Pronunciation:

soo-NI-ti-nib MAL-ate

Brand Names:

• Sutent
• Auro-SUNItinib
• Taro-SUNItinib

Dosage Forms:

• Capsule

Warnings:

Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue sunitinib malate as recommended .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Sunitinib

Uses of This Medicine:

Sunitinib is used to treat a gastrointestinal stromal tumor (GIST) after other medicines (eg, imatinib) did not work very well. It may also be used when patients are not able to take imatinib. GIST is a group of cancer cells that start growing in the wall of the stomach, bowels, or rectum. Sunitinib is also used to treat advanced (late-stage) kidney cancer and as additional treatment in patients at high risk for kidney cancer after surgical removal of the kidney.

Sunitinib is also used to treat a type of pancreatic cancer called pancreatic neuroendocrine tumor (pNET), that cannot be surgically removed and is locally advanced or metastatic (cancer that has spread).

Sunitinib belongs to the group of medicines known as antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by sunitinib, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with sunitinib, you should talk to your doctor about the benefits as well as the risks of using this medicine.

This medicine is available only with your doctor's prescription.

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 sunitinib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sunitinib 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
• Colchicine
• Dronedarone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Mesoridazine
• Nelfinavir
• Pimozide
• Piperaquine
• Posaconazole
• 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.

• Abametapir
• Adagrasib
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apalutamide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Boceprevir
• Bretylium
• Buprenorphine
• Buserelin
• Carbamazepine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexamethasone
• Dexlansoprazole
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Esomeprazole
• Famotidine
• Fedratinib
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Lansoprazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lopinavir
• Lumacaftor
• Lumefantrine
• Macimorelin
• Mavacamten
• Mefloquine
• Methadone
• Methotrexate
• Methotrimeprazine
• Metronidazole
• Mifepristone
• Mirtazapine
• Mitotane
• Mizolastine
• Mobocertinib
• Momelotinib
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nefazodone
• Netupitant
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Omaveloxolone
• Omeprazole
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Pantoprazole
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Pexidartinib
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pipamperone
• Pitolisant
• Ponesimod
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Rabeprazole
• Ranolazine
• Relugolix
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Risperidone
• Ritonavir
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sulpiride
• Sultopride
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zotepine
• 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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
• Bradycardia (very slow heart beat), history of or
• Congestive heart failure, history of or
• Diabetes or
• Heart attack, recent or
• Heart disease (eg, cardiomyopathy, myocardial ischemia, history of or
• Heart rhythm problems (eg, QT prolongation), history of or
• Hypertension (high blood pressure) or
• Kidney disease (other than cancer) or
• Liver disease or
• Proteinuria (protein in the urine) or
• Seizures or
• Stomach problems (eg, perforation, ulcers) or
• Thyroid problems—Use with caution. May make these conditions worse.

• Dental or tooth problems or
• Dental procedures or
• Dental surgery—May increase risk for severe jaw problems.

• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood)—May cause side effects to become worse.

• Infection, severe or
• Surgery or
• Trauma—These conditions may cause adrenal gland problems.

Proper Use of This Medicine:

Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not take more medicine, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food. Do not open the capsules.

Grapefruit and grapefruit juice may cause you to have too much of this medicine in the blood. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine.

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 (capsules):
  • For the treatment of advanced pancreatic cancer or pancreatic neuroendocrine tumor (pNET):
    • Adults—37.5 milligrams (mg) once a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 50 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For the treatment of GIST and kidney cancer:
    • Adults—50 milligrams (mg) once a day for 4 weeks. This is followed by 2 weeks without medicine. Your doctor may tell you to repeat this cycle.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of kidney cancer after surgical removal of kidney:
    • Adults—50 milligrams (mg) once a day for 4 weeks. This is followed by 2 weeks without medicine for nine 6-week cycles. 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 and it is less than 12 hours from your regular time, take it as soon as possible. If you miss a dose and it is more than 12 hours, skip the missed dose and take your next dose at the regular time.

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 see if the medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting sunitinib treatment. Female patients should use an effective form of birth control during treatment with this medicine and for 4 weeks after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for 7 weeks after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

Cancer medicines can cause nausea or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious heart problems (eg, heart attack, heart failure, cardiomyopathy). Tell your doctor if you have chest pain, decreased urine output, dilated neck veins, dizziness, faintness, irregular breathing, irregular heartbeat, nausea, pain or discomfort in arms, jaw, back or neck, sweating, swelling of face, fingers, feet, or lower legs, tightness in the chest, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

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.

This medicine may also increase your risk of bleeding and cause delay in wound healing. Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.

It is important that you check with your doctor before having any dental procedures or surgeries done, or are receiving bisphosphonates (eg, alendronate, ibandronate, risedronate, Actonel®, Boniva®, Fosamax®, Zometa®) while you are using sunitinib. Tell your doctor right away if you have jaw tightness, swelling, numbing, or pain or a loose tooth. This could be symptoms of a severe jaw problem.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you medicine to help prevent this. Call your doctor right away if you have a decrease or change in the amount of urine, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Thrombotic microangiopathy (damage in the smallest blood vessels) may occur while you are using this medicine. Tell your doctor right away if you have a fever, tiredness, confusion, loss of vision, or seizures.

Serious skin reactions, including erythema multiforme (EM), Stevens-Johnson syndrome (SJS), necrotizing fasciitis, and toxic epidermal necrolysis (TEN) can occur with this medicine. 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, red irritated eyes, unusual tiredness and weakness, or fever or chills while you are using this medicine.

Check with your doctor right away if you have back pain, blurred vision, confusion, dizziness, drowsiness, fever, headache, seizures, or unusual tiredness or weakness. These may be symptoms of a rare and serious brain condition called reversible posterior leukoencephalopathy syndrome (RPLS).

This medicine may cause thyroid problems (eg, hyperthyroidism or hypothyroidism). Tell your doctor if you have nervousness, sensitivity to heat, sweating, trouble sleeping, weight loss, constipation, depressed mood, dry skin and hair, feeling cold, hair loss, hoarseness or husky voice, muscle cramps and stiffness, slowed heartbeat, weight gain, unusual tiredness or weakness.

This medicine may cause hypoglycemia (low blood sugar). Tell your doctor right away if you notice changes in your blood sugar or you have shaking, trembling, sweating, fast or pounding heartbeat, faintness or lightheadedness, hunger, or confusion.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

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 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

bloating or swelling of the face, arms, hands, fingers, lower legs, or feet

blurred vision

chest pain

chills

confusion

constipation

coughing up blood

cracked lips

decreased urine output and frequency

diarrhea

difficulty swallowing

dilated neck veins

dizziness

dry mouth

fainting

fast, slow, or irregular heartbeat

fever

headache

increased menstrual flow or vaginal bleeding

irregular breathing

lightheadedness

nervousness

nosebleeds

paralysis

pounding in the ears

prolonged bleeding from cuts

rapid breathing

rapid weight gain

red or black, tarry stools

red or dark brown urine

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

sunken eyes

swelling or inflammation of the mouth

thirst

tightness in the chest

tingling of the hands or feet

trouble breathing

unusual tiredness or weakness

unusual weight gain or loss

wrinkled skin

yellow eyes or skin

Less common

Bleeding from the rectum

bleeding from wounds

depressed mood

dry skin and hair

excessive sweating

feeling cold

hair loss

hoarseness or husky voice

indigestion

loss of appetite

muscle cramps and stiffness

nausea

pain in the chest, groin, or legs, especially the calves

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

severe, sudden headache

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

vision changes

vomiting

vomiting of blood or material that looks like coffee grounds

Rare

Back pain

chest discomfort

cloudy or bloody urine

darkening of the skin

drowsiness

general feeling of tiredness or weakness

light-colored stools

mental depression

seizures

skin rash

stomach pain, continuing

Incidence not known

Blistering, peeling, or loosening of the skin

cough

dark-colored urine

heavy feeling of the jaw

increased thirst

itching

joint pain, stiffness, or swelling

loosening of a tooth

lower back or side pain

muscle cramps or spasms

muscular pain, tenderness, wasting, or weakness

pain, swelling, or numbness in the mouth or jaw

painful or difficult urination

pale skin

red skin lesions, often with a purple center

sores, ulcers, or white spots on lips or tongue or inside the mouth

sore throat

sudden, severe chest pain

unusual bleeding or bruising

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

blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet

change in color of the treated skin

change in taste

difficulty with moving

discouragement

excess air or gas in the stomach or bowels

feeling of fullness

feeling sad or empty

hair color changes

hair loss or thinning of the hair

heartburn

irritability

lack or loss of strength

loss of interest or pleasure

loss of taste

muscle aches or pains

numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet

pain or burning in the throat

passing gas

stomach discomfort or upset

swelling or inflammation of the mouth

swollen joints

trouble concentrating

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.