Vandetanib

Generic Name: vandetanib (van-DET-a-nib)
Brand Name: Caprelsa

Vandetanib may cause serious and sometimes fatal irregular heartbeat (eg, QT prolongation). Sudden deaths have been reported in patients taking vandetanib. It is thought that serious irregular heartbeat may have contributed to these sudden deaths. Do not take vandetanib if you have low blood potassium, calcium, or magnesium levels. Do not take it if you have a history of QT prolongation or long QT syndrome. Tell your doctor or seek medical care at once if irregular heartbeat, light-headedness, or fainting occurs.

Do not take vandetanib if you are taking any medicines that may increase the risk of QT prolongation. There are many medicines that can do this. Tell your doctor about any other medicines or supplements you take. Ask your doctor or pharmacist if you are not sure if any of your medicines may increase this risk.

Electrocardiograms (ECGs) will be performed before and during treatment. These tests are used to check for irregular heartbeat. Lab tests including blood electrolytes may also be done. Be sure to keep all doctor and lab appointments.

Vandetanib can only be prescribed and dispensed through a special program. Make sure you understand all warnings and instructions for using vandetanib. Ask your doctor or pharmacist if you have any questions about this program or the use of vandetanib.


Vandetanib is used for:

Treating certain types of medullary thyroid cancer. It may also be used for other conditions as determined by your doctor.

Vandetanib is a kinase inhibitor. It works by preventing the growth of cancer cells.

Do NOT use vandetanib if:

  • you are allergic to any ingredient in vandetanib
  • you have a history of certain types of irregular heartbeat (eg, QT prolongation, long QT syndrome, torsades de pointes, very slow heartbeat)
  • you have low blood potassium, calcium, or magnesium levels; uncontrolled heart failure; moderate to severe liver problems; or active, severe bleeding
  • you have a recent history of coughing up blood
  • if you take an antiarrhythmic medicine (eg, amiodarone, disopyramide, dofetilide, procainamide, sotalol) or any other medicine that may increase the risk of a certain type or irregular heartbeat (prolonged QT interval) (eg, chloroquine, clarithromycin, dolasetron, granisetron, haloperidol, methadone, moxifloxacin, pimozide). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat.
  • you are taking rifampin or St. John's wort

Contact your doctor or health care provider right away if any of these apply to you.

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Before using vandetanib:

Some medical conditions may interact with vandetanib. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if a member of your family has a history of QT prolongation
  • if you have a history of heart problems (eg, congestive heart failure; fast, slow, or irregular heartbeat), a heart attack, stroke, liver or kidney problems, lung or breathing problems, bleeding problems, high blood pressure, abnormal blood electrolyte (eg, calcium, potassium, magnesium) levels, or coughing up blood
  • if you have an underactive thyroid or high blood levels of thyroid-stimulating hormone (TSH)
  • if you have a history of seizures or you are taking medicine for seizures
  • if you have skin problems, diarrhea, low white blood cell levels, or low blood platelet levels

Some MEDICINES MAY INTERACT with vandetanib. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for allergies, asthma or other lung or breathing problems, cancer, depression or other mental or mood problems, HIV infection, immune system suppression, infections, inflammation, irregular heartbeat or other heart problems, narcotic addiction, nausea and vomiting, pain, seizures, thyroid hormone replacement, Tourette disorder), multivitamin products, and herbal or dietary supplements (eg, St. John's wort) because they may interact with vandetanib. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with vandetanib

This may not be a complete list of all interactions that may occur. Ask your health care provider if vandetanib may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use vandetanib:

Use vandetanib as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Vandetanib comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get vandetanib refilled.
  • Take vandetanib by mouth with or without food.
  • Swallow vandetanib whole. Do not break, crush, or chew before swallowing.
  • If you cannot swallow vandetanib whole, place your dose in a glass containing 2 oz (60 mL) of noncarbonated water only. Stir the mixture for about 10 minutes until the medicine is in very small pieces (the tablets will not completely dissolve). Drink all of the mixture right away. Rinse the container with an additional 4 oz (120 mL) of noncarbonated water, and drink the contents to be sure that the entire dose is taken.
  • If a tablet is crushed, avoid contact with it. If a crushed tablet comes into contact with your skin or your eyes, nose, lips, or mouth, wash thoroughly with water.
  • Continue to take vandetanib even if you feel well. Do not miss any doses.
  • If you miss a dose of vandetanib, take it as soon as possible. If it is within 12 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use vandetanib.

Important safety information:

  • Vandetanib may cause tiredness, weakness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use vandetanib with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do NOT change your dose or stop taking vandetanib without checking with your doctor.
  • Tell your doctor or dentist that you take vandetanib before you receive any medical or dental care, emergency care, or surgery.
  • Serious and sometimes fatal bleeding problems have occurred with the use of vandetanib. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Strokes have occurred with the use of vandetanib. These have sometimes been fatal. Contact your doctor at once if you develop symptoms of a stroke (eg, one-sided weakness, trouble speaking or thinking, change in balance, or blurred eyesight).
  • Vandetanib may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths. Use a sunscreen and wear protective clothing if you must be outside for more than a short time while you take vandetanib and for at least 4 months after you stop taking it.
  • Serious and sometimes fatal rashes (eg, Stevens-Johnson syndrome) have occurred with the use of vandetanib. Contact your doctor at once if you develop a rash; red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes. Treatment with vandetanib should be stopped if rash occurs, unless it is clearly determined that the medicine did not cause the rash. Talk with your doctor for more information.
  • Severe and sometimes fatal lung problems (interstitial lung disease) have occurred with the use of vandetanib. Contact your doctor at once if you develop new or worsened breathing problems (eg, shortness of breath, trouble breathing).
  • A serious brain problem called reversible posterior leukoencephalopathy syndrome (RPLS) has occurred with the use of vandetanib. Contact your doctor at once if you develop symptoms like vision problems, confusion, trouble thinking, headache, or seizures. The risk may be greater if you have high blood pressure. Talk with your doctor for more information.
  • Serious and sometimes fatal heart failure has been reported in patients taking vandetanib. Even if vandetanib is stopped, this effect may not be reversible. Contact your doctor right away if you experience symptoms of heart failure, such as shortness of breath; sudden, unusual weight gain; or swelling of the hands, feet, or ankles.
  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. If you have diarrhea, you may need to take an antidiarrheal medicine. Contact your doctor for instructions.
  • Tell your doctor if you have a wound that does not heal.
  • Women who may become pregnant must use an effective form of birth control while taking vandetanib and for at least 4 months after stopping it. If you have questions about effective birth control, talk with your doctor.
  • Lab tests, including ECGs, thyroid function, blood pressure, and blood electrolyte levels, may be performed while you use vandetanib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: Vandetanib may cause harm to the fetus. Do not become pregnant while you are taking it or for at least 4 months after you stop taking it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking vandetanib while you are pregnant. It is not known if vandetanib is found in breast milk. Do not breast-feed while taking vandetanib.

Possible side effects of vandetanib:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; diarrhea; dry mouth or skin; hair loss; headache; loss of appetite; mild stomach pain or upset; nail changes; nausea; taste changes; tiredness; upper respiratory tract infection (eg, runny or stuffy nose, sneezing, sore throat); vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts or trouble thinking; blood in the urine; coughing up blood; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; joint aches; light-headedness; mental or mood changes (eg, depression); mouth sores or blisters; muscle aches, cramps, or spasms; numbness or tingling of the lips, tongue, fingers, or feet; severe or persistent cough; severe or persistent diarrhea, dizziness, headache, tiredness, or weakness; sluggishness; sudden coordination problems; sudden trouble walking or balancing; tingling, pain, redness, or swelling of the palms of the hands and soles of the feet; unusual bruising or bleeding; unusual tiredness; vision changes (eg, blurred vision); vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of vandetanib:

Store vandetanib at temperatures between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep vandetanib out of the reach of children and away from pets.

General information:

  • If you have any questions about vandetanib, please talk with your doctor, pharmacist, or other health care provider.
  • Vandetanib is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take vandetanib or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about vandetanib. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to vandetanib. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using vandetanib.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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