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

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