Pralatrexate – Folotyn™
|The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.|
| Caution should be exercised in handling, preparing, and administering of the solution. The use of gloves and other protective clothing is recommended.
ADMINISTRATION: The recommended dose of FOLOTYN is 30 mg/m2administered as an intravenous (IV) push over 3-5 minutes via the side port of a free-flowing 0.9% Sodium Chloride Injection, USP IV line once weekly for 6 weeks in 7-week cycles until progressive disease or unacceptable toxicity.
Preparation for Intravenous Push Administration:
|Stability / Miscellaneous|
1. INDICATIONS AND USAGE
2. DOSAGE AND ADMINISTRATION
2.1 Peripheral T-cell Lymphoma
2.2 Vitamin Supplementation
2.3 Preparation and Administration Precautions
Several published guidelines for handling and disposal of anticancer agents are available [see References (15)].
2.4 Preparation for Intravenous Push Administration FOLOTYN vials should be refrigerated at 2-8°C (36-46°F) until use. FOLOTYN vials should be stored in original carton to protect from light until use. 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. The calculated dose of FOLOTYN should be aseptically withdrawn into a syringe for immediate use. Do not dilute FOLOTYN. FOLOTYN vials contain no preservatives and are intended for single use only. After withdrawal of dose, discard vial including any unused portion. Unopened vial(s) of FOLOTYN 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. 2.5 Monitoring and Dose Modifications
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.
Dose Modification Recommendations
Prior to administering any dose of FOLOTYN: Mucositis should be ≤ Grade 1. Platelet count should be ≥ 100,000/µL for first dose and ≥ 50,000/µL for all subsequent doses. Absolute neutrophil count (ANC) should be ≥ 1,000/µL.
20 mg of pralatrexate in 1 mL solution in a vial (20 mg / 1 mL)
40 mg of pralatrexate in 2 mL solution in a vial (40 mg / 2 mL)
5.1 Bone Marrow Suppression
5.3 Folic Acid and Vitamin B12 Supplementation
5.4 Pregnancy Category D
5.5 Decreased Renal Function
5.6 Elevated Liver Enzymes
5.7 Dermatologic Reactions
HOW SUPPLIED/STORAGE AND HANDLING
NDC 48818-001-01: 20 mg of pralatrexate in 1 mL solution in a vial (20 mg / 1 mL)
NDC 48818-001-02: 40 mg of pralatrexate in 2 mL solution in a vial (40 mg / 2 mL)
Vials must be stored refrigerated at 2-8°C (36-46°F) (see USP Controlled Cold Temperature) in original carton to protect from light.
Handle and dispose of FOLOTYN according to guidelines issued for cytotoxic drugs, including the use of gloves and other protective clothing to prevent skin contact [see References (15)].
Each vial of FOLOTYN is intended for single use only. Any unused drug remaining after injection must be discarded
FOLOTYN is a trademark of Allos Therapeutics, Inc.
|1) [PACKAGE INSERT DATA] : FOLOTYN® (pralatrexate) injection. [Allos Therapeutics] Westminster, CO 80020. Revised: 06/2010.|
The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user’s use of or reliance upon this material.PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. Read the disclaimer