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Privacy Policy

Key takeaways:

  • What personal data we collect when you use our website
  • What we do with your personal data
  • How long we store your personal data and why
  • Who may have access to your personal data
  • Your rights around your personal data

What personal data do we collect and why?

Through or in connection with this website we, Vifor Pharma Management Ltd., collect and use personal data such as name, address, telephone number, email address or other information that relates to an identified or identifiable natural person as follows: 

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  • If you send us a question or other communication e.g. by email. We use that information to respond to your request;
  • If you send us an adverse event report. We record and process that information in accordance with our legal obligations;
  • Through our use of a website analytics service to track the use of the website using cookies, to help us to understand the use of our website and how we can improve it. This service involves the collection and use of the IP (internet protocol) address of your computer or device. For more information see our cookie policy. The IP address will only be used to identify you in exceptional circumstances, such as for criminal investigations.

We ask you to indicate whether you are a US healthcare professional. This information is collected anonymously.

With whom do we share your personal data?

If you send us a request, we may share it internally or with other companies of the Vifor Pharma Group to collect the information required to respond to your request. You can see the location of entities of the Vifor Pharma Group at http://www.viforpharma.com/en/about- vifor-pharma/global-presence

We work with third-party service providers who help us to collect and process safety information or who provide other services such as technical support or data hosting. These service providers may have access to your personal data in order to provide the services.

We may also disclose your personal data to: 

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  • official authorities where applicable by law (e.g. reporting adverse events for pharmacovigilance), court order or other legal proceeding;
  • our legal and other expert advisors;
  • distributors, license partners or other companies with whom we collaborate for the purposes specified in this privacy notice.

These service providers and collaboration partners are legally bound to keep all personal data confidential and to use such information only to perform the services for which we engaged them or to comply with legal obligations. We ensure that appropriate safeguards are in place to protect your personal data.

How long do we store your personal data?

We store your personal data for as long as required to fulfill the purposes outlined in this privacy policy, unless a longer or shorter retention period is required or permitted by law. By law we must store your personal data relating to safety information for at least ten years after the medicinal product is no longer available.

What are your rights regarding your personal data?

You are entitled at any time to access your personal data that we hold. To the extent legally permissible, you can request that your data be deleted, that errors be corrected or that processing of your personal data be restricted. You can also object to our processing of your personal data.

If you would like to exercise your rights, please contact us as described in the section “How to contact us” below. Please note that applicable laws may prevent us from complying with certain requests, such as to delete safety information or to restrict our processing of it.

Your California privacy rights

We do not share information that we collect with third parties for the third party’s direct marketing purposes. Some web browsers may transmit “do-not-track” signals to the websites with which the user communicates. Because of differences in how web browsers incorporate and activate this feature, it is not always clear whether users intend for these signals to be transmitted, or whether they are even aware of them. Because there is currently no industry standard concerning what, if anything, websites should do when they receive such signals, we currently do not take action in response to them. If and when a final standard is established and accepted, we will reassess how to respond to these signals.

Links to other sites

We may provide links to other websites that we believe are useful. We cannot guarantee the standards or privacy policies of the websites to which we link. We are not responsible for the content of any website which is not owned by a Vifor Pharma Group company.

Personal data of children

This website is intended for adult use only, meaning anyone 18 years of age or older. We do not knowingly collect personal data from anyone under the age of 18 through this website. We assume that any person who provides their personal data through this website is at least 18 years old. If you would like to contact us about personal data that your child may have provided without your consent, please see the “How to contact us” section below. If we learn that we have collected personal data from a child under the age of 18, we will delete such information promptly.

Updates to this privacy policy

We may update this privacy policy from time to time. In this case, we will post updated versions on this page. If we make significant changes to our privacy policy, we will display a prominent notice of the change on this website so that users are aware of the change. A revised privacy policy will apply only to personal data collected after its effective date (see below).

How to contact us

Please contact us if you have any questions about this privacy policy or if you wish to exercise your privacy rights:

Effective date: December 6, 2019

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.