Caprelsa (generic: vandetanib) is a prescription medication used to treat a rare type of thyroid cancer in adults. Caprelsa belongs to a group of drugs called tyrosine kinase inhibitors. It works by blocking actions of a certain protein that signals cancer cells to multiply, which slows or stops the spread of cancer cells.
This medication comes in tablet form and is taken once a day, with or without food.
Common side effects of Caprelsa include diarrhea, rash, acne, and nausea. Caprelsa can cause blurred vision, drowsiness, and sensitivity to the sun. Do not drive or use machinery until you know how Caprelsa will affect you.
Caprelsa is a prescription medicine used to treat a certain type of thyroid cancer known as medullary thryroid cancer, that cannot be removed by surgery, or that has spread to other parts of the body.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Caprelsa may cause serious side effects, including:
- See "Drug Precautions"
- 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
- Blisters on your skin
- Blisters or sores in your mouth
- Peeling of your skin
- 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 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 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:
- changes in vision
- problems thinking
The most common side effects of Caprelsa include:
- high blood pressure
- feeling tired
- loss of appetite
- stomach (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. For more information, ask your healthcare provider or pharmacist.
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.
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
- dexamethasone (Decadron)
- phenytoin (Dilantin, Phenytek)
- carbamazepine (Tegretol, Carbatrol, Equetro)
- rifampin (Rifadin)
- rifabutin (Mycobutin)
- rifapentin (Priftin)
- phenobarbital (Luminal)
Ask your healthcare provider if you are not sure if your medicine is one listed above.
This is not a complete list of Caprelsa drug interactions. Ask your healthcare provider for more information.
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.
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.
Grapefruit and grapefruit juice may interact with Caprelsa and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
Before receiving Caprelsa, tell your healthcare provider about all of your medical conditions including if you have:
- heart problems, including a condition called congenital long QT syndrome
- irregular heartbeat
- low blood levels of potassium, calcium, or magnesium
- high blood levels of thyroid-stimulating hormone
- high blood pressure (hypertension)
- skin problems
- breathing problems
- recent history of coughing up blood or bleeding
- liver problems
- kidney problems
- seizures or are being treated for seizures
Tell your healthcare provider if you are pregnant or breastfeeding.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Tell your healthcare provider if you 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.
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 healthcare provider about birth control methods to prevent pregnancy while you are taking Caprelsa.
Tell your healthcare provider if you 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.
Caprelsa comes as a tablet to be taken by mouth with or without food. Swallow Caprelsa tablets whole. 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 take it as soon as you remember unless your next dose is in less than 12 hours. In that case, just skip the missed dose and take the next scheduled dose at the normal time.
If you cannot swallow Caprelsa tablets whole:
- Place your dose of Caprelsa in a glass that contains 2 ounces of plain 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, mix with an additional 4 ounces of plain water and swallow the mixture to make sure that you take your full dose of Caprelsa.
Take Caprelsa exactly as prescribed. Follow the directions on your prescription label carefully.
The recommended daily Caprelsa dose is 300 mg.
If you take too much Caprelsa, call your local Poison Control Center or seek emergency medical attention right away.
Caprela tablets are available in 100 mg and 300 mg strengths.
Active ingredient: vandetanib
Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, crospovidone, povidone, and magnesium stearate
Tablet coating:hypromellose 2910, macrogol 300, and titanium dioxide E171
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.
WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH
Caprelsa can prolong the QT interval. Torsades de pointes and sudden death have been reported in patients receiving Caprelsa. Caprelsa should not be used in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Hypocalcemia, hypokalemia and/or hypomagnesemia must be corrected prior to Caprelsa administration and should be periodically monitored. Drugs known to prolong the QT interval should be avoided. If a drug known to prolong the QT interval must be administered, more frequent ECG monitoring is recommended. Given the half-life of 19 days, ECGs should be obtained to monitor the QT at baseline, at 2-4 weeks and 8-12 weeks after starting treatment with Caprelsa and every 3 months thereafter. Following any dose reduction for QT prolongation, or any dose interruptions greater than 2 weeks, QT assessment should be conducted as described above. Because of the 19-day half-life, adverse reactions including a prolonged QT interval may not resolve quickly. Monitor appropriately. Only prescribers and pharmacies certified through the restricted distribution program are able to prescribe and dispense Caprelsa.