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Nexavar (Sorafenib) - Indications and Dosage

 
 



INDICATIONS AND USAGE

1.1 Hepatocellular Carcinoma

NEXAVAR is indicated for the treatment of patients with unresctable hepatocellular carcinoma (HCC).

Renal Cell Carcinoma

NEXAVAR is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

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 therapy. 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 (5)].

Suggested dose modifications for skin toxicity are outlined in Table 1.

Table 1: Suggested Dose Modifications for Skin Toxicity
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: The use of concomitant strong CYP3A4 inducers may decrease sorafenib plasma concentrations and should be avoided (e.g., St. John's Wort, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital). Although a dose increase has not been studied, if a strong CYP3A4 inducer must be co-administered, a NEXAVAR dose increase may be considered. If the dose of NEXAVAR is increased, the patient should be monitored carefully for toxicity [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.

HOW SUPPLIED/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 0026-8488-58

Storage

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.

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