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.

Prepare your patients for treatment with FOLOTYN

Pretreatment with vitamin supplementation is an important part of FOLOTYN therapy1

Prior to administering FOLOTYN, supplement patients with:

Pretreatment with vitamin B12 and folic acid before, during, and after treatment with FOLOTYN

Important Monitoring Information

  • Monitor complete blood cell counts weekly. Serum chemistry tests, including renal and hepatic function, should be performed prior to the start of the first and fourth dose of a given cycle
    • Dose modifications are based on absolute neutrophil count (ANC) and platelet count prior to each dose
    • Persistent liver function test abnormalities may be indicators of liver toxicity and require dose modification or discontinuation
    • Monitor patients for renal function and systemic toxicity and adjust dosing accordingly

3––5 minute IV push administration. 7-week cycle.

FOLOTYN——Once weekly for 6 weeks, in a 7-week cycle1

FOLOTYN—Once weekly for 6 weeks, in a 7‐week cycle

Important Dosing Information

  • No pre-medications are required when administering FOLOTYN
  • The recommended dosage of FOLOTYN is 30 mg/m2 administered as an intravenous push over 3-–5 minutes via the side port of a free-flowing 0.9% Sodium Chloride Injection, intravenous line once weekly for 6 weeks, followed by 1 week of rest in a 7-week cycle
  • The calculated dose of FOLOTYN should be aseptically withdrawn into a syringe for immediate use. Do not dilute FOLOTYN
  • Management of severe or intolerable adverse reactions may require dose omission, reduction or discontinuation of FOLOTYN therapy
  • The risk for toxicity may be greater when administering FOLOTYN to patients with moderate-to-severe impairment due to the contribution of renal excretion (approximately 34%) to the overall clearance of pralatrexate
FOLOTYN therapy can be continued until disease progression or unacceptable toxicity

References:

  • FOLOTYN Prescribing Information. Allos Therapeutics, Inc. 2012.