DOSAGE AND ADMINISTRATION
GENERAL
IMPORTANT: Aranesp® dosing regimens are different for each of the indications described in this section of the package insert. Due to the longer serum half-life, Aranesp® should be administered less frequently than Epoetin alfa (for example, where Epoetin alfa is administered three times a week, Aranesp® should be administered weekly). Aranesp® should be administered under the supervision of a healthcare professional.
Aranesp® is supplied in either vials or in prefilled syringes with UltraSafe® Needle Guards *. Following administration of Aranesp® from the prefilled syringe, the UltraSafe® Needle Guard should be activated to prevent accidental needle sticks.
CHRONIC RENAL FAILURE PATIENTS
Aranesp® is administered either IV or SC as a single weekly injection. The dose should be started and slowly adjusted as described below based on hemoglobin levels. If a patient fails to respond or maintain a response, other etiologies should be considered and evaluated (see PRECAUTIONS: General and Laboratory Tests). When Aranesp® therapy is initiated or adjusted, the hemoglobin should be followed weekly until stabilized and monitored at least monthly thereafter.
For patients who respond to Aranesp® with a rapid increase in hemoglobin (e.g., more than 1.0 g/dL in any 2-week period), the dose of Aranesp® should be reduced (see DOSAGE AND ADMINISTRATION: Dose Adjustment) because of the association of excessive rate of rise of hemoglobin with adverse events (see WARNINGS: Cardiovascular Events, Hemoglobin, and Rate of Rise of Hemoglobin).
The dose should be adjusted for each patient to achieve and maintain a target hemoglobin level not to exceed 12 g/dL.
STARTING DOSE
CORRECTION OF ANEMIA
The recommended starting dose of Aranesp® for the correction of anemia in CRF patients is 0.45 mcg/kg body weight, administered as a single IV or SC injection once weekly. Because of individual variability, doses should be titrated to not exceed a target hemoglobin concentration of 12 g/dL (see DOSAGE AND ADMINISTRATION: Dose Adjustment). For many patients, the appropriate maintenance dose will be lower than this starting dose. Predialysis patients, in particular, may require lower maintenance doses. Also, some patients have been treated successfully with a SC dose of Aranesp® administered once every 2 weeks.
CONVERSION FROM EPOETIN ALFA TO ARANESP®
The starting weekly dose of Aranesp® should be estimated on the basis of the weekly Epoetin alfa dose at the time of substitution (see Table 5). Because of individual variability, doses should then be titrated to maintain the target hemoglobin. Due to the longer serum half-life, Aranesp® should be administered less frequently than Epoetin alfa. Aranesp® should be administered once a week if a patient was receiving Epoetin alfa 2 to 3 times weekly. Aranesp® should be administered once every 2 weeks if a patient was receiving Epoetin alfa once per week. The route of administration (IV or SC) should be maintained.
Table 5. Estimated Aranesp® Starting Doses (mcg/week) Based on Previous Epoetin alfa Dose (Units/week)
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Previous Weekly Epoetin alfa Dose (Units/week)
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Weekly Aranesp®
Dose (mcg/week) |
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< 2,500
|
6.25
|
|
2,500 to 4,999
|
12.5
|
|
5,000 to 10,999
|
25
|
|
11,000 to 17,999
|
40
|
|
18,000 to 33,999
|
60
|
|
34,000 to 89,999
|
100
|
|
>/= 90,000
|
200
|
|
DOSE ADJUSTMENT
The dose should be adjusted for each patient to achieve and maintain a target hemoglobin not to exceed 12 g/dL.
Increases in dose should not be made more frequently than once a month. If the hemoglobin is increasing and approaching 12 g/dL, the dose should be reduced by approximately 25%. If the hemoglobin continues to increase, doses should be temporarily withheld until the hemoglobin begins to decrease, at which point therapy should be reinitiated at a dose approximately 25% below the previous dose. If the hemoglobin increases by more than 1.0 g/dL in a 2-week period, the dose should be decreased by approximately 25%.
If the increase in hemoglobin is less than 1.0 g/dL over 4 weeks and iron stores are adequate (see PRECAUTIONS: Laboratory Tests), the dose of Aranesp® may be increased by approximately 25% of the previous dose. Further increases may be made at 4-week intervals until the specified hemoglobin is obtained.
MAINTENANCE DOSE
Aranesp® dosage should be adjusted to maintain a target hemoglobin not to exceed 12 g/dL. If the hemoglobin exceeds 12 g/dL, the dose may be adjusted as described above. Doses must be individualized to ensure that hemoglobin is maintained at an appropriate level for each patient.
CANCER PATIENTS RECEIVING CHEMOTHERAPY
The recommended starting dose for Aranesp® is 2.25 mcg/kg administered as a weekly SC injection.
The dose should be adjusted for each patient to achieve and maintain a target hemoglobin. If there is less than a 1.0 g/dL increase in hemoglobin after 6 weeks of therapy, the dose of Aranesp® should be increased up to 4.5 mcg/kg. If hemoglobin increases by more than 1.0 g/dL in a 2-week period or if the hemoglobin exceeds 12 g/dL, the dose should be reduced by approximately 25%. If the hemoglobin exceeds 13 g/dL, doses should be temporarily withheld until the hemoglobin falls to 12 g/dL. At this point, therapy should be reinitiated at a dose approximately 25% below the previous dose.
PREPARATION AND ADMINISTRATION OF ARANESP®
Do not shake Aranesp® or leave vials or syringes exposed to bright light. After removing the vials or prefilled syringes from the cartons, keep them covered to protect from room light until administration. Vigorous shaking or exposure to light may denature Aranesp® causing it to become biologically inactive. Always store vials or prefilled syringes of Aranesp® in their carton until use.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration.
Do not dilute Aranesp®.
Do not administer Aranesp® in conjunction with other drug solutions.
Aranesp® is packaged in single-dose vials and prefilled syringes and contains no preservative. Discard any unused portion. Do not pool unused portions from the vials or prefilled syringes. Do not use the vial or prefilled syringe more than one time.
Following administration of Aranesp® from the prefilled syringe, activate the UltraSafe® Needle Guard. Place your hands behind the needle, grasp the guard with one hand, and slide the guard forward until the needle is completely covered and the guard clicks into place. NOTE: If an audible click is not heard, the needle guard may not be completely activated. The prefilled syringe should be disposed of by placing the entire prefilled syringe with guard activated into an approved puncture-proof container.
See the accompanying "Information for Patients" leaflet for complete instructions on the preparation and administration of Aranesp® for patients.
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