Vandetanib (van-DET-a-nib)

Treats medullary thyroid cancer.

Brand Name(s):

Caprelsa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole with water. Do not break, crush, or chew it.
• If you have trouble swallowing the tablets:
  • Dissolve the tablet in a glass containing 2 ounces of water and stir for about 10 minutes. The tablet will normally not dissolve completely. Swallow the mixture right away. Do not use any other liquid.
  • Rinse the glass with an additional 4 ounces of water and swallow the mixture to make sure you get the full dose of this medicine.
  • This mixture may also be given through a nasogastric or gastrostomy tube.
• Do not handle tablets that are crushed or broken. Wash your hands or skin with soap and water right away if you touch crushed or broken tablets.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose and it is within 12 hours of your next regular dose, skip the missed dose and take your next dose when you normally do. If your next dose is more than 12 hours away, take it as soon as you remember and go back to you regular dosing schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how vandetanib works. Tell your doctor if you are using any of the following:
  • Chloroquine, clarithromycin, digoxin, dolasetron, granisetron, haloperidol, metformin, methadone, moxifloxacin, pimozide, rifampicin, St John's wort
  • Medicine for heart rhythm problems (including amiodarone, disopyramide, dofetilide, procainamide, sotalol)
  • Medicine to treat seizures

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 4 months after your last dose. Males who are taking this medicine, with female partners who can become pregnant, must use effective birth control during treatment and for at least 4 months after the last dose of this medicine.
• Do not breastfeed during treatment and for at least 4 months after the last dose.
• Tell your doctor if you have kidney disease, liver disease, bleeding problems, blood vessel disease, lung disease or breathing problems, underactive thyroid, heart failure, heart rhythm problems (including QT prolongation, a history of Torsade de pointes), high blood pressure, mineral imbalance, or a history of stroke or coughing up blood.
• This medicine may cause the following problems:
  • Heart rhythm problems, including QT prolongation and torsades de pointes
  • Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis
  • Lung or breathing problems
  • Stroke
  • Bleeding problems or slow wound healing
  • Heart failure
  • Thyroid problems, including hypothyroidism (underactive thyroid gland)
  • High blood pressure
  • Reversible posterior leukoencephalopathy syndrome (RPLS)
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may make you drowsy, tired, or cause blurred vision. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds. Protect your skin from the sun while you are using this medicine and for 4 months after the last dose.
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests. Do not use this medicine for at least 1 month before and at least 2 weeks after having surgery.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Fast, slow, pounding, or uneven heartbeat
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Headache, seizures, confusion
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Red or dark brown urine, bloody or black, tarry stools, severe diarrhea, unexplained nosebleeds
• Slow wound healing
• Trouble breathing, cold sweat, bluish-colored skin

If you notice these less serious side effects, talk with your doctor:

• Acne, dry skin, severe sunburn
• Change in or loss of taste, dry mouth, loss of appetite
• Hair loss
• Muscle spasm
• Nausea, vomiting, stomach pain or upset

If you notice other side effects that you think are caused by this medicine, tell your doctor

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