Allos Therapeutics

Allos Therapeutics Drugs

• Folotyn
  

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  Folotyn

  

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  2.1 General Dosing and Administration

  Pretreatment Vitamin Supplementation

  Folic Acid: Patients should take folic acid 1.0-1.25 mg orally once daily beginning 10 days before the first dose of FOLOTYN. Continue folic acid during the full course of therapy and for 30 days after the last dose of FOLOTYN [see Warnings and Precautions (5.1)(5.2)].

  Vitamin B12: Administer vitamin B12 1 mg intramuscularly within 10 weeks prior to the first dose of FOLOTYN and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with FOLOTYN [see Warnings and Precautions (5.1)(5.2)].

  Dosing and Administration

  The recommended dose of FOLOTYN is 30 mg/m2 administered as an intravenous push over 3-5 minutes via the side port of a free-flowing 0.9% Sodium Chloride Injection, intravenous line once weekly for 6 weeks in 7-week cycles until progressive disease or unacceptable toxicity. The calculated dose of FOLOTYN should be aseptically withdrawn into a syringe for immediate use. Do not dilute FOLOTYN.

  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. Do not use any vials exhibiting particulate matter or discoloration.

  2.2 Monitoring and Dose Modifications

  Management of severe or intolerable adverse reactions may require dose omission, reduction, or discontinuation of FOLOTYN therapy.

  Monitoring

  Monitor complete blood cell counts and severity of mucositis at baseline and weekly. Perform serum chemistry tests, including renal and hepatic function, prior to the start of the first and fourth dose of each cycle.

  Dose Modification Recommendations

  Prior to administering any dose of FOLOTYN:

  Mucositis should be ≤ Grade 1. Platelet count should be ≥ 100,000/mcL for first dose and ≥ 50,000/mcL for all subsequent doses. Absolute neutrophil count (ANC) should be ≥ 1,000/mcL.

  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

  a Per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3.0)

  Mucositis Gradea on Day of Treatment Action Dose upon Recovery to ≤ Grade 1 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

  G-CSF=granulocyte colony-stimulating factor; GM-CSF=granulocyte macrophage colony-stimulating factor

  Blood Count on Day of Treatment Duration of Toxicity Action Dose upon Restart Platelet < 50,000/mcL 1 week Omit dose Continue prior dose 2 weeks Omit dose 20 mg/m2 3 weeks Stop therapy ANC 500-1,000/mcL and no fever 1 week Omit dose Continue prior dose ANC 500-1,000/mcL with feverorANC < 500/mcL 1 week Omit dose, give G-CSF or GM-CSF support Continue prior dose with G-CSF or GM-CSF support 2 weeks or recurrence Omit dose, give G-CSF or GM-CSF support 20 mg/m2 with G-CSF or GM-CSF support 3 weeks or 2nd recurrence Stop therapy Table 3 FOLOTYN Dose Modifications for All Other Treatment-related Toxicities

  a Per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3.0)

  Toxicity Grade a on Day of Treatment Action Dose upon Recovery to ≤ Grade 2 Grade 3 Omit dose 20 mg/m2 Grade 4 Stop therapy

  2.3 Special Handling Precautions

  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 available1-4.

  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 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 72 hours. Any vials left at room temperature for greater than 72 hours should be discarded.

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