Braftovi 75 mg Capsules

BRAFTOVI is a kinase inhibitor indicated: Melanoma • in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test. ( 1.1 , 2.1 ) Colorectal Cancer (CRC) • in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA‑authorized test. ( 1.2 , 2.1 ) • in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA-authorized test, after prior therapy. …

• Melanoma • Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to the initiation of BRAFTOVI. • The recommended dose is 450 mg orally once daily in combination with binimetinib
• CRC • Confirm the presence of BRAF V600E mutation in plasma or tumor specimens prior to the initiation of BRAFTOVI. • The recommended dose is 300 mg orally once daily in combination with o biweekly cetuximab and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) or cetuximab and FOLFIRI (fluorouracil, leucovorin and irinotecan) o weekly cetuximab NSCLC • Confirm the presence of BRAF V600E mutation in tumor or plasma specimens prior to initiating BRAFTOVI. • The recommended dose is 450 mg orally once daily in combination with binimetinib
• Take BRAFTOVI with or without food
• Patient Selection BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma Confirm the presence of a BRAF V600E or V600K mutation in tumor specimens prior to initiating BRAFTOVI [see Warnings and Precautions , Clinical Studies ]
• Information on FDA-authorized tests for the detection of BRAF V600E and V600K mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics
• BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) Confirm the presence of a BRAF V600E mutation in plasma or tumor tissue prior to initiating BRAFTOVI [see Warnings and Precautions , Clinical Studies ]
• If no mutation is detected in a plasma specimen, test tumor tissue. …

Capsules: 75 mg, hard gelatin, stylized "A" on beige cap and "LGX 75mg" on white body. Capsules: 75 mg. ( 3 )

• The safety and effectiveness of BRAFTOVI have not been established
• In pediatric patients

Of the 690 patients with BRAF mutation-positive melanoma who received BRAFTOVI in combination with binimetinib across multiple clinical trials, 20% were aged 65 to 74 years and 8% were aged 75 years and older [see Clinical Studies (14.1) ] . …

• Advise the patient to read the FDA-authorized 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 noncutaneous malignancies
• Advise patients to contact their healthcare provider immediately for change in or development of new skin lesions [see Warnings and Precautions ]
• 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 ] . …

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• Strong or moderate CYP3A4 inhibitors: Avoid coadministration. If unavoidable, reduce BRAFTOVI dosage. ( 2.6 , 7.1 ) • Strong CYP3A4 inducers: Avoid coadministration. ( 7.1 ) • Sensitive CYP3A4 substrates: Avoid coadministration with CYP3A4 substrates (including hormonal contraceptives) for which a decrease in plasma concentration may lead to reduced efficacy of the substrate. ( 7.2 ) • Transporters: Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with BRAFTOVI. …

• New Primary Malignancies, cutaneous and noncutaneous : Can occur. Monitor for malignancies and perform dermatologic evaluations prior to, while on therapy, and following discontinuation of treatment. ( 5.1 ) • Tumor Promotion in BRAF Wild-Type Tumors : Increased cell proliferation can occur with BRAF inhibitors. ( 5.2 ) • Cardiomyopathy : Assess left ventricular ejection fraction (LVEF) before initiating treatment with BRAFTOVI and binimetinib, and after one month of treatment, then every 2 to 3 months thereafter. The safety of BRAFTOVI in combination with binimetinib has not been established in patients with LVEF below 50%. …

The following adverse reactions are described elsewhere in the labeling: • New Primary Malignancies [see Warnings and Precautions (5.1) ] • Tumor Promotion in BRAF Wild-Type Tumors [see Warnings and Precautions (5.2) ] • Cardiomyopathy [see Warnings and Precautions (5.3) ] • Hepatotoxicity [see Warnings and Precautions (5.4) ] • Hemorrhage [see Warnings and Precautions (5.5) ] • Uveitis [see Warnings and Precautions (5.6) ] • QT Prolongation [see Warnings and Precautions (5.7) ] • Embryo-Fetal Toxicity [see Warnings and Precautions (5.8) ] • Risks Associated with BRAFTOVI as a Single Agent [see Warnings and Precautions (5.9) ] • Risks Associated with Combination Treatment [see Warnings and P …

8.1 Pregnancy Risk Summary Based on its mechanism of action, BRAFTOVI can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available clinical data on the use of BRAFTOVI during pregnancy. …

Since encorafenib is 86% bound to plasma proteins, hemodialysis is likely to be ineffective in the treatment of overdose with BRAFTOVI.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Do not use if safety seal under cap is broken or missing. Dispense in original bottle. Do not remove desiccant. …

Tómala en cuanto te acuerdes, salvo que falte poco para la siguiente. En ese caso, sáltate la olvidada. Nunca tomes dos dosis a la vez para compensar. Revisa tu prospecto, porque algunos medicamentos son distintos.