Adult Dosing
Relapsed/refractory peripheral T-cell lymphoma
- 30 mg/m2 IV over 3-5 mins once wkly for 6 wk in 7-wk cycles
- Provide supplemental IM vitamin B12 1 mg 10 wks before first dose and q8-10weeks thereafter
- Provide folic acid 1.0-1.25 mg PO before first dose and continue during the full course of therapy and for 30 days after the last dose
- If adverse reactions occur, dose may be decreased to 20 mg/m2
Note: Do not administer if ANC is <1,000/mcL, platelets are <100,000/mcL for the first dose and 50,000/mcLfor subsequent doses, and mucositis is > grade 1
Pediatric Dosing
- Safety and effectiveness of in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Therapy may cause thrombocytopenia, neutropenia, and anemia. Carefully monitor blood counts and omit or modify dose for hematologic toxicities
- Incidences of mucositis may have been reported. Omit or modify dose if
Grade 2 mucositis is observed - Fatal dermatologic reactions may occur. With further treatment dermatologic reactions may be progressive and increase in severity. Closely monitor patients with dermatologic reactions and withheld or discontinue therapy if dermatologic reactions become severe
- Pralatrexate is associated with tumor lysis syndrome. Monitor patients and treat if needed
- Therapy may cause fetal harm. Women should avoid becoming pregnant while being treated with pralatrexate, and pregnant women should be informed of the potential harm to the fetus
- Use caution in patients with moderate to severe renal function impairment
- Therapy may cause elevated liver function test abnormalities. If liver function test abnormalities are Grade 3, omit or modify dose
- Pralatrexate is not recommended in patients with end-stage renal disease undergoing dialysis as it may cause serious adverse events such as toxic epidermal necrolysis and mucositis
Caution: Use cautiously in
- Moderate-severe renal impairment
Supplemental Patient Information
- Prior to initiating therapy discuss with physician if suffering from liver problems, kidney problems, any other medical conditions or are pregnant or plan to become pregnant
Pregnancy Category:D
Breastfeeding: Probably unsafe. Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.
