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Caprelsa oral

Important Note

Warnings
Uses
Side Effects
Precautions
Interactions
Overdose
Caprelsa oral Warnings

Vandetanib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting). Get medical help right away if you have any of these symptoms.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions). Do not use vandetanib if you have a certain heart problem (long QT syndrome). Before using vandetanib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation/long QT syndrome), family history of certain heart problems (QT prolongation/long QT syndrome, sudden cardiac death).

Vandetanib should not be used in people with low levels of calcium, potassium, or magnesium in the blood. Low levels of these minerals may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting.

To lower your risk, your doctor will check your mineral levels with a blood test and your heart with a test (EKG) before and periodically during treatment. Low mineral levels should be corrected before you start treatment. If you develop QT prolongation, your doctor may stop treatment for a while and restart it at a lower dose, and check your EKG again.

Since vandetanib stays in your body for a long time, it may take a while for side effects such as QT prolongation to go away after you stop taking it. Discuss the risks and benefits of treatment with your doctor.

This medication is only available through a restricted program from certified prescribers and pharmacies called the Vandetanib REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Caprelsa oral Uses

This medication is used to treat thyroid cancer (medullary type) that cannot be removed by surgery or that has spread to other parts of the body. It works by slowing or stopping the growth of cancer cells. Vandetanib belongs to a class of drugs known as tyrosine kinase inhibitors.

How to use Caprelsa oral

Read the Medication Guide provided by your pharmacist before you start taking vandetanib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow this medication whole. If you cannot swallow the tablets whole, place your dose in a glass of non-carbonated water (2 ounces or 60 milliliters) and stir for about 10 minutes until the tablet has broken apart. Note that the tablet will not completely dissolve. Do not use other liquids. Swallow the mixture right away. Rinse the glass with 4 ounces (120 milliliters) of non-carbonated water, stir to mix, and then swallow.

Do not break or crush the tablets. Do not touch the dust or powder from this medication. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets. If contact occurs, wash the area thoroughly.

The dosage is based on your medical condition and response to treatment.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition worsens.

Caprelsa oral Side Effects

See also Warning section.

Nausea, decreased appetite, changes in taste, dry mouth, stomach pain, vomiting, diarrhea, headache, or blurred vision may occur. Nail problems (such as nail bed swelling/tenderness/infection) may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If you have persistent/severe diarrhea or vomiting, your doctor may need to check your blood mineral levels and adjust your vandetanib treatment.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Vandetanib can commonly cause a rash that is usually not serious. Mild to moderate skin reactions include acne, dry skin, or a mildly irritated/red/itchy rash. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, get medical help right away if you develop any rash.

Tell your doctor right away if you have any serious side effects, including: sunburn-like rash (sun sensitivity), redness/pain/swelling of the palms of the hands or soles of the feet, depression, signs of heart failure (such as swelling ankles/feet, trouble breathing, unusual tiredness), signs of an underactive thyroid (such as weight gain, cold intolerance, slow heartbeat, constipation, unusual tiredness).

Vandetanib may cause or worsen high blood pressure. There have been rare reports of serious attacks of extremely high blood pressure (hypertensive crisis). Check your blood pressure regularly and tell your doctor right away of high results or if you have an unusual, severe headache.

Vandetanib may cause a rare (possibly fatal) type of breathing problem (interstitial lung disease). Get medical help right away if you have sudden/worsening shortness of breath, cough, or fever.

Vandetanib may also rarely cause a serious brain condition. Get medical help right away if you develop headaches, seizures, vision changes, confusion, or problems thinking.

Get medical help right away if you have any serious side effects, including: signs of bleeding (such as bloody vomit, vomit that looks like coffee grounds, black/bloody stools), signs of a stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, blisters, peeling skin, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, fever, joint pain.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Caprelsa oral Precautions

See also Warning section.

Before taking vandetanib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, high blood pressure, recent bleeding (including recently coughing up blood).

This drug may cause blurred vision. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. Follow these instructions while taking vandetanib and for 4 months after stopping treatment.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Women of child-bearing age should avoid becoming pregnant during treatment and for at least 4 months after stopping treatment. Discuss the use of reliable forms of birth control for this time frame with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. However, because of the possible undesirable effects on a nursing infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Caprelsa oral Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Many drugs besides vandetanib may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, sotalol, macrolide antibiotics (such as clarithromycin), among others.

Other medications can affect the removal of vandetanib from your body, which may affect how vandetanib works. Examples include dexamethasone, St. John's wort, rifamycins (such as rifabutin, rifampin), drugs used to treat seizures (such as carbamazepine, phenytoin, phenobarbital), among others.

Caprelsa oral Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: rash, diarrhea, high blood pressure.

NOTES:

Do not share this medication with others.

Laboratory and/or medical tests (such as EKG, blood mineral levels including calcium/magnesium/potassium, thyroid function tests, blood pressure, eye exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE:

If you miss a dose, take it as soon as you remember if it is more than 12 hours before the next dose. If it is less than 12 hours before the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

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