provider before taking CAPRELSA?

Before you take CAPRELSA, tell your health care provider if you:

• have any heart problems, including a condition called congenital long QT syndrome
• have an irregular heartbeat
• take or have stopped taking a medicine that causes QT prolongation
• have low blood levels of potassium, calcium, or magnesium
• have high blood levels of thyroid-stimulating hormone
• have high blood pressure
• have skin problems
• have a history of breathing problems
• have a recent history of coughing up blood or bleeding
• have diarrhea
• have liver problems
• have kidney problems
• have seizures or are being treated for seizures
• are pregnant or plan to become pregnant. CAPRELSA can cause harm to your unborn baby. Talk to your health care provider if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if CAPRELSA passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of CAPRELSA
• plan to have surgery or have had a recent surgery. You should stop taking CAPRELSA at least 1 month before planned surgery.

Females who are able to become pregnant:

• 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.
• Talk to your healthcare provider about birth control methods to prevent pregnancy while you are taking CAPRELSA.

Medicines to avoid

CAPRELSA and other medicines may affect each other, causing side effects. Tell your health care provider about all the medicines you take, including prescription medicines, non-prescription medicines, vitamins, and herbal supplements.

It is especially important to tell your health care provider if you take

• St. John's wort
• Medicines that can affect how your liver breaks down medicine
• Medicine for your heart

Ask your healthcare provider if you are not sure if your medicine is one listed above.

Do not take other medicines while taking CAPRELSA until you have talked with your healthcare provider or pharmacist.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Examples of some medicines you may need to avoid while taking CAPRELSA are listed in the table below.

For lists of other possible or conditional risk drugs, please visit the CredibleMeds^® website at www.crediblemeds.org.

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.