Braftovi ®(Encorafenib) | Tafinlar + Mekinist ®(Dabrafenib) |
|---|---|
Prescription Only | Prescription Only |
| Dosage & Administration | Dosage & Administration comparison data |
Administration | |
Oral. Learn more. | Oral. Learn more. |
Dosing | |
450 mg (six 75 mg capsules) orally once daily in combination with binimetinib until disease progression or unacceptable toxicity.. Learn more. | The recommended dosage of TAFINLAR in adult patients is 150 mg (two 75 mg capsules) orally twice daily. The recommended dosage for TAFINLAR in pediatric patients is based on weight. Take TAFINLAR at least 1 hour before or at least 2 hours after a meal.. Learn more. |
Latin Shorthand | |
Take 450mg (six 75mg caps) PO QD with binimetinib until disease progression or unacceptable tox.". Learn more. | Adult dose: TAFINLAR 150mg (2x75mg caps) PO BID. Pediatric dose: Based on weight. Administer TAFINLAR at least 1 hour before or 2 hours after eating. Learn more. |
| Financial Assistance | Financial Assistance comparison data |
Out-Of-Pocket Costs With Copay Card | |
$0. Learn more. | $25. Learn more. |
Annual Cap | |
$25,000. Learn more. | $15,000. Learn more. |
Assistance Expiration | |
Calendar Year. Learn more. | Calendar Year. Learn more. |
Generics | |
No lower-cost generic available | No lower-cost generic available |
| Physician Advisory | Physician Advisory comparison data |
Adverse Reactions | |
Melanoma: Most common adverse reactions (≥25%) for BRAFTOVI, in combination with binimetinib, are fatigue, nausea, vomiting, abdominal pain, and arthralgia. (6.1)
CRC: Most common adverse reactions (≥25%) for BRAFTOVI, in combination with cetuximab, are fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia, and rash. (6.1)
NSCLC: Most common adverse reactions (≥25%) for BRAFTOVI, in combination with binimetinib, are fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash, and cough.. Learn more. | Most common adverse reactions (≥ 20%) for TAFINLAR as a single agent are
hyperkeratosis, headache, pyrexia, arthralgia, papilloma, alopecia, and
palmar-plantar erythrodysesthesia syndrome.
Most common adverse reactions (≥ 20%) for TAFINLAR in combination with
trametinib include:
• Unresectable or metastatic melanoma: pyrexia, rash, chills, headache,
arthralgia, and cough.
• Adjuvant treatment of melanoma: pyrexia, fatigue, nausea, headache,
rash, chills, diarrhea, vomiting, arthralgia, and myalgia.
• NSCLC: pyrexia, fatigue, nausea, vomiting, diarrhea, dry skin, decreased
appetite, edema, rash, chills, hemorrhage, cough, and dyspnea.
• Adult patients with solid tumors: pyrexia, fatigue, nausea, rash, chills,
headache, hemorrhage, cough, vomiting, constipation, diarrhea, myalgia,
arthralgia, and edema.
• Pediatric patients with solid tumors: pyrexia, rash, vomiting, fatigue, dry
skin, cough, diarrhea, dermatitis acneiform, headache, abdominal pain,
nausea, hemorrhage, constipation, and paronychia.
• Pediatric patients with LGG: pyrexia, rash, headache, vomiting,
musculoskeletal pain, fatigue, diarrhea, dry skin, nausea, hemorrhage,
abdominal pain, and dermatitis acneiform. . Learn more. |
Mechanism of Actions (MoA) | |
BRAF Inhibitors. Learn more. | BRAF Inhibitors. Learn more. |
Special Populations | |
Is BRAFTOVI safe to use during pregnancy? No, BRAFTOVI can cause fetal harm when administered to a pregnant woman. There are no available clinical data on its use during pregnancy. Animal studies showed developmental changes and abortifacient effects at doses greater than those used clinically. Pregnant women or females of reproductive potential should be informed of the potential risk to the fetus. What is the recommendation for breastfeeding while using BRAFTOVI? There are no data on the presence of BRAFTOVI in human milk. Due to potential serious adverse reactions in a breastfed child, women are advised not to breastfeed during BRAFTOVI treatment and for 2 weeks after the last dose. Does BRAFTOVI affect fertility in males? In male rats, BRAFTOVI showed impacts on fertility at doses approximately 13 times the human exposure at the clinical dose. Males considering BRAFTOVI treatment should discuss potential impacts on fertility with their healthcare provider. Are there specific precautions for females of reproductive potential using BRAFTOVI? Females of reproductive potential should undergo pregnancy testing before starting BRAFTOVI. Effective contraception is advised during treatment and for 2 weeks after the last dose. Non-hormonal contraception methods are recommended due to potential interactions. Has BRAFTOVI been studied in pediatric patients? The safety and effectiveness of BRAFTOVI haven't been established in pediatric patients. What information is available regarding the use of BRAFTOVI in elderly patients? Clinical studies included elderly patients (aged 65 and older) with BRAF mutation-positive melanoma, metastatic CRC, and NSCLC. No significant differences in safety or effectiveness were observed between older and younger patients. Are there recommended dosage adjustments for patients with hepatic impairment? No dosage adjustment is recommended for patients with mild hepatic impairment. However, there's no established dosage for those with moderate or severe hepatic impairment. Is there a recommended BRAFTOVI dosage adjustment for patients with renal impairment? No dosage adjustment is recommended for patients with mild to moderate renal impairment. There isn't a recommended dosage for those with severe renal impairment. | Is Tafinlar safe to use during pregnancy? Tafinlar can cause harm to a fetus when administered to a pregnant woman. Limited data in pregnant women exists. Animal studies showed developmental toxicity at doses greater than human exposure at the recommended clinical dose. Pregnant women should be informed of the potential risks. Are there risks associated with breastfeeding while using Tafinlar? There is no data available on the presence of Tafinlar in human milk or its effects on breastfed infants or milk production. Due to potential adverse reactions, women are advised not to breastfeed during Tafinlar treatment and for 2 weeks after the last dose. What precautions should be taken for females and males of reproductive potential using Tafinlar? Females of reproductive potential should undergo pregnancy testing before initiating Tafinlar. Effective contraception is advised during treatment and for 2 weeks after the last dose. Non-hormonal contraception methods are recommended due to potential interactions. Male patients with female partners of reproductive potential should use condoms during treatment and for 2 weeks after the last dose to prevent drug exposure. Is Tafinlar used in pediatric patients? Tafinlar, in combination with trametinib, is approved for pediatric patients (1 year and older) with specific solid tumors and BRAF V600E mutations, as well as those with LGG and BRAF V600E mutations requiring systemic therapy. Safety and effectiveness have been established in pediatric patients based on studies that enrolled various age groups. What data is available regarding geriatric use of Tafinlar? Clinical studies included elderly patients in various tumor types receiving Tafinlar, either alone or in combination. No significant differences in effectiveness or safety were observed between geriatric patients and younger adults in these studies, except for increased incidences of certain side effects in some cases. Is there a recommended dosage adjustment for patients with hepatic impairment? For patients with mild hepatic impairment, no dosage adjustment is recommended. However, those with moderate to severe hepatic impairment may experience increased exposure to Tafinlar due to altered metabolism. No specific dosage recommendation has been established for these patients. |