Sorafenib Package Insert

HIGHLIGHTS OF PRESCRIBING INFORMATION These Highlights Do Not ...
See full prescribing information for complete boxed warning. Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended [see Warnings and Precautions (5.1)]. ... Document Retrieval

National PBM Monograph Template Rev20091005
Sorafenib has demonstrated that a clinical benefit can be obtained in the advanced HCC population. Remaining questions include: Should sorafenib be used in patients with Child-Pugh B liver dysfunction? How should sorafenib be dosed in those with hepatic and/or renal impairment? References: 1. Sorafenib (Nexavar®) Package Insert. ... Return Doc

RENAL CELL CARCINOMA TREATMENT REGIMENS (Part 1 Of 2)
By the FDA for the treatment of advanced RCC: sunitinib, sorafenib, pazopanib, axitinib, temsirolimus, everolimus, and bevacizumab in combination with interferon. • Prior to targeted therapies, systemic treatment options were limited to cytokine therapy, notably IL-2 and ... Retrieve Content

Contribution Of OATP1B1 And OATP1B3 To The Disposition Of ...
Contribution of OATP1B1 and OATP1B3 to the Disposition of Sorafenib and Sorafenib-Glucuronide sorafenib-glucuronide and suggest a role for these transporters in the in vivo handling of glucuronic acid (Caprelsa package insert; see: www.astraze-neca-us.com ... Retrieve Here

PHARMACY COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 3/17/16 ...
Criteria for initial therapy: Nexavar (sorafenib) is considered medically necessary and will be approved when ALL of the following criteria are met: 1. Prescriber is an Oncologist . 2. Individual is 18 years of age or older Package Insert. Revised by manufacturer 11-2013. Accessed 03-03-2016. ... Fetch Doc

Nexavar® (sorafenib) For Kidney Cancer
Adapted from the NEXAVAR (sorafenib) package insert. Bayer HealthCare Pharmaceuticals Inc, 2014 KCA disclaimer statement: you should rely primarily upon your doctor for medical information. www.kidneycancer.org. Title: Nexavar® (sorafenib) for Kidney Cancer ... Get Content Here

Reference ID: 4177271 - Genentech
3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Unresectable or Metastatic Melanoma ZELBORAF® is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ... Access Doc

*Sections Or Subsections Omitted From The Full Prescribing ...
3 of 13 partners of reproductive potential during therapy and for 3 months after the final dose of ERIVEDGE. Advise pregnant women of the potential risk to a fetus [see Use in Specific Populations (8.1, 8.3) and Clinical Pharmacology (12.1)]. ... Fetch Document

CONTRAINDICATIONS------------------------------
2.6 Preparation of VIDAZA VIDAZA is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 The VIDAZA vial is single-dose and does not contain any preservatives. Discard unused portions of each vial properly [see How Supplied/Storage and Handling (16)]. Do not save any unused portions for later administration. ... Get Doc

EISAI AND MERCK & CO., INC., KENILWORTH, N.J., U.S.A ...
Sorafenib, thereby demonstrating the effect of LENVIMA in patients with HCC resulting from HBV. (For the detailed data, please refer to “Notes for Editors” below.) In the China package insert, the five most common adverse reactions observed in patients treated with ... Get Content Here

Sorafenib In Differentiated Thyroid Carcinoma
Sorafenib in DTC Monograph Addendum Updated version may be found at www.pbm.va.gov or vaww.pbm.va.gov 1 Sorafenib in Differentiated Thyroid Carcinoma National Drug Monograph Addendum May 2015 (for more detailed information refer to the product package insert) Comments ... Document Viewer

Nimotuzumab - Wikipedia
Nimotuzumab (h-R3, BIOMAb EGFR, Biocon, India; TheraCIM, CIMYM Biosciences, Canada; Theraloc, Oncoscience, Europe, CIMAher, Center of Molecular Immunology, Havana, Cuba) is a humanized monoclonal antibody that as of 2014 had orphan status in the US and EU for glioma, and marketing approval in India, China, and other countries for squamous cell carcinomas of the head and neck, and was ... Read Article

HIGHLIGHTS OF PRESCRIBING INFORMATION EMEND Capsules And ...
3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) EMEND for oral suspension,in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: ... Get Content Here

Targeted Therapy Of Renal Cell Carcinoma - Researchgate.net
Sorafenib, and sunitinib), as well as emerging treatments and some surprising toxicity data from the 2006 Annual Meeting of the Sutent [package insert]. New York, NY: ... Fetch Doc

RENAL CELL CARCINOMA CHEMOTHERAPY REGIMENS
RENAL CELL CARCINOMA CHEMOTHERAPY REGIMENS The selection, dosing, and administration of anti-cancer agents and the management of associated toxicities are complex. Sorafenib (Nexavar) 11, Sutent [package insert]. New York, NY: Pfizer Labs; 2010. 3. Gore ME, Szczylik C, Porta C, et al ... Read More

Systemic Therapy Of Hepatocellular Carcinoma
Sorafenib [package insert]. Leverkusen, Germany. Systemic Therapy of HCC 423. Safety considerations in the clinic when treating with sorafenib are important for providers. Cardiac ischemia in the SHARP trial was reported to be 2.7%. Caution ... View Document

LETTERS TO THE EDITOR - Mayoclinicproceedings.org
To the Editor: Sorafenib is a multikinase inhibitor recently approved by the US Food and Drug Administration for use in the treatment of metastatic renal cell carcinoma. ... Content Retrieval

Clinical Policy: Sorafenib (Nexavar)
Sorafenib. In: National Comprehensive Cancer network Drug and Biologics Compendium. Available at ncccn.org. Accessed January 10, 2018. Updated DTC indication per package insert Edited studies to reflect those focusing on FDA-approved indications . ... Fetch This Document

Systemic Therapy For Hepatocellular Carcinoma And ...
Interrupt sorafenib treatment until toxicity resolves to grade 0–1. When resuming treatment, decrease sorafenib dose by 1 dose level (400 mg daily or 400 mg every other day) Third occurrence Discontinue sorafenib treatment (Data from Nexavar (sorafenib) [package insert]. West Haven, CT: Bayer Healthcare; 2005.) 190 Chung ... Access Document