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Nexavar Dosage

Generic name: SORAFENIB 200mg
Dosage form: tablet, film coated

Medically reviewed by Drugs.com. Last updated on Mar 24, 2020.

Recommended Dose for Hepatocellular Carcinoma, Renal Cell Carcinoma, and Differentiated Thyroid Carcinoma

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.

Dose Modifications for Adverse Reactions

Temporary interruption of NEXAVAR is recommended in patients undergoing major surgical procedures [see Warnings and Precautions (5.7)].

Temporary interruption or permanent discontinuation of NEXAVAR may be required [see Table 1 and Warnings and Precautions (5)].

Table 1: Adverse Reactions Requiring Dose Modification of Nexavar
Adverse Reaction CTCAE Grade Action Dose Reduce and Resume Nexavar
Cardiovascular Events
Cardiac Ischemia and/or Infarction Grade 2 and above Permanently discontinue Do not resume
Congestive Heart Failure Grade 3 Interrupt a until ≤ Grade 1 Decrease one dose levelb c
Grade 4 Permanently discontinue Do not resume
Hemorrhage
requiring medical intervention
Grade 2 and above Permanently discontinue Do not resume
Hypertension Grade 2 asymptomatic and diastolic pressure 90-99 mm Hg Treat with anti-hypertensive therapy Continue NEXAVAR dosing as scheduled and closely monitor blood pressure.
Grade 2 (symptomatic/persistent)
OR
Grade 2 symptomatic increase by >20 mm Hg (diastolic) or >140/90 mm Hg if previously within normal limits
OR Grade 3
Interrupt until symptoms resolve and diastolic blood pressure < 90 mm Hg Treat with anti-hypertensives. Reduce dose to one dose levelc when resumed.
If needed, reduce another dose level. b c
Grade 4 Permanently discontinue Do not resume
Gastrointestinal Perforation Any grade Permanently discontinue Do not resume
QT Prolongation Monitor electrolytes and electrocardiograms If QTc is >500 milliseconds or for an increase from baseline of 60 milliseconds or greater Interrupt
Correct electrolyte abnormalities (magnesium, potassium, calcium).
Use medical judgement before restarting
Severe DILI > Grade 3 ALT in the absence of another caused
AST/ALT > 3xULN with bilirubin > 2xULN in the absence of another caused
Permanently discontinue Do not resume

Non-hematological toxicities

Grade 2

Treat on time

Decrease one dose levelc

Grade 3

1st occurrence

Interrupt until ≤ Grade 2

Decrease one dose levelc

No improvement within 7 days or 2nd or 3rd occurrence

Interrupt until ≤ Grade 2

Decrease two dose levelsc

4th occurrence

Interrupt until ≤ Grade 2

Decrease three dose levelsc

Grade 4

Permanently discontinue

Do not resume

ULN-upper limit of normal; DILI-drug induced liver injury

a
If no recovery after 30 day interruption, treatment will be discontinued unless the patient is deriving clinical benefit
b
If more than 2 dose reductions are required, treatment will be discontinued
c
Hepatocellular and renal cell carcinoma (400 mg daily, 200 mg daily or 400 every other day) and thyroid cancer (800 mg to 600 mg, 400 mg, and 200 mg). See details below for reduction per indication
d
In addition, any grade Alkaline phosphatase increase in the absence of known bone pathology and Grade 2 or worse Bilirubin increase; Any 1 of the following: INR ≥ 1.5, Ascites and/or encephalopathy in the absence of underlying cirrhosis or other organ failure considered to be due to DILI.

Dose modifications for Hepatocellular Carcinoma and Renal Cell Carcinoma

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 dermatologic toxicities are outlined in Table 2.

Table 2: Suggested Dose Modifications for Dermatologic Toxicities in Patients with Hepatocellular Carcinoma, Renal Cell Carcinoma and Differentiated Thyroid Carcinoma

Dermatologic Toxicity Grade

Occurrence

NEXAVAR Dose Modification

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 treatment with NEXAVAR and consider topical therapy for symptomatic relief.

If no improvement within 7 days, see below

Decrease NEXAVAR dose 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 treatment until toxicity resolves to
Grade 0–1

Interrupt NEXAVAR until resolved or improved to Grade 1

When resuming treatment, decrease NEXAVAR dose by one dose level (400 mg daily or 400 mg every other day)

If NEXAVAR is resumed, decrease dose (see Table 3)

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 treatment until toxicity resolves to Grade 0–1

Interrupt NEXAVAR until resolved or improved to Grade 1

When resuming treatment, decrease NEXAVAR dose by one dose level (400 mg daily or 400 mg every other day)

NEXAVAR is resumed, decrease dose by one dose level (see Table 3)

2nd occurrence

Interrupt NEXAVAR treatment until toxicity resolves to
Grade 0–1

Interrupt NEXAVAR until resolved or improved to Grade 1

When resuming treatment, decrease NEXAVAR dose by one dose level (400 mg daily or 400 mg every other day)

When NEXAVAR is resumed, decrease dose by 2 dose levels (see Table 3)

3rd occurrence

Discontinue NEXAVAR treatment

Dose modifications for Differentiated Thyroid Carcinoma

Table 3: Recommended Doses for Patients with Differentiated Thyroid Carcinoma Requiring Dose Reduction

Dose Reduction

NEXAVAR Dose

First Dose Reduction

600 mg daily dose

400 mg and 200 mg 12 hours apart (2 tablets and 1 tablet 12 hours apart – either dose can come first)

Second Dose Reduction

400 mg daily dose

200 mg twice daily (1 tablet twice daily)

Third Dose Reduction

200 mg daily dose

200 mg once daily (1 tablet once daily)

When dose reduction is necessary for dermatologic toxicities, reduce the NEXAVAR dose as indicated in Table 2.

Following improvement of Grade 2 or 3 dermatologic toxicity to Grade 0–1 after at least 28 days of treatment on a reduced dose of NEXAVAR, the dose of NEXAVAR may be increased one 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).

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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