BRAFTOVI 75 MG — DIN 02513099

What is BRAFTOVI?

BRAFTOVI 75 MG contains ENCORAFENIB : 75 MG. It is listed in the Health Canada Drug Product Database under DIN 02513099, held by PFIZER CANADA ULC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 05-Jul-2021. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is BRAFTOVI used for?

BRAFTOVI is indicated in combination with cetuximab and mFOLFOX6 for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by a validated test. This indication has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization. BRAFTOVI is also indicated in combination with binimetinib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test. Additionally, it is indicated in combination with cetuximab for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by a validated test, after prior therapy. These latter two indications have been issued market authorization without conditions.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

BRAFTOVI capsules should be swallowed whole with water, with or without food. The concomitant administration of encorafenib with grapefruit juice should be avoided. If a dose 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. For Melanoma: The recommended dose of BRAFTOVI is 450 mg (six 75 mg capsules) taken orally once daily in combination with binimetinib until disease progression or unacceptable toxicity. For mCRC: The recommended dose of BRAFTOVI is 300 mg (four 75 mg capsules) taken orally once daily in combination with cetuximab and mFOLFOX6 (leucovorin, fluorouracil and oxaliplatin) or in combination with cetuximab until disease progression or unacceptable toxicity. For cetuximab dosing in combination with BRAFTOVI and mFOLFOX6: Administer cetuximab on a biweekly schedule. Initial and subsequent doses: 500 mg/m² administered as a 120-minute intravenous infusion every 2 weeks. For cetuximab dosing in combination with BRAFTOVI: Administer cetuximab on a weekly schedule. Initial dose: 400 mg/m² administered as a 120-minute intravenous infusion. Subsequent doses: 250 mg/m² administered as a 60-minute infusion every week. Dose reductions for BRAFTOVI in melanoma: First dose reduction to 300 mg once daily, second dose reduction to 225 mg once daily. Permanently discontinue if unable to tolerate 225 mg once daily. Dose reductions for BRAFTOVI in mCRC: First dose reduction to 225 mg once daily, second dose reduction to 150 mg once daily. Permanently discontinue if unable to tolerate 150 mg once daily. Avoid coadministration with strong or moderate CYP3A4 inhibitors. If unavoidable, reduce BRAFTOVI dose as per Table 4. After inhibitor discontinuation, resume prior BRAFTOVI dose.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

BRAFTOVI (encorafenib) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Warnings and precautions

Serious adverse drug reactions identified in clinical trials include New Primary Cutaneous Malignancies, Major Hemorrhagic Events, Uveitis, Venous Thromboembolism, and QT Prolongation. BRAFTOVI is indicated for use in combination with binimetinib, cetuximab, or cetuximab and mFOLFOX6. Confirmation of BRAF V600 mutation using a validated test is required. BRAFTOVI may promote malignancies in BRAF wild-type cells. When used as a single agent, BRAFTOVI increases the risk of certain adverse reactions compared to combination therapy. Patients should be monitored for new primary malignancies, both cutaneous and non-cutaneous. Dermatologic evaluations should be performed prior to and every 2 months during treatment, and for up to 6 months after discontinuation. Suspicious skin lesions should be managed with excision and dermatopathologic evaluation. Patients should be instructed to inform their physician immediately if new skin lesions develop. Permanently discontinue BRAFTOVI for RAS mutation-positive non-cutaneous malignancies. BRAFTOVI is associated with dose-dependent QTc interval prolongation. Monitor patients at risk for QTc prolongation, correct hypokalemia and hypomagnesemia, and withhold, reduce dose, or permanently discontinue for QTc > 500 ms. Venous thromboembolism (VTE) has occurred in patients. Hyperglycemia can occur; monitor glucose regularly and adjust anti-diabetic treatments accordingly. Advise patients to report symptoms of severe hyperglycemia. Hemorrhage can occur; withhold, reduce dose, or permanently discontinue based on severity. Hepatotoxicity can occur; monitor liver laboratory tests before and monthly during treatment, and as clinically indicated. Uveitis has been reported; assess patients for visual disturbances and perform ophthalmologic examination if symptoms occur. Withhold, reduce dose, or permanently discontinue based on severity. BRAFTOVI can cause fetal harm; verify pregnancy status in females of reproductive potential and advise effective non-hormonal contraception during treatment and for 2 weeks after the final dose. Advise male patients with female partners who are pregnant or could become pregnant to use effective barrier contraception during treatment and for at least 1 week after the last dose. Severe cutaneous adverse reactions (SCARs) including SJS, TEN, DRESS, and AGEP have been reported; monitor closely for skin reactions and withdraw encorafenib and binimetinib or cetuximab if SCARs appear. Rash can occur; perform dermatologic evaluation and withhold, reduce dose, or permanently discontinue based on severity.