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ANC 500-1,000/mcL and no fever 1 week Omit dose Continue prior dose
ANC 500-1,000/mcL with fever
or
ANC < 500/mcL 1 week Omit dose, give 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
3 weeks or 2nd recurrence Stop therapy
Table 3 Folotyn Dose Modifications for All Other Treatment-related Toxicities a Per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3.0)
Toxicity Grade a on Day of Treatment Action Dose upon Recovery to ≤ Grade 2
Grade 3 Omit dose 20 mg/m2
Grade 4 Stop therapy
Special Handling Precautions
Folotyn is a cytotoxic anticancer agent. Caution should be exercised in handling, preparing, and administering of the solution. The use of gloves and other protective clothing is recommended. If Folotyn comes in contact with the skin, immediately and thoroughly wash with soap and water. If Folotyn comes in contact with mucous membranes, flush thoroughly with water.
Several published guidelines for handling and disposal of anticancer agents are available1-4.
•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 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.
Dosage Forms and Strengths
Folotyn is available as a clear yellow solution in sterile, single-use vials containing pralatrexate at a concentration of 20 mg/mL in the following presentations:
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)
Contraindications
None
Warnings and Precautions
Bone Marrow Suppression
Folotyn can cause bone marrow suppression, manifested by thrombocytopenia, neutropenia, and/or anemia. Monitor complete blood counts and omit and/or reduce the dose based on ANC and platelet count prior to each dose as outlined in Section 2.2 Table 2. Administer vitamin B12 and instruct patients to take folic acid to reduce the risk of treatment-related hematological toxicity [see Dosage and Administration (2.1)(2.2) and Adverse Reactions (6.1)].
Mucositis
Folotyn can cause mucositis. Monitor for mucositis weekly and if ≥ Grade 2 mucositis is observed, omit and/or reduce the dose as outlined in Section 2.2 Table 1. Administer vitamin B12 and instruct patients to take folic acid to reduce the risk of mucositis [see Dosage and Administration (2.1)(2.2) and Adverse Reactions (6.1)].
Dermatologic Reactions
Folotyn can cause severe dermatologic reactions, which may result in death. These dermatologic reactions have been reported in clinical studies (14/663 patients [2.1%]) and post marketing experience, and have included skin exfoliation, ulceration, and toxic epidermal necrolysis (TEN). They may be progressive and increase in severity with further treatment, and may involve skin and subcutaneous sites of known lymphoma. Monitor patients with dermatologic reactions closely, and if severe, withhold or |
