Classes
DEA Class; Rx
Common Brand Names; Folotyn
- Antineoplastics, Antimetabolite
Description
Novel antifolate for relapsed or refractory peripheral T-cell lymphoma, a rare form of non-Hodgkin’s lymphoma.
Indications
Indicated for relapsed or refractory PTCL
Contraindications
Hypersensitivity
Adverse Effects
Inflammatory disease of mucous membrane, Any grade (70% )
Thrombocytopenia, Any grade (41% )
Nausea (40% )
Fatigue (36% )
Anemia, Any grade (34% )
Constipation (33% )
Pancytopenia, Thrombocytopenia, Grade 3/4 (33% )
Edema (30% )
Cough (28% )
Neutropenia, Any grade (24% )
Inflammatory disease of mucous membrane, Grade 3/4 (21% )
Neutropenia, Grade 3/4 (20% )
Dyspnea (19% )
Anemia (17% )
Warnings
Treatment can cause mucositis; administer vitamin B12 and instruct patients to take folic acid to reduce risk of mucositis; monitor for mucositis weekly and omit and/or reduce dose for grade 2 or higher mucositis
Treatment interruption or dose reduction to 20 mg/sq.meter may be required with severe mucositis, thrombocytopenia, or elevated liver function tests
Caution with moderate-to-severe renal impairment (higher risk for toxicity); monitor for systemic toxicity and adjust dose accordingly
Reports of severe dermatologic reactions including skin exfoliation, ulceration, and toxic epidermal necrolysis; reactions may be progressive and increase in severity with further treatment and may involve skin and subcutaneous sites of known lymphoma; monitor closely for dermatologic reactions (withhold or discontinue treatment)
Treatment can cause tumor lysis syndrome (TLS); monitor patients who are at increased risk of TLS and treat promptly
Avoid breastfeeding
Probenecid decreases renal elimination of pralatrexate
Pregnancy and Lactation
Based on findings from animal studies and mechanism of action therapy can cause fetal harm when administered to a pregnant woman
There is no data on presence in human milk or effects on breastfed child or milk production; because of potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 1 week after last dose
Maximum Dosage
30 mg/m2 IV once weekly.
30 mg/m2 IV once weekly.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Pralatrexate
IV solution
- 20mg/mL
- 40mg/2mL