This policy distinguishes between “Personal Information,” “Anonymous Data” and other information that you provide when using this Site.
“Personal Information” means data that allows someone to identify or contact you, including, for example, your name, address, telephone number, e-mail address, health information, as well as any other non-public information about you that is associated with or linked to any of the foregoing data such as your gender and nationality. “Anonymous Data” is data that does not personally identify you. In addition, there is other technical information that is collected as described more below.
A Note to Users Outside of the United States
Types of Data We Collect
We collect Personal Information and Anonymous Data from you when you visit our site and when you send us information or communications. In addition, there is technical data that we collect about you, such as IP address, cookies, URL and other types of information as described below.
Information Collected via Technology
In addition to using the IP address of your computer to maintain communications with you as you move about the Site, we also may use your IP address to personalize content provided on the Site.
Use of Your Data
- General Use. In general, Personal Information you submit to us is used either to respond to questions that you have, provide you with technical assistance using this Site, or to provide you with information about our products, services, AMAG or other information that might be helpful to you. In addition, we may use your Personal Information to contact you if required by law, as discussed below.
- Opt Out of Use of Personal Information. Visitors to our Site will always have the right to opt out of receiving such information at any time (an “Opt Out Request”) by contacting us at the phone number, mailing address or email provided on this website. After you send us an Opt Out Request, you will no longer receive communications from us, allowing a reasonable period of time for us to update our systems. Should you decide to opt-out of receiving future mailings, we may share your e-mail address with third parties to ensure that you do not receive further communications from them. We will also stop using your Personal Information in a way that identifies you. We may however still use your Personal Information to create Anonymous Data, as described below.
- Creation of Anonymous Data. We may create “Anonymous Data” records from Personal Information by excluding information (such as your name) that makes the data personally identifiable to you. We use this Anonymous Data to analyze request and usage patterns so that we may enhance the content of our Site and services and improve site navigation. We reserve the right to use and disclose Anonymous Data for any purpose.
Disclosure of Your Personal Information
- Disclosures Required By Law. Regardless of any choices you make regarding your Personal Information (as described below), we may disclose Personal Information if it believes in good faith that such disclosure is necessary to (a) comply with relevant laws or to respond to subpoenas or warrants served on Company; or (b) protect or defend the rights or property of Company or users of the products or related services.
Security of Your Personal Information
We use commercially reasonable efforts to protect the security of your Personal Information by employing industry-standard security technologies and procedures to help protect your Personal Information from unauthorized access, use, or disclosure. Only a restricted number of AMAG employees may access the Personal Information we collect. AMAG does not disclose email addresses or any other Personal Information to third parties unless required by law or regulation, or as described above. Even though we have taken steps to protect your Personal Information from being intercepted, accessed, used, or disclosed by unauthorized persons, we cannot fully eliminate security risks associated with Personal Information.
Personal and/or Anonymous Data Collected by Third Parties
We may also receive Personal and/or Anonymous Data about you from other sources like telephone or fax, or from companies that provide our products or services by way of a co-branded or private-labeled website or companies that offer their products and/or services on our website). We may add this information to the information we have already collected from you via our website in order to improve the products and services we provide.
Indication and Dosing
Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD).
The recommended dose of Feraheme is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later, each dose infused over at least 15 minutes while the patient is in a reclined or semi-reclined position.
Important Safety Information
Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.
- Only administer Feraheme when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
- Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration.
- Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated.
Feraheme is contraindicated in patients with:
- Known hypersensitivity to Feraheme or any of its components
- History of allergic reaction to any intravenous iron product
Warnings and Precautions
- Fatal and serious hypersensitivity reactions including anaphylaxis, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, or unresponsiveness have occurred in patients receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity have occurred (pruritus, rash, urticaria, and wheezing). These reactions have occurred following the first dose or subsequent doses in patients in whom a previous Feraheme dose was tolerated.
- Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with parenteral iron products. Carefully consider the potential risks and benefits before administering Feraheme to these patients.
- Only administer Feraheme when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Closely observe patients for signs and symptoms of hypersensitivity including monitoring of blood pressure and pulse during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each infusion.
- In clinical studies predominantly in patients with CKD, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of these subjects. In other trials excluding patients with Stages 4 and 5 CKD, moderate to severe hypersensitivity reactions were reported in 2.6% (26/1,014) of patients treated with Feraheme.
- Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of Feraheme may have more severe outcomes.
- In the post-marketing experience, fatal and serious anaphylactic type reactions presenting with cardiac/ cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of Feraheme may have more severe outcomes.
- Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Monitor for signs and symptoms of hypotension following each Feraheme administration.
- Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme.
- As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.
- The most common adverse reactions (≥ 2%) following the administration of Feraheme are diarrhea, nausea, dizziness, hypotension, constipation, and peripheral edema.
- In clinical trials, adverse reactions leading to treatment discontinuation and occurring in ≥ 2
Feraheme-treatedpatients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.
- The following additional serious adverse reactions have been reported from the post-marketing experience with Feraheme: tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have usually occurred within 30 minutes after the administration of Feraheme. Reactions have occurred following the first dose or subsequent doses of Feraheme.