p therapy
Table 3 FOLOTYN Dose Modifications for All Other Treatment-related Toxicities Toxicity Gradeaon Day of Treatment Action Dose upon Recovery to ≤Grade 2
a Per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCICTCAE, Version 3.0)
Grade 3 Omit dose 20 mg/m2
Grade 4 Stop therapy
3 DOSAGE FORMS AND STRENGTHS
FOLOTYN is available in sterile, single-use vials containing pralatrexate at a concentration of 20mg/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)
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Bone Marrow Suppression
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)].
5.2 Mucositis
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)].
5.3 Dermatologic Reactions
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.
5.4 Tumor Lysis Syndrome
Tumor lysis syndrome has been reported in patients with lymphoma receiving FOLOTYN. Patients receiving FOLOTYN should be monitored closely and treated for complications.
5.5 Folic Acid and Vitamin B12 Supplementation
Patients should be instructed to take folic acid and receive vitamin B12 to potentially reduce treatment-related hematological toxicity and mucositis [see Dosage and Administration (2.2)].
5.6 Pregnancy Category D
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)].
5.7 Decreased Renal Function
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)].
5.8 Elevated Liver Enzymes
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)].
6 ADVERSE REACTIONS
The most common adverse reactions observed in patients with peripheral T-cell lymphoma (PTCL) treated with FOLOTYN were mucositis, thrombocytopenia, nausea, and fatigue.
6.1 Clinical Trial
