Find Ireland: sunitinib malate

soo-NI-ti-nib MAL-ate

Oral route(Capsule)

Hepatotoxicity has been observed in clinical trials and postmarketing experience. This hepatotoxicity may be severe, and deaths have been reported .

Commonly used brand name(s)

In the U.S.

Sutent

Available Dosage Forms:

Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Sunitinib

Uses For sunitinib malate

Sunitinib belongs to the group of medicines known as antineoplastics. It is used to treat a gastrointestinal stromal tumor (GIST) after a medicine called 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, intestines, or rectum. Sunitinib is also used to treat advanced (late-stage) kidney cancer.

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 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 and your doctor should talk about the benefits sunitinib malate will do as well as the risks of using it.

sunitinib malate is available only with your doctor's prescription.

Before Using sunitinib malate

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 sunitinib malate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sunitinib malate 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 sunitinib 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 sunitinib 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.

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.

Interactions with 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 sunitinib malate, 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 sunitinib malate 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

Fluconazole

Mesoridazine

Pimozide

Posaconazole

Sparfloxacin

Thioridazine

Using sunitinib malate 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.

Alfuzosin

Amiodarone

Amitriptyline

Amoxapine

Apomorphine

Arsenic Trioxide

Asenapine

Astemizole

Atazanavir

Azithromycin

Boceprevir

Bretylium

Carbamazepine

Chloroquine

Chlorpromazine

Ciprofloxacin

Cisapride

Citalopram

Clarithromycin

Clomipramine

Clozapine

Conivaptan

Crizotinib

Dasatinib

Desipramine

Dexamethasone

Disopyramide

Dofetilide

Dolasetron

Droperidol

Erythromycin

Flecainide

Gatifloxacin

Gemifloxacin

Granisetron

Halofantrine

Haloperidol

Ibutilide

Iloperidone

Imipramine

Indinavir

Itraconazole

Ketoconazole

Lapatinib

Levofloxacin

Lopinavir

Lumefantrine

Mefloquine

Methadone

Mitotane

Moxifloxacin

Nefazodone

Nelfinavir

Nilotinib

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Ondansetron

Paliperidone

Pazopanib

Perflutren Lipid Microsphere

Phenobarbital

Phenytoin

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Ranolazine

Rifabutin

Rifampin

Rifapentine

Ritonavir

Salmeterol

Saquinavir

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

St John's Wort

Telavancin

Telithromycin

Terfenadine

Tetrabenazine

Toremifene

Trazodone

Trifluoperazine

Trimipramine

Vandetanib

Vardenafil

Vemurafenib

Voriconazole

Ziprasidone

Interactions with Food/Tobacco/Alcohol

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.

Proper Use of sunitinib malate

Your doctor will tell you how much of sunitinib malate 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 use more medicine or use it more often than your doctor tells you to.

You may take sunitinib malate with or without food. Do not open the capsules.

sunitinib malate comes with a Medication Guide and a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of sunitinib malate 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 sunitinib malate. 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 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 advanced pancreatic cancer or pancreatic neuroendocrine tumor (pNET):
  - Adults—37.5 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 50 mg per day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

sunitinib malate needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

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 sunitinib malate

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects.

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.

Using sunitinib malate while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Before you have any medical tests, tell the medical doctor in charge that you are using sunitinib malate. The results of some tests may be affected by sunitinib malate.

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.

Sunitinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.

Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.

Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.

Avoid contact sports or other situations where bruising or injury could occur.

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.

Check with your doctor right away if you are rapidly gaining weight or have shortness of breath; chest pain or discomfort; extreme tiredness or weakness; irregular breathing; uneven heartbeats; or excessive swelling of the hands, wrist, ankles, or feet. These may be symptoms of a heart problem.

sunitinib malate can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or dizziness. Call your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

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

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

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

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 (e.g., St. John's Wort) or vitamin supplements.

sunitinib malate 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

Bleeding gums

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

blurred vision

chest pain

chills

confusion

coughing up blood

cracked lips

decreased urination

decreased urine output

diarrhea

difficulty with breathing or swallowing

dilated neck veins

dizziness

dry mouth

extreme fatigue

fainting

fast, slow, or irregular heartbeat

fever

headache

increase in heart rate

increased menstrual flow or vaginal bleeding

irregular breathing

labored 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

shortness of breath

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

troubled breathing

unusual tiredness or weakness

unusual weight gain or loss

wheezing

wrinkled skin

yellow eyes or skin

Less common

Constipation

depressed mood

dry skin and hair

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

sudden, unexplained shortness of breath

vision changes

vomiting

Rare

Back pain

chest discomfort

cloudy or bloody urine

convulsions

darkening of the skin

drowsiness

general feeling of tiredness or weakness

irregular or slow heart rate

light-colored stools

mental depression

skin rash

stomach pain, continuing

swelling of the face, feet, or lower legs

Incidence not known

Cough

dark-colored urine

decreased frequency or amount of urine

increased thirst

lower back or side pain

muscle cramps or spasms

muscular pain, tenderness, wasting, or weakness

painful or difficult urination

pale skin

sore throat

sudden, severe chest pain

unusual bleeding or bruising

weight gain

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

Abdominal or stomach pain

acid or sour stomach

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 intestines

feeling sad or empty

full feeling

hair color changes

hair loss or thinning of the hair

heartburn

irritability

joint pain

lack of appetite

lack or loss of strength

loss of interest or pleasure

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

sleeplessness

stomach discomfort, upset, or pain

swollen joints

trouble concentrating

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.

See also: sunitinib malate side effects (in more detail)

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More sunitinib malate resources

Sunitinib malate Side Effects (in more detail)
Sunitinib malate Dosage
Sunitinib malate Use in Pregnancy & Breastfeeding
Sunitinib malate Drug Interactions
Sunitinib malate Support Group
7 Reviews for Sunitinib malate - Add your own review/rating

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Wednesday, October 26, 2016

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