dosing and administration

The recommended dosage of FOLOTYN ® is 30 mg/m2 administered as an intravenous push over 3 to 5 minutes once weekly for 6 weeks, followed by 1 week of rest.1

  • No pre-medications are required when administering FOLOTYN
  • Monitor complete blood cell counts 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
  • Persistent liver function test abnormalities may be indicators of liver toxicity and require dose modification
  • Treatment with FOLOTYN may cause mucositis, severity of which should be monitored weekly. If ≥ Grade 2, dose should be modified
  • Management of severe or intolerable adverse reactions may require dose omission, reduction or interruption of FOLOTYN therapy
  • Dose modifications are based on absolute neutrophil count (ANC) and platelet count prior to each dose

Folotyn dosing and administration

Dose modification guidelines

Based on patient tolerance, doses of FOLOTYN may be omitted or reduced

  • Omitted doses will not be made up at the end of the cycle; once a dose reduction occurs for toxicity, do not re-escalate

Prior to administering any dose, mucositis should be ≤ Grade 1

  • Treatment with FOLOTYN may cause mucositis. If ≥Grade 2 mucositis is observed, dose should be modified. Severity of mucositis should be monitored weekly

Folotyn dosing and administration guidelines toxicities

Folotyn dosing and administration guidelines mucositis

Hematologic toxicities

In the case of hematologic toxicity, doses of FOLOTYN may be omitted or reduced. Prior to administering FOLOTYN :

  • 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
  • Omitted doses will not be made up at the end of the cycle; once a dose reduction occurs for toxicity, do not re-escalate.

Folotyn dose modification guidelines hemotologic toxicities

 

Important Safety Information

Warnings and Precautions

  • FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit or modify dose for hematologic toxicities.
  • Mucositis may occur. If ≥Grade 2 mucositis is observed, omit or modify dose. Patients should be instructed to take folic acid and receive vitamin B12 to potentially reduce treatment-related hematological toxicity and mucositis.
  • 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.
  • Tumor lysis syndrome may occur. Monitor patients and treat if needed.
  • 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.
  • Use caution and monitor patients when administering FOLOTYN 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.

Adverse Reactions

  • The most common adverse reactions were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events were 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 with probenecid or other drugs that may affect relevant transporter systems (eg, NSAIDs), requires close monitoring for signs of systemic toxicity.

 

Please see FOLOTYN Full Prescribing Information

Reference:

1 FOLOTYN Prescribing Information. Allos Therapeutics, Inc. 2012.

 
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