CAPRELSA® (kap-rel-sah) (Vandetanib)
- January 11, 2021
- 0
CAPRELSA®
(kap-rel-sah)
(Vandetanib)
Chemotherapy
CAPRELSA®
(kap-rel-sah)
(Vandetanib)
Chemotherapy
What is CAPRELSA (Vandetanib)?
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.
What is the most important information I should know about CAPRELSA?
CAPRELSA can cause serious side effects. These serious side effects include:
- 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
- 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
- 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 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
- 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 healthcare 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 healthcare 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 trouble seeing in one or both eyes
- Sudden, severe headache
- Sudden confusion, trouble speaking or understanding
- Sudden trouble walking, dizziness, loss of balance or coordination
- Bleeding. Bleeding can happen during your treatment with CAPRELSA. Tell your healthcare 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 healthcare 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. Your healthcare provider should check your blood levels to monitor your electrolytes more frequently if you have diarrhea.
- Thyroid hormones. You can have changes in your thyroid hormone when taking CAPRELSA. Your healthcare provider should monitor your thyroid hormone levels while taking CAPRELSA
- High blood pressure (hypertension). If you develop high blood pressure or your high blood pressure gets worse, your healthcare provider may lower your dose of CAPRELSA or tell you to stop taking CAPRELSA until your blood pressure is under control. Your healthcare 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 healthcare provider right away if you have: Headaches, Seizures, Confusion, Changes in vision, Problems thinking
- The most common side effects of CAPRELSA include: Diarrhea, Rash, Acne, Nausea, High blood pressure, Headache, Feeling tired, Loss of appetite, Upper respiratory tract infections, Stomach (abdominal) pain
How should I take CAPRELSA?
- 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 tablets whole with water.
- 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 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.
- Ff 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 and 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.
- 12 hours or more, take the missed dose as soon as you remember. Take the next dose at the normal time.
Important Safety Information
- 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.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking CAPRELSA?
Before you take CAPRELSA, tell your healthcare 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 healthcare 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. You and your healthcare provider should decide if you will take CAPRELSA or breastfeed. You should not do both.
- Especially tell your healthcare provider if you take: St. John’s Wort. You should not take St. John’s Wort while taking CAPRELSA, Certain medicines that can affect how your liver breaks down medicine, A medicine for your heart
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. CAPRELSA and other medicines may affect each other causing side effects.
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General information about CAPRELSA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CAPRELSA for a condition for which it was not prescribed. Do not give CAPRELSA to other people, even if they have the same symptoms you have. It may harm them.
What are the ingredients in CAPRELSA?
Active ingredient: Vandetanib
Inactive ingredient:
Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, crospovidone, povidone, and magnesium stearate
Tablet film-coat: hypromellose 2910, macrogol 300, and titanium dioxide E171
