Binefaros

Advanced renal cell carcinoma (RCC); hepatocellular carcinoma (HCC); locally advanced or metastatic differentiated thyroid carcinoma (DTC) refractory to radioactive iodine.

Adult 400 mg (2 tab of 200 mg) bid (equiv to a total daily dose of 800 mg). Continue as long as clinical benefit is observed or until unacceptable toxicity occurs. HCC & RCC When necessary, reduce dose to 2 tab of 200 mg once daily. DTC When necessary, reduce dose to 600 mg daily in divided doses (2 tab of 200 mg & 1 tab of 200 mg 12 hr apart).

Should be taken on an empty stomach: Can be administered w/ a low or moderate-fat meal. Swallow tab w/ a glass of water. If patient intends to have a high-fat meal: Tab should be taken at least 1 hr before or 2 hr after meal.

Severe hypersensitivity. Combination w/ carboplatin & paclitaxel in patients w/ squamous cell lung cancer.

Risk of dermatological toxicities eg, hand-foot skin reaction & rash; arterial HTN; decreases in blood glucose; cardiac ischaemia/infarction events; QT interval prolongation which may lead to an increased risk for ventricular arrhythmias; GI perforation. Increased risk of bleeding. Consider permanent discontinuation in case of severe or persistent HTN, or hypertensive crisis despite the institution of antihypertensive therapy; & in any bleeding event requiring medical intervention. Temporarily interrupt treatment in case of symptomatic hypoglycemia. Consider temporary or permanent discontinuation of treatment in patients who develop cardiac ischaemia &/or infarction. Temporarily interrupt therapy in patients undergoing major surgical procedures. Regularly monitor BP. Regularly monitor patients taking concomitant warfarin or phenprocoumon for changes in prothrombin time, INR, or clinical bleeding episodes. Concomitant use w/ compd that are metabolized/eliminated predominantly by UGT1A1 (eg, irinotecan) or UGT1A9 pathways; docetaxel; neomycin or other antibiotics. Reports of higher mortality in patients w/ squamous cell carcinoma of the lung treated w/ sorafenib in combination w/ platinum-based chemotherapies. Monitor fluid balance & electrolytes in patients at risk of renal dysfunction. Exposure might increase in patients w/ severe hepatic impairment. Women of childbearing potential must use effective contraception during treatment. Not to be used during pregnancy unless clearly necessary. Women must not breastfeed during treatment. Safety & efficacy in childn & adolescents <18 yr has not yet been established. Reports of cases of renal failure in elderly; consider monitoring of renal function. DTC: Carefully evaluate prognosis in the individual patient considering max lesion size, symptoms related to the disease & progression rate before initiating treatment. Management of suspected adverse drug reactions may require temporary interruption or dose reduction of sorafenib therapy. Due to potential risk of bleeding, tracheal, bronchial, & esophageal infiltration should be treated w/ localized therapy prior to administering treatment. Close monitoring of blood Ca level & TSH is recommended. RCC: Benefit-risk in high-risk patients has not been evaluated.

Infection; lymphopenia; anorexia, hypophosphatemia; hemorrhage (including GI, resp tract & cerebral haemorrhage), HTN; diarrhea, nausea, vomiting, constipation; dry skin, rash, alopecia, hand & foot skin reaction, erythema, pruritus; arthralgia; fatigue, pain (including mouth, abdominal, bone, tumor pain & headache), fever; decreased wt, increased amylase & lipase. Folliculitis; leucopenia, neutropenia, anemia, thrombocytopenia; hypothyroidism; hypocalcemia, hypokalemia, hyponatremia, hypoglycemia; depression; peripheral sensory neuropathy; dysgeusia; tinnitus; CHF, myocardial ischemia & MI; flushing; rhinorrhea, dysphonia; stomatitis (including dry mouth & glossodynia), dyspepsia, dysphagia, GERD; keratoacanthoma/squamous cell cancer of the skin, exfoliative dermatitis, acne, skin desquamation, hyperkeratosis; myalgia, muscle spasms; renal failure, proteinuria; erectile dysfunction; asthenia, flu-like illness, mucosal inflammation; transient increase in transaminases.

Decreased conc w/ rifampicin & other CYP3A4 inducers eg, St. John's wort, phenytoin, carbamazepine, phenobarb & dexamethasone. May increase plasma conc of P-gp substrates eg, digoxin. Increased exposure of sorafenib, paclitaxel & 6-OH paclitaxel w/ co-administration of paclitaxel, carboplatin & sorafenib (w/o a 3-day break in sorafenib dosing). Increased exposure of capecitabine & 5-FU. Increased AUC of doxorubicin, irinotecan, SN-38. Increased AUC & C_max of docetaxel. Decreased exposure w/ neomycin.

Targeted Cancer Therapy

L01EX02 - sorafenib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.

Rx