Vemurafenib Package Insert

MELANOMA TREATMENT REGIMENS (Part 1 Of 3)
MELANOMA TREATMENT REGIMENS (Part 1 of 3) ‡ Vemurafenib, dabrafenib, and trametinib are recommended only for patients with V600 mutation of the BRAF gene documented Yervoy [package insert]. Princeton, NJ: Bristol-Myers Squibb; ... Retrieve Here

GUIDE FOR KEYTRUDA
GUIDE FOR KEYTRUDA . Before prescribing KEYTRUDA, please read the Selected Safety Information on pages 7–11 and the accompanying Prescribing Information. The Medication Guide also is available. 2 INDICATIONS AND USAGE ... Fetch Document

Ipilimumab - Wikipedia
Ipilimumab (trade name Yervoy) is a monoclonal antibody that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.. Cytotoxic T lymphocytes (CTLs) can recognize and destroy cancer cells. However, an inhibitory mechanism interrupts this destruction. ... Read Article

SPECIALTY GUIDELINE MANAGEMENT - Provider.carefirst.com
CVS Caremark is an independent company that provides pharmacy benefit management services to CareFirst BlueCross BlueShield and CareFirst BlueChoice, Inc. members. 1. Zelboraf [package insert]. South San Francisco, CA: Genentech USA, Inc.; November 2017. therapy with vemurafenib in ... Read Here

TEST UPDATE - PAML
With Vemurafenib, a potent inhibitor of mutated BRAF recently approved by the FDA. The package insert requires confi rmation of BRAF V600E mutation positivity prior to treatment with Vemurafenib. The BRAF V600E mutation can be detected in 40-60% of cutaneous melanomas. 3. ... Document Retrieval

Drug Information Bulletin - Ipapharma.org
Vemurafenib Risk of acute kidney injury The MHLW and the PMDA have announced that the package insert for vemurafenib (Zelboraf®) has been updated to include the risk of acute kidney injury as a clinically significant adverse reaction. In addition, the company core datasheet (CCDS) has also been updated. ... Get Content Here

BRAF Mutation Testing In Solid Tumors
Simultaneously approved with the launch of vemurafenib to selectcandidatesforthis targetedtherapy.Thecobasassayis a real-time PCR assay that qualitatively detects the V600E1 mutation in formalin-fixed, paraffin-embedded (FFPE) human melanoma tissues (directional package insert: cobas 4800 BRAF Mutation Test; Roche Molecular Systems Inc., ... Doc Viewer

An Overview Of Transporter Information In Package Inserts Of ...
PI package insert PK pharmacokinetics PD pharmacodynamics SLC solute carrier VMAT vesicular monoamine transporter INTRODUCTION Transporters are membrane-bound proteins that control the access of endogenous compounds and xenobiotics (drugs) to various sites in the human body. They can influ-ence both drug pharmacokinetics (PK) and pharmacody- ... Retrieve Content

MELANOMA TREATMENT REGIMENS (Part 1 Of 2)
Improved survival with vemurafenib in melanoma with BRAF V600E mutation. Zelboraf. [package insert]. San Francisco, CA: Genentech; 2011. 13. Eton O, Legha SS, Bedikian AY et al. Sequential biochemo-therapy versus chemotherapy for metastatic melanoma: results from a phase III randomized trial. ... View Document

Reference ID: 4212951 - Genentech
Based on its mechanism of action, vemurafenib may promote growth and development of malignancies [refer to the Full Prescribing Information for vemurafenib]. In Trial 1, 0.8% of patients in the COTELLIC with vemurafenib arm and 1.2% of patients in the vemurafenib arm developed non-cutaneous malignancies. ... Retrieve Document

1. Zelboraf FDA-approved Test. BRAF V600
Zelboraf™ (vemurafenib) is a kinase inhibitor indicated for the treatment of patients with 1. Zelboraf [package insert]. South San Francisco, CA: Genentech, Inc.; August 2015. 2. The NCCN Drugs and Biologics Compendium (NCCN Compendium™). Available at ... Retrieve Content

WHO Pharmaceuticals NEWSLETTER 2
Updated the local package insert of canagliflozin (Invokana®) to include the risk of lower limb amputation. In addition, the product registration holder of canagliflozin has issued a DHPC letter on this safety issue in agreement with the NPRA. Canagliflozin is a sodium glucose co-transporter 2 that is used for the management of Type II ... Retrieve Doc

409 Pharmacy- BRAF Kinase And MEK Inhibitors SP
BRAF Kinase and MEK inhibitors for Unresectable or Metastatic Melanoma Table of Contents [package insert]. South San Francisco, CA: Genentech, USA, Inc.: 2012. vemurafenib in previously treated patients with BRAF V600E mutation-postitive metastatic melanoma. ... Retrieve Content

Cotellic/Zelboraf - Themelanomanurse.org
Missed dose of Zelboraf can be taken up to 4 hours prior to the next dose. Do not take a double dose to make up for a missed dose. For more information see Genentech USA, Inc. (2016). ... Fetch Full Source

WHO Pharmaceuticals NEWSLETTER No.
Vemurafenib and Tumour lysis syndrome .. 25 Feature Summary of Recommendations from the Twelfth Meeting of the WHO package insert and the addition of the following texts to the subsection of the “Clinically significant adverse reactions” under “Adverse ... Content Retrieval

Package Leaflet: Information For The User YERVOY 5 Mg/ml ...
Package leaflet for this medicine. If you have any questions about nivolumab, please ask your doctor. 2. What you need to know before you use YERVOY . You should not be given YERVOY if you are allergic to ipilimumab or any of the other ingredients of this medicine (listed in Section 6 "Contents of the pack and other information"). ... View Document

COTELLIC (cobimetinib) - Provider.carefirst.com
A. Cotellic is used in combination with vemurafenib . B. Tumor is positive for BRAF V600E or V600K mutation . III. CONTINUATION OF THERAPY . All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria. IV. REFERENCES . 1. Cotellic [package insert]. ... Document Retrieval

Proposed Additions And Deletions To The NIOSH Hazardous Drug ...
Proposed Additions and Deletions to the NIOSH Hazardous Drug List 2014 Established Name Proprietary Name Drug Class Formulation(s) Dosage FDA pregnancy Category Drug Package Insert Drugs Recommended by NIOSH to be Added to the 2012 Hazardous Drug List abacavir Ziagen antiviral tablets, oral solution 600mg C PI abiraterone ... Content Retrieval

Cobimetinib - Wikipedia
Cobimetinib (trade name Cotellic) is a MEK inhibitor developed by Exelixis and Genentech ().It is used in combination with vemurafenib, a BRAF inhibitor, to treat melanoma. In November 2015, the U.S. Food and Drug Administration approved cobimetinib for unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib (Zelboraf). ... Read Article

Molecular And Biomarker Testing: Their Role In Cancer ...
Sensitive to the drug vemurafenib. Both the package insert for this drug and the NCCN Melanoma Guideline specify that the mutation test must be done to determine which patients can benefit from vemurafenib treatment. These tests are critical tools in the practice of oncology. However, new tests are being developed that, ... Get Content Here

Prior Authorization Approval Criteria - Fchp.org
No prior BRAF-inhibitor therapy (such as dabrafenib, vemurafenib, etc) Criteria for continuation of therapy: Patient’s therapy has been re-evaluated within the last 12 months, unless a re-evaluation is not clinically appropriate for the patient’s condition at this time. ... Read Here

Drug News Issue 54 - Drugoffice.gov.hk
DILI reported with Zelboraf ® (vemurafenib) based on the above study. Healthcare professionals are reminded to monitor the risks of liver injury, as indicated in the local package insert for Zelboraf ®. In Hong Kong, Zelboraf Film-coated Tab 240mg (HK-61970) is registered by Roche HK Ltd., and is ... Access Document