Dosing & Administration

Recommended Dosing

TAFINLAR + MEKINIST OFFERS PATIENTS EASY-TO-FOLLOW DOSING INSTRUCTIONS AND A LOW PILL BURDEN^1,2

TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) dosing schedule

Convenient at-home dosing

No disruption to daily activities by treatment visits
No time spent at infusion center or traveling to treatment

Storage and handling

TAFINLAR should be stored at room temperature between 68 °F and 77 °F (20 °C-25 °C); excursions permitted between 59 °F and 86 °F (15 °C-30 °C). Store and dispense in the original bottle with the desiccant¹
MEKINIST should be stored at 68 °F to 77 °F (20 °C-25 °C); excursions permitted between 59 °F and 86 °F (15 °C-30 °C). Dispensed in the original bottle. Do not remove desiccant. Protect from moisture and light, and do not place medication in pill boxes²

For complete dosage and storage information, please see the full Prescribing Information for the appropriate medications.

Both TAFINLAR and MEKINIST should be taken at least 1 hour before or 2 hours after a meal. Ensure a 12-hour interval between TAFINLAR doses and a 24-hour interval between MEKINIST doses.^1,2

Do not take a missed dose of TAFINLAR within 6 hours of the next dose, or a missed dose of MEKINIST within 12 hours of next dose^1,2
Do not open, crush, or break TAFINLAR capsules¹
Do not crush or break MEKINIST tablets²
Keep TAFINLAR, MEKINIST, and all medicine out of the reach of children^1,2

Adjuvant Dosing:

Continue treatment with TAFINLAR + MEKINIST for a period of 12 months or until disease recurrence or unacceptable toxicity occurs^1,2

Metastatic Dosing:

Treatment with TAFINLAR + MEKINIST should continue until disease progression or unacceptable toxicity occurs^1,2

Dose Reductions

THE OVERALL MANAGEMENT OF CERTAIN ADVERSE REACTIONS MAY REQUIRE TREATMENT INTERRUPTION, DOSE REDUCTION, OR TREATMENT DISCONTINUATION, DEPENDING ON SEVERITY^1,2

Recommended Dose Modifications

Severity of Adverse Reaction^a	TAFINLAR^1,b	MEKINIST^2,c
Hemorrhage
Grade 3	See Other Adverse Reactions (Including Hemorrhage for TAFINLAR)	Withhold MEKINIST If improved, resume MEKINIST at lower dose If not improved, permanently discontinue MEKINIST
Grade 4	See Other Adverse Reactions (Including Hemorrhage for TAFINLAR)	Permanently discontinue MEKINIST
New Primary Malignancies
Noncutaneous RAS-mutation–positive malignancies	Permanently discontinue TAFINLAR	No dose modifications recommended for MEKINIST
Venous Thromboembolism
Uncomplicated DVT or PE	No dose modifications recommended for TAFINLAR	Withhold MEKINIST for up to 3 weeks If improved to grade 0/1, resume MEKINIST at lower dose If not improved, permanently discontinue MEKINIST
Life-threatening PE	No dose modifications recommended for TAFINLAR	Permanently discontinue MEKINIST
Cardiomyopathy
Asymptomatic, absolute decrease in LVEF of 10% or greater from baseline and is below institutional LLN from pretreatment value	No dose modifications recommended for TAFINLAR	Withhold MEKINIST for up to 4 weeks If improved to normal LVEF value, resume MEKINIST at lower dose If not improved to normal LVEF value, permanently discontinue MEKINIST
Symptomatic cardiomyopathy or congestive heart failure Absolute decrease in LVEF of greater than 20% from baseline that is below LLN	Withhold TAFINLAR until LVEF improves to at least the institutional LLN and absolute decrease to less than or equal to 10% compared to baseline, then resume at same dose	Permanently discontinue MEKINIST
Ocular Toxicities
Retinal pigment epithelial detachment	No dose modifications recommended for TAFINLAR	Withhold MEKINIST for up to 3 weeks If improved, resume MEKINIST at same or lower dose If not improved, permanently discontinue MEKINIST or resume MEKINIST at lower dose
Retinal vein occlusion	No dose modifications recommended for TAFINLAR	Permanently discontinue MEKINIST
Uveitis (including iritis and iridocyclitis) that is mild or moderate but does not respond to ocular therapy Severe uveitis	Withhold TAFINLAR for up to 6 weeks If improved to grade 0/1, then resume TAFINLAR at same or lower dose If not improved, permanently discontinue TAFINLAR	No dose modifications recommended for MEKINIST
Pulmonary
Interstitial lung disease/pneumonitis	No dose modifications recommended for TAFINLAR	Permanently discontinue MEKINIST
Febrile Reactions
Fever of 100.4 °F to 104 °F (or first symptoms in case of recurrence)	Withhold TAFINLAR until fever resolves, then resume at same or lower dose	Withhold MEKINIST until fever resolves, then resume MEKINIST at same or lower dose
Fever higher than 104 °F Fever complicated by rigors, hypotension, dehydration, or renal failure	Withhold TAFINLAR until febrile reactions resolve for at least 24 hours, then resume at lower dose Or Permanently discontinue TAFINLAR	Withhold MEKINIST until febrile reactions resolve for at least 24 hours, then resume MEKINIST at lower dose Or Permanently discontinue MEKINIST
Skin Toxicities
Intolerable grade 2 Grade 3 or 4	Withhold TAFINLAR for up to 3 weeks If improved, resume TAFINLAR at lower dose If not improved, permanently discontinue TAFINLAR	Withhold MEKINIST for up to 3 weeks If improved, resume MEKINIST at lower dose If not improved, permanently discontinue MEKINIST
Severe cutaneous adverse reactions	Permanently discontinue TAFINLAR	Permanently discontinue MEKINIST
Other Adverse Reactions (Including Hemorrhage for TAFINLAR)
Intolerable grade 2 Any grade 3	Withhold TAFINLAR If improved to grade 0/1, resume TAFINLAR at lower dose If not improved, permanently discontinue TAFINLAR	Withhold MEKINIST If improved to grade 0/1, resume MEKINIST at lower dose If not improved, permanently discontinue MEKINIST
First occurrence of any grade 4	Withhold TAFINLAR until adverse reaction improves to grade 0/1. Then resume at a lower dose Or Permanently discontinue TAFINLAR	Withhold MEKINIST until adverse reaction improves to grade 0/1. Then resume at a lower dose Or Permanently discontinue MEKINIST
Recurrent grade 4	Permanently discontinue TAFINLAR	Permanently discontinue MEKINIST

DVT, deep venous thromboembolism; LLN, lower limit of normal; LVEF, left ventricular ejection fraction; PE, pulmonary embolism; RAS, monomeric G protein.
^aNational Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. ^bDose modifications are not recommended for TAFINLAR when administered with MEKINIST for the following adverse reactions of MEKINIST: retinal vein occlusion, retinal pigment epithelial detachment, interstitial lung disease/pneumonitis, and uncomplicated venous thromboembolism. Dose modification of TAFINLAR is not required for new primary cutaneous malignancies. ^cDose modifications are not recommended for MEKINIST when administered with TAFINLAR for the following adverse reactions of TAFINLAR: noncutaneous malignancies and uveitis. Dose modification of MEKINIST is not required for new primary cutaneous malignancies.

NEXT: Mechanism of Action

References: 1. Tafinlar. Prescribing information. Novartis Pharmaceuticals Corp. 2. Mekinist. Prescribing information. Novartis Pharmaceuticals Corp.

Dosing & Administration

IMPORTANT SAFETY INFORMATION

INDICATIONS