Folotyn

FOLOTYN — pralatrexate injection
Acrotech Biopharma LLC

1 INDICATIONS AND USAGE

FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing Information

Pretreatment Vitamin Supplementation

Folic Acid
Instruct patients to take folic acid 1 to 1.25 mg orally once daily beginning 10 days before the first dose of FOLOTYN. Continue folic acid during treatment with FOLOTYN and for 30 days after the last dose [see Warnings and Precautions (5.1, 5.2)].

Vitamin B12
Administer vitamin B12 1 mg intramuscularly within 10 weeks prior to the first dose of FOLOTYN and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with FOLOTYN [see Warnings and Precautions (5.1, 5.2)].

2.2 Recommended Dosage

The recommended dosage of FOLOTYN is 30 mg/m2 intravenously over 3-5 minutes once weekly for 6 weeks in 7-week cycles until progressive disease or unacceptable toxicity.

2.3 Dosage Modifications for Renal Impairment and End Stage Renal Disease

2.4 Monitoring and Dosage Modifications for Adverse Reactions

Monitoring
Monitor complete blood cell counts and severity of mucositis at baseline and weekly. Perform serum chemistry tests, including renal and hepatic function, prior to the start of the first and fourth dose of each cycle.

Recommended Dosage Modifications Do not administer FOLOTYN until:

  • Mucositis Grade 1 or less.
  • Platelet of 100,000/mcL or greater for first dose and 50,000/mcL or greater for all subsequent doses.
  • Absolute neutrophil count (ANC) of 1,000/mcL or greater.

Dosage modifications for adverse reactions are provided in Tables 1, 2, and 3.

Table 1 FOLOTYN Dose Modifications for Mucositis
Mucositis Gradea on Day of Treatment Action Recommended Dose upon Recovery to Grade 0 or 1
Patients Without Severe Renal Impairment Patients with Severe Renal Impairment
Grade 2 Omit dose Continue prior dose Continue prior dose
Grade 2 recurrence Omit dose 20 mg/m2 10 mg/m2
Grade 3 Omit dose 20 mg/m2 10 mg/m2
Grade 4 Stop therapy

a Based National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0)

Table 2 FOLOTYN Dosage Modifications for Myelosuppression
Blood Count on Day of Treatment Duration of Toxicity Action Recommended Dose Upon Recovery
Patients Without Severe Renal Impairment Patients with Severe Renal Impairment
Platelet less than 50,000/mcL 1 week Omit dose Continue prior dose Continue prior dose
2 weeks Omit dose 20 mg/m2 10 mg/m2
3 weeks Stop therapy
ANC 500 to 1,000/mcL and no fever 1 week Omit dose Continue prior dose Continue prior dose
ANC 500 to 1,000/mcL with fever or ANC less than 500/mcL 1 week Omit dose, give G‑CSF or GM‑CSF Continue prior dose with G-CSF or GM‑CSF Continue prior dose with G-CSF or GM‑CSF support
2 weeks or recurrence Omit dose, give G‑CSF or GM‑CSF 20 mg/m2 with G-CSF or GM-CSF 10 mg/m2 with G-CSF or GM-CSF
3 weeks or 2nd recurrence Stop therapy

G-CSF=granulocyte colony-stimulating factor; GM-CSF=granulocyte macrophage colony-stimulating factor

Table 3 FOLOTYN Dosage Modifications for All Other Adverse Reactions
Toxicity Grade a on Day of Treatment Action Recommended Dose upon Recovery to Grade 2 or Lower
Patients Without Severe Renal Impairment Patients with Severe Renal Impairment
Grade 3 Omit dose 20 mg/m2 10 mg/m2
Grade 4 Stop therapy

a Based on NCI CTCAE version 3.0

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