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 based on overall response rate. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing and Administration

Pretreatment Vitamin Supplementation

Folic Acid: Patients should take folic acid 1.0-1.25 mg orally once daily beginning 10 days before the first dose of FOLOTYN. Continue folic acid during the full course of therapy and for 30 days after the last dose of FOLOTYN [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)].

Dosing and Administration

The recommended dose of FOLOTYN is 30 mg/m2 administered as an intravenous push over 3-5 minutes via the side port of a free-flowing 0.9% Sodium Chloride Injection, intravenous line once weekly for 6 weeks in 7-week cycles until progressive disease or unacceptable toxicity. The calculated dose of FOLOTYN should be aseptically withdrawn into a syringe for immediate use. Do not dilute FOLOTYN.

For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73 m2), the recommended dose of FOLOTYN is 15 mg/m2.

FOLOTYN is a clear, yellow solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use any vials exhibiting particulate matter or discoloration.

2.2 Monitoring and Dose Modifications

Management of severe or intolerable adverse reactions may require dose omission, reduction, or discontinuation of FOLOTYN therapy.

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.

Dose Modification Recommendations

Prior to administering any dose of FOLOTYN:

Mucositis should be ≤ Grade 1.
Platelet count should be ≥ 100,000/mcL for first dose and ≥ 50,000/mcL for all subsequent doses.
Absolute neutrophil count (ANC) should be ≥ 1,000/mcL.

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. For dose modifications and omissions, use the guidelines in Tables 1, 2, and 3.

For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73 m2), the recommended starting dose of FOLOTYN is 15 mg/m2 with dose modification to 10 mg/m2 for the toxicities specified in Tables 1, 2, and 3.

Table 1 FOLOTYN Dose Modifications for Mucositis
Mucositis Gradea on Day of Treatment Action Dose upon Recovery to ≤ Grade 1 Dose Upon Recovery in 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 Per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3.0)

Table 2 FOLOTYN Dose Modifications for Hematologic Toxicities
Blood Count on Day of Treatment Duration of Toxicity Action Dose upon Restart Dose Upon Recovery in Patients with Severe Renal Impairment
Platelet < 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 500-1,000/mcL and no fever 1 week Omit dose Continue prior dose Continue prior dose
ANC 500-1,000/mcL with feveror ANC < 500/mcL 1 week Omit dose, give G‑CSF or GM‑CSF support Continue prior dose with G-CSF or GM‑CSF support Continue prior dose with G-CSF or GM‑CSF support
2 weeks or recurrence Omit dose, give G‑CSF or GM‑CSF support 20 mg/m2 with G-CSF or GM-CSF support 10 mg/m2 with G-CSF or GM-CSF support
3 weeks or 2nd recurrence Stop therapy

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

Table 3 FOLOTYN Dose Modifications for All Other Treatment-related Toxicities
Toxicity Grade a on Day of Treatment Action Dose upon Recovery to ≤ Grade 2 Dose Upon Recovery in Patients with Severe Renal Impairment
Grade 3 Omit dose 20 mg/m2 10 mg/m2
Grade 4 Stop therapy

a Per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3.0)

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