Does Bayer HealthCare offer reimbursement assistance? Yes. In most cases, your treatment will be covered by your insurance carrier. If you need help determining whether your treatment will be covered, call the Reimbursement Support Line at 1-87.REACH.4IT (1.877.322.4448) between 9 AM and 8 PM EST, Monday through Friday. In the event that your treatment is not covered, Bayer HealthCare will work with your physician's office and your insurance company to help you get the treatment you need. In addition, Bayer HealthCare offers a patient assistance program that provides treatment to uninsured patients who meet the program requirements.

For reimbursement assistance for Nexavar, please visit the REACH website. The REACH (Resources for Expert Assistance and Care Helpline) Program provides help with understanding insurance coverage and finding other programs to financially assist patients receiving Nexavar.

 

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REACH Program
The REACH (Resources for Expert Assistance and Care Helpline) Program
provides help with understanding insurance coverage and finding other programs to financially assist patients receiving Nexavar.

 

Nexavar Important Safety Information

Name of the medicinal product: Nexavar^® 200 mg film-coated tablets.

Qualitative and quantitative composition: 200 mg sorafenib (as tosylate)

Indication:

1. Treatment of hepatocellular carcinoma.
2. Treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

Contraindications: Hypersensitivity to sorafenib or to any of the excipients.

Warnings and Precautions: Hand-foot skin reaction and rash, usually CTC grade 1 and 2. Increased incidence of arterial hypertension (usually mild to moderate, early in the course of treatment). Blood pressure should be monitored regularly and treated as appropriate. Increased risk of bleeding. Increased incidence of cardiac ischaemia/infarction. Gastrointestinal perforation in less than 1%; sorafenib to be discontinued. Levels of sorafenib may be increased in patients with severe hepatic impairment. Infrequent bleeding events or elevations in INR have been reported in some patients taking warfarin concomitantly. Patients on such therapy should be monitored. Temporary treatment interruption and/or dose modification or discontinuation may be considered, depending on the severity of the observed adverse reactions. No formal studies on wound healing have been conducted. Temporary interruption of sorafenib therapy is recommended in patients undergoing major surgical procedures. Experience of use in the elderly is limited and cases of renal failure have been reported. High risk patients according to MSKCC prognostic group were not included in the phase III study in renal cell carcinoma and benefit-risk has not been evaluated in these patients. Caution is recommended when administering sorafenib with compounds that are metabolised/eliminated predominantly by the UGT1A1 (e.g. irinotecan) or UGT1A9 pathways. Caution is recommended when sorafenib is co-administered with docetaxel. The risk of reduced plasma concentrations of sorafenib should be considered before starting a treatment course with antibiotics.

Undesirable effects: Very common: lymphopenia, hypophosphataemia, haemorrhage (incl. gastrointestinal, respiratory tract, cerebral), hypertension, diarrhoea, nausea, vomiting, rash, alopecia, hand-foot syndrome (palmar plantar erythrodysaesthesia syndrome), erythema, pruritus, fatigue, pain (mouth, abdominal, bone, tumour, headache), increased amylase and lipase. Common: leucopenia, neutropenia, anaemia, thrombocytopenia, anorexia, depression, peripheral sensory neuropathy, tinnitus, hoarseness, constipation, stomatitis (including dry mouth and glossodynia), dyspepsia, dysphagia, dry skin, dermatitis exfoliative, acne, skin desquamation, arthralgia, myalgia, renal failure, erectile dysfunction, asthenia, fever, influenza like illness, weight decrease, transient increase in transaminases. Uncommon: folliculitis, infection, hypersensitivity reactions (including skin reactions and urticaria), hypothyroidism, hyperthyroidism, hyponatraemia, dehydration, reversible posterior leukoencephalopathy, myocardial ischaemia and infarction, congestive heart failure, hypertensive crisis, rhinorrhea, gastro oesophageal reflux disease, pancreatitis, gastritis, gastrointestinal perforations, increase in bilirubin, jaundice, cholecystitis, cholangitis, eczema, erythema multiforme, keratoacanthoma / squamous cell cancer of the skin, Stevens-Johnson syndrome, gynaecomastia, increase in alkaline phosphatase, INR abnormality, prothrombin level abnormality. On prescription only.

Date of Revision of the Text: July 2009. Please note! For current prescribing information refer to the package insert and /or contact your local Bayer Schering Pharma Organisation. Bayer Schering Pharma AG, 13342 Berlin, Germany.