weeks Omit dose 20 mg/m2
3 weeks Stop therapy
ANC 500-1,000/μL and no fever 1 week Omit dose Continue prior dose
ANC 500-1,000/μL with fever
or
ANC < 500/μL 1 week Omit dose, give G‑CSF or GM‑CSF support Continue prior dose with G‑CSF or GM‑CSF support
2 weeks or recurrence Omit dose, give G‑CSF or GM‑CSF support 20 mg/m2 with G‑CSF or GM‑CSF support
3 weeks or 2nd recurrence Stop therapy
Table 3 FOLOTYN Dose Modifications for All Other Treatment-related Toxicities Toxicity Grade a on Day of Treatment Action Dose upon Recovery to ≤ Grade 2
a Per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3.0)
Grade 3 Omit dose 20 mg/m2
Grade 4 Stop therapy
FOLOTYN is available in sterile, single-use vials containing pralatrexate at a concentration of 20 mg/mL in the following presentations:
20 mg of pralatrexate in 1 mL solution in a vial (20 mg / 1 mL)
40 mg of pralatrexate in 2 mL solution in a vial (40 mg / 2 mL)
None.
FOLOTYN can suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Dose modifications are based on ANC and platelet count prior to each dose [see Dosage and Administration (2.5) and Adverse Reactions (6)].
Treatment with FOLOTYN may cause mucositis. If ≥ Grade 2 mucositis is observed, omit dose and follow guidelines in Section 2.5, Table 1 [see Dosage and Administration (2.5)].
FOLOTYN has been associated with severe dermatologic reactions, which may result in death. These dermatologic reactions have been reported in clinical studies (14/663 patients [2.1%]) and post marketing experience, and have included skin exfoliation, ulceration, and toxic epidermal necrolysis (TEN). These reactions may be progressive and increase in severity with further treatment, and may involve skin and subcutaneous sites of known lymphoma. Patients with dermatologic reactions should be monitored closely, and if severe, FOLOTYN should be withheld or discontinued.
Tumor lysis syndrome has been reported in patients with lymphoma receiving FOLOTYN. Patients receiving FOLOTYN should be monitored closely and treated for complications.
Patients should be instructed to take folic acid and receive vitamin B to potentially reduce treatment-related hematological toxicity and mucositis [see Dosage and Administration (2.2)].
FOLOTYN can cause fetal harm when administered to a pregnant woman. FOLOTYN was embryotoxic and fetotoxic in rats and rabbits. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1)].
Although FOLOTYN has not been formally tested in patients with renal impairment, caution is advised when administering FOLOTYN to patients with moderate to severe impairment. Monitor patients for renal function and systemic toxicity due to increased drug exposure [see Clinical Pharmacology (12.3)].
Liver function test abnormalities have been observed after FOLOTYN administration. Persistent liver function test abnormalities may be indicators of liver toxicity and require dose modification. Monitor patients for liver function [see Dosage and Administration (2.5)].
The most common adverse reactions observed in patients with periphe
