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Terms And Condition Of Use

Last updated: June 1, 2024

WELCOME!

Please read these terms and conditions of use (“Terms”) carefully. This page describes the terms and conditions governing your use of https://www.pharmacosmos.us/ and any of our other websites, their respective subdomains, and software applications containing a link to these Terms (in each case, the “Site”). These Terms are a binding agreement between you and, if applicable, the company or other legal entity you represent (collectively, “you” or “your”) and Pharmacosmos Therapeutics Inc., and its applicable subsidiaries or affiliates, if any (“Pharmacosmos,” “we,” “our,” or “us”). You should assume that you may use the information that you see or read on the Site only as provided in these Terms, in the text on the Site, or with the written permission of Pharmacosmos. The content of this Site and any services provided on the Site are provided subject to the following notices, terms, and conditions.

BY USING THE SITE, YOU ARE STATING THAT YOU HAVE READ AND UNDERSTAND, AND AGREE TO BE BOUND BY, THESE TERMS (WHETHER OR NOT YOU CONFIRM YOUR AGREEMENT, SUCH AS BY CLICKING “I AGREE”). IF YOU DO NOT AGREE TO THESE TERMS, YOU ARE NOT PERMITTED TO USE THE SITE.

THESE TERMS CONTAIN (A) IN SECTION 12, A WAIVER OF RIGHTS TO PARTICIPATE IN A CLASS ACTION OR JURY TRIAL REGARDING ANY CLAIM OR CAUSE OF ACTION ARISING OUT OF THESE TERMS OR YOUR USE OF THE SITE AND (B) IN SECTION 8, VARIOUS LIMITATIONS AND EXCLUSIONS OF LIABILITY AND A RELEASE BY YOU OF ALL CLAIMS FOR DAMAGE AGAINST US AND CERTAIN THIRD PARTIES THAT MAY ARISE OUT OF THE USE OR OTHERWISE RELATES TO THE USE OF THE SITE.

IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY, CALL 911 IMMEDIATELY.

The Site, or portions of the Site, may be subject to additional terms (“Additional Terms”), which will be described in separate policies posted on the applicable Site. The Additional Terms will supplement these Terms and will control over any conflict between the Additional Terms and these Terms with respect to the specific Site, or portions thereof, subject to the Additional Terms.

  1. NO MEDICAL ADVICE. The information, files, documents, text, photographs, images, video, audio, and any other materials accessed through or made available for use or download through the Site (“Content”), including, without limitation, any information about diseases, conditions, treatments, or medicines, are for informational purposes only. The Content is not intended to be and is not a substitute for professional medical advice, diagnosis, or treatment. Nothing on the Site (i) is intended to create a physician-patient relationship or (ii) should be construed as the giving of advice or the making of a recommendation regarding any decision or action related to your health or the health of others. Inclusion of Content on the Site does not mean that Pharmacosmos supports or recommends a specific treatment, drug, physician, or test. Any reliance on Content is solely at your own risk. You should consult a doctor or other qualified health care professional regarding any questions you have about your health or before making any decisions related to your health or wellness. Never disregard medical advice or delay in seeking it because of something you have read on this site or in the Content. If you are a doctor or other qualified health care professional, you should not offer any medical advice or treatment on the Site, nor should you allow the content of the Site to substitute for your own medical judgment, which you should exercise in evaluating the information on the Site. Please thoroughly review the information provided on the Site before deciding whether any of the products, services, or treatments mentioned are right for you or others.
  2. JURISDICTION OF ACCESS. Pharmacosmos develops and markets medicines for use by patients of healthcare professionals. Marketing of these medicines is regulated by government agencies in each of the countries in which Pharmacosmos does business. Marketing regulations in each of these countries may restrict what information about our products may be disclosed to the public. This Site may contain information about products that may or may not be available in certain countries, may be available under different trademarks in some countries, and may only be approved or cleared for use in certain countries subject to varying indications or restrictions. Nothing contained on this Site should be construed as a promotion or solicitation for any product or for the use of any product in a way that is not authorized by the laws and regulations of the country where the site is being accessed. Specific questions about the availability and use of products described on this Site should be directed to Pharmacosmos at medinfo@pharmacosmos.us .

    The Site is controlled and operated by us from our offices within the United States of America and is not intended to subject us to the laws or jurisdictions of any state, country, or territory other than the United States although the Site may be compliant with such laws. If you access the Site from outside the United States, you do so at your own risk and are responsible for compliance with any applicable laws, statutes, treaties, ordinances, permits, certificates, judgments, decisions, decrees, rules, regulations, and orders of any governmental authority (“Laws”). Pharmacosmos makes no claims that the Content is appropriate or may be downloaded outside of the United States or that Pharmacosmos’ practices and policies will comply with any Laws of other countries or states.

  3. PRIVACY LAW COMPLIANCE. You specifically warrant that your communications to or through the Site will be made in compliance with all privacy laws and regulations to which you are subject, including, as applicable, the privacy regulations implementing the Health Insurance Portability and Accountability Act of 1996), and that you will be solely responsible for any liability arising out your communication of information in a manner not compliant with such laws and regulations.
  4. APPROPRIATE AND LAWFUL USE OF THE SITE. You agree not to use the Site or the Content: (a) in violation of these Terms or any Laws; (b) to transmit or upload information or content that is false, inaccurate, or misleading; (c) to transmit or display any material that, in our sole discretion, is illegal, abusive, graphically distressing, inflammatory, profane, threatening, hateful, tortious, defamatory, discriminatory, obscene, sexually explicit or contains pornography, libelous, invasive of another’s privacy, or otherwise objectionable or offensive, or to harass or harm Pharmacosmos, another entity or another individual; (d) to infringe, misappropriate, or violate any copyright, patent, trademark, trade secret, or other proprietary rights or rights of publicity or privacy of any party; (e) to transmit any unsolicited or unauthorized advertising or promotional materials; (f) to transmit any material that contains adware, malware, spyware, software viruses, or any other harmful code; (g) to impersonate any person or entity, or otherwise misrepresent your affiliation with a person or entity; (h) except as may be a result of standard search engine or Internet browser usage, frame, mask, extract data or other materials from, copy, or distribute the Content or other materials (including by use of any automation, robot, scraper, or other data-mining technology or process); (i) to interfere with or disrupt the Site or any software, hardware, telecommunications equipment, or networks used by us; (j) disparage or injure the reputation or goodwill of Pharmacosmos or any of its officers, directors, or employees; (k) further or promote any criminal activity or enterprise or provide instructional information about illegal activities; (l) obtain or attempt to access or otherwise obtain any materials or information through any means not intentionally made available or provided for through the Site; or (m) interfere with other users’ use and enjoyment of the Site (for example, by spamming, soliciting, or overly promoting personal interests).

    You are prohibited from violating or attempting to violate the security of the Site, including, without limitation: (1) accessing data not intended for you or logging onto a server that you are not authorized to access; (2) attempting to probe, scan, or test the vulnerability of a system or network or to breach security or authentication measures without proper authorization; or (3) accessing or using the Site or any portion thereof without authorization, in violation of these Terms or in violation of any Laws. Violations of system or network security may result in civil or criminal liability. We will investigate occurrences that may involve such violations and may involve, and cooperate with, law enforcement authorities in prosecuting people who are involved in such violations. You agree not to use any device, software, or routine to interfere or attempt to interfere with the proper working of the Site or any activity being conducted on the Site.

    We reserve the right to investigate and take appropriate legal action against anyone who, in our sole discretion, violates these Terms, including without limitation, removing the offending content from the Site, suspending or terminating the access of such violators to the Site, and reporting violations to law enforcement authorities.

  5. OUR CONTENT AND PROPRIETARY RIGHTS.
    1. Reservation of Intellectual Property Rights. Pharmacosmos hereby reserves any and all of its intellectual property and other proprietary rights in the Site and all Content developed or acquired by Pharmacosmos. You are also advised that Pharmacosmos reserves the right to strictly and aggressively enforce its intellectual property rights to the fullest extent of the law, including the seeking of criminal prosecution. Nothing contained in the Site or in these Terms shall be construed as conferring by implication, estoppel, or otherwise any license or right under any intellectual property or proprietary right of Pharmacosmos or any third party. You must abide by all rights notices, information, or restrictions contained in or attached to any Content and must not remove any trademark, copyright, or other notice from the Site or any Content.
    2. Trademarks. The trademarks, tradenames, logos, service marks, trade dress, and products (collectively the “Trademarks”) displayed on the Site are registered and unregistered Trademarks of Pharmacosmos or a third party. The Trademarks displayed on the Site may be protected in the United States and internationally. Ownership of the Trademarks and the goodwill associated with them remains with us or those other entities. Your use of the Trademarks displayed on the Site or any other content on the Site, except as provided in these Terms, is strictly prohibited and may be in violation of certain Laws.
    3. Copyright. The entire contents of this Site—including, but not limited to, images and text—are subject to copyright protection. You may not copy the contents of the Site other than for noncommercial individual reference with all copyright or other proprietary notices retained. Except as expressly provided in these Terms, via specific language on the Site, or by our prior, express, written consent, you may not copy, display, download, distribute, modify, reproduce, republish or retransmit any information, images, text, or documents contained in this Site or any portion thereof in any electronic medium or in hard copy, or create any derivative work based on such content.
    4. Software. The technology and software underlying the Site is our property (the “Software”). You agree not to copy, modify, create a derivative work of, reverse engineer, reverse assemble or otherwise attempt to discover any source code, sell, assign, sublicense, or otherwise transfer any right in the Software.
  6. THIRD PARTY CONTENT (INCLUDING YOUR CONTENT).
    1. Third Party Content. Under no circumstances will Pharmacosmos be liable in any way for any content or materials of any third parties, including, but not limited to, for any errors or omissions in any content, or for any loss or damage of any kind incurred as a result of the use of any such content (collectively, “Third Party Content”) on the Site. We do not control any Third Party Content on the Site and do not guarantee the availability or display of any Third Party Content. We reserve the right to remove any Third Party Content at any time in our sole discretion. Any opinions, advice, reviews, statements, views, positions, services, offers, or other Third Party Content expressed or made available on the Site are solely those of the respective authors or distributors, and do not necessarily reflect our opinions, views, or position. We take no responsibility and assume no liability for any Third Party Content. You use or rely on Third Party Content at your own risk.
    2. License of User Content. If you submit information or material through any means (collectively, “Your Content”) to the Site, you, to the extent you have any rights in such information or material, grant us a nonexclusive, royalty-free, worldwide, perpetual, irrevocable, and fully sublicensable right to use, reproduce, modify, adapt, publish, translate, create derivative works from, distribute, perform, and display Your Content throughout the world in any media, form, format, or forum. You grant us and our sublicensees the right to use the name, screen name (if applicable), city or zip code, and other biographical information that you submit in connection with Your Content, if we or they choose. You represent and warrant that: (i) you own or otherwise control all of the rights to the content that you post, including any intellectual property or other proprietary rights other than content that you clearly identify as third party content, e.g., links to third party websites; (ii) Your Content is accurate; (iii) neither Your Content nor your posting or submission of Your Content violates any of these Terms, including without limitation the prohibitions on use of the Site set forth above; and (iv) neither Your Content nor your posting or submission of Your Content will cause injury to any person or entity, including any privacy or security risk. Pharmacosmos has no responsibility for any of Your Content or the consequences of your sharing any of Your Content with others. We have the right but not the obligation to monitor and edit or remove any content from the Site in our sole discretion without notice or consent. If you believe your copyright, trademark, or other intellectual property right is being infringed by the Site or a user of the Site, please provide written notice to us at legal@pharmacosmos.us .
    3. Feedback. If you provide any comments, suggestions, ideas, concepts, changes, or other feedback about us, the Site, or our products, (your “Feedback”), whether through Your Content or by other means: (i) you hereby assign to Pharmacosmos all of your right, title, and interest to all your Feedback and all associated intellectual property rights, (ii) you grant us all necessary rights to use your Feedback; (iii) you acknowledge and agree that we are free to use and otherwise act on your Feedback with no financial, credit, or other obligation whatsoever to you, but we are not obligated to use your Feedback in any way; (iv) you acknowledge and agree that we are not obligated to keep your Feedback confidential; and (v) you represent that your Feedback is entirely your original work and will not knowingly provide Pharmacosmos any of your Feedback that is subject to third party intellectual property rights.
  7. THIRD PARTY SERVICES AND SITES. Portions of the Site may allow you to use third party products and services, which may include without limitation social networking services, and the Site may contain links to third party websites or resources (such products, services, websites, and resources, collectively “Third Party Services”). We are not associated with such Third Party Services. Your use of Third Party Services is subject to the license agreements, terms and conditions, privacy policies, and other policies and agreements applicable to such Third Party Services. We do not approve or endorse any Third Party Services, their content, or any views expressed on any Third Party Service, nor is the Site approved or endorsed by any Third Party Services. Pharmacosmos has no responsibility to you for any Third Party Services.

    If you wish to link to the Site, you may include an active link on any website you control directing a browser to the home page of that Site, provided that you agree to remove the link at any time upon our request. You may not link to or otherwise provide access to the Site in any way that: (a) alters the look, feel, or functionality of any aspect of the Site; (b) disparages the Site or products or that could injure the reputation or goodwill of Pharmacosmos or any of its products; (c) implies that Pharmacosmos is endorsing you or your products or services; or (d) misrepresents your or your site’s relationship with Pharmacosmos.

  8. INDEMNITY AND RELEASE. You agree that you will release, indemnify, and hold harmless us, our affiliates (if any), and our or their respective content providers, suppliers, licensors, distributors, or customers, and any of our or their respective officers, directors, employees, contractors, representatives, or agents (collectively, the “Pharmacosmos Parties”) from and against all claims, actions, losses, demands, liabilities, settlements, damages, and expenses (including, without limitation, attorneys’ fees) arising out of or resulting from: (i) your use of the Site, (ii) Your Content, (iii) your connection to the Site, (iv) your violation of these Terms or a breach of any of your representations or warranties under these Terms, or (v) your infringement, misappropriation, or other violation of any intellectual property rights, rights of publicity, privacy rights, or any other rights of another.

    If you are a California resident, you waive California Civil Code Section 1542, which says: “A general release does not extend to claims that the creditor or releasing party does not know or suspect to exist in his or her favor at the time of executing the release and that, if known by him or her, would have materially affected his or her settlement with the debtor or released party.” If you are a resident of another jurisdiction, you waive any comparable statute or doctrine. This defense and indemnification obligation will survive the availability of, and your use of, the Site.

  9. DISCLAIMER OF WARRANTIES. YOU UNDERSTAND AND AGREE THAT USE OF THE SITE, OUR CONTENT, ANY THIRD PARTY CONTENT, OR ANY THIRD PARTY SERVICES IS AT YOUR SOLE RISK. THE SITE IS PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS. PHARMACOSMOS DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES OF ANY KIND, WHETHER EXPRESS, IMPLIED, OR STATUTORY, WITH RESPECT TO THE SITE, OUR CONTENT, ANY THIRD PARTY CONTENT, OR ANY THIRD PARTY SERVICES (INCLUDING, BUT NOT LIMITED TO, THE IMPLIED OR STATUTORY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR USE OR PURPOSE, TITLE, QUIET ENJOYMENT, AND NONINFRINGEMENT, AND ANY WARRANTIES ARISING OUT OF COURSE OF DEALING, USAGE, OR TRADE). IN PARTICULAR, PHARMACOSMOS DOES NOT REPRESENT OR WARRANT THAT ANY INFORMATION OR OTHER CONTENT OBTAINED OR VIEWED BY YOU AS A RESULT OF YOUR USE OF THE SITE WILL BE ACCURATE OR RELIABLE, OR THAT YOUR ACCESS TO THE SITE OR CONTENT WILL BE UNINTERRUPTED OR ERROR-FREE. PHARMACOSMOS DOES NOT WARRANT THAT FILES AVAILABLE FOR DOWNLOAD WILL BE FREE OF VIRUSES, WORMS, TROJAN HORSES, OR OTHER DESTRUCTIVE PROGRAMMING. YOU ARE RESPONSIBLE FOR IMPLEMENTING PROCEDURES SUFFICIENT TO SATISFY YOUR NEEDS FOR DATA BACK-UP AND SECURITY. PHARMACOSMOS DISCLAIMS ALL EQUITABLE INDEMNITIES. THE FOREGOING DISCLAIMERS CONSTITUTE AN ESSENTIAL PART OF THESE TERMS.
  10. LIMITATION OF LIABILITY. YOU UNDERSTAND AND AGREE THAT TO THE EXTENT PERMITTED UNDER LAW, IN NO EVENT WILL PHARMACOSMOS BE LIABLE UNDER ANY THEORY OF LIABILITY (WHETHER IN CONTRACT, TORT, STATUTORY, OR OTHERWISE) FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, PERSONAL INJURY/WRONGFUL DEATH, PUNITIVE, OR EXEMPLARY DAMAGES, INCLUDING BUT NOT LIMITED TO, DAMAGES FOR LOSS OF PROFITS, GOODWILL, USE, OR DATA (EVEN IF SUCH PARTIES WERE ADVISED OF, KNEW OF OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES), INCLUDING BUT NOT LIMITED TO AS A RESULT OF: (A) YOUR USE OF OR INABILITY TO USE THE SITE; (B) ANY OF OUR CONTENT, ANY THIRD PARTY CONTENT, OR ANY THIRD PARTY SERVICES AVAILABLE THROUGH A THE SITE; OR (C) ANY LOSS OF DATA. SHOULD PHARMACOSMOS BE FOUND TO BE LIABLE TO YOU OR ANY THIRD PARTY NOTWITHSTANDING THE FOREGOING, SUCH LIABILITY WILL NOT EXCEED $100.00 IN THE AGGREGATE.

    Some jurisdictions do not allow the exclusion of certain warranties or the limitation or exclusion of liability for incidental or consequential damages. Accordingly, some of the above limitations and disclaimers may not apply to you. To the extent that we may not, as a matter of applicable law, disclaim any implied warranty or limit our liabilities, the scope and duration of such warranty and the extent of liability of Pharmacosmos will be the minimum permitted under such applicable Law.

  11. MODIFICATIONS TO TERMS. We may update or change any of the terms and conditions contained in these Terms at any time and in our sole discretion, by posting on the “Terms of Use” page of the Site or emailing to you at the email address you provided to us a change notice or a revised set of Terms. If any modification is unacceptable to you, your only recourse is to terminate your use of the Site. Your continued use of the Site following our posting or emailing of a change notice or revised Terms as provided in this section will constitute your binding acceptance of the change. For this reason, we encourage you to review these Terms every time you use the Site.
  12. GOVERNING LAW; DISPUTE RESOLUTION. You and we agree that in the event of any dispute between us, we will first try to resolve it by talking with each other. These Terms and the relationship between us will be governed by the laws of the State of New Jersey as applied to agreements made, entered into, and performed entirely in New Jersey. All lawsuits arising out of or relating to these Terms or your use of the Site will be brought in the federal or state courts located in New Jersey. We and you hereby irrevocably submit to the exclusive personal jurisdiction of such courts for such purpose and waive any objection to such courts on any basis, including without limitation improper venue or inconvenience of the forum. You agree that regardless of any statute or law to the contrary, any claim or cause of action arising out of or related to use of the Site or these Terms must be filed within one (1) year after such claim or cause of action arose or be forever barred. You may only resolve disputes with us on an individual basis and may not bring and expressly waive bringing a claim as a plaintiff or a class member in a class, consolidated, or representative action. Class actions and private attorney general actions are not allowed. YOU HEREBY WAIVE YOUR RIGHT TO A JURY TRIAL IN ANY CLAIM OR CAUSE OF ACTION ARISING OUT OF YOUR USE OF THE SITE OR THESE TERMS.
  13. ELECTRONIC COMMUNICATIONS NOTICE. When you use the Site or send emails to us, you are communicating with us electronically. You consent to receiving communications from us electronically. We may communicate with you by email or posting notices on the applicable Site. You agree that all agreements and other communications that we provide to you electronically satisfy any legal requirement that such communications be in writing. In order to access any such communications, you must have a computer or other Internet-enabled device. In order to retain copies of any such communications, you must have a printer or data storage device. If you have a printer, you may print paper copies of any such communications for your own use. If you wish to withdraw your consent for us to communicate with you electronically, you may not use the Site.
  14. MOBILE SITE. The Site may include certain services that are available via a mobile device, including (i) the ability to upload content to the Site via a mobile device and (ii) the ability to browse the Site from a mobile device (collectively, the “Mobile Site”). To the extent you access the Site through a mobile device, your wireless service carrier’s standard charges, data rates, and other fees may apply. In addition, downloading, installing, or using certain elements of the Mobile Site may be prohibited or restricted by your carrier, and not all aspects of the Mobile Site may work with all carriers or devices. By using the Mobile Site, you agree that we may communicate with you regarding Pharmacosmos by electronic means and that certain information about your usage of the Mobile Site may be communicated to us.
  15. AGE RESTRICTION.

    The Site is intended for persons eighteen (18) years or older. Persons under the age of eighteen (18) should not access or use the Site.

  16. MISCELLANEOUS.
    1. Interpretation. The language in these Terms will be interpreted as to its fair meaning and not strictly for or against either party.
    2. Conflicts. If anything on the Site conflicts or is inconsistent with these Terms, these Terms will control.
    3. Relationship of the Parties. These Terms create no partnership, employment relationship, joint venture, franchise, or agency between the parties of any kind. Neither party has the right to assume or create, either directly or indirectly, any liability or any obligation of any kind, expressed or implied, in the name of or on behalf of the other party, and neither party will represent that it has such authority.
    4. Refusal of Service; Termination. We reserve the right to refuse service, disable or prohibit logins, remove or edit content (including Third Party Content) or features, limit access to content or features, or modify or discontinue any of our features or the Site in our sole discretion. The services available to you may vary depending on where you are located. We may terminate, suspend, or modify your access to all or part of the Site, without notice, if you violate these Terms or you engage in any conduct that we, in our sole and absolute discretion, believe is in violation of any Law or is otherwise harmful to the interests of us, any other user of the Site, or any third party. We will not be liable if, for any reason, the Site is unavailable. You are responsible for making all arrangements necessary for you to have access to the Site. In addition, you are solely responsible for ensuring that any access or use of the Site through your Internet connection complies with these Terms.
    5. Equitable Remedies. You acknowledge that if you violate or breach these Terms, it may cause irreparable harm to Pharmacosmos and its affiliates. Accordingly, you agree that, if you violate or breach these Terms, Pharmacosmos shall have the right to seek a decree of specific performance or injunctive relief against you in addition to any other legal or equitable remedies that Pharmacosmos may have.
    6. Entire Agreement; Waiver; Invalidity. These Terms, together with any Additional Terms constitute the entire and exclusive agreement between us with respect to their subject matter, and govern your use of the Site, superseding any prior agreements or negotiations between us with respect to that subject matter. Our failure to exercise or enforce any right or provision of these Terms will not constitute a waiver of such right or provision. If any provision of these Terms is found by a court of competent jurisdiction to be invalid, you nevertheless agree that the court should endeavor to give effect to our intentions as reflected in the provision, and that the other provisions of these Terms remain in full force and effect. The section titles in these Terms are for convenience only and have no legal or contractual effect.
    7. Questions; Comments. If you have any questions about the Site or these Terms, please contact us at: Pharmacosmos Therapeutics Inc., East Tower, 120 Headquarters Plaza 6th Floor, Morristown, NJ 07960, (908) 769-7100 , legal@pharmacosmos.us .
INDICATIONS

Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

  • who have intolerance to oral iron or have had unsatisfactory response to oral iron
  • who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.


WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Monoferric. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Monoferric is contraindicated in patients with prior serious hypersensitivity reactions to Monoferric or any of its components. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Monoferric treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.

Iron Overload

Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Monoferric to patients with iron overload.


ADVERSE REACTIONS

Adverse reactions were reported in 8.6% (172/2008) of patients treated with Monoferric. Adverse reactions related to treatment and reported by ≥1% of the treated patients were nausea (1.2%) and rash (1%). Adjudicated serious or severe hypersensitivity reactions were reported in 6/2008 (0.3%) patients in the Monoferric group. Hypophosphatemia (serum phosphate <2.0 mg/dL) was reported in 3.5% of Monoferric-treated patients in Trials 1 & 2.

To report adverse events, please contact Pharmacosmos at 1-888-828-0655. You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Please see Full Prescribing Information.

IMPORTANT SAFETY INFORMATION + -

INDICATIONS

Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

  • who have intolerance to oral iron or have had unsatisfactory response to oral iron
  • who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.


WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Monoferric. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Monoferric is contraindicated in patients with prior serious hypersensitivity reactions to Monoferric or any of its components. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Monoferric treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.

Iron Overload

Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Monoferric to patients with iron overload.


ADVERSE REACTIONS

Adverse reactions were reported in 8.6% (172/2008) of patients treated with Monoferric. Adverse reactions related to treatment and reported by ≥1% of the treated patients were nausea (1.2%) and rash (1%). Adjudicated serious or severe hypersensitivity reactions were reported in 6/2008 (0.3%) patients in the Monoferric group. Hypophosphatemia (serum phosphate <2.0 mg/dL) was reported in 3.5% of Monoferric-treated patients in Trials 1 & 2.

To report adverse events, please contact Pharmacosmos at 1-888-828-0655. You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Please see Full Prescribing Information.

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