Generic Name and Formulations:
Pralatrexate 20mg/mL; soln for IV inj; preservative-free.
Spectrum Pharmaceuticals, Inc.
Indications for FOLOTYN:
Relapsed or refractory peripheral T-cell lymphoma.
Prior to administration: mucositis should be ≤Grade 1, platelets should be ≥100,000/μL for first dose and ≥50,000/μL for subsequent doses, absolute neutrophil count should be ≥1,000/μL. Give by IV push over 3–5min. 30mg/m2 once weekly for 6 weeks in 7-week cycles. Continue until disease progression or unacceptable toxicity develops. Supplement with vitamin B12 (1mg IM every 8–10 weeks, starting within 10 weeks before first Folotyn dose) and folic acid (1–1.25mg orally daily, beginning 10 days before starting Folotyn and for 30 days after stopping). Severe renal impairment (CrCL 15–<30mL/min): 15mg/m2. Dose modifications for toxicities: see full labeling.
End stage renal disease (including dialysis): avoid, unless benefit justifies potential risk for toxicity. Omit and/or reduce dose to manage toxicities (eg, hematological, mucositis, hepatic impairment); see full labeling. Monitor CBCs and for mucositis at baseline and weekly. Monitor serum chemistry, renal and hepatic function before the 1st and 4th dose per cycle. Monitor for dermatological reactions; withhold dose or discontinue if severe. Monitor patients at increased risk of tumor lysis syndrome. Renal or hepatic impairment. Embryo-fetal toxicity. Pregnancy (Cat.D), nursing mothers: not recommended.
May be potentiated by probenecid, NSAIDs, trimethoprim/sulfamethoxazole.
Folate analogue inhibitor.
Mucositis, thrombocytopenia, neutropenia, anemia, abnormal liver function tests, nausea, fatigue, pyrexia, dehydration, sepsis, dyspnea; dermatological reactions (eg, skin exfoliation, ulceration, toxic epidermal necrolysis), tumor lysis syndrome.
Single-use vials (1mL, 2mL)—1