Pronunciation:

van-DET-a-nib

Brand Names:

• Caprelsa

Dosage Forms:

• Tablet

Warnings:

Vandetanib can prolong the QT interval, and torsades de pointes and sudden death have been reported with its use. Do not use in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome; electrolyte depletion must be corrected prior to starting vandetanib and should be periodically monitored. Avoid drugs that are known to prolong the QT interval. Vandetanib is only available through a restricted distribution program (Vandetanib REMS) .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

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 a form before you use 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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of vandetanib in the elderly.

Breast-feeding—

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.

Other medicines—

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.

• Bepridil
• Cisapride
• Dronedarone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Mesoridazine
• Nelfinavir
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• 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.

• Adagrasib
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Buprenorphine
• Buserelin
• Carbamazepine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Digoxin
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Etrasimod
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lumefantrine
• Macimorelin
• Mefloquine
• Metformin
• Methadone
• Metronidazole
• Mifepristone
• Mirtazapine
• Mitotane
• Mizolastine
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Repotrectinib
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Risperidone
• Ritonavir
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zuclopenthixol

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
• Diarrhea or
• Heart failure or
• Hypertension (high blood pressure) or
• Hypothyroidism (an underactive thyroid) or
• Lung disease (eg, interstitial lung disease, pneumonitis)—Use with caution. May make these conditions worse.

• Heart rhythm problems (eg, bradyarrhythmia, congenital long QT syndrome, Torsades de pointes), or history of or
• Hemoptysis (spitting or coughing up blood), recent 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)—Use with caution. These conditions must be corrected first before using this medicine.

• Kidney disease, moderate or severe or
• Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, moderate or severe—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using 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 also take it with or without food.

If you have trouble swallowing the tablets:

• Dissolve the tablet in a glass containing 2 ounces of water. Do not use any other liquid.
• Stir the mixture for about 10 minutes. The tablet will normally not dissolve completely. Swallow it right away.
• Rinse the glass with an additional 4 ounces of 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 right away.

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 medullary thyroid cancer:
    • Adults—300 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
    • 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 within 12 hours since your regular time, 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 regular time, skip the missed dose 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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may also be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. 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 the 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. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause heart rhythm problems (eg, QT prolongation and torsades de pointes). Check with your doctor right away if you have chest pain or discomfort, fainting, irregular or slow heart rate, or trouble breathing.

Serious skin reactions (eg, Stevens-Johnson syndrome or toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red, irritated eyes, red skin lesions often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness while you are using this medicine.

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 chest pain, chills, cough, fever, general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing. These may be symptoms of a serious lung problem (eg, interstitial lung disease or pneumonitis).

Call your doctor right away if you have confusion, difficulty with speaking, slow speech, an inability to speak, an inability to move your arms, legs, or facial muscles, double vision, or a headache. These may be symptoms of a stroke.

This medicine may cause bleeding problems. 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, or red or black, tarry stools. 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.

Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain. These may be signs of a heart condition called congestive heart failure (CHF).

This medicine may cause diarrhea. This may also increase your risk of having an electrolyte imbalance (eg, 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 using this medicine.

This medicine may cause hypothyroidism (underactive thyroid gland). Check with your doctor right away if you have constipation, a depressed mood, dry skin and hair, feeling cold, hair loss, hoarseness or husky voice, muscle cramps and stiffness, a slow heartbeat, weight gain, or unusual tiredness or weakness.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

Check with your doctor if you have a headache, seizures, confusion, blurred vision or any other changes in vision. These may be symptoms of a rare and serious condition called reversible posterior leukoencephalopathy syndrome (RPLS).

This medicine may cause slow wound healing. Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using it for at least 1 month before and at least 2 weeks after having surgery.

This medicine may cause blurred vision, tiredness, or weakness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

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

Side Effects of This Medicine:

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

Bleeding gums

blindness

blistering, crusting, irritation, itching, or reddening of the skin

blurred vision

body aches or pain

chest pain or tightness

chills

cloudy urine

confusion

cough

coughing up blood

difficulty with breathing or swallowing

dizziness

ear congestion

fainting

fever

headache

increased menstrual flow or vaginal bleeding

increased sensitivity of the skin to sunlight

irregular heartbeat, recurrent

loss of voice

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

seizures

severe sunburn

slow or fast heartbeat

sneezing

sore throat

stomach cramps or pain

stuffy or runny nose

tenderness

tremor

trouble breathing

unusual tiredness or weakness, severe

watery or bloody diarrhea

Less common

Blue lips, fingernails, or skin

dilated neck veins

extreme tiredness or weakness

infection from breathing foreign substance into the lungs

irregular heartbeat

irregular, fast or slow, or shallow breathing

lightheadedness

swelling of the face, fingers, feet, or lower legs

weight gain

Rare

Bloating

constipation

decreased urine output

indigestion

loss of appetite

nausea

pains in the stomach, side, or abdomen, possibly radiating to the back

yellow eyes or skin

Incidence not known

General feeling of discomfort or illness

itching

joint or muscle pain

red, irritated eyes

red skin lesions, often with a purple center

sores, ulcers, or white spots in the mouth or on the lips

thickening of bronchial secretions

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

Belching

blemishes on the skin

change in or loss of taste

cracked, dry, or scaly skin

cracks in the skin

decreased weight

depression

discoloration of the fingernails or toenails

dry mouth or skin

hair loss or thinning of the hair

heartburn

lack or loss of strength

loosening of the fingernails

loss of heat from the body

muscle aches or spasms

pimples

rash with flat lesions or small raised lesions on the skin

redness or other discoloration of the skin

redness or soreness around the fingernails

stomach discomfort or upset

trouble sleeping

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.