IMPORTANT SAFETY INFORMATIONPRESCRIBING INFORMATION

FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL). This indication is based on overall response rate. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated.

FOLOTYN adverse event profile1,2

  • The most common adverse reactions were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%)
  • The most common serious adverse events were pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia
69% of patients in the PROPEL trial remained at the target dose of 30 mg/m2 for the entire duration of treatment. 23% of patients in the PROPEL trial discontinue treatment due to adverse reactions, including mucositis (6%, n=7) and thromobcytopenia (5%, n=5).
  • Incidence of febrile neutropenia: 5% (Grade 3)
  • In vitro studies indicated that pralatrexate does not induce or inhibit the activity of CYP450 isozymes at concentrations of pralatrexate that can be reasonably expected clinically
  • FOLOTYN is renally excreted—in patients with cancer without renal impairment, approximately 34% of the administered dose of FOLOTYN was excreted unchanged into urine. The mean fraction of the administered dose excreted as unchanged diastereomers in urine (fe) decreased with declining renal function
  • When administering FOLOTYN to patients receiving probenecid or other drugs that may affect relevant transporter systems (eg, NSAIDs), monitor patients closely for signs of systemic toxicity due to increased drug exposure

Adverse reactions (incidence ≥10% of patients)1

Adverse reactions
  • * Stomatitis or mucosal inflammation of the gastrointestinal and genitourinary tracts
  • † Five patients with platelets <10,000/mcL
  • ‡ Alanine aminotransferase, aspartate aminotransferase, and transaminases increased

References:

  • Folotyn [package insert]. Westminster, CO: Allos Therapeutics, Inc.
  • Data on file. Spectrum Pharmaceuticals, Inc.