Caprelsa - Vandetanib Tablets

What is this medication?

VANDETANIB (van DET a nib) treats thyroid cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

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

COMMON BRAND NAME(S): Caprelsa

What should I tell my care team before I take this medication?

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

• Alcohol use
• Bleeding problems, coughing up blood
• Diarrhea
• Having or recent surgery
• Heart disease
• Heart failure
• High blood pressure
• High or low levels of electrolytes, such as magnesium, calcium, or potassium in your blood
• Irregular heartbeat or rhythm
• Kidney disease
• Liver disease
• Lung or breathing disease, such as asthma or COPD
• Seizures
• Slow heartbeat
• Thyroid disease
• An unusual or allergic reaction to vandetanib, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. If you cannot swallow the tablets whole, place your dose in a glass with 2 ounces of noncarbonated water. Stir for 10 minutes or until the tablets are in very small pieces. Drink the mixture right away. If there is residue in the glass, add 4 ounces of water, swirl, and drink that too. You can take this medication with or without food. If it upsets your stomach, take it with food. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

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 care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have 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 unless it is less than 12 hours before the next dose. If it is less than 12 hours before the next dose, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dengue vaccine
• Dronedarone
• Ketoconazole
• Levoketoconazole
• Pimozide
• Thioridazine
• Ziprasidone

This medication may also interact with the following:

• Certain antibiotics, such as clarithromycin or moxifloxacin
• Certain medications for irregular heartbeat, such as amiodarone, disopyramide, dofetilide, procainamide, sotalol
• Certain medications for nausea, such as dolasetron or granisetron
• Digoxin
• Haloperidol
• Metformin
• Methadone
• Other medications that cause heart rhythm changes
• St. John's wort

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

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 medication?

Visit your care team for regular checks on your progress. Report any side effects. Continue your course of treatment even though you have side effects unless your care team tells you to stop.

You may need blood work done before or while taking this medication. Your care team may also give you a test called an electrocardiogram (ECG) to check your heart before and during treatment.

Before having surgery, talk to your care team to make sure it is ok. This medication can increase the risk of poor healing of your surgical site or wound. You will need to stop this medication for 1 month before surgery. After surgery, wait at least 2 weeks before restarting this medication. Make sure the surgical site or wound is healed enough before restarting this medication. Talk to your care team if you have questions.

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

This medication may make you feel tired or give you blurred vision. Do not drive or operate machinery until you know how this medication affects you.

Talk to your care team if you or your partner may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 4 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 4 months after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 4 months after the last dose.

Do not breastfeed while taking this medication and for 4 months after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Dry cough, shortness of breath or trouble breathing
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Severe or prolonged diarrhea
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Acne
• Fatigue
• Loss of appetite
• Nausea
• Skin reactions on sun-exposed areas
• Stomach pain

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 medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of it safely.

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.