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Pralatrexate

    DEA Class; Rx

    Common Brand Names; Folotyn

    • Antineoplastics, Antimetabolite

    Novel antifolate for relapsed or refractory peripheral T-cell lymphoma, a rare form of non-Hodgkin’s lymphoma.

    Indicated for relapsed or refractory PTCL

    Hypersensitivity

    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% )

    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

    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

    Adults

    30 mg/m2 IV once weekly.

    Geriatric

    30 mg/m2 IV once weekly.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Pralatrexate 

    IV solution

    • 20mg/mL
    • 40mg/2mL