Sutent

Sutent

sunitinib

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Sunitinib malate
Indications/Uses
GI stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. Advanced renal cell carcinoma (RCC). Unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) w/ disease progression.
Dosage/Direction for Use
GIST & RCC 50 mg once daily for 4 consecutive wk followed by 2-wk rest period. pNET 37.5 mg once daily w/o scheduled rest period.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue use if signs & symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis occur; patients w/ nephrotic syndrome. Hemorrhagic & GI events; intra-abdominal malignancies; pancreatitis; CV events; QT interval prolongation; treatment-related HTN; history of aneurysm; seizures; osteonecrosis of the jaw; tumor lysis syndrome; necrotizing fasciitis; thrombotic microangiopathy; proteinuria. May impair wound healing. Perform complete blood counts prior to treatment; baseline laboratory measurement of thyroid function; baseline urinalysis. Regularly monitor blood glucose levels in diabetic patients. Avoid concomitant use w/ strong CYP3A4 inducers & inhibitors. May affect ability to drive & use machines. Severe hepatic impairment; hepatotoxicity. May affect fertility. Women of childbearing potential. Not to be used in pregnancy & lactation. Ped patients.
Adverse Reactions
Infections; anaemia, thrombocytopenia, neutropenia, leukopenia; hypothyroidism; decreased appetite; insomnia; headache, dysgeusia; HTN; dyspnoea, epistaxis; abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, stomatitis, constipation; rash, palmar-plantar erythrodysaesthesia syndrome, skin discolouration, hair colour changes, dry skin; arthralgia, pain in extremity; fatigue, mucosal inflammation, oedema, pyrexia. Lymphopenia; dehydration, hypoglycaemia; depression; dizziness, paraesthesia, ageusia; periorbital oedema, eyelid oedema, increased lacrimation; myocardial ischaemia; DVT; pulmonary embolism, haemoptysis, pleural effusion, oropharyngeal pain; GI haemorrhage, oesophagitis, abdominal distention, GERD, oral pain, glossodynia, gingival bleeding, dry mouth, flatulence; skin reaction, lesion & exfoliation, erythema, pruritus, blister, alopecia, nail disorder; myalgia; renal failure, proteinuria, chromaturia; chills, flu-like illness; decreased ejection fraction, Hb, platelet count, WBC & wt, increased lipase, blood uric acid, amylase & blood creatine phosphokinase.
Drug Interactions
Increased plasma conc w/ strong CYP3A4 inhibitors eg, ketoconazole, ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice. Decreased plasma conc w/ strong CYP3A4 inducers eg, rifampin, dexamethasone, phenytoin, carbamazepine, phenobarb, St. John's wort.
ATC Classification
L01XE04 - sunitinib ; Belongs to the class of protein kinase inhibitors, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Sutent cap 12.5 mg
Packing/Price
28's
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