Vandetanib (By mouth)

Introduction

Vandetanib (van-DET-a-nib)

Treats medullary thyroid cancer that cannot be treated with surgery or that has already spread to different parts of the body.

Brand Name(s)

Caprelsa

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• 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.
• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• Swallow the tablets whole. Do not break, crush, or chew it.
• If you have trouble swallowing the tablets:
  • Dissolve the tablet in a glass containing 2 ounces of non-carbonated water. Do not use any other liquid.
  • Stir the mixture for 10 minutes and swallow it right away.
  • Rinse the glass with an additional 4 ounces of non-carbonated 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 tubes.
• Be careful not to handle crushed or broken tablets. If you have contact with broken or crushed tablets, wash your hands or skin with soap and water immediately.
• This medicine is available only under a registered distribution program called Vandetanib REMS (Risk Evaluation and Mitigation Strategy) Program. You will be asked to sign an agreement form before you take this medicine. This form tells you about the benefits and risks of using this medicine. Make sure you understand what is on the form before you sign it.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use it, and it is less than 12 hours since your last dose, take it as soon as you can and take your next dose at the normal time. If you miss a dose and it is more than 12 hours since your last dose, wait and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you are also using St. John's wort, dexamethasone (Decadron®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rimactane®), rifapentine (Priftin®), heart rhythm medicine (such as amiodarone, disopyramide, dofetilide, procainamide, sotalol, Betapace®, Cordarone®, Norpace®, Procanbid®, or Tikosyn®), or medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, Luminal®, or Tegretol®).
• Tell your doctor if you are also using arsenic trioxide (Trisenox®), cisapride (Propulsid®), chloroquine (Aralen®), methadone (Dolophine®), medicine for depression (such as amitriptyline, fluoxetine, nortriptyline, Elavil®, Pamelor®, Prozac®, Sarafem®, or Vivactil®), certain antibiotics (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, sparfloxacin, Avelox®, Biaxin®, Levaquin®, or Zagam®), medicine to treat nausea or vomiting (such as dolasetron, granisetron, Anzemet®, or Kytril®), or medicine to treat mental illness (such as haloperidol, mesoridazine, pimozide, prochlorperazine, quetiapine, thioridazine, ziprasidone, Compazine®, Geodon®, Haldol®, Mellaril®, Orap®, Serentil®, or Seroquel®).

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. In addition, use effective birth control for at least 4 months after stopping treatment.
• Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, liver disease, blood vessel disease, heart failure, heart rhythm problems (such as QT prolongation), high blood pressure, seizures, a history of stroke, or mineral imbalance (such as low potassium, magnesium, calcium in the blood). Tell your doctor if you have bleeding problems, lung disease or breathing problems, an underactive thyroid, or a recent history of coughing up blood.
• This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.
• Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.
• This medicine may cause a serious skin problem called hand-foot syndrome. Check with your doctor right away if you have a skin rash or any redness, pain, swelling, or blisters on the palms of your hands or the soles of your feet. If you get this skin problem, your doctor may adjust the dose or stop treatment for a short time.
• This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. Use sunscreen and protective clothing while you are using this medicine and for 4 months after the last dose.
• Call your doctor right away if you have unexplained shortness of breath, cough, and fever that comes on suddenly.
• Stop using this medicine and call your doctor right away if you have confusion, difficulty in speaking, slow speech, inability to speak, inability to move arms, legs, or facial muscles, double vision, or headache. These may be symptoms of a stroke.
• This medicine may increase your chance of bleeding. Tell your doctor right away if you have bleeding gums, coughing up blood, difficulty in breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, nosebleeds, prolonged bleeding from cuts, red or dark brown urine, red or black, tarry stools, or shortness of breath. To help with this problem, stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• If you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.
• This medicine may cause diarrhea. This may also increase your risk of having an electrolyte imbalance (e.g., low potassium, magnesium, or calcium in the blood). Tell your doctor right away if you start having muscle cramps or twitching, mood or mental changes, or unusual tiredness or weakness while being treated with this medicine.
• Stop using this medicine and check with your doctor if you have headache, seizures, confusion, blurred vision or other visual problems. These may be symptoms of a rare and serious condition called reversible posterior leukoencephalopathy syndrome (RPLS).
• Check with your doctor immediately if blurred vision, difficulty in reading, any other change in vision, or eye pain or irritation occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
• This medicine may cause blurred vision. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert or not able to see well.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may also be needed to check for unwanted effects.

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.
• Blurred vision or changes in vision.
• Cloudy urine.
• Confusion, or trouble with thinking.
• Dry mouth, increased thirst, or muscle cramps.
• Fast, pounding, or uneven heartbeat.
• Numbness or weakness in your face, arm, or leg, or on one side of your body.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Red or black, tarry stools.
• Red or dark brown urine.
• Redness, pain, swelling, or blisters on the palms of your hands or the soles of your feet.
• Seizures or tremors.
• Severe diarrhea.
• Sudden or severe headache, or problems with vision, speech, or walking.
• Swelling in your hands, ankles, or feet.
• Unexplained nosebleeds.
• Unexplained shortness of breath, cough, and fever.
• Unusual tiredness or weakness.

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

• Acne, dry skin, or severe sunburn.
• Depression.
• Headache, trouble sleeping.
• Mild diarrhea, nausea, vomiting, decreased appetite, stomach pain, or upset stomach.
• Mild rash or itching skin.
• Stuffy or runny nose.
• Tiredness.
• Weight changes.

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