Generic Name

Sorafenib

Precaution

Interrupt teatment if patient develops cardiac infarction, ischaemia and/or bleeding fatalities. Regular monitoring of BP, CBC and platelet is recommended. Monitor INR in patients who are on treatment with warfarin. Adequate contraception should be used during and for at least 2 wk after stopping treatment. May need to discontinue treatment if severe or persistent hypertension occurs. Lactation: not known whether distributed in breast milk, discouraged

Indication

Renal cell carcinoma, Hepatocellular Carcinoma, Thyroid Cancer

Contra Indication

Hypersensitivity

Dose

N/A

Side Effect

>10% Thrombocytopenia (12-46%),Anemia (44%),Diarrhea (43%),Rash/desquamation (40%),Fatigue (37%),Abd pain (31%),Hand-foot skin reaction (30%),Weight loss (30%),Anorexia (29%),Alopecia (27%),Nausea (24%),Lymphopenia (23%),Neutropenia (18%),Hemorrhage (15-18%),Hypertension (9-17%),Vomiting (16%),Constipation (15%),Neuropathy (13%),Dry skin (11%) 1-10% Headache (10%),Joint pain (10%),Congestive heart failure, MI (1.9%),QT prolonation (rare) <1% Acute renal failure,Angioedema and arrhythmia may occur,Bone pain reported Frequency Not Defined Stevens-Johnson Syndrome,Hyperthyroidism,Interstitial lung disease Potentially Fatal: Bleeding fatalities. Hypertensive crisis.

Pregnancy Category

Mode of Action

Sorafenib inhibits cell surface and intracellular kinases to reduce proliferation of tumour cells.

Interaction

Inducers of isoenzyme CYP3A4 e.g. carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin may decrease sorafenib plasma concentration. Coadmin with sorafenib may increase the plasma concentration of doxorubicin and irinotecan.

Pregnancy Category Note

Pregnancy There are no available data in pregnant women to inform a drug associated risk Animal data Based on findings from animal studies and mechanism of action, therapy may cause fetal harm when administered to a pregnant woman; in animal reproduction studies, oral administration to pregnant rats and rabbits during period of organogenesis resulted in embryo-fetal toxicities at maternal exposures that were significantly lower than human exposures at recommended dose of 400 mg twice daily; apprise pregnant women and females of reproductive potential of potential risk to fetus Pregnancy testing Verify pregnancy status of females of reproductive potential prior to initiation of therapy Contraception Females: Therapy may cause fetal harm when administered to a pregnant woman; advise females of reproductive potential to use effective contraception during treatment and for 6 months following last dose of drug Males: Based on genotoxicity and findings in animal reproduction studies, advise male patients with female partners of reproductive potential and pregnant partners to use effective contraception during treatment and for 3 months after the last dose Infertility Males: Based on findings in animal studies, therapy may impair fertility in males of reproductive potential Lactation There are no data on presence of drug or its metabolites in human milk, or its effects on breast-fed child or on milk production; drug was present in milk of lactating rats; because of potential for serious adverse reactions in breastfed child from drug, advise lactating women not to breastfeed during treatment and for 2 weeks after last dose

Adult Dose

Oral Advanced renal cell carcinoma, Hepatocellular Carcinoma, Thyroid Cancer Adult: 400 mg bid. May continue until patient is no longer responding or unacceptable toxicity occurs. Hepatic Impairment Mild to moderate: Dose adjustment not necessary Severe hepatic impairment: Not studied

Child Dose

Safety and efficacy not established

Renal Dose

Renal Impairment Mild to moderate: Dose adjustment not necessary Severe renal impairment: Not studied

Administration

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 whole, do not chew/crush.