These highlights do not include all the information needed to use FOLOTYN safely and effectively. See full prescribing information for FOLOTYN.FOLOTYN (pralatrexate injection)Solution for intravenous injectionInitial U.S. Approval: 2009
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.
FOLOTYN should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
The recommended dose of FOLOTYN is 30 mg/m administered 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.
Patients should take low-dose (1.0-1.25 mg) oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of FOLOTYN, and dosing should continue during the full course of therapy and for 30 days after the last dose of FOLOTYN. Patients should also receive a vitamin B (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of FOLOTYN and every 8-10 weeks thereafter. Subsequent vitamin B injections may be given the same day as treatment with FOLOTYN [see Warnings and Precautions (5.5)].
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 available [see References (15)].
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:
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 Grade a on Day of Treatment Action Dose upon Recovery to ≤ Grade 1
a Per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE, 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
