INDICATIONS AND USAGE（适应症）

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.

DOSAGE（服用剂量）

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.

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.

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 The calculated dose of FOLOTYN should be aseptically withdrawn into a syringe for immediate use.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.

ADVERSE REACTIONS（不良反应）

Bone Marrow Suppression

Mucositis

Dermatologic Reactions

Tumor Lysis Syndrome

Hepatic Toxicity

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/5e4cf15b-bf7b-4b83-863e-e9ef27741a51/spl-doc?hl=Folotyn

Folotyninformation