Aranesp® is indicated for the treatment of anemia:

• associated with chronic renal failure, including patients on dialysis and patients not on dialysis
• in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. Aranesp® use has not been demonstrated in controlled clinical trials to improve symptoms of anemia, quality of life, fatigue, or patient well-being. Aranesp® is not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.

IMPORTANT: See BOXED WARNINGS and WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events.

Aranesp® is supplied in vials or in prefilled syringes with UltraSafeR Needle Guards*. Following administration of Aranesp® from the prefilled syringe, the UltraSafeR Needle Guard should be activated to prevent accidental needlesticks.

Aranesp® is also supplied in prefilled SureClick™ autoinjectors containing the same dosage strengths as the prefilled syringes. Because the autoinjectors are designed to deliver the full content, autoinjectors should only be used for patients who need the full dose. If the required dose is not available in an autoinjector, prefilled syringes, or vials should be used to administer the required dose. Autoinjectors are for subcutaneous administration only.

Chronic Renal Failure Patients

Aranesp® may be administered either intravenously or subcutaneously as a single weekly injection. In patients on hemodialysis, the intravenous route is recommended. 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, this should be evaluated (see WARNINGS: Pure Red Cell Aplasia, PRECAUTIONS: Lack or Loss of Response to Aranesp® and PRECAUTIONS: Laboratory Tests). When Aranesp® therapy is initiated or adjusted, the hemoglobin should be followed weekly until stabilized and monitored at least monthly thereafter. During therapy, hematological parameters should be monitored regularly. Doses must be individualized to ensure that hemoglobin is maintained at an appropriate level for each patient. For patients who respond to Aranesp® with a rapid increase in hemoglobin (e.g., more than 1 g/dL in any 2-week period), the dose of Aranesp® should be reduced. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Starting Dose

Correction of Anemia

The initial dose by subcutaneous or intravenous administration is 0.45 mcg/kg body weight, as a single injection once weekly. Alternatively, in patients not receiving dialysis, an initial dose of 0.75 mcg/kg may be administered subcutaneously as a single injection once every 2 weeks. If hemoglobin excursions outside the recommended range occur, the Aranesp® dose should be adjusted as described below.

The use of Aranesp® in pediatric CRF patients as the initial treatment to correct anemia has not been studied.

Maintenance Dose

The dose should be individualized to maintain hemoglobin levels within the range of 10 to 12 g/dL (see Dose Adjustment). If hemoglobin excursions outside the recommended range occur, the Aranesp® dose should be adjusted as described below. For many patients, the appropriate maintenance dose will be lower than the starting dose. CRF patients not on dialysis, in particular, may require lower maintenance doses. In the maintenance phase, AranespR may continue to be administered as a single injection once weekly or once every 2 weeks.

Dose Adjustment

The dose should be adjusted for each patient to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL. If hemoglobin excursions outside the recommended range occur, the Aranesp® dose should be adjusted as described below. 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 g/dL in a 2-week period, the dose should be decreased by approximately 25%.

If the increase in hemoglobin is less than 1 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.

For patients whose hemoglobin does not attain a level within the range of 10 to 12 g/dL despite the use of appropriate Aranesp® dose titrations over a 12-week period:

• do not administer higher Aranesp® doses and use the lowest dose that will maintain a hemoglobin level sufficient to avoid the need for recurrent RBC transfusions,
• evaluate and treat for other causes of anemia (see PRECAUTIONS: Lack or Loss of Response to Aranesp®), and
• thereafter, hemoglobin should continue to be monitored and if responsiveness improves, Aranesp® dose adjustments should be made as described above; discontinue Aranesp® if responsiveness does not improve and the patient needs recurrent RBC transfusions.

Conversion From Epoetin alfa to Aranesp®

The starting weekly dose of Aranesp® for adults and pediatric patients should be estimated on the basis of the weekly Epoetin alfa dose at the time of substitution (see Table 6). For pediatric patients receiving a weekly Epoetin alfa dose of < 1,500 units/week, the available data are insufficient to determine an Aranesp® conversion dose. Because of variability, doses should be titrated to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL. 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 (intravenous or subcutaneous) should be maintained.

Table 6. Estimated Aranesp® Starting Doses (mcg/week) for Patients Based on Previous Epoetin alfa Dose (Units/week)

Cancer Patients Receiving Chemotherapy

For pediatric patients, see PRECAUTIONS: Pediatric Use.

The recommended starting dose for Aranesp® administered weekly is 2.25 mcg/kg as a subcutaneous injection.

The recommended starting dose for Aranesp® administered once every 3 weeks is 500 mcg as a subcutaneous injection.

For both dosing schedules, the dose should be adjusted for each patient to maintain the lowest hemoglobin level sufficient to avoid the need for RBC transfusion and not to exceed the upper safety limit of 12 g/dL. If the rate of hemoglobin increase is more than 1 g/dL per 2-week period or when the hemoglobin reaches a level needed to avoid transfusion, the dose should be reduced by 40% of the previous dose. If the hemoglobin exceeds 12 g/dL, Aranesp® should be temporarily withheld until the hemoglobin approaches a level where transfusions may be required. At this point, therapy should be reinitiated at a dose 40% below the previous dose.

For patients receiving weekly administration, if there is less than a 1 g/dL increase in hemoglobin after 6 weeks of therapy, the dose of Aranesp® should be increased up to 4.5 mcg/kg. Discontinue AranespR following the completion of a chemotherapy course (see BOXED WARNINGS: Cancer).

Preparation and Administration of Aranesp®

Do not shake AranespR or leave vials, syringes, or prefilled SureClick™ autoinjectors exposed to bright light. After removing the vials, prefilled syringes, or autoinjectors from the cartons, keep them covered to protect from room light until administration. Vigorous shaking or exposure to light may denature AranespR, causing it to become biologically inactive. Always store vials, prefilled syringes, or autoinjectors of AranespR 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, prefilled syringes, or autoinjectors exhibiting particulate matter or discoloration.

Do not dilute Aranesp®.

Do not administer Aranesp® in conjunction with other drug solutions.

Aranesp® contains no preservatives. Discard any unused portion. Do not pool unused portions from the vials or prefilled syringes. Do not use the vial, prefilled syringe, or autoinjector more than one time

Following administration of Aranesp® from the prefilled syringe, activate the UltraSafeR 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 SureClick™ autoinjector is designed to deliver the full dose. The completion of the injection is signaled by an audible click. Removal of the autoinjector from the injection site automatically extends a needle cover.

The autoinjectors, the syringes used with vials, and the entire prefilled syringe with activated needle guard should be disposed of in a puncture-proof container.

See the accompanying "Information for Patients" leaflet for complete instructions on the preparation and administration of Aranesp® for patients, including injection site selection.

Aranesp® is available in single-dose vials in two solutions, an albumin solution and a polysorbate solution. The words "Albumin Free" appear on the polysorbate container labels and the package main panels as well as other panels as space permits. Aranesp® single-dose prefilled syringes and prefilled SureClick™ autoinjectors are available in albumin and polysorbate solutions. Both prefilled syringes and autoinjectors are supplied with a 27-gauge, ½-inch needle.

Each prefilled syringe is equipped with an UltraSafeR Needle Guard that is manually activated to cover the needle during disposal. The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex). The autoinjector has a needle cover that automatically extends as the autoinjector is removed from the injection site after completion of the injection.

Aranesp® is available in the following packages:

Single-dose prefilled SureClick™ Autoinjector with a 27-gauge, ½-inch needle, Polysorbate Solution

1 Autoinjector/Pack

25 mcg/0.42 mL
(NDC 55513-090-01)

40 mcg/0.4 mL
(NDC 55513-091-01)

60 mcg/0.3 mL
(NDC 55513-092-01)

100 mcg/0.5 mL
(NDC 55513-093-01)

150 mcg/0.3 mL
(NDC 55513-094-01)

200 mcg/0.4 mL
(NDC 55513-095-01)

300 mcg/0.6 mL
(NDC 55513-096-01)

500 mcg/1 mL
(NDC 55513-097-01)

Single-dose prefilled SureClick™ Autoinjector with a 27-gauge, ½-inch needle, Albumin Solution

1 Autoinjector/Pack

25 mcg/0.42 mL
(NDC 55513-080-01)

40 mcg/0.4 mL
(NDC 55513-081-01)

60 mcg/0.3 mL
(NDC 55513-082-01)

100 mcg/0.5 mL
(NDC 55513-083-01)

150 mcg/0.3 mL
(NDC 55513-084-01)

200 mcg/0.4 mL
(NDC 55513-085-01)

300 mcg/0.6 mL
(NDC 55513-086-01)

500 mcg/1 mL
(NDC 55513-087-01)

Storage

Store at 2 to 8 C (36 to 46 F). Do not freeze or shake. Protect from light.

This product, or its use, may be covered by one or more US Patents, including US Patent No. 5,618,698, in addition to others including patents pending.

Manufactured by: Amgen Manufacturing, Limited, a subsidiary of Amgen Inc. One, Amgen Center Drive, Thousand Oaks, CA 91320-1799. * UltraSafe® is a registered trademark of Safety Syringes, Inc. Issue Date: 05/2008. FDA Rev date: 5/5/2008

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