Soravar 200

Sorafenib tosilate

Hepatocellular carcinoma (HCC). Patients w/ advanced renal cell carcinoma (RCC) who have failed prior interferon-α or interleukin-2 based therapy or are considered unsuitable for such therapy. Progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hurthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine.

Adult 400 mg bid (total daily dose: 800 mg). When necessary, reduce dose to 2 tab of 200 mg once daily for HCC & RCC, & to 600 mg daily in divided doses (two 200-mg tab & one 200-mg tab 12 hr apart) for DTC. If additional dose reduction is necessary, reduce to 400 mg daily in divided doses (two 200-mg tab 12 hr apart), & if necessary, further reduce to one 200-mg tab once daily. Dose may be increased after improvement of non-haematological adverse reactions.

Should be taken on an empty stomach: Take on an empty stomach or w/ a low or moderate fat meal. If the patient intends to have a high fat meal, sorafenib should be taken on an empty stomach at least 1 hr before or 2 hr after meals. Swallow w/ a glass of water.

Hypersensitivity.

Risk of dermatological toxicities; arterial HTN; formation of aneurysms &/or artery dissections; decreases in blood glucose; haemorrhage; treatment-emergent cardiac ischaemia/infarction events; QT interval prolongation; GI perforation (uncommon). Patients taking concomitant warfarin or phenprocoumon should be monitored regularly for changes in prothrombin time, INR or clinical bleeding episodes. Temporary interrupt therapy in patients undergoing major surgical procedures. Caution when co-administered w/ compd that are metabolised/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 + platinum-based chemotherapies. Monitoring of fluid balance & electrolytes in patients at risk of renal dysfunction is advised. Severe hepatic impairment (Child Pugh C). Do not use during pregnancy unless clearly necessary. Women of childbearing potential must use effective contraception during treatment. Do not breast-feed during treatment. Childn & adolescents <18 yr. Reports of renal failure in elderly; consider monitoring of renal function. RCC: Benefit-risk in high-risk patients has not been evaluated. DTC: Management of suspected adverse drug reactions may require temporary interruption or dose reduction of sorafenib therapy. Treat tracheal, bronchial & oesophageal infiltration w/ localized therapy prior to administering sorafenib. Close monitoring of blood Ca & TSH levels are recommended.

Infection; lymphopenia; anorexia, hypophosphataemia; haemorrhage (GI, resp tract & cerebral), HTN; diarrhoea, nausea, vomiting, constipation; dry skin, rash, alopecia, hand foot skin reaction, erythema, pruritus; arthralgia; fatigue, pain (including mouth, abdominal, bone, tumour pain & headache), fever; decreased wt, increased amylase, increased lipase. Folliculitis; leucopenia, neutropenia, anaemia, thrombocytopenia; hypothyroidism; hypocalcaemia, hypokalaemia, hyponatraemia, hypoglycaemia; depression; peripheral sensory neuropathy, dysgeusia; tinnitus; CHF, myocardial ischaemia & infarction; flushing; rhinorrhoea, 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/ CYP3A4 inducers (eg, rifampicin, St. John's wort, phenytoin, carbamazepine, phenobarb, dexamethasone). Potential increase in plasma conc of P-gp substrates eg, digoxin. Increased capecitabine & 5-FU exposure. Increased AUC of doxorubicin/irinotecan. Increased AUC & Cmax 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