Droxia

Droxia Manufacturers

• E.r. Squibb & Sons, L.l.c.
  

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  Droxia | E.r. Squibb & Sons, L.l.c.

  

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  2.1  Dosing Information Table 1:     Dosing Recommendation Based on Blood Count

  Dosing Regimen

  Dose

  Dose Modification Criteria

  Monitoring Parameters

  Initial Recommended
  Dosing

  15 mg/kg/day as a single dose

  Base dosage on the patient’s actual or ideal weight, whichever is less.

  Monitor the patient’s blood count every 2 weeks [see Warnings and Precautions (5.1)].

  Dosing Based on
  Blood Counts

    In an acceptable
    range

  Increase dose
  5 mg/kg/day every 12 weeks

  Maximal dose:
  35 mg/kg/day*

  *Maximal dose is the highest dose that does not produce toxic blood counts over 24 consecutive weeks.

  Increase dosing only if blood counts are in an acceptable range.

  Do not increase if myelosuppression occurs.

  Blood Counts Acceptable Range

  neutrophils ≥2500 cells/mm3

  platelets ≥95,000/mm3

  hemoglobin >5.3 g/dL

  reticulocytes ≥95,000/mm3 if
      the hemoglobin
      concentration <9 g/dL

    Between acceptable
    and toxic range

  Do not increase dose.

  If blood counts are considered toxic, discontinue DROXIA until hematologic recovery.

  Blood Counts Toxic Range

  neutrophils <2000 cells/mm3

  platelets <80,000/mm3

  hemoglobin <4.5 g/dL

  reticulocytes <80,000/mm3 if
      the hemoglobin
      concentration <9 g/dL

  Dosing After
  Hematologic
  Recovery

  Reduce dose by
  2.5 mg/kg/day.

  Reduce the dose from the dose associated with hematologic toxicity.

  May titrate up or down every 12 weeks in 2.5 mg/kg/day increments.

  The patient should be at a stable dose with no hematologic toxicity for 24 weeks.

  Discontinue the treatment permanently if a patient develops hematologic toxicity twice.

  Patients must be able to follow directions regarding drug administration and their monitoring and care.

  Fetal hemoglobin (HbF) levels may be used to evaluate the efficacy of DROXIA in clinical use. Obtain HbF levels every three to four months. Monitor for an increase in HbF of at least two-fold over the baseline value.

  DROXIA causes macrocytosis, which may mask the incidental development of folic acid deficiency. Prophylactic administration of folic acid is recommended.

  DROXIA is a cytotoxic drug. Follow applicable special handling and disposal procedures [see References (15)].

  2.2 Dose Modifications for Renal Impairment

  Reduce the dose of DROXIA by 50% in patients with creatinine clearance of less than 60 mL/min or with end-stage renal disease (ESRD) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Creatinine clearance values were obtained using 24-hour urine collections.

  *  On dialysis days, administer DROXIA to patients with ESRD following hemodialysis.

  Creatinine Clearance

  (mL/min)

  Recommended DROXIA Initial Dose

  (mg/kg daily)

  ≥60

  15

  <60 or ESRD*

  7.5

  Monitor the hematologic parameters closely in these patients.

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