Details

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Sunitinib Malate 12.5mg, 25mg, 50mg Capsules is an anti cancer drug that is a multiple receptor tyrosine kinase (RTK) inhibitor.

It is the malate salt of sunitinib

Mechanism of action: It acts by Inhibits receptor tyrosine kinases  like VEGF-R1 (Vascular endothelial growth factor -R1), VEGF-R2, VEGF-R3, PDGFR-α , PDGFR-β(platelet-derived growth factor-β) and c-kit.  resulting in inhibition of angiogenesis, invasion, and metastasis. This stops further growth of the tumor, new blood vessels formation and spreading of the tumor.

It is available as Sutent in both International and Indian markets.

 

Uses

• Sunitinib Malate 12.5mg, 25mg, 50mg Capsules is approved for treatment of advanced renal cell carcinoma(RCC).
• It is also indicated in Gastrointestinal stromal tumor(GIST) progression and in case of intolerance to imatinib.
• Sutent is used in locally advanced or metastatic pancreatic neuroendocrine tumors(pNET).

 

Dosage

• Sunitinib Malate 12.5mg, 25mg, 50mg Capsules is available as hard gelatin capsules with orange , caramel or yellow cap and orange or yellow body containing sunitinib malate and other inactive ingredients.
• It is taken orally with or without food.
• Final dosages are determined by the doctor on the basis of factors such as pre existing medical conditions, age, weight and ongoing medications.
• Usual dose of Sutent for RCC and GIST is 50mg/day for 4 weeks followed by 2 weeks off and for pNET  5 mg/day for the time period the doctor has prescribed.
• Dose is adjusted to minimise the dose related side effects.

Side effects

• Headache
• Fever & Chills
• Abdominal pain
• Fatigue
• Hypertension
• Skin rash
• Thyroid Dysfunction
• Asthenia
• Bleeding
• Cardiac toxicity leading to congestive heart failure
• Nausea and vomiting
• Impaired wound healing
• Adrenal toxicity
• Diarrhea
• Rashes or blisters on palms and soles
• Dry , thick and cracking skin
• Back pain
• Cough & dyspnea
• Mucositis
• weight gain or weight loss
• hair loss
• Abnormal heartbeat

 

Precautions

• Sunitinib Malate 12.5mg, 25mg, 50mg Capsules is not recommended for pregnant women as it causes severe harm to the fetus and also not recommended in breastfeeding women.
• Sutent must be used carefully in patients with liver, kidney and heart dysfunction.
• Routine blood tests, thyroid, liver, kidney and heart function tests must be done.
• This drug interacts with CYP3A4 inhibitors such as ketoconazole and CYP3A4 inducers such as rifampin.
• Tell the doctor about pre existing medical conditions, ongoing medications and any allergy before starting the drug.

Always tell the doctor about pregnancy or future plan of pregnancy or breastfeeding.