The indication for FOLOTYNTM is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
FOLOTYNTM may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood
counts and omit or modify dose for hematologic toxicities (see Dosage and Administration, section 2.5).
Mucositis may occur. If ≥Grade 2 mucositis is observed, omit or modify dose (see Dosage and Administration, section 2.5).
Patients should be instructed to take folic acid and receive vitamin B12 to potentially reduce treatment-related hematological toxicity and mucositis.
FOLOTYNTM can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYNTM and pregnant women should be informed of the potential harm to the fetus.
Use caution and monitor patients when administering FOLOTYNTM to patients with moderate to severe renal function impairment.
Elevated liver function test abnormalities may occur and require monitoring. If liver function test abnormalities are ≥Grade 3, omit or modify dose (see Dosage and Administration, section 2.5).
Adverse Reactions
The most common adverse reactions were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%).
The most common serious adverse events are pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea,
and thrombocytopenia.
Use in Specific Patient Population
Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the
drug to the mother.
Drug Interactions
Co-administration of drugs subject to renal clearance (e.g., probenecid, NSAIDs, and trimethoprim/sulfamethoxazole)
may result in delayed renal clearance.
