Vandetanib

Vandetanib may cause QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death). Tell your doctor if you or anyone in your family has or has ever had long QT syndrome (an inherited condition in which a person is more likely to have QT prolongation) or you have or have ever had low levels of calcium, potassium or magnesium in your blood, an irregular heartbeat, heart failure, or a heart attack. If you experience any of the following symptoms, stop taking vandetanib and call your doctor immediately or get emergency medical treatment: fast, pounding, or irregular heartbeat; fainting; lightheadedness; or loss of consciousness. Vandetanib may remain in your body for several months after you stop taking the medication, so you may continue to be at risk of side effects during that time.

Using some medications with vandetanib may increase the risk of QT prolongation. Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking vandetanib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests, such as blood tests and electrocardiograms (EKGs, tests that record the electrical activity of the heart) before and regularly during your treatment to be sure that it is safe for you to take vandetanib. Your doctor will also order these tests any time that your dose of vandetanib is changed or if you begin taking certain new medications.

A program called Caprelsa Risk Evaluation and Mitigation Strategy (REMS) has been set up to manage the risks of this medication. You will only be able to receive vandetanib if the doctor who prescribes your medication is enrolled in the program. You can only receive the medication from a pharmacy that participates in the program. Ask your doctor if you have any questions about participating in the program or how to get your medication.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

Talk to your doctor about the risks of taking vandetanib.

Vandetanib is used to treat a certain type of thyroid cancer. Vandetanib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Vandetanib comes as a tablet to take by mouth. Take with or without food once a day. Take vandetanib at around the same time every day. The length of your treatment depends on how well your body responds to the medication and the side effects that you experience.

Take vandetanib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole with a glass of water. Do not split, chew, or crush them. If a tablet is accidentally crushed, avoid contact with your skin. If any contact occurs, wash the affected area well with water.

If you are unable to swallow the tablets whole, you may dissolve them in water. Place the tablet in a glass that contains 2 ounces of plain, non-carbonated drinking water. Do not use any other liquid to dissolve the tablet. Stir the mixture for about 10 minutes until the tablet is in very small pieces; the tablet will not dissolve completely. Drink the mixture right away. Rinse the glass with another 4 ounces of non-carbonated water and drink the rinse water to be sure that you swallow all of the medication.

Your doctor may decrease your dose of vandetanib or tell you to stop taking vandetanib for a period of time during your treatment. This depends on how well the medication works for you and the side effects you experience. Talk to your doctor about how you are feeling during your treatment. Continue to take vandetanib even if you feel well. Do not stop taking vandetanib without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking vandetanib,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• the following herbal product may interact with vandetanib: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking vandetanib. Do not start this medication while taking vandetanib without discussing with your healthcare provider.
• tell your doctor if you have recently coughed up blood or had any other type of bleeding problems and if you have or have ever had high blood pressure; any type of skin problem; seizures; osteoporosis (a condition in which bones become thin and weak and break easily); jaw problems; or thyroid, lung, kidney, or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant or plan to father a child. You may need to take a pregnancy test before starting treatment. You should use birth control to prevent pregnancy while you are taking vandetanib and for at least 4 months after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you or your partner becomes pregnant while taking vandetanib, call your doctor immediately. Vandetanib may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed during your treatment with vandetanib and for at least 4 months after your final dose.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking vandetanib. If you are scheduled to have surgery, your doctor will tell you to stop taking vandetanib at least 1 month before the surgery. If you have recently had surgery, your doctor will tell you when you can start taking vandetanib again (usually at least 14 days after surgery).
• you should know that vandetanib may make you feel drowsy, weak, or cause blurred vision. Do not drive a car or operate machinery until you know how this medication affects you.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Vandetanib may make your skin sensitive to sunlight during your treatment and for at least 4 months after stopping your treatment.
• you should know that vandetanib may cause osteonecrosis of the jaw (ONJ, a serious condition of the jawbone), especially if you have dental surgery or treatment while you are taking the medication. A dentist should examine your teeth and perform any needed treatments, including cleaning or fixing ill-fitted dentures, before you start to take vandetanib. Be sure to brush your teeth and clean your mouth properly while you are taking vandetanib. Talk to your doctor before having any dental treatments while you are taking this medication.

Unless your doctor tells you otherwise, continue your normal diet.

If your next dose is due in 12 hours or more, take the missed dose as soon as you remember it. However, if the next dose will be taken in less than 12 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Vandetanib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• heartburn
• loss of appetite
• stomach pain
• runny nose, congestion, or sore throat
• unusual tiredness or weakness
• depression
• nail problems or changes
• hair loss
• change in sense of taste

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• diarrhea
• rash; acne; dry, peeling, itchy skin; blisters or sores on the skin or in the mouth; redness of the face, hands, or soles of the feet; fever; or muscle or joint aches
• chest pain (which may get worse with deep breaths or cough), cough, shortness of breath, or fever
• swelling of the hands, feet, ankles, or lower legs; shortness of breath; or sudden weight gain
• 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, or loss of balance or coordination; or sudden severe headache
• seizures; headaches; confusion; problems thinking; or vision changes
• unusual bruising or bleeding
• painful or swollen gums, jaw pain, or loose teeth

Vandetanib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• fast, pounding, or irregular heartbeat
• fainting
• lightheadedness
• loss of consciousness

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to vandetanib. Your doctor will also check your blood pressure regularly during your treatment with vandetanib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Caprelsa^®