Adult Dosing
Hepatocellular carcinoma (HCC)
- 400 mg PO bid, until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs
- May reduce to 400 mg PO daily or 400 mg PO q2 days, if adverse reaction occurs
Renal cell carcinoma (RCC)
- 400 mg PO bid, until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs
- May reduce to 400 mg PO daily or 400 mg PO q2 days, if adverse reaction occurs
Differentiated thyroid carcinoma (DTC)
- 400 mg PO bid, until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs
- Recommended doses for patients with DTC requiring dose reduction - First dose reduction: 600 mg/day (divided as 2 doses of 400 mg and 200 mg 12 hours apart, either dose can come first), second dose reduction: 400 mg PO bid, third dose reduction: 200 mg PO qd
Note:
- To be taken without food, at least 1 hour before or 2 hours after a meal
- See package insert for the toxicity related dose adjustment
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
- The incidence of cardiac ischemia/infarction has been observed with sorafenib therapy, consider temporary or permanent discontinuation of the therapy if cardiac ischemia and/or infarction develops
- Sorafenib administration increases the risk of bleeding, sometimes with fatal outcome, discontinue the drug is such bleeding occurs
- Hypertension has been reported with sorafenib therapy, monitor BP weekly during the first 6 weeks of therapy and periodically thereafter, treat mild to moderate hypertension with standard medical practice and in case of severe or persistent hypertension despite institution of antihypertensive therapy, temporary or permanent discontinuation of drug should be considered
- Sorafenib causes hand-foot skin reaction and skin rashes, manage dermatologic toxicities with topical therapies and if required modify the dose or temporary discontinue the drug. In case of severe toxicity consider permanent discontinuation of sorafenib
- Gastrointestinal perforation can occur with sorafenib therapy, discontinue the drug in such cases of GI perforation
- Infrequent bleeding or elevations in the International Normalized Ratio (INR) have been reported in some patients taking warfarin while on sorafenib therapy, monitor the patient regularly for changes in prothrombin time, INR or clinical bleeding episodes
- Temporary discontinue sorafenib therapy in patients undergoing major surgical procedures, as it may affect the wound healing
- Use of sorafenib in combination with carboplatin and paclitaxel in Non-small cell lung cancer increases the rate of mortality, hence contraindicated
- Sorafenib caused embryo-fetal toxicities, advise women of childbearing potential to avoid becoming pregnant during the therapy
- Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug-induced hepatitis have been reported with sorafenib
- Impairs exogenous thyroid suppression hence monitor TSH levels monthly and adjust thyroid replacement medication as needed in patients with differentiated thyroid carcinoma
Cautions: Use cautiously in
- Severe hepatic impairment
- Unstable coronary artery disease
- Recent MI
- Hypertension
- Concomitant warfarin
Pregnancy Category:D
Breastfeeding: Safety unknown. As many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from sorafenib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Drug Name: Nexavar 200 MG Oral Tablet
Ingredient(s): Sorafenib
Imprint: 200
Color(s): Red
Shape: Round
Size (mm): 10.00
Score: 1
Inactive Ingredient(s): croscarmellose sodium / cellulose, microcrystalline / hypromellose / sodium lauryl sulfate / magnesium stearate / polyethylene glycol / titanium dioxide / ferric oxide red
Drug Label Author:
Bayer HealthCare Pharmaceuticals Inc.
DEA Schedule:
Non-Scheduled
