Caprelsa

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.

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, chloroquine, disopyramide, dofetilide, granisetron, haloperidol, methadone, moxifloxacin, 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, primidone), among others.

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), blood vessel problems (such as an aneurysm or a tear/break in the aorta or other blood vessels), recent surgery/injury.

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. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Get medical help right away if you get sunburned or have skin blisters/redness. 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).

This medication may cause wounds to heal slowly or poorly. Before having surgery, talk with your doctor about the risks and benefits of this medication. Your doctor may tell you to temporarily stop treatment with this medication at least 1 month before surgery. Ask your doctor for specific instructions about when to stop and when to restart treatment with vandetanib. Tell your doctor right away if you have wounds that are not healing well.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see also Warning section).

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.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using vandetanib. Vandetanib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 4 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 4 months after the last dose. Consult your doctor before breastfeeding.

Vandetanib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause 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.

To receive this medication in the United States, you must understand, agree to, and carefully follow the requirements of the Calprelsa REMS Program. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

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. Take your next dose at the regular time. Do not double the dose to catch up.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. 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.

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.

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 last or get worse, tell your doctor or pharmacist promptly. If you have diarrhea or vomiting that is severe or doesn't stop, 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 this medication has been prescribed because your doctor 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. Get medical help right away if you develop any rash.

Tell your doctor right away if you have any serious side effects, including: redness/pain/swelling of the palms of the hands or soles of the feet, depression, slow wound healing, signs of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), signs of an underactive thyroid (such as weight gain, cold intolerance, slow heartbeat, constipation, unusual tiredness), signs of kidney problems (such as change in the amount of urine).

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

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, trouble speaking, sudden vision changes, confusion), sudden/severe pain in the stomach/chest/back.

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 or at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

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