"The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfiel"...
Anemia Due To Chronic Kidney Disease
Anemia Due To Chemotherapy In Patients With Cancer
Aranesp is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Limitations Of Use
Aranesp has not been shown to improve quality of life, fatigue, or patient well-being.
Aranesp is not indicated for use:
- In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
- Inpatients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
- As a substitute for RBC transfusions in patients who require immediate correction of anemia [see CLINICAL PHARMACOLOGY].
DOSAGE AND ADMINISTRATION
Evaluation Of Iron Stores And Nutritional Factors
Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Aranesp [see WARNINGS AND PRECAUTIONS].
Patients With Chronic Kidney Disease
In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see WARNINGS AND PRECAUTIONS]. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see BOXED WARNING and Clinical Studies].
For all patients with CKD
When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
- Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
- If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Aranesp by 25% or more as needed to reduce rapid responses.
- For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
- For patients who do not respond adequately over a 12-week escalation period, increasing the Aranesp dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue Aranesp if responsiveness does not improve.
For patients with CKD on dialysis
- Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL.
- If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp.
- The recommended starting dose is 0.45 mcg/kg intravenously or subcutaneously as a weekly injection or 0.75 mcg/kg once every 2 weeks as appropriate. The intravenous route is recommended for patients on hemodialysis.
For patients with CKD not on dialysis
- Consider initiating Aranesp treatment only when the
hemoglobin level is less than 10 g/dL and the following considerations apply:
- The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and,
- Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
- If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Aranesp, and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions.
- The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate.
When treating patients who have chronic kidney disease and cancer, physicians should refer to WARNINGS AND PRECAUTIONS.
Refer patients who self-administer Aranesp to the Instructions for Use [see PATIENT INFORMATION].
Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis
Aranesp is administered less frequently than epoetin alfa.
- Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly.
- Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly.
Estimate the starting weekly dose of Aranesp for adults and pediatric patients on the basis of the weekly epoetin alfa dose at the time of substitution (see Table 1). Maintain the route of administration (intravenous or subcutaneous injection).
Table 1: Estimated Aranesp Starting Doses (mcg/week)
for Patients With CKD on Dialysis Based on Previous Epoetin alfa Dose
|Previous Weekly Epoetin alfa Dose (Units/week)||Aranesp Dose (mcg/week)|
|1,500 to 2,499||6.25||6.25|
|2,500 to 4,999||12.5||10|
|5,000 to 10,999||25||20|
|11,000 to 17,999||40||40|
|18,000 to 33,999||60||60|
|34,000 to 89,999||100||100|
|*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.|
Conversion from Epoetin alfa to Aranesp in patients with CKD not on dialysis
The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp.
Patients On Cancer Chemotherapy
Initiate Aranesp in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy.
Use the lowest dose of Aranesp necessary to avoid RBC transfusions.
Recommended Starting Dose
The recommended starting dose and schedules are:
- 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course
- 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course
|Dose Adjustment||Weekly Schedule||Every 3 Week Schedule|
||Reduce dose by 40%||Reduce dose by 40%|
|If hemoglobin exceeds a level needed to avoid RBC transfusion||
|If hemoglobin increases by less than 1 g/dL and remains below 10 g/dL after 6 weeks of therapy||Increase dose to 4.5 mcg/kg/week||No dose adjustment|
||Discontinue Aranesp||Discontinue Aranesp|
Preparation And Administration
- The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
- Do not shake. Do not use Aranesp that has been shaken or frozen.
- Protect vials and prefilled syringes from light.
- 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.
- Discard unused portion of Aranesp in vials or prefilled syringes. Do not re-enter vial.
- Do not dilute Aranesp and do not administer in conjunction with other drug solutions.
Dosage Forms And Strengths
Aranesp is available as a polysorbate-containing solution.
- Single-dose vials: 25, 40, 60, 100, 200, 300, and 500 mcg Aranesp/1 mL, and 150 mcg Aranesp/0.75 mL
- Single-dose prefilled syringes: 25 mcg Aranesp/0.42 mL, 40 mcg Aranesp/0.4 mL, 60 mcg Aranesp/0.3 mL, 100 mcg Aranesp/0.5 mL, and 150 mcg Aranesp/0.3 mL, 200 mcg Aranesp/0.4 mL, 300 mcg Aranesp/0.6 mL, and 500 mcg Aranesp/1 mL
Storage And Handling
Store at 36°F to 46°F (2°C to 8°C). Do not freeze.
Do not shake. Protect from light; store Aranesp in the carton until use.
Do not use Aranesp that has been shaken or frozen.
Aranesp is available in the following packages:
|1 Vial/Pack, 4 Packs/Case||4 Vials/Pack, 10 Packs/Case|
|200 mcg/1 mL
|25 mcg/1 mL
| 300 mcg/1 mL
|40 mcg/1 mL
|60 mcg/1 mL
|100 mcg/1 mL
| 150 mcg/0.75 mL
Single-dose Prefilled Syringe (SingleJect®) with a 27-gauge, ½-inch needle with an UltraSafe® Needle Guard that is manually activated to cover the needle during disposal
|1 Syringe/Pack, 4 Packs/Case||4 Syringes/Pack, 10 Packs/Case|
|200 mcg/0.4 mL
|25 mcg/0.42 mL
|300 mcg/0.6 mL
|40 mcg/0.4 mL
|500 mcg/1 mL
|60 mcg/0.3 mL
|100 mcg/0.5 mL
| 150 mcg/0.3 mL
Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, CA 91320-1799 U.S.A. Revised: 12/2013
Last reviewed on RxList: 1/27/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Aranesp Information
Aranesp - User Reviews
Aranesp User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.