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

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 pharmacy that specializes in prescription cancer medicines. 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

When you start your treatment with CAPRELSA, you will receive your CAPRELSA Welcome Kit from Biologics. The CAPRELSA Welcome Kit is designed to help answer your questions about your treatment and includes:

  • CAPRELSA Patient Brochure
  • Guide to Understanding CAPRELSA Side Effects
  • Support Magnet
  • CAPRELSA Medication Guide
  • CAPRELSA Prescribing Information

The Most Important Information About CAPRELSA

CAPRELSA can change the electrical activity in your heart. This change is called QT prolongation. It can cause irregular heartbeats and could lead to death. Do not take CAPRELSA if you have had a condition called long QT syndrome since birth.

Your health care provider should perform certain tests. These will check levels of your blood potassium, calcium, magnesium, and thyroid-stimulating hormone (TSH). The electrical activity of your heart should also be checked using a test called an electrocardiogram (ECG). You should have these tests before starting CAPRELSA and regularly during your CAPRELSA treatment, as follows:

  • 2 to 4 weeks after starting CAPRELSA
  • 8 to 12 weeks after starting CAPRELSA
  • Every 3 months thereafter
  • If your health care provider changes your dose
  • If you take medicine that causes QT prolongation
  • As instructed by your health care provider

Call your health care provider right away if you

  • Feel faint
  • Feel light-headed
  • Feel your heart not beating normally

These may be symptoms of QT prolongation. Your health care provider may stop CAPRELSA treatment for awhile and then restart you on a lower dose.

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.
    • If you are able to become pregnant, 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 health care provider about birth control methods to prevent pregnancy while you are taking CAPRELSA.
  • Are breastfeeding or plan to breastfeed. It is not known if CAPRELSA passes into your breast milk. You and your health care provider should decide if you will take CAPRELSA or breastfeed. You should not do both.

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

Keep a list of medicines to show to your health care provider and pharmacist. Ask if you are not sure whether your medicine is included in the list above. 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.

Drug Type Brand Name Examples Generic Name
Antiarrhythmic
(affects the rhythm
of heartbeats)
Cordarone®, Pacerone®
Norpace®
Tikosyn®
---
Betapace®, Sorine®
Amiodarone
Disopyramide
Dofetilide
Procainamide
Sotalol
Antibiotic Biaxin®
Avelox®
Clarithromycin
Moxifloxacin
Antimalarial Aralen® Chloroquine
Antinausea and
antivomiting
Anzemet®
Granisol®, Sancuso®
Dolasetron
Granisetron
Antipsychotic Haldol®
Orap®
Haloperidol
Pimozide
Narcotic
analgesic
Dolophine®, Methadose® Methadone

This is not a complete list. If you have any questions, talk with your health care provider or pharmacist.

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

Product names are registered trademarks of their respective companies.

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.