Privacy Policy

This Privacy Policy applies to our data collection and use practices relating to our website located at www.spectrumpharm.com. References in this Privacy Policy to “we,” “us” or “our” refer to Acrotech Biopharma, LLC. (“Acrotech”). By using our website, you agree to the terms of this Privacy Policy and any modifications made to this Privacy Policy.

Please be aware that this Privacy Policy will not necessarily apply to information you may have provided or will provide to us in settings other than by or through our website.

Collection of Information

When you use our website, we collect personal information that you choose to provide voluntarily to us. For example, you may provide personal information on a customer feedback page. In addition, when you visit our website, you will be assigned a permanent “cookie” (a small text file) to be stored on your computer’s hard drive. We may also collect certain technical information from your computer, including your Internet Protocol (IP) address, during your visit to our website. Some third party service providers may also use cookies on this website in connection with advertising or otherwise. We do not have access to or control over these third party cookies.

Use of Information

We use the information that we collect to communicate with you.

We may also use the personal information that we collect to provide you with details about promotions and services that we believe may be of interest to you, but we will only do so if you separately request, at the time of registration or at a later date, to receive these details. If you no longer wish to receive communications about such promotions and services, you may opt out at any time by notifying us at optout@AcrotechBiopharma.com.

We use the aggregate statistical data that we collect to better serve you. For example, we use aggregate statistical data to identify the effectiveness of our promotional activities; and provide special savings offers, such as free samples, coupons, rebates and other promotions, to you.

Sharing of Information with Third Parties

We will not sell your personal information to third parties.

We may share your personal information with our subsidiaries, affiliates, agents, representatives and business partners for the limited purpose of providing services or information to us or our customers at our direction. We may also provide to third parties certain personal information that is necessary to fulfill an order you have placed with us, such as providing your name and address to a shipping carrier for delivery. We expect our agents and business partners to follow our privacy policies when using customer information provided by us. We are not responsible for any additional information that you provide directly to these third parties.

We may also disclose the aggregate statistical data that we collect to third parties in order to allow them to measure the effectiveness of programs and advertisements aimed at our customers.

Disclosure Of Information In Response To A Court Order Or In An Emergency

We will disclose information when compelled by a subpoena or court order, or when we believe, in our reasonable discretion, that such disclosure is warranted to cooperate with inquiries by law enforcement agencies or in emergencies where physical safety is at risk.

Contacting Us About Your Online Privacy

You may always contact us to remove or update personally identifiable information from our database by sending an e-mail to us at optout@Acrotech Biopharma.com. If you have any questions or comments about the way your personally identifiable information collected in via our website is used and handled, please e-mail us at listusage@Acrotech Biopharma.com.

Security

We have put into place physical, electronic and managerial procedures to safeguard and secure the information we collect about you. For example, we operate secure data networks protected by industry standard firewalls and password protection systems that are intended to keep unauthorized persons from accessing your personal information. Nevertheless, we cannot guarantee that unauthorized access or disclosure of your personal information will never occur.

Third Party Websites

As a convenience to our website visitors, this website may contain links to third-party web sites. Third party websites are not covered by this Privacy Policy and Acrotech will have no control over the information you enter or the cookies your browser accepts while on a third party’s website. You should examine the terms of use and privacy policies of other website pages whenever you leave a Acrotech website. Acrotech Biopharma is not responsible for the privacy practices or the content included on third party websites.

Amendment or Modification of this Privacy Statement

We reserve the right to amend this Privacy Policy at any time and only the current Privacy Policy, as set forth on our websites www.folotyn.com, www.FOLOTYN.com and www.AcrotechBiopharma.com will be deemed effective.

FOLOTYN Important Safety Information

Indication

FOLOTYN^® (pralatrexate injection) is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

FOLOTYN Important Safety Information

Warnings and Precautions

Myelosuppression: FOLOTYN can cause myelosuppression, manifested by thrombocytopenia, neutropenia, and/or anemia. Monitor complete blood counts and omit and/or reduce the dose based on ANC and platelet count.
Mucositis: FOLOTYN can cause mucositis. Monitor for mucositis weekly and omit and/or reduce the dose for ≥ grade 2 mucositis.
Dermatologic Reactions: Dermatologic reactions, including fatal reactions, occurred and may be progressive and increase in severity with further treatment. Monitor closely and withhold or discontinue FOLOTYN based on severity.
Tumor Lysis Syndrome: FOLOTYN can cause tumor lysis syndrome. Monitor patients who are at increased risk of TLS and treat promptly.
Hepatic Toxicity: FOLOTYN can cause hepatic toxicity and liver function test abnormalities. Monitor liver function tests. Omit dose until recovery, adjust or discontinue therapy based on the severity.
Risk of Increased Toxicity with Renal Impairment: Patients with severe renal function impairment may be at greater risk for increased exposure and adverse reactions. Reduce FOLOTYN dosage in patients with severe renal impairment. Avoid FOLOTYN use in patients with end stage renal disease with or without dialysis. If the potential benefit of administration justifies the potential risk, monitor renal function and reduce the dose based on adverse reactions.
Embryo-Fetal Toxicity: FOLOTYN can cause fetal harm. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with FOLOTYN and for 6 months after last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with FOLOTN and for three months after last dose.

Adverse Reactions

The most common adverse reactions occurring in greater than 35% of patients were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse reactions occurring in more than 3% of patients were pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia.

Drug Interactions

Avoid coadministration with probenecid or nonsteroidal anti-inflammatory drugs (NSAIDs). If coadministration is unavoidable, monitor for increased risk of adverse reactions.

Use in Specific Populations

Lactation: Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with FOLOTYN and for 1 week after the last dose.
Pregnancy Testing: Verify pregnancy status in females of reproductive potential prior to initiation of FOLOTYN
Pediatric Use: The Safety and effectiveness of FOLOTYN in pediatric patients have not been established.
Renal Impairment: Reduce the dose of FOLOTYN for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m²). No dosage modification is recommended for patients with mild or moderate renal impairment.

Please click here to see full Prescribing Information for FOLOTYN.

ISI-FOL-0180