ZELBORAF TABLET 240MG [SIN14308P]

Product Info

ZELBORAF TABLET 240MG

[SIN14308P]

2.1 Therapeutic Indication(s)
Zelboraf® is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (see section 3.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

2.2 Dosage and Administration
General
Treatment with Zelboraf should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products.
Patients treated with Zelboraf must have a previously confirmed BRAF V600 mutation-positive tumor status by a validated test. (see section 2.4 and 3.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Standard Dosage
The recommended dose of Zelboraf is 960 mg (four 240 mg tablets) twice daily. Zelboraf may be taken with or without food, but consistent intake of both daily doses on an empty stomach should be avoided (see Section 3.2.1 Absorption – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
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 treatment with Zelboraf continue until disease progression or the development of unacceptable toxicity (see Tables 1 and 2).

Missed Doses
If a planned 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.

Vomiting
In case of vomiting after Zelboraf administration the patient should not take an additional dose of the medicinal product but the treatment should be continued as usual.

Dose Modifications (see sections 2.4.1 General, Warnings and Precautions and section 2.6.1 Clinical Trials, Undesirable Effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
Management of symptomatic adverse events or prolongation of QTc may require dose reduction, temporary interruption or treatment discontinuation of Zelboraf. Dose modifications or interruptions are not recommended for cutaneous squamous cell carcinoma (cuSCC). Dose reductions resulting in a dose below 480 mg twice daily are not recommended.

2.2.1 Special Dosage Instructions
Pediatric use: The safety and efficacy of Zelboraf in patients under the age of 18 have not been established. Zelboraf is not approved for use in patients under the age of 18 years (see section 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Geriatric use: No special dose adjustment of Zelboraf is required in patients aged > 65 years.

Renal impairment: There have been no specific renal impairment studies; based on retrospective analyses of data from clinical trials, no starting dose adjustment is required in patients with mild or moderate renal impairment.

Hepatic impairment: There have been no specific hepatic impairment studies; based on retrospective analyses of data from clinical trials, no starting dose adjustment is required in patients with mild or moderate hepatic impairment.

2.3 Contraindications
Zelboraf is contraindicated in patients with known hypersensitivity to vemurafenib or to any of its excipients (see section 2.4.1 General, Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).