Tafinlar Package Insert

PURPOSE OF THE POLICY STATEMENT OF THE POLICY PROCEDURES
To establish prior authorization criteria for Tafinlar. STATEMENT OF THE POLICY. Health Alliance Medical Plans will approve the use of Tafinlar when the following criteria have 3.1 Tafinlar [package insert]. GlaxoSmithKline. Research Triangle Park, NC. May 2013. Title: Rheumatoid Arthritis ... Return Document

Objectives - Amazon Web Services
4/22/2014 2 Outline Review currently available oral agents on the market Describe common drug-food interactions and management issues Review the “grapefruit” issue and effects on medication metabolism Discuss the acid suppression therapy issues with specific oral agents Describe issues with supplements, ... Read Here

COVERAGE POLICY - Montana And Idaho Health Insurance
Tafinlar is NOT covered for members with the following criteria: A. Use not approved by the FDA; and B. The use is unapproved and not supported by the literature or evidence as an accepted off-label use. (see Off-Label Use Policy for determining ‘accepted use’) REFERENCES . 1. Tafinlar® (dabrafenib) Package Insert. GlaxoSmithKline. ... Return Doc

409 Pharmacy- BRAF Kinase And MEK Inhibitors SP
Mekinist™(trametinib) is not indicated for the treatment of patients who have received prior BRAF-inhibitor therapy We cover Tafinlar® (dabrafenib) for the treatment of unresectable or metastatic melanoma when all of the following criteria are met6: Unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved ... Fetch Content

MEDICATION SAFETYINSECONDS
Pradaxa® (dabigatran) product package insert. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; January 2015. 3. Tafinlar® (dabrafenib) product package insert. Research Triangle Park, NC: GlaxoSmithKline; January 2014. (continued from page 1) Figure 1. Mixed case (tallMAN) lettering for dabrafenib was imple- ... Access Content

Dabrafenib/Trametinib Combination Therapy For Melanoma: A ...
• Possible treatment-related adverse events (AEs) should be discussed with patients prior to initiating trametinib/dabrafenib therapy. Patients should be informed of the importance of immediately reporting ... Get Doc

SAFETY DATA SHEET - MsdsDigital
Information/package insert/product label or consult their pharmacist or physician. For health and safety information for individual ingredients used during manufacturing, refer to the appropriate safety data sheet for each ingredient. Uses advised against No other uses are advised. 1.3. Details of the supplier of the safety data sheet ... Access Doc

Specialty In The Pipeline: Oral Oncolytics
Tafinlar (dabrafenib) [package insert] Novartis Pharmaceuticals Corporation East Hanover New Jersey; January 2018 Tyrosine Kinase Receptor cell differentiation, migration, angiogenesis, cell survival ... Retrieve Here

Blue Cross And Blue Shield Of Vermont And The Vermont Health ...
TAFINLAR® (dabrafenib) DESCRIPTION: Dabrafenib is an inhibitor of some mutated forms of BRAF kinases with in vitro IC50 values of 0.65, 0.5, and 1.84 nM for BRAF V600E, BRAF V600K, and BRAF V600D enzymes, ... Read Content

(dabrafenib) And Mekinist® (trametinib) In Patients With ...
M-DAB-1189912 5/18 May 30, 2018 Submission Request National Comprehensive Cancer Network ® (NCCN ®) RE: Clinical Evidence in Support of Tafinlar ® (dabrafenib) and Mekinist ... Retrieve Doc

SAFETY DATA SHEET - Msdsdigital.com
Information/package insert/product label or consult their pharmacist or physician. For health and safety information for individual ingredients used during manufacturing, refer to the appropriate safety data sheet for each ingredient. Restrictions on use No other uses are advised. Details of manufacturer or importer Manufacturer GlaxoSmithKline ... View Document

Specialty Drug Utilization Criteria Contents
TAFINLAR ® ‡(DABRAFENIB • See package insert for dose variations with elevated liver enzymes, neutropenia, and thrombocytopenia ; How Supplied • 80 mg/4 mL, 200mg/10 mL and 400 mg/20 mL single-use vials for IV administration ... Document Viewer

Regulatory Perspective For Companion Diagnostics
Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) • Labeling (package insert) 11. Overview of CoDx Validation Tafinlar (dabrafenib) THxID BRAF Kit bioMérieux Inc. Zelboraf (vemurafenib) cobas 4800 BRAF V600 Mutation Test ... Access Full Source

Clinical Pharmacy Program Guidelines For Tafinlar 1.
Tafinlar will be approved for uses not outlined above if supported by The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium. Tafinlar [package insert]. Research Triangle Park, NC: GlaxoSmithKline; June 2017. 2. The NCCN Drugs and Biologics Compendium (NCCN ... Doc Retrieval

410697 C THxID™-BRAF - Biomerieux-usa.com
Selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar®] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist™]. ... Content Retrieval

WARNINGS AND PRECAUTIONS - GSK Source - Home Page
SELZENTRY (maraviroc) tablets, for oral use SELZENTRY (maraviroc) oral solution Initial U.S. Approval: 2007 WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. • Hepatotoxicity has been reported which may be preceded by severe rash or other features of a systemic allergic reaction (e.g., fever, ... Content Retrieval

HIGHLIGHTS OF PRESCRIBING INFORMATION Pediatric Patient ...
Sofosbuvir-containing regimen, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. ... Access Doc