Darbepoetin Alfa

Darbepoetin alfa is a prescription medication used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney disease or chemotherapy. Darbepoetin alfa belongs to a group of drugs called erythropoiesis-stimulating agents (ESAs). These medications work by causing the soft tissue inside the bones where blood cells are made (bone marrow) to make more red blood cells.

Darbepoetin alfa is a prescription erythropoietin medicine used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney disease or chemotherapy. 

Darbepoetin Alfa may be found in some form under the following brand names:

• Aranesp

Using darbepoetin alfa can lead to death or other serious side effects.

• You may get serious heart problems such as heart attack, stroke, heart failure, and may die sooner if you are treated with darbepoetin alfa to reach a normal or near-normal hemoglobin level.
• You may get blood clots at any time while taking darbepoetin alfa.

Call your doctor or get medical help right away if you have any of these symptoms of blood clots:

• Chest pain
• Trouble breathing or shortness of breath
• Pain in your legs, with or without swelling
• A cool or pale arm or leg
• Sudden confusion, trouble speaking, or trouble understanding others' speech
• Sudden numbness or weakness in your face, arm, or leg, especially on one side of your body
• Sudden trouble seeing
• Sudden trouble walking, dizziness, loss of balance or coordination
• Loss of consciousness (fainting)
• Hemodialysis vascular access stops working

Other possible side effects of darbepoetin alfa include:

• High blood pressure is the most common side effect of darbepoetin alfa in people with chronic kidney disease.  Your doctor will check your blood pressure often. 
• Seizures can occur with darbepoetin alfa treatment. 
• Your body may make antibodies to darbepoetin alfa that can block or lessen your body's ability to make red blood cells and cause you to have severe anemia. Symptoms to watch for include: unusual tiredness, lack of energy, dizziness, or fainting. 
• Serious allergic reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness and fainting because of a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have a serious allergic reaction, stop using darbepoetin alfa and call your doctor or get medical help right away. The needle cover on the prefilled syringe contains latex. If you know you are allergic to latex, talk to your doctor before using darbepoetin alfa.

Common side effects of darbepoetin alfa include:

• shortness of breath
• cough
• low blood pressure during dialysis
• abdominal pain
• edema (swelling) of the arms or legs

This is not a complete list of darbepoetin alfa side effects. Ask your doctor or pharmacist for more information.

No darbepoetin alfa drug interactions have been identified, however, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

You must be counseled by your doctor regarding the risks of darbepoetin alfa and sign the ESA APPRISE Oncology Program Patient and Healthcare Professional (HCP) Acknowledgement Form before you begin to receive darbepoetin alfa. 

Do not take darbepoetin alfa if you:

• Have high blood pressure that is not controlled (uncontrolled hypertension). 
• Have been told by your doctor that you have or have ever had certain types of bleeding or clotting disorders. 
• Have allergies to any of the ingredients in darbepoetin alfa. This includes if you have an allergy to latex. The needle cover on the prefilled syringe contains latex. If you know you are allergic to latex, talk to your doctor before using darbepoetin alfa.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of darbepoetin alfa there are no specific foods that you must exclude from your diet when receiving darbepoetin alfa.

Tell your doctor about all your medical conditions, including if you:

• Have heart disease. 
• Have high blood pressure. 
• Have had a seizure (convulsion) or stroke. 
• Are allergic to latex.
• Have any other medical conditions.

Tell your doctor if you are pregnant or breastfeeding.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant of if you are planning to become pregnant. It is not known if darbepoetin alfa will harm your unborn baby. 

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if darbepoetin alfa is excreted in human breast milk or if it will harm your nursing baby.

Darbepoetin alfa comes as a liquid to be injected under the skin (subcutaneously) or intravenously (into a vein). This medication is usually given once a week, once every two weeks, or once every three weeks. You will likely start on a low dose of darbepoetin alfa. Your doctor will adjust your dose depending on your lab results. Follow these directions carefully.

Darbepoetin alfa injections may be given by a healthcare provider (doctor or nurse), or your doctor may teach you to give yourself injections. Never shake vials or syringes containing darbepoetin alfa. Always inject darbepoetin alfa in its own syringe. Do not dilute it with any liquid and do not mix it with any other medications.

When injecting darbepoetin alfa choose a new location on your body each time you inject yourself. Choose the outer areas of your upper arms, your stomach, the front of your middle thighs, and the upper, outer areas of your buttocks. If you are being treated with dialysis, your doctor may tell you to inject darbepoetin alfa into the port where dialysis tubing is connected to your body.

If you will be injecting darbepoetin alfa yourself, take darbepoetin alfa exactly as prescribed. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you based on your medical conditions, your weight, and other factors.

The recommended starting dose for people with chronic kidney disease patients on dialysis is based on weight as follows:

• 0.45 mcg/kg intravenously (into a vein) or subcutaneously (injection under the skin) weekly, or
• 0.75 mcg/kg intravenously or subcutaneously every 2 weeks
• Intravenous route is recommended for people on hemodialysis

Recommended starting dose for patients with chronic kidney disease who are not on dialysis:

• 0.45 mcg/kg intravenously or subcutaneously at 4 week intervals

Recommended starting dose for cancer patients on chemotherapy:

• 2.25 mcg/kg subcutaneously weekly until chemotherapy treatments end or
• 500 mcg subcutaneously every 3 weeks until chemotherapy treatments end

Your doctor will adjust your dose as necessary based on your lab results as well as how you feel and other factors.

If you take too much darbepoetin alfa call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If darbepoetin alfa is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Do not shake darbepoetin alfa.
• Protect darbepoetin alfa from light.
• Store darbepoetin alfa in the refrigerator.
• Do not freeze darbepoetin alfa. Do not use darbepoetin alfa that has been frozen.
• Throw away the darbepoetin alfa vial or prefilled syringe after one use. Do not re-use even if there is medicine left.
• Keep darbepoetin alfa and all medicines out of the reach of children.

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

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, darbepoetin alfa dose, or dosing strategy that does not increase these risks.
• Use the lowest darbepoetin alfa dose sufficient to reduce the need for red blood cell (RBC) transfusions.

Cancer:

• ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
• Prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense darbepoetin alfa to patients with chemotherapy induced anemia.
• Use the lowest dose to avoid RBC transfusions.
• Use ESAs only for anemia from myelosuppressive chemotherapy.
• ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
• Discontinue following the completion of a chemotherapy course.