DOSAGE AND ADMINISTRATION
Recommended Dose
The recommended dose of ZELBORAF is 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal.
ZELBORAF tablets should be swallowed whole with a glass of water. ZELBORAF tablets should not be chewed or crushed.
Duration of treatment
It is recommended that patients are treated with ZELBORAF until disease progression or unacceptable toxicity occurs.
Missed doses
If a dose is missed, it can be taken up to 4 hours prior to the next dose to maintain the twice daily regimen. Both doses should not be taken at the same time.
Dose Modifications
Management of symptomatic adverse drug reactions or prolongation of QTc may require dose reduction, treatment interruption, or treatment discontinuation of ZELBORAF (Table 1). Dose modifications or interruptions are not recommended for cutaneous squamous cell carcinoma (cuSCC) adverse reactions [see Warnings and Precautions and Adverse Reactions]. Dose reductions resulting in a dose below 480 mg twice daily are not recommended.
Table 1 Dose Modification Information
| Grade (CTC-AE)The intensity of clinical adverse events graded by the Common Terminology Criteria for Adverse Events v4.0 (CTC-AE)
|
Recommended ZELBORAF Dose Modification |
|
Grade 1 or Grade 2 (tolerable)
|
Maintain ZELBORAF at a dose of 960 mg twice daily. |
|
Grade 2 (Intolerable) or Grade 3
|
|
| 1st Appearance |
Interrupt treatment until grade 0 — 1. Resume dosing at 720 mg twice daily. |
| 2nd Appearance |
Interrupt treatment until grade 0 — 1. Resume dosing at 480 mg twice daily. |
| 3rd Appearance |
Discontinue permanently |
|
Grade 4
|
|
| 1st Appearance |
Discontinue permanently or interrupt ZELBORAF treatment until grade 0 — 1.
Resume dosing at 480 mg twice daily. |
| 2nd Appearance |
Discontinue permanently |
DOSAGE FORMS AND STRENGTHS
Film-coated tablet: 240 mg
|
