Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Inform patients of the following:
New Primary Malignancies
Advise patients that BRAFTOVI increases the risk of developing new primary cutaneous and non-cutaneous malignancies. Advise patients to contact their healthcare provider immediately for change in or development of new skin lesions [see Warnings and Precautions (5.1)].
Tumor Promotion in BRAF Wild-Type Tumors
Advise patients of the need to confirm BRAF V600E or V600K mutation prior to initiating BRAFTOVI [see Warnings and Precautions (5.2)].
Cardiomyopathy
Advise patients to report any symptoms of heart failure to their healthcare provider [see Warnings and Precautions (5.3)].
Hepatotoxicity
Advise patients that serial testing of serum liver tests (ALT, AST, bilirubin) is recommended during treatment with BRAFTOVI. Instruct patients to report symptoms of liver dysfunction including jaundice, dark urine, nausea, vomiting, loss of appetite, fatigue, bruising, or bleeding [see Warnings and Precautions (5.4)].
Hemorrhage
Advise patients to notify their healthcare provider immediately with any symptoms suggestive of hemorrhage, such as unusual bleeding [see Warnings and Precautions (5.5)].
Uveitis
Advise patients to contact their healthcare provider if they experience any changes in their vision [see Warnings and Precautions (5.6)].
QT Prolongation
Advise patients that BRAFTOVI can cause QTc interval prolongation and to inform their physician if they have any QTc interval prolongation symptoms, such as syncope [see Warnings and Precautions (5.7)].
Embryo-Fetal Toxicity
Lactation
Advise women not to breastfeed during treatment with BRAFTOVI and for 2 weeks after the last dose [see Use in Specific Populations (8.2)].
Infertility
Advise males of reproductive potential that BRAFTOVI may impair fertility [see Use in Specific Populations (8.3)].
Drug Interactions
Coadministration of BRAFTOVI with a strong or moderate CYP3A inhibitor may increase encorafenib concentrations; coadministration of BRAFTOVI with a strong CYP3A inducer may decrease encorafenib concentrations. Advise patients that they may need to avoid certain medications while taking BRAFTOVI and to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products. Advise patients to avoid grapefruit and grapefruit juice while taking BRAFTOVI [see Drug Interactions (7.1)].
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Inform patients of the following:
New Primary Malignancies
Advise patients that BRAFTOVI increases the risk of developing new primary cutaneous and non-cutaneous malignancies. Advise patients to contact their healthcare provider immediately for change in or development of new skin lesions [see Warnings and Precautions (5.1)].
Tumor Promotion in BRAF Wild-Type Tumors
Advise patients of the need to confirm BRAF V600E or V600K mutation prior to initiating BRAFTOVI [see Warnings and Precautions (5.2)].
Cardiomyopathy
Advise patients to report any symptoms of heart failure to their healthcare provider [see Warnings and Precautions (5.3)].
Hepatotoxicity
Advise patients that serial testing of serum liver tests (ALT, AST, bilirubin) is recommended during treatment with BRAFTOVI. Instruct patients to report symptoms of liver dysfunction including jaundice, dark urine, nausea, vomiting, loss of appetite, fatigue, bruising, or bleeding [see Warnings and Precautions (5.4)].
Hemorrhage
Advise patients to notify their healthcare provider immediately with any symptoms suggestive of hemorrhage, such as unusual bleeding [see Warnings and Precautions (5.5)].
Uveitis
Advise patients to contact their healthcare provider if they experience any changes in their vision [see Warnings and Precautions (5.6)].
QT Prolongation
Advise patients that BRAFTOVI can cause QTc interval prolongation and to inform their physician if they have any QTc interval prolongation symptoms, such as syncope [see Warnings and Precautions (5.7)].
Embryo-Fetal Toxicity
Lactation
Advise women not to breastfeed during treatment with BRAFTOVI and for 2 weeks after the last dose [see Use in Specific Populations (8.2)].
Infertility
Advise males of reproductive potential that BRAFTOVI may impair fertility [see Use in Specific Populations (8.3)].
Drug Interactions
Coadministration of BRAFTOVI with a strong or moderate CYP3A inhibitor may increase encorafenib concentrations; coadministration of BRAFTOVI with a strong CYP3A inducer may decrease encorafenib concentrations. Advise patients that they may need to avoid certain medications while taking BRAFTOVI and to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products. Advise patients to avoid grapefruit and grapefruit juice while taking BRAFTOVI [see Drug Interactions (7.1)].
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