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DOSAGE AND ADMINISTRATION
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].|
|Dosing Based on Blood Counts|
|In an acceptable range||Increase dose 5 mg/kg/day every 12 we e ks 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 ≥ 9 5,000/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/mm³platelets < 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 is a cytotoxic drug. Follow applicable special handling and disposal procedures [see REFERENCES].
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 and CLINICAL PHARMACOLOGY]. Creatinine clearance values were obtained using 24-hour urine collections.
|Creatinine Clearance (mL/min)||Recommended DROXIA Initial Dose (mg/kg daily)|
|< 60 or ESRD*||7.5|
|* On dialysis days, administer DROXIA to patients with ESRD following hemodialysis.|
Monitor the hematologic parameters closely in these patients.
Dosage Forms And Strengths
- 200 mg opaque blue-green capsules, imprinted with black ink “DROXIA” and “6335.”
- 300 mg opaque purple capsules, imprinted with black ink “DROXIA” and “6336.”
- 400 mg opaque reddish-orange capsules, imprinted with black ink “DROXIA” and “6337.”
Storage And Handling
DROXIA® (hydroxyurea capsules, USP) is supplied in HDPE bottles with a plastic safety screw cap. Each bottle contains 60 capsules. DROXIA is supplied in the following strengths:
200 mg opaque blue-green capsules, marked in black ink
with “DROXIA” and “6335” (NDC 0003- 6335-17).
300 mg opaque purple capsules, marked in black ink with “DROXIA” and “6336” (NDC 0003-6336- 17).
400 mg opaque reddish-orange capsules, marked in black ink with “DROXIA” and “6337” (NDC 0003- 6337-17).
Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Keep tightly closed.
Handling And Disposal
DROXIA is a cytotoxic drug. Follow applicable special handling and disposal procedures [see REFERENCES ].
To decrease the risk of contact, advise caregivers to wear disposable gloves when handling DROXIA or bottles containing DROXIA. Wash hands with soap and water before and after contact with the bottle or capsules when handling DROXIA. Do not open DROXIA capsules. Avoid exposure to crushed or opened capsules. If contact with crushed or opened capsules occurs on the skin, wash affected area immediately and thoroughly with soap and water. If contact with crushed or opened capsules occurs on the eye(s), the affected area should be flushed thoroughly with water or isotonic eyewash designated for that purpose for at least 15 minutes. If the powder from the capsule is spilled, immediately wipe it up with a damp disposable towel and discard in a closed container, such as a plastic bag; as should the empty capsules. The spill areas should then be cleaned three times using a detergent solution followed by clean water. Keep the medication away from children and pets. Contact your doctor for instructions on how to dispose of outdated capsules.
Manufactured for: Bristol-Myers Squibb Company, Princeton, New Jersey 08543 USA. Revised: March 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/27/2016
Additional Droxia Information
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