Pralatrexate Application Scope

Pralatrexate (trade name Folotyn) is a folate analogue metabolism inhibitor primarily used for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL).

712 In addition, preclinical studies have demonstrated significant anti-tumour activity against high-risk neuroblastomas (particularly MYCN-amplified), which is up to 10-fold more potent than methotrexate and less toxic.

pralatrexate

Pralatrexate Characteristics

Ingredients: N-(4-{1-[(2,4-diaminopteridin-6-yl)methyl]but-3-yn-1-yl}benzoyl)-L-glutamic acid.
Properties:

Molecular formula: C₂₃H₂₃N₇O₅, molecular weight: 477.481 g/mol.

Transparent yellow solution for intravenous injection, need to be stored away from light.

Specification: 20 mg/mL (1 mL/vial or 2 mL/vial).
Packing specification: single use sterile vial.
Unopened: refrigerated at 2-8°C, stored away from light; store at room temperature for up to 72 hours.
Expiry date: not explicitly mentioned (need to refer to specific product instructions).
Execution standard: FDA approved (approved in the USA in 2009).
Approval number: NDA #022468 (USA).
Revision date: Not explicitly mentioned.
Manufacturer: Originally developed by Allos Therapeutics, now a subsidiary of Spectrum Pharmaceuticals.

Guidelines For The Use Of Pralatrexate

Dosage and Administration

RECOMMENDED DOSE: 30 mg/m² by intravenous push (3-5 minutes) once weekly for 6 consecutive weeks (7-week cycle) until disease progression or intolerable toxicity.

Supplement Requirements:

Folic acid: 1.0-1.25 mg orally daily, beginning 10 days before treatment and continuing until 30 days after discontinuation.

Vitamin B12: 1 mg intramuscularly during the first 10 weeks of treatment, repeated every 8-10 weeks thereafter.

Adverse Reactions

Common adverse reactions: myelosuppression (thrombocytopenia, neutropenia, anaemia), mucositis, elevated liver enzymes, skin reactions (e.g., exfoliative dermatitis).

Serious reactions: Grade 4 mucositis or haematological toxicity requiring discontinuation.
Contraindications: Pralatrexate is contraindicated in persons with hypersensitivity to Pralatrexate or its components.
Precautions: Bone marrow suppression: regular monitoring of blood counts is required.

Mucositis: Withhold dosing if grade ≥2.

Hepatic and renal function: use with caution in moderate to severe renal insufficiency; monitor liver enzymes.

Pregnancy Risk: Pregnancy Category D. May cause fetal harm.

Pralatrexate Interactions

Drug Interactions

Folate antagonists: may increase toxicity; avoid combination.

Nephrotoxic drugs: may increase risk of Pralatrexate accumulation.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.