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Questions and Answers on Medication Guides for Erythropoiesis-Stimulating Agents (ESAs)
Epoetin alfa (marketed as Procrit, Epogen)
Darbepoetin alfa (marketed as Aranesp)
1. Why were Medication Guides for ESAs developed?
The Medication Guides were developed to provide patients with important information about the risks of using ESAs. The information in the Medication Guides may affect a patient’s decision to take the drug and it gives patients a starting point for discussion with their healthcare provider about the medical decision to prescribe an ESA.
2. What are Erythropoiesis-Stimulating Agents (ESAs)?
ESAs are man-made forms of the protein human erythropoietin. ESAs are given to patients with low red blood counts due to kidney failure, or due to side effects from other drugs (chemotherapy or zidovudine), or given to patients scheduled for certain types of elective surgery. ESAs work by stimulating the bone marrow to make more red blood cells so that there is a lower chance that the patient will need red blood cell transfusions.
3. What are these important risks of using ESAs and how can they be managed?
Using ESAs can lead to serious side effects which may result in death. Some of these side effects are more likely to happen if the patient has cancer or chronic kidney failure.
In patients with all types of cancer for which ESA use is FDA-approved:
- The tumor may grow faster and the patient may die sooner when ESA treatment is used.
- The healthcare provider should prescribe the lowest dose of the ESA that is needed to avoid red blood cell transfusions.
- ESAs work by stimulating the bone marrow to make more red blood cells. ESAs have not been shown to improve the symptoms of anemia, quality of life, fatigue, or well-being for patients with cancer. For that reason, ESAs should be used only to reduce the chance that a patient with low red blood counts (anemia) will get a blood transfusion.
- Treatment with an ESA should be stopped when chemotherapy treatment is finished.
In all patients taking an ESA:
There is risk of serious heart problems such as heart attack, stroke, heart failure, and a higher chance of death if patients are treated with an ESA to a hemoglobin level above 12 g/dL.
Patients may get blood clots at any time while taking an ESA. Patients who are receiving an ESA and scheduled for surgery should talk to their healthcare provider about whether or not to also take a blood thinner to reduce the chance of blood clots during or following surgery. Clots can form in blood vessels (veins), especially in the leg (deep venous thrombosis or DVT). Pieces of a blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus). The possible symptoms of blood clots are:
- Chest pain
- Trouble breathing or shortness of breath
- Pain in the legs, with or without swelling
- A cool or pale arm or leg
- Sudden confusion, or trouble speaking or understanding speech
- Sudden numbness or weakness of the face, an arm, or leg, especially on one side of the body
- Sudden trouble seeing
- Sudden trouble walking, dizziness, loss of balance or coordination
- Loss of consciousness (fainting)
- Hemodialysis vascular access stops working. In patients with chronic kidney failure and a hemodialysis vascular access, blood clots may form in this access.
4. When should the Medication Guide be given to patients?
The Medication Guide must be given directly to a patient or the patient’s caregiver when the drug is dispensed to the patient.
5. Some dialysis centers are preparing their own guides, perhaps to use in lieu of Amgen’s FDA-approved Medication Guide. Is this acceptable?
The FDA-approved Medication Guide must be provided to patients or the patient's caregiver when the drug is dispensed to the patient. Dialysis centers may supplement the Medication Guide with additional information for patients. Additional information provided by the manufacturer, such as promotional labeling and advertising pieces, may be distributed provided the information in such pieces is compliant with promotional regulations (i.e., it is not false or misleading, it does not omit material facts, and it presents a fair balance of risk and benefit information).
6. Are the FDA and Amgen considering other actions to improve the safe use of ESAs?
The FDA is working with Amgen on a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the ESAs outweigh their risks.
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Date created: December 2, 2008
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