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BRAFTOVI is a brand name for Encorafenib, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
, Ophthalmologic) • Grade 1-3 • If Grade 1 or 2 does not respond to specific ocular therapy, or for Grade 3 uveitis, withhold BRAFTOVI for up to 6 weeks. • If uveitis is Grade 1 and it improves to Grade 0, then resume at the same dose.
• If uveitis is Grade 2 or Grade 3 and it improves to Grade 0 or 1, then resume at a reduced dose. • If not improved, permanently discontinue BRAFTOVI plus binimetinib. • Grade 4 Permanently discontinue BRAFTOVI. QTc Prolongation (see 7.
Warnings and Precautions, Cardiovascular) • QTcF greater than 500 ms and less than or equal to 60 ms increase from baseline Withhold BRAFTOVI until QTcF less than or equal to 500 ms. Resume at reduced dose. • If more than one recurrence, permanently discontinue BRAFTOVI.
• QTcF greater than 500 ms and greater than 60 ms increase from baseline Permanently discontinue BRAFTOVI. Hepatotoxicity • Grade 2 AST or ALT increased Maintain BRAFTOVI dose. • If no improvement within 2 weeks, withhold BRAFTOVI until improves to Grade 0-1 or to pretreatment/baseline levels and then resume at same dose.
• Grade 3 or 4 AST or ALT increased See Other Adverse Reactions. Dermatologic • Grade 2 If no improvement within 2 weeks, withhold BRAFTOVI until Grade 0-1. Resume at same dose. • Grade 3 Withhold BRAFTOVI until Grade 0-1. Resume at same dose if first occurrence or reduce dose if recurrent.
• Grade 4 Permanently discontinue BRAFTOVI. Other Adverse Reactions (including Hemorrhage) (see 7. Warnings and Precautions, Hematologic) BRAFTOVI (encorafenib) – Product Monograph Page 10 of 59 • Recurrent Grade 2 or • First occurrence of any Grade 3 Withhold BRAFTOVI for up to 4 weeks.
• If improves to Grade 0-1 or to pretreatment/baseline level, resume at reduced dose. • If no improvement, permanently discontinue BRAFTOVI. • First occurrence of any Grade 4 Permanently discontinue BRAFTOVI, or Withhold BRAFTOVI for up to 4 weeks.
• If improves to Grade 0-1 or to pretreatment/baseline level, then resume at reduced dose. • If no improvement, permanently discontinue BRAFTOVI. • Recurrent Grade 3 Consider permanently discontinuing BRAFTOVI. • Recurrent Grade 4 Permanently discontinue BRAFTOVI.
03. Dose modification of BRAFTOVI when administered with binimetinib or with cetuximab is not recommended for new primary cutaneous malignancies; ocular events other than uveitis, iritis, and iridocyclitis; interstitial lung disease/pneumonitis; cardiac dysfunction; creatine phosphokinase (CPK) elevation; rhabdomyolysis; and venous thromboembolism.
For information on dose modifications for adverse reactions associated with binimetinib, cetuximab, and mFOLFOX6, see the Product Monographs of binimetinib, cetuximab and the individual product components of mFOLFOX6 (leucovorin, fluorouracil and oxaliplatin).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dose modifications for coadministration with strong or moderate CYP3A4 inhibitors Avoid coadministration with strong or moderate CYP3A4 inhibitors during treatment with BRAFTOVI. If coadministration with a strong or moderate CYP3A4 inhibitor is unavoidable, reduce the BRAFTOVI dose according to the recommendations in Table 4.
After the inhibitor has been discontinued for 3 to 5 elimination half-lives, resume the BRAFTOVI dose that was taken prior to initiating the CYP3A4 inhibitor (see 9. Drug Interactions). Table 4 - Recommended dose reductions for BRAFTOVI for coadministration with strong or moderate CYP3A4 inhibitors Planned Dose Dose for Co-administration with Moderate CYP3A4 Dose for Co-administration with Strong CYP3A4 450 mg 225 mg 150 mg 300 mga 150 mg 75 mg 225 mga 75 mg 75 mg 150 mg 75 mg 75 mgb a Planned dose refers to recommended dose reductions for BRAFTOVI for adverse reactions based on dosing recommendations in Table 1 (melanoma) and Table 2 (mCRC).
b Encorafenib exposure at the 75 mg QD BRAFTOVI dosage when co-administered with a strong CYP3A4 inhibitor is expected to be higher than at the 150 mg QD dosage in the absence of a CYP3A4 inhibitor and similar to exposure at the 225 mg QD dosage in the absence of a CYP3A4 inhibitor.
Monitor patients closely for adverse reactions and use clinical judgement when using BRAFTOVI with strong CYP3A4 inhibitors at the 150 mg dose level. 3. Clinical Pharmacology, Pharmacokinetics). 3. Clinical Pharmacology, Pharmacokinetics).
A recommended dose has not been established for patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. 3. Clinical Pharmacology, Pharmacokinetics). A recommended dose has not been established for patients with severe renal impairment (CLcr < 30 mL/min).
1. Indications, Pediatrics). 4. Administration BRAFTOVI (encorafenib) capsules should be swallowed whole with water, and may be taken with or without food. The concomitant administration of encorafenib with grapefruit juice should be avoided (see 9.
Drug Interactions). 5. Missed Dose If a dose of BRAFTOVI is missed, it should not be taken if it is less than 12 hours until the next dose. Do not take an additional dose if vomiting occurs after BRAFTOVI administration but continue with the next scheduled dose.
5. Overdose There is no specific treatment in the event of BRAFTOVI (encorafenib) overdose. Since encorafenib is 86% bound to plasma proteins, hemodialysis is likely to be ineffective in the treatment of overdose with BRAFTOVI. For the most recent information in the […]