Fetroja Digital Formulary Kit

A number of resources are available to help assist in your institution’s review of Fetroja for formulary inclusion. Please note: these resources are for formulary decision makers only.

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PRIVACY STATEMENT

Shionogi Inc. – Online Privacy Notice

Effective Date: 31 May 2017

This Online Privacy Notice applies to information about you that Shionogi Inc. (“Shionogi,” “we” or “us”) may obtain when you use shionogi.com or any other website or online location that is operated by Shionogi and links to this Privacy Notice (the “Sites”). This Privacy Notice also describes how we may collect, use or share information about you; your choices regarding our use of your information; the ways in which we safeguard the information we collect; and how you may contact us regarding our privacy practices.

Information Collection

Information You Provide

We obtain information that you provide to us directly; for example, data you submit when you contact us or apply for a job. The information we collect may include personal information such as your name, address, phone number and other details relevant to your job application.

Information Collected Automatically

In addition to information you submit to us, we may collect certain information using automated means such as cookies, web beacons and web server logs. The types of information we collect automatically may include IP addresses, device identifiers, browser characteristics, operating system details, language preferences, referring URLs, length of visits and pages viewed. We may combine this automatically collected information with other information we obtain about you.

Data Analytics

Shionogi uses third-party web analytics services on our Sites, such as Google Analytics. These service providers help us analyze how visitors use the Sites. To learn more about opting out of data collection through Google Analytics, click here.

Your web browser may have settings that allow you to transmit a “Do Not Track” signal when you visit various websites or use online services. Like many websites, the Sites are not designed to respond to “Do Not Track” signals received from browsers. To learn more about “Do Not Track” signals, you may wish to visit www.allaboutdnt.com.

Information Use

We may use the information we collect about you for various purposes, including to:

  • Personalize and improve your online experience;
  • Respond to requests, comments or questions;
  • Improve the Sites, our marketing efforts and other products and services we may offer;
  • Monitor and analyze trends, usage and activities of visitors to the Sites;
  • Contact you regarding your use of the Sites or, in our discretion, changes to our policies;
  • Prevent fraud or other misuse of the Sites;
  • Comply with legal requirements, industry standards and our policies; or
  • For any other purpose, with your consent.

In addition, we use information collected online through cookies, web beacons and other automated means for purposes such as recognizing your computer when you visit the Sites, tracking your activity as you navigate the Sites or analyzing your use of the Sites. We also may use the information we obtain about you in other ways for which we provide notice at the time of collection.

Information Sharing

We may permit our agents, vendors, consultants and other service providers to access information we collect about you through the Sites to carry out work on our behalf. These third-party service providers are prohibited from using such personal information for any purpose(s) other than to provide their services we have engaged them to perform.

We also may share your information: (1) if we are required to do so by law, regulation or legal process (such as in response to a court order or subpoena); (2) to fulfill requests by government agencies, such as law enforcement authorities; (3) when we believe disclosure is necessary or appropriate to prevent physical harm or financial loss, or in connection with an investigation of suspected or actual illegal activity; (4) to enforce our policies or protect legal rights, property or safety; (5) with affiliates or business partners or (6) in the event of a merger, partnership or other collaboration with another organization.

Information Security

We maintain appropriate safeguards to help protect personal information collected through the Sites from loss, theft, misuse or other unauthorized access, disclosures, alteration or destruction. Although we use reasonable efforts to safeguard information, transmission via the Internet is not completely secure and we cannot guarantee the security of your information collected through the Sites.

Links to Other Websites

The Sites may include links to other websites for your convenience and information. Those websites may be operated by entities not affiliated with Shionogi, and may have their own privacy policies or notices, which we strongly suggest you review. Shionogi is not responsible for the content or privacy practices of any linked websites that we do not control.

Children’s Privacy

The Sites are not intended for, nor targeted to, children under 13, and we do not knowingly or intentionally collect information about children under 13. If we learn that we have received information from a user of the Sites who is under the age of 13, we will delete the information.

Your Choices

You may request that we update, correct or delete your information collected through the Sites by emailing data.privacy@shionogi.com. To help protect your privacy and security, we may take reasonable steps to verify your identity prior to honoring any such requests.

Many web browsers provide options to allow you to stop accepting new cookies or to disable existing cookies. Please be aware that if you disable the cookies on your computer you may not be able to use certain features of the Sites or other websites, and disabling cookies may invalidate opt-outs that rely on cookies to function.

You may unsubscribe from receiving promotional emails from us by following the instructions provided in those email communications. Please note that even if you opt out of receiving promotional communications from us, we may continue to send you non-promotional emails, such as communications regarding our ongoing relationship with you.

Information for Users Outside the United States

If you are visiting the Sites from outside the United States, please be aware that information we collect through the Sites will be transferred to and stored on our servers in the United States. By using the Sites, you acknowledge and consent to the transfer and processing of your personal data in the United States as described in this Privacy Notice. Please be aware that the data protection laws and regulations applicable to your personal data transferred to the United States may be different from the laws in your country of residence.

Shionogi complies with the EU-U.S. Privacy Shield Framework as set forth by the U.S. Department of Commerce regarding the collection, use and retention of personal data transferred to the United States from the European Union. Please click here to view our EU-U.S. Privacy Shield Statement.

Changes to This Privacy Notice

We may change this Privacy Notice from time to time. If we make changes, we will notify you by revising the date at the top of this Privacy Notice. We encourage you to review this Privacy Notice whenever you visit the Sites to stay informed about our information practices.

How to Contact Us

If you have questions regarding this Privacy Notice, you may email us at data.privacy@shionogi.com, or write to us at:

Shionogi Inc. Attn: Privacy Inquiry 300 Campus Drive Florham Park, NJ 07932


Important Safety Information

Contraindications

Fetroja is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of Fetroja.

Warnings and Precautions

Increase in All-Cause Mortality in Patients With Carbapenem-Resistant Gram-Negative Bacterial Infections

An increase in all-cause mortality was observed in patients treated with Fetroja as compared to best available therapy (BAT) in a multinational, randomized, open-label trial in critically-ill patients with carbapenem-resistant Gram-negative bacterial infections (NCT02714595). Patients with nosocomial pneumonia, bloodstream infections, sepsis, or cUTI were included in the trial. BAT regimens varied according to local practices and consisted of 1 to 3 antibacterial drugs with activity against Gram-negative bacteria. Most of the BAT regimens contained colistin.

The increase in all-cause mortality occurred in patients treated for nosocomial pneumonia, bloodstream infections, or sepsis. The 28-Day all-cause mortality was higher in patients treated with Fetroja than in patients treated with BAT [25/101 (24.8%) vs. 9/49 (18.4%), treatment difference 6.4%, 95% CI (-8.6, 19.2)]. All-cause mortality remained higher in patients treated with Fetroja than in patients treated with BAT through Day 49 [34/101 (33.7%) vs. 10/49 (20.4%), treatment difference 13.3%, 95% CI (-2.5, 26.9)]. Generally, deaths were in patients with infections caused by Gram-negative organisms, including nonfermenters such as Acinetobacter baumannii, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa, and were the result of worsening or complications of infection, or underlying comorbidities. The cause of the increase in mortality has not been established. The safety and efficacy of Fetroja has not been established for the treatment of nosocomial pneumonia, bloodstream infections, or sepsis.

Reserve Fetroja for use in patients who have limited or no alternative treatment options for the treatment of cUTI. Closely monitor the clinical response to therapy in patients with cUTI.

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Hypersensitivity was observed in Fetroja clinical trials. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before therapy with Fetroja is instituted, inquire about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactam antibacterial drugs. Discontinue Fetroja if an allergic reaction occurs.

Clostridioides difficile-Associated Diarrhea (CDAD)

Clostridioides difficile-Associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including Fetroja. CDAD may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile.

C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued. Manage fluid and electrolyte levels as appropriate, supplement protein intake, monitor antibacterial treatment of C. difficile, and institute surgical evaluation as clinically indicated.

Seizures and Other Central Nervous System (CNS) Adverse Reactions

Cephalosporins, including Fetroja, have been implicated in triggering seizures. Nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported with cephalosporins particularly in patients with a history of epilepsy and/or when recommended dosages of cephalosporins were exceeded due to renal impairment. Adjust Fetroja dosing based on creatinine clearance. Anticonvulsant therapy should be continued in patients with known seizure disorders. If CNS adverse reactions including seizures occur, patients should undergo a neurological evaluation to determine whether Fetroja should be discontinued.

Development of Drug-Resistant Bacteria

Prescribing Fetroja in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and may increase the risk for development of drug-resistant bacteria.

Adverse Reactions

The most common adverse reactions occurring in (≥2%) of patients receiving Fetroja compared to imipenem/cilastatin in clinical trials were: diarrhea (4% vs 6%), infusion site reactions (4% vs 5%), constipation (3% vs 4%), rash (3% vs <1%), candidiasis (2% vs 3%), cough (2% vs <1%), elevations in liver tests (2% vs <1%), headache (2% vs 5%), hypokalemia (2% vs 3%), nausea (2% vs 4%), and vomiting (2% vs 1%).

Indication

Fetroja® (cefiderocol) is indicated in patients 18 years of age or older who have limited or no alternative treatment options for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex.

Approval of this indication is based on limited clinical safety and efficacy data for Fetroja.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs, Fetroja should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Please see Full Prescribing Information for Fetroja.

Reference: Fetroja (cefiderocol) [package insert]. Florham Park, NJ: Shionogi Inc.; 2019.