Website Linking Policy
Acrotech Biopharma, LLC (“Acrotech”) ordinarily does not prohibit links to this website, provided that any such link does not improperly connote an endorsement by or affiliation with Acrotech, or otherwise adversely impact Acrotech, and pursuant to the terms below.
If you are interested in linking to this website or any other Acrotech owned websites, please notify Acrotech Biopharma by sending an e-mail to webmaster@AcrotechBiopharma.com. Include your name, your organization name, contact information (such as a phone number and/or e-mail address) as well as the URL of your site and a list of any URLs from which you intend to link to this site.
By linking to any page on the Acrotech websites, you hereby agree to be bound by the terms and conditions as set forth below:
Links may be text-based using the words: “FOLOTYN®”, “FOLOTYN” , “Acrotech®”, “Acrotech”, or “Acrotech.com” the “Acrotech Marks”. You may not use the FOLOTYN® logo, Acrotech logo or any Acrotech logo as a link. By linking, you acknowledge and agree that, other than as set forth herein, all rights to the Acrotech Marks, other Acrotech marks, the content appearing on the Acrotech website and the design of the Acrotech website belong to Acrotech Biopharma, LLC Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent, trademark, or copyright owned by Acrotech Biopharma, LLC.
You may not create frames around any of the pages of the Acrotech websites or use other techniques that alter in any way the visual presentation or appearance of any of the Acrotech websites.
You must not misrepresent your relationship with any AcrotechTM product or Acrotech Biopharma, LLC (or any Acrotech-owned business entity, Acrotech subsidiary, or Acrotech-affiliated business entity) or present false or misleading impressions about any Acrotech product or Acrotech Biopharma, LLC (or any Acrotech-owned business entity, Acrotech subsidiary, or Acrotech-affiliated business entity). No links to any AcrotechTM website may be used in a manner that implies or suggests that Acrotech approves or endorses you, your website or your goods and services (in all cases, except as Acrotech may have agreed separately with you in writing).
Acrotech has no responsibility or liability for any content appearing on your website. You agree to indemnify and defend Acrotech against all claims arising out of or based upon your website.
No link(s) may appear on any page on your website or within any context containing content or materials that may be interpreted as libelous, obscene or criminal, or which infringes, otherwise violates, or advocates the infringement or other violation of, any third party rights.
Acrotech may at any time, in its sole discretion, without cause, terminate your right to link to any web pages of any AcrotechTM website. In such event, upon request, you agree to immediately remove all links to any AcrotechTM website and to cease using the Acrotech Marks.
Acrotech Biopharma, LLC, reserves the right to change this linking policy at any time. Changes will be posted on this page.
© 2017 Acrotech Biopharma, LLC All rights reserved.
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
