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Vifor Pharma Web Site Terms of Use

PLEASE READ THE FOLLOWING TERMS AND CONDITIONS CAREFULLY BEFORE USING THIS WEB SITE. By using this web site, you agree to these terms and conditions. If you do not agree, please exit and disregard the information contained herein.

1. General Information

This web site is owned and administered by Vifor Pharma Management Ltd., Flughofstrasse 61, CH-8152 Glattbrugg, Switzerland (“Vifor Pharma”). It contains information about the pharmaceutical product Mircera and is intended for US healthcare professionals. This web site and its contents are intended to comply with the laws and regulations of Switzerland. While you can access this web site from outside Switzerland, it is administered and managed in Switzerland.

2. Medical Information

Please note that this website is intended to provide information about Vifor Pharma’s products. While there may also be general information on this web site related to certain medical conditions, their diagnosis and treatment, no information on this web shall be understood as offering personalised medical diagnosis or patient-specific treatment advice. Only a doctor or other healthcare professional, can determine if a product described on this web site is appropriate for an individual patient.

The products and/or their indications mentioned on this web site may not be licensed in your country and/or may be subject to further local variations. For specific product information always consult the local summary of product characteristics.

3. Copyright and Restriction on Use of Material (Noncommercial Use)

This web site is copyright protected. You are not allowed to copy, print, download, edit, share or otherwise use any textual or graphic, video or audio material from this web site without obtaining Vifor Pharma’s prior written approval.

4. Disclaimer / Limitation of Liability

Information and related materials on this web site are subject to change without notice. This web site, and all information and related materials it contains, are provided “as is”. Vifor Pharma will use reasonable efforts to include accurate, complete and up-to-date information on this web site. However, Vifor Pharma disclaims all warranties or representations, express or implied as to the accuracy, completeness, fitness for a particular purpose, suitability, non-infringement functionality or availability of this web site or the information on this web site nor of the frequency that such information is updated. You agree that access to this web site is at your own risk, and that neither Vifor Pharma nor its affiliates, employees or any other party involved in creating or delivering this web site shall be liable for any damages of any kind, including without limitation, any special, direct or indirect, incidental, or consequential or punitive damages (even if Vifor Pharma has been advised of the possibility of such damages) arising out of the access to or use of the information contained on this web site, or any errors or omissions, misprints, out-of- date information, technical or pricing inaccuracies, typographical or other errors appearing on this web site. Vifor Pharma shall not be liable for any damage to or corruption of data and/or computer equipment, including without limitation, due to any viruses or malware that may infect your computer.

5. Links to other Web Sites / Embedded Third Party Software

This web site may contain links to, or be accessed from links on other web sites. This web site may also contain third party programs embedded in this web site. Vifor Pharma does not have responsibility for, or control of and makes no representation or warranty regarding, the contents, availability, operation or performance of such other web sites to which this web site may be linked or from which this web site may be accessed or embedded third party programs.

6. Trademarks

All trademarks, logos and service marks appearing in this web site, and as designated with either a trademark symbol or a font that is different from the surrounding text, are owned by or licensed to Vifor Pharma or its affiliates.

7. No License

Nothing in these Web Site Terms of Use or the web site shall be construed as conferring any license or right of use to any patent, copyright, trademark or any other intellectual property right of Vifor Pharma. Please be advised that Vifor Pharma protects its intellectual property rights to the fullest extent of the law.

8. Submissions (Information provided to Vifor Pharma)

The submission of any unsolicited information, such as questions, comments, or suggestions, to Vifor Pharma, either through this web site or by any other means of communication, shall not be considered confidential. Vifor Pharma shall have no obligation to you of any kind with respect to such information. By submitting any information to Vifor Pharma, you understand that Vifor Pharma shall be free to reproduce, use, disclose, display, exhibit, transmit, perform, create derivative works from, and distribute the information to others without limitation, and to authorize others to do the same. In addition, Vifor Pharma shall be free to use any ideas, concepts, know-how or techniques contained in such information for any purpose whatsoever, including but not limited to, developing, manufacturing and marketing pharmaceutical products and other items incorporating such ideas, concepts, know-how or techniques.

9. Other

These Web Site Terms of Use shall be governed by and construed in accordance with laws of Switzerland. If any provision herein is held to be unlawful, void, or for any reason unenforceable, that provision shall be eliminated or limited to the extent necessary and such elimination or limitation shall not affect the validity and enforceability of any remaining provisions. These Web Site Terms of Use constitute the entire agreement between Vifor Pharma and you relating to the subject matter herein and you agree to indemnify Vifor Pharma for any third party claims or damages resulting from your failure to abide by these Web Site Terms of Use. Vifor Pharma reserves the right to alter or delete material from this web site at any time. Vifor Pharma may, at any time, revise these Web Site Terms of Use by updating this posting. You are bound by any such revisions and should, therefore, periodically review these terms to review the then current Web Site Terms of Use.

Thank you for visiting this web site. If you have any comments or concerns, please contact us at mircera@viforpharma.com.

IMPORTANT SAFETY INFORMATION

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WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE CHRONIC KIDNEY DISEASE:

CHRONIC KIDNEY DISEASE:

  • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
  • No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.
  • Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions.

CANCER:

  • MIRCERA® is not indicated and is not recommended for the treatment of anemia due to cancer chemotherapy. A dose-ranging study of MIRCERA® was terminated early because of more deaths among patients receiving MIRCERA® than another ESA.
  • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.

CONTRAINDICATIONS

MIRCERA® is contraindicated in patients with:

  • Uncontrolled hypertension
  • Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs
  • History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria).

INCREASED MORTALITY, MYOCARDIAL INFARCTION, STROKE, AND THROMBOEMBOLISM

  • In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 to 14 g/dL) to lower targets (9 to 11.3 g/dL), ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups.
  • Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Use caution in patients with coexistent cardiovascular disease and stroke. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks.
  • In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. These adverse reactions included myocardial infarction and stroke.
  • In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.

INCREASED MORTALITY AND/OR INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE IN PATIENTS WITH CANCER

  • MIRCERA® is not indicated and is not recommended for use in the treatment of anemia due to cancer chemotherapy. A dose-ranging trial of MIRCERA® in 153 patients who were undergoing chemotherapy for non-small cell lung cancer was terminated prematurely because more deaths occurred among patients receiving
  • MIRCERA® than another ESA. ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. These findings were observed in studies of patients with advanced head and neck cancer receiving radiation therapy, in patients receiving chemotherapy for metastatic breast cancer or lymphoid malignancy, and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy.

HYPERTENSION

  • MIRCERA® is contraindicated in patients with uncontrolled hypertension.
  • In MIRCERA® clinical studies, approximately 27% of patients with CKD, including patients on dialysis and patients not on dialysis, required intensification of antihypertensive therapy. Hypertensive encephalopathy and/or seizures have been observed in patients with CKD treated with MIRCERA®.
  • Appropriately control hypertension prior to initiation of and during treatment with MIRCERA®. Reduce or withhold MIRCERA® if blood pressure becomes difficult to control. Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions.

SEIZURES

  • Seizures have occurred in patients participating in MIRCERA® clinical studies. During the first several months following initiation of MIRCERA®, monitor patients closely for premonitory neurologic symptoms. Advise patients to contact their healthcare practitioner for new-onset seizures, premonitory symptoms, or change in seizure frequency.

LACK OR LOSS OF HEMOGLOBIN RESPONSE TO MIRCERA®

  • For lack or loss of hemoglobin response to MIRCERA®, initiate a search for causative factors (e.g., iron deficiency, infection, inflammation, bleeding).
  • If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient response to MIRCERA® therapy.

PURE RED CELL APLASIA (PRCA)

  • Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in the postmarketing setting in patients treated with MIRCERA®. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. PRCA was not observed in clinical studies of MIRCERA®.
  • PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which MIRCERA® is not approved).
  • If severe anemia and low reticulocyte count develop during treatment with MIRCERA®, withhold MIRCERA® and evaluate patients for neutralizing antibodies to erythropoietin. Serum samples should be obtained at least a month after the last MIRCERA® administration to prevent interference of MIRCERA® with the assay. Contact Vifor at 1-800-576-8295 to perform assays for binding and neutralizing antibodies. Permanently discontinue MIRCERA® in patients who develop PRCA following treatment with MIRCERA® or other erythropoietin protein drugs. Do not switch patients to other ESAs as antibodies may cross-react.

SERIOUS ALLERGIC REACTIONS

  • Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including MIRCERA®) in the postmarketing setting. Discontinue MIRCERA® therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected.

SEVERE CUTANEOUS REACTIONS

  • Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including MIRCERA®) in the postmarketing setting. Discontinue MIRCERA® therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected.

DIALYSIS MANAGEMENT

  • Patients may require adjustments in their dialysis prescription after initiation of MIRCERA®. Patients receiving MIRCERA® may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis.

ADVERSE EVENTS IN PATIENTS WITH CHRONIC KIDNEY DISEASE

  • Most frequent adverse reactions (≥5%) in adult patients with CKD treated with MIRCERA® were hypertension, diarrhea, nasopharyngitis, upper respiratory tract infection, headache, muscle spasms, procedural hypotension, fluid overload, vomiting, back pain, cough, hypotension, constipation, urinary tract infection, pain in extremity, arteriovenous fistula thrombosis, arteriovenous fistula site complication.
  • In pediatric patients on hemodialysis, all reported adverse reactions regardless of causality (more than 5% incidence) were headache, nasopharyngitis, hypertension, vomiting, bronchitis, abdominal pain, arteriovenous fistula thrombosis, cough, device related infection, hyperkalemia, pharyngitis, pyrexia, thrombocytopenia, and thrombosis in device.

INDICATIONS AND LIMITATIONS OF USE

  • MIRCERA® is indicated for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis and adult patients not on dialysis, and pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA.
  • MIRCERA® is not indicated and is not recommended for use in the treatment of anemia due to cancer chemotherapy, or as a substitute for RBC transfusions in patients who require immediate correction of anemia.
  • MIRCERA® has not been shown to improve quality of life, fatigue, or patient well-being.

Please see full Prescribing Information including Boxed WARNING, and Medication Guide for MIRCERA® (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use.