Nexavar Dosage

Generic name: SORAFENIB 200mg
Dosage form: tablet, film coated
Drug classes: Multikinase inhibitors, VEGF/VEGFR inhibitors

Medically reviewed by Drugs.com. Last updated on Aug 28, 2023.

Recommended Dosage

The recommended dosage of NEXAVAR is 400 mg orally twice daily without food (at least 1 hour before or 2 hours after a meal) until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity.

Dosage Modifications for Adverse Reactions

Recommended Dosage Modifications

The recommended dosage modifications for adverse reactions are provided in Tables 1, 2, and 3.

Table 1: Recommended Dose Reductions for Adverse Reactions
Dose Reduction	Hepatocellular Carcinoma and Renal Cell Carcinoma	Differentiated Thyroid Carcinoma
First Dose Reduction	400 mg orally once daily	400 mg orally in the morning and 200 mg orally in the evening about 12 hours apart OR 200 mg orally in the morning and 400 mg orally in the evening about 12 hours apart
Second Dose Reduction	200 mg orally once daily OR 400 every other day	200 mg orally twice daily
Third Dose Reduction	None	200 mg orally once daily

Table 2: Recommended Dosage Modifications of NEXAVAR for Adverse Reactions
Adverse Reaction	Severity1	NEXAVAR Dosage Modification
Cardiovascular Events
Cardiac Ischemia and/or Infarction	Grade 2 and above	Permanently discontinue.
Congestive Heart Failure	Grade 3	Interrupt2 until Grade 1 or less, resume at reduced dose by 1 dose level.3
Congestive Heart Failure	Grade 4	Permanently discontinue.
Hemorrhage	Grade 2 and above requiring medical intervention	Permanently discontinue.
Hypertension	Grade 2 (symptomatic/persistent) OR Grade 2 symptomatic increase by greater than 20 mm Hg (diastolic) or greater than 140/90 mm Hg if previously within normal limits OR Grade 3	Interrupt until symptoms resolve and diastolic blood pressure less than 90 mm Hg, then resume at reduced dose by 1 dose level.3 If needed, reduce another dose level.3
Hypertension	Grade 4	Permanently discontinue.
Gastrointestinal Perforation	Any grade	Permanently discontinue.
QT Interval Prolongation	Greater than 500 milliseconds OR Increase from baseline of 60 milliseconds or greater	Interrupt and correct electrolyte abnormalities (magnesium, potassium, calcium). Use medical judgement before restarting.
Drug-Induced Liver Injury	Grade 3 ALT or higher in the absence of another cause4 OR AST/ALT greater than 3 × upper limit normal (ULN) with bilirubin greater than 2 × ULN in the absence of another cause4	Permanently discontinue.
Non-hematological toxicities	Grade 2	Continue treatment at reduced dose by 1 dose level.
	Grade 3
	1st occurrence	Interrupt until Grade 2 or less, then resume at reduced dose by 1 dose level.
	No improvement within 7 days OR 2nd or 3rd occurrence	Interrupt until Grade 2 or less, then resume at reduced dose by 2 dose levels.
	4th occurrence	Interrupt until Grade 2 or less, then resume at reduced dose by 2 dose levels for HCC and RCC or 3 dose levels for DTC.
	Grade 4	Permanently discontinue.

1: Adverse reactions graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0).
2: If no recovery after 30 day interruption, discontinue treatment unless the patient is deriving clinical benefit.
3: If more than 2 dose reductions are required, permanently discontinue treatment.
4: In addition, any grade increased alkaline phosphatase in the absence of known bone pathology and Grade 2 or worse increased bilirubin; any 1 of the following: INR of 1.5 or greater, ascites and/or encephalopathy in the absence of underlying cirrhosis or other organ failure considered to be due to drug-induced liver injury.

Table 3: Recommended Dosage Modifications for Dermatologic Toxicities
Dermatologic Toxicity Grade	Occurrence	NEXAVAR Dosage Modification
Dermatologic Toxicity Grade		Hepatocellular and Renal Cell Carcinoma	Differentiated Thyroid Carcinoma
Grade 2: Painful erythema and swelling of the hands or feet and/or discomfort affecting the patient’s normal activities	1st occurrence	Continue NEXAVAR and consider topical therapy for symptomatic relief. If no improvement within 7 days, see below.	Decrease NEXAVAR to 600 mg daily. If no improvement within 7 days, see below.
	No improvement within 7 days at reduced dose OR 2nd and 3rd occurrence	Interrupt NEXAVAR until resolved or improved to Grade 0 to 1.	Interrupt NEXAVAR until completely resolved or improved to Grade1.
		When resuming treatment, decrease dose by 1 dose level.	When resuming treatment, decrease dose by 1 dose level for 2nd occurrence and 2 doses levels for 3rd occurrence.
	4th occurrence	Discontinue NEXAVAR treatment.
Grade 3: Moist desquamation, ulceration, blistering, or severe pain of the hands or feet, resulting in inability to work or perform activities of daily living	1st occurrence	Interrupt NEXAVAR until resolved or improved to Grade 0 to 1	Interrupt NEXAVAR until completely resolved or improved to Grade 1.
	1st occurrence	When resuming treatment, decrease dose by 1 dose level.	When resuming treatment, decrease dose by 1 dose level.
	2nd occurrence	Interrupt NEXAVAR until resolved or improved to Grade 0 to 1	Interrupt NEXAVAR until completely resolved or improved to Grade 1.
	2nd occurrence	When resuming treatment, decrease dose by 1 dose level.	When resuming treatment, decrease dose by 2 dose levels.
	3rd occurrence	Discontinue NEXAVAR treatment.

Following improvement of Grade 2 or 3 dermatologic toxicity to Grade 0 or 1 for at least 28 days on a reduced dose of NEXAVAR, the dose of NEXAVAR may be increased 1 dose level from the reduced dose. Approximately 50% of patients requiring a dose reduction for dermatologic toxicity are expected to meet these criteria for resumption of the higher dose and roughly 50% of patients resuming the previous dose are expected to tolerate the higher dose (that is, maintain the higher dose level without recurrent Grade 2 or higher dermatologic toxicity).