Rx Item-Folotyn 20Mg/Ml(1) Vial 1Ml By Allos Therapeutics Refrigerated

FOLOTYN- pralatrexate injection
Allos Therapeutics

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 The calculated dose of FOLOTYN should be aseptically withdrawn into a syringe for immediate use.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

Folotyn 20Mg/Ml(1) Vial 1Ml By
Folotyn 20Mg/Ml(1) Vial 1Ml By Allos Therapeutics Refrigerated Item No.:RX703829 703829 NDC No.48818000101 48818-001-01 4881800101 UPC No.:348818001018 NDC No. 48818-0001-01 UPC/GTIN No. 3-48818-001

Folotyn 20Mg/Ml(1) Vial 1Ml By Allos The
BRAND: FOLOTYN NDC: 48818-0001-01,48818000101 UPC: 3-48818-00101-8,348818001018 ALLOS THERAPEUTICS Specialty Healthcare-

PRALATREXATE INTRAVEN VIA
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Drug info from Dailymed
Drug info from Dailymed