Patient Resource Center
For more information about FOLOTYN
Please call Acrotech Biopharma, LLC, and its wholly-owned subsidiary Allos Therapeutics, Inc. at 1-888-255-6788 and talk to the members of your healthcare team.
Acrotech Biopharma, LLC, and its wholly owned subsidiary Allos Therapeutics, Inc. is committed to helping patients with relapsed or refractory PTCL, including those who do not have insurance or who are having trouble with coverage or reimbursement issues. To see if you might be eligible for the Specialty Therapy Access Resources (STAR®) program, please call 1-888-53-STAR7 (1-888-537-8277) Monday through Friday, between 9 am and 5 pm Eastern Time, or visit www.AcrotechPatientAccess.com.
Acrotech Biopharma, LLC does not guarantee coverage and/or reimbursement for its products. Coverage, coding, and reimbursement policies vary significantly by payer, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. Healthcare professionals should always verify coverage, coding, and reimbursement guidelines on a payer and patient-specific basis.
Additional Resources:
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Lymphoma Research Foundation (LRF)
LRF is the nation’s largest nonprofit organization devoted exclusively to funding lymphoma research and serving those impacted by blood cancer.
Helpline: 1-800-500-9976
www.lymphoma.org
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Leukemia & Lymphoma Society
We lead the way in immunotherapy, genomics and personalized medicine. Become a Monthly Donor. Become a Hero Today. Save a Life Today. BBB Accredited Charity. Help Fund Cancer Research. Make a Difference.
1-800-955-4572
www.lls.org
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American Cancer Society
Every Cancer. Every Patient. Everywhere. Create a Future Free from the Fear of Cancer. You Can Help Improve the Lives of People with Cancer by Donating to Cancer Research.
1-800-ACS-2345 (1-800-227-2345)
www.cancer.org
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Cancer.Net
Trusted, compassionate information for people with cancer and their families and caregivers, from the American Society of Clinical Oncology (ASCO), the voice of the world’s cancer physicians and oncology professionals.
1-888-651-3038
www.cancer.net
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National Cancer Institute
Accurate, up-to-date, comprehensive cancer information from the U.S. government’s principal agency for cancer research.
1-800-4-CANCER (1-800-422-6237)
www.cancer.gov
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Clinical Trials
ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.
www.clinicaltrials.gov
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
