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.

The recommended dosage of FOLOTYN is 30 mg/m2 administered as an intravenous push over 3–5 minutes once weekly for 6 weeks, followed by 1 week of rest in a 7-week cycle1

  • FOLOTYN is administered as an intravenous push over 3-5 minutes via the side port of a free-flowing 0.9% Sodium Chloride Injection, intravenous line
  • For patients with severe renal impairment (eGFR 15 to <30 mL/min/1.73m2), the recommended dose of FOLOTYN is 15 mg/m2. For patients with mild to moderate renal impairment, dose reduction is not necessary
FOLOTYN—Once weekly for 6 weeks, in a 7‐week cycle

Important Dosing Information

  • No pre-medications are required when administering FOLOTYN
  • The calculated dose of FOLOTYN should be aseptically withdrawn into a syringe for immediate use.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

Selected Safety Information

WARNINGS AND PRECAUTIONS

  • Patients with moderate to severe renal function impairment may be at greater risk for increased exposure and toxicity. Monitor patients for renal function and systemic toxicity and adjust dosing accordingly. Avoid FOLOTYN use in patients with end stage renal disease including those undergoing dialysis unless the potential benefit justifies the potential risk.
FOLOTYN therapy can be continued until disease progression or unacceptable toxicity

FOLOTYN Drug Interactions

No formal clinical assessments of pharmacokinetic drug-drug interactions between FOLOTYN and other drugs have been conducted1

The effect of co-administration of the uricosuric drug probenecid (an inhibitor of multiple transporter systems including the multidrug resistance-associated protein 2 (MRP2) efflux transporter) on pralatrexate pharmacokinetics was investigated in a Phase 1 clinical study. Co-administration of increasing doses of probenecid resulted in delayed clearance of pralatrexate and a commensurate increase in exposure.

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.

There are no contraindications for FOLOTYN.

How Supplied

FOLOTYN is available as single-dose vials containing pralatrexate at a concentration of 20 mg/mL1

FOLOTYN is available in single-dose clear glass vials containing pralatrexate at a concentration of 20 mg/mL as a preservative-free, sterile, clear yellow solution individually packaged for intravenous use in the following presentations:

  • NDC 48818-001-01: 20 mg of pralatrexate in 1 mL solution in a vial (20 mg/1 mL)
  • NDC 48818-001-02: 40 mg of pralatrexate in 2 mL solution in a vial (40 mg/2 mL)

Reference:

  • Folotyn [package insert]. Westminster, CO: Allos Therapeutics, Inc.