Generic Name

Pralatrexate

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Classification

FDA Approved Indications

• Relapsed or refractory peripheral T-cell lymphoma (PTCL)

Mechanism of Action

Pralatrexate is a folate analogue metabolic inhibitor that selectively inhibits dihydrofolate reductase (DHFR), leading to inhibition of DNA synthesis, repair, and cellular replication, primarily affecting rapidly dividing cancer cells.

Dosage and Administration

Adult: Dose: 30 mg/m² IV weekly for 6 weeks followed by 1 week of rest (total 7-week cycles). Premedicate with folic acid and vitamin B12 before starting therapy and during treatment to reduce toxicity.

Pediatric: Not typically used in pediatric patients; safety and efficacy not established.

Geriatric: Use with caution; monitor for toxicity, especially in patients with decreased renal function.

Renal Impairment: Dose modification may be necessary; consult specific guidelines.

Hepatic Impairment: No specific dose adjustment recommended; monitor hepatic function.

Pharmacokinetics

Absorption: Administered intravenously, rapid and complete absorption is not applicable.

Distribution: Widely distributed; high affinity for tissues.

Metabolism: Metabolized minimally; primarily excreted unchanged.

Excretion: Primarily renal excretion.

Half Life: Approximate half-life of 13 hours.

Contraindications

• Hypersensitivity to pralatrexate or its components.

Precautions

• Risk of myelosuppression, mucositis, infections, renal toxicity, hepatotoxicity, and pulmonary toxicity. Use with caution in pregnant or breastfeeding women. Monitor blood counts, renal and hepatic function regularly.

Adverse Reactions - Common

• Myelosuppression (neutropenia, anemia, thrombocytopenia) (Very common)
• Stomatitis/mucositis (Common)
• Nausea, vomiting (Common)
• Fatigue (Common)

Adverse Reactions - Serious

• Severe myelosuppression leading to infections or bleeding (Serious (rare))
• Renal toxicity (Serious (rare))
• Pulmonary toxicity (pneumonitis, fibrosis) (Serious (rare))
• Hepatotoxicity (Serious (rare))

Drug-Drug Interactions

• Other myelosuppressive agents, nephrotoxic drugs, hepatotoxic drugs

Drug-Food Interactions

• Folate supplements (should be managed carefully to balance efficacy and toxicity)

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Report fever, sore throat, mouth sores, or unusual bleeding.
• Maintain good oral hygiene.
• Follow dosing schedule and attend all monitoring appointments.
• Use effective contraception during treatment and for some time after.

Special Considerations

Black Box Warnings:

• Severe myelosuppression, mucositis, and renal toxicity.

Genetic Factors: N/A

Lab Test Interference: Potential interference with folate and vitamin B12 levels; interpret labs accordingly.

Overdose Management

Signs/Symptoms: Severe myelosuppression, mucositis, renal failure.

Treatment: Supportive care including blood product transfusions, growth factors, hydration, and symptomatic management. Hemodialysis may be considered in cases of toxicity.

Storage and Handling

Storage: Store at controlled room temperature, 20°C to 25°C (68°F to 77°F). Keep in original container.

Stability: Stable under recommended storage conditions until expiration date.