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DOSAGE AND ADMINISTRATION
The recommended daily dose of NEXAVAR is 400 mg (2 x 200 mg tablets) taken twice daily without food (at least 1 hour before or 2 hours after a meal). Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction of NEXAVAR. When dose reduction is necessary, the NEXAVAR dose may be reduced to 400 mg once daily. If additional dose reduction is required, NEXAVAR may be reduced to a single 400 mg dose every other day [see WARNINGS AND PRECAUTIONS].
Suggested dose modifications for skin toxicity are outlined in Table 1.
Table 1: Suggested Dose Modifications for Skin
|Skin Toxicity Grade||Occurrence||Suggested Dose Modification|
|Grade 1: Numbness, dysesthesia, paresthesia, tingling, painless swelling, erythema or discomfort of the hands or feet which does not disrupt the patient's normal activities||Any occurrence||Continue treatment with NEXAVAR and consider topical therapy for symptomatic relief|
|Grade 2: Painful erythema and swelling of the hands or feet and/or discomfort affecting the patient's normal activities||1st occurrence||Continue treatment with NEXAVAR and consider topical therapy for symptomatic relief If no improvement within 7 days, see below|
|No improvement within 7 days or 2nd or 3rd occurrence||Interrupt NEXAVAR treatment until toxicity resolves to Grade 0–1 When resuming treatment, decrease NEXAVAR dose by one dose level (400 mg daily or 400 mg every other day)|
|4th occurrence||Discontinue NEXAVAR treatment|
|Grade 3: Moist desquamation, ulceration, blistering or severe pain of the hands or feet, or severe discomfort that causes the patient to be unable to work or perform activities of daily living||1st or 2nd occurrence||Interrupt NEXAVAR treatment until toxicity resolves to Grade 0–1 When resuming treatment, decrease NEXAVAR dose by one dose level (400 mg daily or 400 mg every other day)|
|3rd occurrence||Discontinue NEXAVAR treatment|
No dose adjustment is required on the basis of patient age, gender, or body weight.
Concomitant strong CYP3A4 inducers
Avoid concomitant use of strong CYP3A4 inducers (such as, carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, rifabutin, St. John's wort), when possible, because inducers can decrease the systemic exposure to sorafenib [see DRUG INTERACTIONS].
Dosage Forms And Strengths
Tablets containing sorafenib tosylate (274 mg) equivalent to 200 mg of sorafenib.
NEXAVAR tablets are round, biconvex, red film-coated tablets, debossed with the “Bayer cross” on one side and “200” on the other side.
Storage And Handling
NEXAVAR tablets are supplied as round, biconvex, red film-coated tablets, debossed with the “Bayer cross” on one side and “200” on the other side, each containing sorafenib tosylate equivalent to 200 mg of sorafenib.
Bottles of 120 tablets NDC 50419-488-58
Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) (see USP controlled room temperature). Store in a dry place.
Manufactured for: Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470. Manufactured in Germany Onyx Pharmaceuticals, Inc., 249 East Grand Avenue, South San Francisco, CA 94080. Distributed and marketed by: Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470. Marketed by: Onyx Pharmaceuticals, Inc. 249 East Grand Avenue, South San Francisco, CA 94080. Revised: 10/2013
Last reviewed on RxList: 12/2/2013
This monograph has been modified to include the generic and brand name in many instances.
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