Generic Name: vandetanib (van-DET-a-nib)
Brand Name: Caprelsa
Caprelsa may cause serious and sometimes fatal irregular heartbeat (eg, QT prolongation). Sudden deaths have been reported in patients taking Caprelsa. It is thought that serious irregular heartbeat may have contributed to these sudden deaths. Do not take Caprelsa 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 Caprelsa 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.
Caprelsa can only be prescribed and dispensed through a special program. Make sure you understand all warnings and instructions for using Caprelsa. Ask your doctor or pharmacist if you have any questions about this program or the use of Caprelsa.
Caprelsa is used for:
Treating certain types of medullary thyroid cancer. It may also be used for other conditions as determined by your doctor.
Caprelsa is a kinase inhibitor. It works by preventing the growth of cancer cells.
Do NOT use Caprelsa if:
- you are allergic to any ingredient in Caprelsa
- 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.
Before using Caprelsa:
Some medical conditions may interact with Caprelsa. 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 Caprelsa. 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 Caprelsa. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Caprelsa
This may not be a complete list of all interactions that may occur. Ask your health care provider if Caprelsa 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 Caprelsa:
Use Caprelsa as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Caprelsa comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Caprelsa refilled.
- Take Caprelsa by mouth with or without food.
- Swallow Caprelsa whole. Do not break, crush, or chew before swallowing.
- If you cannot swallow Caprelsa 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 Caprelsa even if you feel well. Do not miss any doses.
- If you miss a dose of Caprelsa, 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 Caprelsa.
Important safety information:
- Caprelsa may cause tiredness, weakness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Caprelsa 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 Caprelsa without checking with your doctor.
- Tell your doctor or dentist that you take Caprelsa before you receive any medical or dental care, emergency care, or surgery.
- Serious and sometimes fatal bleeding problems have occurred with the use of Caprelsa. 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 Caprelsa. 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).
- Caprelsa 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 Caprelsa 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 Caprelsa. 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 Caprelsa 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 Caprelsa. 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 Caprelsa. 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 Caprelsa. Even if Caprelsa 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 Caprelsa 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 Caprelsa. 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: Caprelsa 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 Caprelsa while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Caprelsa.
Possible side effects of Caprelsa:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
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.
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 Caprelsa:
Store Caprelsa 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 Caprelsa out of the reach of children and away from pets.
- If you have any questions about Caprelsa, please talk with your doctor, pharmacist, or other health care provider.
- Caprelsa 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 Caprelsa 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 Caprelsa. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Caprelsa. 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 Caprelsa.
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.