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Sutent 12.5 mg Capsule
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Sutent 12.5 mg Capsule

Manufactured byPFIZER LTD
ContainsSunitinib
Description

Sutent 12.5 mg Capsule is used to treat certain types of advanced or progressive tumors of the stomach, intestines, esophagus, pancreas, or kidneys. This medicine is not recommended for use in patients below 18 years of age.

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Side effectsConcernsUsage

Side effects

Major & minor side effects for Sutent 12.5 mg Capsule

  • Bleeding gums
  • Blurred vision
  • Thyroid imbalances
  • Loss of appetite
  • Dizziness
  • Dry mouth
  • Headache
  • Nosebleed
  • Difficulty in breathing
  • Cough
  • Nausea and Vomiting
  • Constipation or diarrhea
  • Unusual tiredness and weakness

Uses of Sutent 12.5 mg Capsule

What is it prescribed for?

  • Advanced Renal Cell Carcinoma (RCC)
  • Gastrointestinal stromal tumor
  • Pancreatic neuroendocrine tumours (pNET)
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Concerns

Commonly asked questions

  • How long does it take for this medicine to take effect?
    The peak effect of this medicine can be observed within 6-12 hours of the administration of the dose.
  • How long do the effects of this medicine last?
    The amount of time for which this medicine remains active in the body is not clinically established.
  • Is it safe to consume alcohol while taking this medicine?
    Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
  • Is this a habit forming medicine?
    No habit-forming tendencies were reported.
  • Can this medicine be taken during pregnancy?
    This medicine is not recommended for use in pregnant women unless necessary. The risks and benefits should be discussed with the doctor before taking this medicine.
  • Can this medicine be taken while breast-feeding?
    This medicine is not recommended for use in breastfeeding women. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may advise you to discontinue the drug or to discontinue breastfeeding based on your clinical condition

Allergy

This medicine is not recommended for use in patients with a known allergy to Sunitinib or any other inactive ingredients present along with it.
Warnings for special population

Pregnancy

This medicine is not recommended for use in pregnant women unless necessary. The risks and benefits should be discussed with the doctor before taking this medicine.

Breast-feeding

This medicine is not recommended for use in breastfeeding women. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may advise you to discontinue the drug or to discontinue breastfeeding based on your clinical condition
General warnings

Skin and tissue disorders

This medicine should be used with caution since it may increase the risk of serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, etc. Report any unusual symptoms to the doctor on priority. Management of dermatological toxicities may include topical therapies for symptomatic relief, temporary treatment discontinuation and/or dose modification, or in severe or persistent cases, permanent discontinuation of the treatment. Patients are recommended to avoid sun exposure and should use sun protection.

Gastrointestinal disorders

Use of this medicine may cause gastrointestinal disorders such as diarrhea, nausea, vomiting, abdominal pain, indigestion, etc. Close monitoring and supportive care should be initiated is recommended in such cases.

Hypertension

This medicine should be used with caution in patients with increased blood pressure since it may worsen the condition. Appropriate dose adjustments and frequent clinical monitoring are advised. An alternative treatment option should be considered in some cases based on the clinical condition.

Haematological disorders

Use of this medicine may cause decreased neutrophil count and platelet counts. This medicine is not recommended for use in patients with lower values of absolute neutrophil count and platelet counts. Monitoring of these levels is necessary while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition of the patient.

Cardiac disorders

This medicine may cause cardiovascular events such as heart failure, cardiomyopathy, left ventricular ejection fraction decline to below the lower limit of normal, myocarditis, myocardial ischemia, and heart attack. This medicine should be used with caution in patients who are suffering from heart diseases due to the increased risk of worsening of the patient's condition. You may require a dose adjustment and more frequent clinical monitoring to safely use this medicine. An alternative treatment option may be necessary in some cases based on the clinical condition of the patient.

Thyroid Disorder

Use of this medicine may cause hypothyroidism or hyperthyroidism, hence caution is advised in patients with thyroid dysfunction. Appropriate dose adjustments and frequent clinical monitoring are advised. An alternative treatment option may be necessary in some cases based on the clinical condition of the patient.

Liver toxicity

This medicine should be used with caution in patients with liver diseases due to the increased risk of serious adverse effects. Close monitoring of liver function is recommended for patients on treatment with this medicine. Report any unusual symptoms to the doctor immediately. Appropriate dose adjustments and frequent clinical monitoring are advised in such cases. An alternative treatment option may be necessary in some cases based on the clinical condition of the patient.

Hypoglycemia

This medicine may cause decreased blood sugar levels resulting in fainting and hospitalization. This medicine should be used with caution in patients with diabetes mellitus. Appropriate dose adjustments and frequent clinical monitoring are advised.

Kidney Disease

This medicine should be used with caution in patients with kidney diseases since it may worsen the condition. Close monitoring of kidney function tests and urine analysis is necessary while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition of the patient.

Infections

Use of this medicine may affect the immune system making you susceptible to opportunistic infections from a wide variety of pathogens. It is advised to not use this medicine during an active infection. Use of this medicine should be discontinued after consulting the doctor if a serious infection develops.

Driving or Operating machinery

Use of this medicine may cause blurred vision or dizziness in some patients. It is advised that you do not perform any activities such as driving a vehicle or operating machinery if you experience any of these symptoms during treatment with this medicine.

Use in Children

This medicine is not recommended for use in patients below 18 years of age since the safety and efficacy of use are not clinically established.

Missed Dose

Take the missed dose as soon as you remember. If it is almost 12 hours due for the next scheduled dose, then the missed dose can be skipped. Contact your doctor for further instructions if you miss more than one scheduled dose of this medicine.

Overdose

Seek emergency medical treatment or contact the doctor in case of an overdose.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

Instructions

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
Interaction with Medicine

Efavirenz

Mifepristone

Clozapine

Amiodarone

Ceritinib

Disease interactions

Liver Disease

This medicine should be used with extreme caution in patients with impaired liver function due to the increased risk of liver toxicity which may lead to liver failure. Regular monitoring of the liver function tests is necessary while taking this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Lung Toxicity

This medicine should be used with caution in patients with a history of interstitial lung disease presenting with acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation due to the increased risk of the lung toxicity. Appropriate dose adjustments and frequent clinical monitoring are advised in such cases. Replacement with a suitable alternative may be required in some cases based on the clinical condition.

Adrenal Toxicity

This medicine should be used with caution in patients with hormonal and metabolic changes resulting from an injury, trauma, or a severe infection due to the increased risk of adverse effects. Appropriate dose adjustments and frequent clinical monitoring are advised in such cases. Replacement with a suitable alternative may be required in some cases based on the clinical condition.

Cardiovascular disorders

This medicine should be used with extreme caution in patients suffering from diseases of the heart due to the increased risk of worsening of the patient's condition. Close monitoring of heart function and vital signs is recommended for such patients. Appropriate corrective measures, dose adjustments, or replacement with a suitable alternative may be necessary in some cases based on the clinical condition.

Dermtologic Toxicity

This medicine should be used with caution since it may cause some dermatologic or soft tissue toxicities. In case of any dermatologic or soft tissue toxicity withhold treatment, and appropriate measures should be instituted. If the patient is diagnosed with severe or life-threatening complications like Stevens-Johnson syndrome or toxic epidermal necrolysis discontinue the use of this agent. Appropriate dose adjustments and frequent clinical monitoring are advised in such cases. Replacement with a suitable alternative may be required based on the clinical condition.

Bleeding

This medicine should be used with caution in patients with bleeding complications since it may worsen the condition. Appropriate dose adjustments and frequent clinical monitoring are advised. An alternative treatment option should be considered in some cases based on the clinical condition.

Hypertension

This medicine should be used with caution in patients with increased blood pressure since it may worsen the condition. Appropriate dose adjustments and frequent clinical monitoring are advised. An alternative treatment option should be considered in some cases based on the clinical condition.

Hypoglycemia

Use of this medicine may cause decreased blood sugar levels resulting in fainting and hospitalization. This medicine should be used with caution in patients with diabetes mellitus. Appropriate dose adjustments and frequent clinical monitoring are advised. An alternative treatment option should be considered in some cases based on the clinical condition.

Osteonecrosis of the jaw (ONJ)

Use of this medicine may cause Osteonecrosis of the jaw (ONJ) which is associated with tooth extraction and/or local infection with delayed healing. Patients who are taking bisphosphonate medications or have a dental disease could be at an increased risk of developing ONJ. Appropriate dose adjustments and frequent clinical monitoring are advised.

Thyroid disorders

This medicine should be used with caution in patients with thyroid hormone abnormalities due to the increased risk of worsening of the patient's condition. Appropriate dose adjustments and frequent clinical monitoring are advised. An alternative treatment option should be considered in some cases based on the clinical condition.

Impaired kidney function

This medicine should be used with caution in patients with kidney diseases since it may worsen the condition. Close monitoring of kidney function tests and urine analysis is necessary while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition of the patient.
Food interactions
Avoid grapefruit or grapefruit juice consumption during treatment with this medicine since it may increase the risk of side effects. Report any unusual symptoms to your doctor on priority. Appropriate dose adjustments and frequent clinical monitoring are advised.
Lab interactions
Information not available.
This is not an exhaustive list of possible drug interactions. You should consult your doctor about all the possible interactions of the drugs you’re taking.
Take Sutent 12.5 mg Capsule exactly as prescribed by the doctor. Do not take in larger or smaller quantities than recommended. Take this medicine with or without food. You may require frequent blood tests and liver function tests while taking this medicine. You may also require frequent followups with your doctor to check the progress of treatment. Do not stop the use of this medicine without consulting your doctor.
Miscelleneous

Can be taken with or without food, as advised by your doctor

To be taken as instructed by doctor

May cause sleepiness

How it works
This medicine works by inhibiting the actions of certain abnormal proteins that cause the cancer cells to multiply. This helps in stopping the growth and spread of cancer.
Legal Status

Approved

Approved

Approved

Approved

Classification

Category

Multikinase inhibitors, Antineoplastics, VEGF/VEGFR inhibitors

Schedule

Schedule H

[Internet]. Dailymed.nlm.nih.gov. 2018 [cited 26 December 2018]. Available from:

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c

[Internet]. Medicines.org.uk. 2018 [cited 26 December 2018]. Available from:

https://www.medicines.org.uk/emc/product/227/smpc#

[Internet]. Drugbank.ca. 2018 [cited 26 December 2018]. Available from:

https://www.drugbank.ca/drugs/DB01268

[Internet]. Ebs.tga.gov.au. 2018 [cited 26 December 2018]. Available from:

https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-02256-3&d=201812261016933
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Information on this page was last updated on 31 Jan 2019

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