Vandetanib

Vandetanib is used in adults to treat thyroid cancer.

Vandetanib is available only from a certified pharmacy under a special program.

Vandetanib may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Vandetanib is usually taken once per day, with or without food.

Swallow the tablet whole and do not crush or chew it. Take vandetanib with a full glass of water.

If you cannot swallow a tablet whole, place it into a glass with 2 ounces of plain water. Stir until the tablet is dispersed (it will not dissolve completely). Drink this mixture right away. Add 4 ounces more water to the glass, swirl gently and drink right away.

The dispersed tablet mixture can also be given through a nasogastric (NG) or gastronomy feeding tube. Follow your doctor's instructions.

You will need blood tests and an electrocardiograph or ECG (sometimes called an EKG) every 2 weeks to 3 months. Your dose or medication schedule may be changed based on the results.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop taking vandetanib for at least 1 month before having surgery. Follow your doctor's instructions about when to start taking the medicine again.

Do not stop taking vandetanib unless your doctor tells you to. If you stop for longer than 2 weeks for any reason, do not start taking vandetanib again without asking your doctor. You may need an ECG before you start taking the medicine again.

Store at room temperature away from moisture and heat.

Vandetanib can lead to a serious heart issue, particularly if you are taking certain other medicines or have specific health conditions. You should not take vandetanib if you have long QT syndrome. Inform your doctor about all the medicines you are currently using.

You will need medical tests every 2 weeks to 3 months.

Contact your doctor immediately if you experience fast or pounding heartbeats, fluttering in your chest, shortness of breath, or sudden dizziness.

You should not use vandetanib if you are allergic to it, or if you have:

• long QT syndrome.

Tell your doctor if you have ever had:

• a heart rhythm disorder (in you or a family member);
• other heart problems, or high blood pressure;
• low blood levels of calcium, magnesium, or potassium;
• abnormal thyroid function tests;
• a seizure;
• breathing problems, cough with bloody mucus;
• liver or kidney disease;
• skin problems; or
• severe diarrhea.

You may need to have a negative pregnancy test before starting this treatment.

Do not use vandetanib if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 4 months after your last dose. Tell your doctor right away if you become pregnant.

Do not breastfeed while using this medicine, and for at least 4 months after your last dose.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

You may need to stop taking vandetanib permanently if you have a severe skin reaction.

Vandetanib may cause serious side effects. Call your doctor right away if you have:

• fast or pounding heartbeats, fluttering in your chest, sudden dizziness (like you might faint);
• wheezing, dry cough, feeling short of breath;
• any wound that won’t heal;
• severe or ongoing diarrhea;
• unusual bruising or bleeding;
• cough with bloody mucus, vomit that looks like coffee grounds;
• swelling, rapid weight gain;
• headache, confusion, change in mental status, seizure;
• thyroid symptoms—extreme tiredness, dry skin, joint pain or stiffness, muscle pain or weakness, hoarse voice, feeling more sensitive to cold temperatures, weight gain; or
• high blood pressure—severe headache, pounding in your neck or ears, anxiety, irregular heartbeats.

Stop using vandetanib and call your doctor right away if you have signs of a stroke:

• sudden numbness or weakness (especially on one side of the body);
• confusion, trouble speaking or understanding what is said to you;
• sudden severe headache; or
• problems with vision or balance.

Common side effects of vandetanib may include:

• high blood pressure;
• diarrhea, stomach pain, nausea, loss of appetite;
• headache, tiredness;
• acne, skin rash; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Thyroid Cancer:

Initial dose: 300 mg orally once daily. Duration of therapy: Continue drug until disease progression or unacceptable toxicity occurs. Use: For the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or doing anything dangerous until you know how vandetanib will affect you. Your reactions might be impaired.

Avoid taking an herbal supplement that contains St. John's wort while you are taking vandetanib.

Avoid exposure to sunlight or tanning beds. Vandetanib can make you more likely to get sunburned for up to 4 months after you stop taking the medicine. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outside.

Vandetanib can cause a serious heart problem. Your risk may be higher if you also take certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect vandetanib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Inform your doctor about all your current medicines and any medicine you start or stop using.