Vandetanib Oral tablet

What is this medicine?

VANDETANIB (van DET a nib) is a medicine for certain types of thyroid cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding disorders

• diarrhea

• heart disease

• high blood pressure

• high levels of thyroid-stimulating hormone (TSH) in the blood

• history of irregular heartbeat

• history of low levels of calcium, magnesium, or potassium in the blood

• kidney disease

• liver disease

• lung or breathing disease, like asthma

• seizures

• skin conditions or sensitivity

• an unusual or allergic reaction to vandetanib, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• arsenic trioxide

• certain antibiotics like ciprofloxacin, levofloxacin, moxifloxacin

• certain antipsychotics like haloperidol, pimozide, sertindole, thioridazine, ziprasidone

• certain medicines for irregular heart beat like amiodarone, disopyramide, dofetilide, ibutilide, procainamide, propafenone, quinidine, sotalol

• certain medicines for nausea like chlorpromazine, droperidol

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• certain medicines used to treat infections like chloroquine, clarithromycin, erythromycin, pentamidine

• dexamethasone

• dolasetron

• granisetron

• methadone

• rifampin

• rifabutin

• rifapentine

• St. John's wort, Hypericum perforatum

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional right away if you have any change in your eyesight.

You may need blood work done while you are taking this medicine. If you get diarrhea, call your doctor. You may need to have your blood work checked.

Your doctor will monitor your heart while your are taking this medicine. Be sure to keep your appointments.

This medicine can make you more sensitive to the sun. Keep out of the sun while taking this medicine and for 4 months after stopping it. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you.

Do not become pregnant while taking this medicine. Women should use effective birth control while taking this medicine and for 4 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• bloody or black, tarry stools

• breathing problems

• changes in vision

• chest pain or palpitations

• confusion, trouble speaking or understanding

• cough

• diarrhea

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• fever, chills, or sore throat

• high blood pressure

• light-colored stools

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• red or dark-brown urine

• red spots on the skin

• seizures

• severe headaches

• shakiness

• spitting up blood or brown material that looks like coffee grounds

• sudden numbness or weakness of the face, arm or legs

• swelling of the legs or ankles

• trouble walking, dizziness, loss of balance or coordination

• unusual bleeding or bruising

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• loss of appetite

• nausea

• stomach pain

• tiredness

• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.