Terms of Use

The information provided on this Acrotech Biopharma, LLC. Website is for general informational and educational use only and is subject to the following terms and conditions. By accessing and using this website, you acknowledge and accept, without limitation or qualification, this Terms of Use Agreement. If you do not wish to be bound by this agreement, you may not access or use any materials on this website.

1. Scope of Use

Acrotech Biopharma, LLC. (“Acrotech”) maintains this website for your personal information and education. The information, documents and related graphics are available for your personal use, provided that the materials are not modified in any way and all copyright and other proprietary notices contained on the provided materials are maintained. This website and all its contents are intended to comply with United States laws that it may be subject to and Acrotech makes no representation that the information is appropriate for use in locations outside of the United States. Other countries may have laws, regulatory requirements, and medical practices that differ from those in the U.S. Those who access this site from other locations do so on their own initiative and are responsible to comply with applicable local laws and regulations. Any offer, product, or service available through this website is void where prohibited.

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7. Limitations of Liability.

Use of this site is at the user’s own risk. Neither Acrotech nor any other party involved in the creating, producing, or delivering the website is liable for any direct, incidental, consequential, indirect or punitive damages arising out of access to or use of this website and/or the information provided, regardless of whether Acrotech has been advised as the possibility of such damages.

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9. Governing Law.

This Terms of Use Agreement and your use of this website shall be governed by the laws of the United States and the State of California without regard to its conflicts of law provisions. Any legal action or proceeding arising from or relating to your access or use of this website shall be brought exclusively in a federal or state court of proper jurisdiction in the State of California.

10. Modifications.

Acrotech Biopharma reserves the right to revise the terms and conditions of this agreement at any time without notice and such changes will be deemed effective upon posting. Continued use of the website following posting of an amended Terms of Use will indicate acceptance of such changes and therefore, this agreement should be reviewed periodically.

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