Sunitinib Capsules

What is this medication?

SUNITINIB (soo NI ti nib) treats some types of 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): Sutent

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

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

• Bleeding problems
• Dental, gum disease, or wear dentures
• Diabetes
• Having or recent surgery
• Heart disease
• High blood pressure
• History of irregular heartbeat or rhythm
• History of low levels of calcium, magnesium, or potassium in the blood
• Kidney disease
• Liver disease
• Thyroid disease
• An unusual or allergic reaction to sunitinib, other medications, foods, dyes, or preservatives
• 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. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

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:

• Dronedarone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Pimozide
• Posaconazole
• Saquinavir
• Thioridazine

This medication may also interact with the following:

• Certain antibiotics, such as clarithromycin, rifabutin, rifapentine, rifampin, telithromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infections, such as itraconazole, voriconazole
• Certain medications for irregular heart beat, such as amiodarone, encainide, flecainide, propafenone, quinidine
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Dexamethasone
• Dofetilide
• Grapefruit juice
• Nefazodone
• Other medications that cause heart rhythm changes
• St. John's wort

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?

Your condition will be monitored carefully while you are receiving this medication. You may need blood work while taking this medication.

Tell your dentist and dental surgeon that you are taking this medication. You should not have major dental surgery while on this medication or for 3 weeks before taking this medication. See your dentist to have a dental exam and fix any dental problems before starting this medication. Take good care of your teeth while on this medication. Make sure you see your dentist for regular follow-up appointments.

Before having surgery or dental work, 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 3 weeks 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 questions.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 4 weeks 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 weeks 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 mediation and for 7 weeks after the last dose.

Do not breastfeed while taking this medication and for 4 weeks 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
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• 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
• High thyroid levels (hyperthyroidism)—fast or irregular heartbeat, weight loss, excessive sweating or sensitivity to heat, tremors or shaking, anxiety, nervousness, irregular menstrual cycle or spotting
• Increase in blood pressure
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low blood sugar (hypoglycemia)—tremors or shaking, anxiety, sweating, cold or clammy skin, confusion, dizziness, rapid heartbeat
• Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression
• Osteonecrosis of the jaw—pain, swelling, or redness in the mouth, numbness of the jaw, poor healing after dental work, unusual discharge from the mouth, visible bones in the mouth
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stomach pain, bloody diarrhea, pale skin, unusual weakness or fatigue, decrease in the amount of urine, which may be signs of hemolytic uremic syndrome
• Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)
• TTP—purple spots on the skin or inside the mouth, pale skin, yellowing skin or eyes, unusual weakness or fatigue, fever, fast or irregular heartbeat, confusion, change in vision, trouble speaking, trouble walking
• Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain

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

• Change in taste
• Diarrhea
• Loss of appetite with weight loss
• Nausea
• Pain, redness, or swelling with sores inside the mouth or throat
• Stomach pain
• Unusual weakness or fatigue

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 medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.