tions
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. IfFOLOTYN comes in contact with the skin, immediately and thoroughly wash with soap and water. IfFOLOTYN comes in contact with mucous membranes, flush thoroughly with water.
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. Donot 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The calculated dose of FOLOTYN should be aseptically withdrawn into a syringe for immediate use.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 72hours. Any vials left at room temperature for greater than 72 hours should be discarded.
2.5 Monitoring and Dose Modifications
Management of severe or intolerable adverse reactions may require dose omission, reduction, or interruption of FOLOTYN therapy.
Monitoring
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.
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.
Table 1 FOLOTYN Dose Modifications for Mucositis Mucositis Gradeaon Day of Treatment Action Dose upon Recovery to ≤Grade 1
a Per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCICTCAE, Version 3.0)
Grade 2 Omit dose Continue prior dose
Grade 2 recurrence Omit dose 20 mg/m2
Grade 3 Omit dose 20 mg/m2
Grade 4 Stop therapy
Table 2 FOLOTYN Dose Modifications for Hematologic Toxicities Blood Count on Day of Treatment Duration of Toxicity Action Dose upon Restart
Platelet < 50,000/μL 1 week Omit dose Continue prior dose
2 weeks Omit dose 20 mg/m2
3 weeks Stop therapy
ANC 500-1,000/μL and no fever 1 week Omit dose Continue prior dose
ANC 500-1,000/μL with fever
or
ANC <500/μL 1 week Omit dose, giveG‑CSF or GM‑CSF support Continue prior dose with G‑CSF or GM‑CSF support
2 weeks or recurrence Omit dose, giveG‑CSF or GM‑CSF support 20 mg/m2 withG‑CSF or GM‑CSFsupport
3 weeks or 2ndrecurrence Sto