Usual Adult Dose for Lymphoma

Usual Adult Dose: 30 mg/m2 via intravenous push over 3 to 5 minutes once weekly for 6 weeks in 7 week cycles.

Duration: Until disease progression or unacceptable toxicity.

Comments:

• Patients should take low dose (1 mg to 1.25 mg) oral folic acid daily.
• Folic acid should start 10 days before the first dose of pralatrexate and continue for 30 days after the last dose.
• Patients should also receive a B12 (1 mg) injection within 10 weeks before the first dose of pralatrexate and every 8 to 10 weeks thereafter.
• Subsequent B12 injections may be given the same day as treatment with pralatrexate.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Persistent liver function test abnormalities may be indicators of liver toxicity and require dose modification.

Dose Adjustments

Management of severe or intolerable adverse reactions may require dose omission, reduction, or interruption of pralatrexate therapy.

Doses may be omitted or reduced based on patient tolerance. Omitted doses will not be made up at the end of the cycle. Once a dose reduction occurs for toxicity, do not re-escalate.

Dose Modifications for Mucositis:
A) If mucositis is grade 2 on the day of treatment, omit the dose. Upon recovery to grade 1 or less, continue the prior dose.
B) If mucositis is a recurrence of grade 2 on the day of treatment, omit the dose. Upon recovery to grade 1 or less, treatment may be resumed at 20 mg/m2.
C) If mucositis is grade 3 on the day of treatment, omit the dose. Upon recovery to grade 1 or less, treatment may be resumed at 20 mg/m2.
D) If mucositis is grade 4 on the day of treatment, therapy should be discontinued.

Dose Modifications for Hematologic Toxicities:
1) Blood count on day of treatment reveals a platelet less than 50,000/mcL:
A) If the duration of the toxicity is 1 week, omit the dose. Upon restart, continue the prior dose.
B) If the duration of the toxicity is 2 weeks, omit the dose. Upon restart, treatment may be resumed at 20 mg/m2.
C) If the duration of the toxicity is 3 weeks, therapy should be discontinued.

2) ANC is 500 to 1,000/mcL and no fever:
If the duration of the toxicity is 1 week, omit the dose. Upon restart, continue the prior dose.

3) ANC 500 to 1,000/mcL with fever or ANC less than 500/mcL:
A) If the duration of the toxicity is 1 week, omit the dose and give G-CSF or GM-CSF support. Upon restart, continue the prior dose with G-CSF or GM-CSF support.
B) If the duration of the toxicity is 2 weeks or a recurrence, omit the dose and give G-CSF or GM-CSF support. Upon restart, treatment may be resumed at 20 mg/m2 with G-CSF or GM-CSF support.
C) If the duration of the toxicity is 3 weeks or a second recurrence, therapy should be discontinued.

4) Dose modifications for all other treatment-related toxicities:
A) If a toxicity is grade 3, omit the dose. Upon restart, treatment may be resumed at 20 mg/m2.
B) If a toxicity is grade 4, therapy should be discontinued.

Precautions

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Prior to administering any dose of pralatrexate:
1) Mucositis should be grade 1 or less.
2) The platelet count should be greater than or equal to 100,000/mcL for first dose and greater than or equal to 50,000/mcL for all subsequent doses.
3) The absolute neutrophil count (ANC) should be greater than or equal to 1,000/mcL.

Monitoring:

• Complete blood cell counts and severity of mucositis should be monitored weekly.
• Serum chemistry tests, including renal and hepatic function, should be performed prior to the start of the first and fourth dose of a given cycle.

• Keep refrigerated; protect from light.
• Unopened vials are stable if stored in the original carton at room temperature for 72 hours.
• Any vials left at room temperature for greater than 72 hours should be discarded.