Sutent

Sutent

sunitinib

Manufacturer:

Pfizer
Concise Prescribing Info
Contents
Sunitinib malate
Indications/Uses
GI stromal tumor (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) after failure of cytokine-based therapy. Pancreatic neuroendocrine tumors (pNET).
Dosage/Direction for Use
GIST & MRCC 50 mg once daily for 4 wk followed by 2 wk off (schedule 4/2) to complete 6-wk cycle. May be increased or decreased by 12.5 mg up to 75 mg or down to 25 mg. pNET 37.5 mg (3 cap of 12.5 mg concomitantly) once daily w/o a schedule rest period. May be increased or decreased by 12.5 mg. Max: 50 mg daily. Co-administration w/ potent CYP3A4 inducers eg, rifampin Increase dose by 12.5 mg increments to max of 87.5 mg daily (GIST & RCC) or 62.5 mg daily (pNET). Co-administration w/ potent CYP3A4 inhibitors eg, ketoconazole Reduce dose by 12.5 mg decrements to min of 37.5 mg daily (3 cap of 12.5 mg concomitantly) (GIST & MRCC) or 25 mg daily (pNET).
Administration
May be taken with or without food.
Contraindications
Special Precautions
Not for use in patients w/ NSCLC. Discontinue if CHF, pancreatitis & hepatic failure occur. Interrupt treatment &/or reduce dose in patients w/o clinical evidence of CHF but w/ ejection fraction of <50% & >20% below baseline. Hemorrhagic events, thyroid dysfunction, GI disorders, other dermatologic effects. Hair or skin depigmentation may occur. Patients w/ cardiac events w/in 12 mth prior to treatment eg, MI (including severe/unstable angina), coronary/peripheral artery bypass graft, symptomatic CHF, CVA/transient ischemic attack, or pulmonary embolism; history of QT interval prolongation, taking antiarrhythmics or w/ preexisting cardiac disease, bradycardia or electrolyte disturbances. Concomitant use w/ strong CYP3A4 inhibitors. Consider baseline & periodic evaluations of LVEF during treatment. Perform CBC w/ platelet count & serum chemistries including phosphate at the beginning of each cycle. Monitor for CHF, HTN, adrenal insufficiency, thyroid dysfunction. May affect ability to drive or operate machinery. Severe (Child-Pugh class C) hepatic impairment. Impaired renal function. May impair fertility. Women of childbearing potential should avoid becoming pregnant while on treatment. Pregnancy & lactation. Ped patients.
Adverse Reactions
Fatigue; diarrhea, nausea, mucositis/stomatitis, vomiting, constipation, abdominal pain; HTN; rash, skin discoloration, hand-foot syndrome; headache; arthralgia, back pain, myalgia/limb pain; dyspnea; anorexia; bleeding (all sites). GIST: Asthenia; GI effects; decreased LVEF; renal/metabolic effects; neutropenia, lymphopenia, anemia, thrombocytopenia. MRCC: Dyspepsia, glossodynia, flatulence; peripheral edema; dry skin, hair color changes, alopecia; dizziness; dehydration.
Drug Interactions
Increased Cmax and AUC0-∞ w/ ketoconazole. Increased conc w/ strong CYP3A4 inhibitors eg, ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice. Reduced Cmax and AUC0-∞ w/ rifampin. Decreased conc w/ strong CYP3A4 inducers eg, dexamethasone, phenytoin, carbamazepine, rifampin, phenobarb, St. John's wort.
ATC Classification
L01EX01 - sunitinib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Sutent cap 12.5 mg
Packing/Price
30's (Rp13,022,827/pak)
Form
Sutent cap 25 mg
Packing/Price
30's (Rp32,557,064/pak)
Form
Sutent cap 50 mg
Packing/Price
30's (Rp65,114,127/pak)
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in