Tafinlar 50 – 75 MG Hard Capsules
Product Description
- TAFINLAR (dabrafenib) capsules for oral use are supplied as 50 mg and 75 mg capsules for oral administration. Each 50 mg capsule contains 59.25 mg dabrafenib mesylate equivalent to 50 mg of dabrafenib free base. Each 75 mg capsule contains 88.88 mg dabrafenib mesylate equivalent to 75 mg of dabrafenib free base. The inactive ingredients of TAFINLAR are colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose. Capsule shells contain hypromellose, red iron oxide (E172), and titanium dioxide (E171).Recommended dose level reductions and recommendations for dose modifications are provided in Tables 1 and 2, respectively.
Table 1 Recommended dose level reductions
Dose level Dabrafenib dose
Used as monotherapy or in combination with trametinib
Trametinib dose*
Only when used in combination with dabrafenib
Starting dose 150 mg twice daily
2 mg once daily
1st dose reduction 100 mg twice daily
1.5 mg once daily
2nd dose reduction 75 mg twice daily
1 mg once daily
3rd dose reduction 50 mg twice daily
1 mg once daily
Dose adjustment for dabrafenib below 50 mg twice daily is not recommended, whether used as monotherapy or in combination with trametinib. Dose adjustment for trametinib below 1 mg once daily is not recommended, when used in combination with dabrafenib. *For dosing instructions for treatment with trametinib monotherapy, see trametinib SmPC, Posology and Method of administration.
Table 2 Dose modification schedule based on the grade of any adverse events (AE)
Grade (CTC-AE)* Recommended dabrafenib dose modifications Used as monotherapy or in combination with trametinib
Grade 1 or Grade 2 (Tolerable) Continue treatment and monitor as clinically indicated. Grade 2 (Intolerable) or Grade 3 Interrupt therapy until toxicity is Grade 0 to 1 and reduce by one dose level when resuming therapy. Grade 4 Discontinue permanently, or interrupt therapy until Grade 0 to 1 and reduce by one dose level when resuming therapy. * The intensity of clinical adverse events graded by the Common Terminology Criteria for Adverse Events (CTC-AE) v4.0
When an individual’s adverse reactions are under effective management, dose re-escalation following the same dosing steps as de-escalation may be considered. The dabrafenib dose should not exceed 150 mg twice daily.
If treatment-related toxicities occur when dabrafenib is used in combination with trametinib, then both treatments should be simultaneously dose reduced, interrupted or discontinued. Exceptions where dose modifications are necessary for only one of the two treatments are detailed below for pyrexia, uveitis, RAS mutation positive non-cutaneous malignancies (primarily related to dabrafenib), left ventricular ejection fraction (LVEF) reduction, retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED) and interstitial lung disease (ILD)/pneumonitis (primarily related to trametinib).
Dose modification exceptions (where only one of the two therapies is dose reduced) for selected adverse reactions
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Copyright by Doğan Pharma 2024. All rights reserved.
Copyright by Doğan Pharma 2024. All rights reserved.
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