Folotyn Pralatrexate Injection

1. Indications and Usage
Peripheral T-Cell Lymphoma (PTCL):
Indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.
2. Dosage and Administration
Pre-Treatment Vitamin Supplementation (Mandatory):
Folic Acid: Patients must take folic acid orally (1 mg daily or 5 mg three times weekly). Initiate at least 10 days prior to the first dose and continue until 30 days after the last dose.
Vitamin B12: Administer intramuscularly (1 mg) within 10 weeks prior to the first dose, and every 8-10 weeks thereafter.
Recommended Dosage:
30 mg/m² administered as an intravenous push over 3 to 5 minutes once weekly for 6 weeks, followed by a 1-week rest period (7-week cycle).
Administration Instructions:
Administer via a peripheral intravenous line. No dilution is required for the intravenous push.
3. Mechanism of Action
Antifolate Metabolite:
Pralatrexate is a non-classical antifolate.
Physiological Effect:
It is a substrate for the reduced folate carrier (RFC), which allows for rapid and high accumulation of pralatrexate inside cells. It inhibits dihydrofolate reductase (DHFR), depleting the precursors necessary for DNA synthesis, leading to cell cycle arrest and apoptosis in malignant cells.
4. Safety and Warnings
Mucositis:
Severe mucositis is a common and potentially dose-limiting toxicity. Monitor mucositis at least weekly and manage with oral hygiene and topical treatments (e.g., “Magic Mouthwash”).
Bone Marrow Suppression:
Pralatrexate may cause thrombocytopenia, neutropenia, and anemia. Monitor complete blood counts (CBC) weekly during treatment.
Embryo-Fetal Toxicity:
Based on its mechanism of action, pralatrexate can cause fetal harm. Females of reproductive potential should use effective contraception.
Renal and Hepatic Impairment:
Dosage adjustment is required for patients with renal impairment. Use with caution in patients with hepatic impairment.
5. Adverse Reactions
Most Common:
Mucositis, thrombocytopenia, nausea, fatigue, anemia, constipation, pyrexia, cough, and epistaxis.
6. Drug Interactions
Renal Clearance Competitors:
Drugs that affect renal clearance (e.g., NSAIDs, trimethoprim, sulfamethoxazole) may delay pralatrexate clearance and increase systemic exposure. Use with caution.
Probenecid:
Can delay the clearance of pralatrexate, leading to increased systemic exposure.
7. Pharmaceutical Information
Storage:
Store in the original carton at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.