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Vandetanib

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Abdominal or stomach cramps
  • Bleeding gums
  • Blurred vision
  • Chest pain
  • Cloudy urine
  • Confusion
  • Convulsions
  • Cough
  • Coughing up blood
  • Difficulty with breathing or swallowing
  • Dizziness
  • Fainting
  • Fever or chills
  • Headache
  • Increased menstrual flow or vaginal bleeding
  • Irregular heartbeat recurrent
  • Mood or mental changes
  • Muscle cramps in the hands, arms, feet, legs, or face
  • Nervousness
  • Nosebleeds
  • Numbness and tingling around the mouth, fingertips, or feet
  • Paralysis
  • Pounding in the ears
  • Prolonged bleeding from cuts
  • Red or black, tarry stools
  • Red or dark brown urine
  • Shortness of breath
  • Sneezing
  • Sore throat
  • Tightness in the chest
  • Tremor
  • Troubled breathing
  • Wheezing

Less common

  • Blue lips, fingernails, or skin
  • Chest pain or discomfort
  • Dilated neck veins
  • Extreme fatigue
  • Foreign substance into the lungs
  • Infection from breathing
  • Irregular breathing
  • Irregular heartbeat
  • Irregular, fast or slow, or shallow breathing
  • Lightheadedness
  • No breathing
  • Swelling of the face, fingers, feet, or lower legs
  • Weight gain

Rare

  • Bloating
  • Constipation
  • Darkened urine
  • Decreased urine output
  • Indigestion
  • Loss of appetite
  • Nausea
  • Pains in the stomach, side, or abdomen, possibly radiating to the back
  • Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Acid or sour stomach
  • Belching
  • Blemishes on the skin
  • Blindness
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • Cracked, dry, or scaly skin
  • Cracks in the skin
  • Decreased appetite
  • Decreased vision
  • Decreased weight
  • Depression
  • Dry skin
  • Heartburn
  • Increased sensitivity of the skin to sunlight
  • Itching skin
  • Lack or loss of strength
  • Loss of heat from the body
  • Muscle aches
  • Pimples
  • Rash with flat lesions or small raised lesions on the skin
  • Red, swollen skin
  • Redness or other discoloration of the skin
  • Severe sunburn
  • Sleeplessness
  • Stomach discomfort, upset, or pain
  • Stuffy or runny nose
  • Swelling
  • Trouble sleeping
  • Unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Precautions

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood tests may also be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should continue to use birth control at least 4 months after you have stopped taking this medicine. However, if you think you have become pregnant while using the medicine, tell your doctor right away.

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.

Avoid overexposing your skin to sunlight. Always use sunscreen or sun blocking lotions and wear protective clothing and hats 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 the 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. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert or able to see well.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (St. John’s wort) or vitamin supplements.

Proper Use

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.

Take this medicine exactly as directed even if you feel well. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Swallow the tablet whole. Do not break, crush, or chew it. You may take the tablet with or without food.

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.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For the treatment of medullary thyroid cancer:
      • Adults—300 milligrams (mg) once a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of this medicine 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 or forget to use it, 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.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of vandetanib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vandetanib in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Dronedarone
  • Mesoridazine
  • Pimozide
  • Saquinavir
  • Sparfloxacin
  • Thioridazine
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amiodarone
  • Arsenic Trioxide
  • Asenapine
  • Carbamazepine
  • Cisapride
  • Citalopram
  • Clarithromycin
  • Crizotinib
  • Dexamethasone
  • Disopyramide
  • Dofetilide
  • Droperidol
  • Erythromycin
  • Flecainide
  • Fluconazole
  • Gatifloxacin
  • Halofantrine
  • Haloperidol
  • Ibutilide
  • Iloperidone
  • Levofloxacin
  • Lumefantrine
  • Methadone
  • Moxifloxacin
  • Nilotinib
  • Paliperidone
  • Pazopanib
  • Phenobarbital
  • Phenytoin
  • Quinidine
  • Ranolazine
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Sodium Phosphate
  • Sotalol
  • St John’s Wort
  • Sunitinib
  • Telithromycin
  • Tetrabenazine
  • Vemurafenib
  • Voriconazole

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems or
  • Blood vessel problems or
  • Diarrhea or
  • Heart failure or
  • Hypertension (high blood pressure) or
  • Hypothyroidism (an underactive thyroid) or
  • Lung disease or breathing problems (e.g., interstitial lung disease, pneumonitis) or
  • Seizures or
  • Stroke, history of—Use with caution. May make these conditions worse.
  • Bradyarrhythmia (abnormally slow heartbeat) or
  • Congenital long QT syndrome, or history of or
  • Heart failure, uncompensated or
  • Hemoptysis (spitting or coughing up of blood), recent history of or
  • Torsade de pointes, history of—Should not be used in patients with these conditions.
  • Hypocalcemia (low calcium in the blood) or
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood)—These conditions must be corrected first before using this medicine.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Liver disease—Use is not recommended. It is not known if this medicine will work in patients with this condition.

Description

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

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.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, vandetanib is used in certain patients with the following medical conditions:

  • Non-small cell lung cancer, locally advanced or metastatic (cancer that has already spread), after failure of first- or second-line cancer treatment (chemotherapy).