HIGHLIGHTS OF PRESCRIBING INFORMATION
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 injection
Initial U.S. Approval: 2009

 
RECENT MAJOR CHANGES
Warnings and Precautions, Mucositis (5.2)4/2010

Warnings and Precautions, Dermatologic Reactions (5.3)1/2011

Warnings and Precautions, Tumor Lysis Syndrome (5.4) 1/2011

 
INDICATIONS AND USAGE
FOLOTYN is a folate analog metabolic inhibitor 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. (1)

 
DOSAGE AND ADMINISTRATION
The recommended dose of FOLOTYN is 30 mg/m2 administered as an intravenous push over 3 to 5 minutes once weekly for 6 weeks in 7-week cycles. (2.1)
Supplement patients with vitamin B12 1mg intramuscularly every 8-10weeks and folic acid 1.0-1.25 mg orally on a daily basis. (2.2)
Treatment interruption or dose reduction to 20 mg/m2 may be needed to manage adverse drug reactions. (2.5)

 
DOSAGE FORMS AND STRENGTHS
Sterile, single-use vials containing pralatrexate at a concentration of 20mg/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) (3)
 
CONTRAINDICATIONS
None. (4)

 
WARNINGS AND PRECAUTIONS
Thrombocytopenia, neutropenia, and anemia may occur. Monitor blood counts and omit or modify dose for hematologic toxicities. (2.5, 5.1)
Mucositis may occur. If ≥ Grade 2 mucositis is observed, omit or modify dose. (2.5, 5.2)
Fatal dermatologic reactions may occur. Dermatologic reactions may be progressive and increase in severity with further treatment. Patients with dermatologic reactions should be monitored closely, and if severe, FOLOTYN should be withheld or discontinued. (5.3)
Tumor lysis syndrome may occur. Monitor patients and treat if needed. (5.4)
FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYN, and pregnant women should be informed of the potential harm to the fetus. (5.6, 8.1)
Use caution in patients with moderate to severe renal function impairment. (5.7)
Elevated liver function test abnormalities may occur. If liver function test abnormalities are ≥ Grade 3, omit or modify dose. (2.5, 5.8)

 
ADVERSE REACTIONS
Most common adverse reactions are mucositis, thrombocytopenia, nausea, and fatigue. Most common serious adverse reactions are pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Allos Therapeutics, Inc at 1-888-ALLOS88 (1-888-255-6788) or www.FOLOTYN.com or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch

 
DRUG INTERACTIONS
Co-administration with probenecid, NSAIDs, and trimethoprim/sulfamethaxazole may result in delayed renal clearance. (7)

 
USE IN SPECIFIC POPULATIONS
Women should be advised against breastfeeding while being treated with FOLOTYN. (8.3)

See 17 for PATIENT COUNSELING INFORMATION