What is Aranesp?

Aranesp (darbepoetin alfa) is a man-made form of a protein that helps your body produce red blood cells. The amount of this protein in your body may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.

Aranesp is used to treat anemia (a lack of red blood cells in the body).

Aranesp may also be used for purposes not listed in this medication guide.

Important information about Aranesp

Aranesp may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Get emergency medical help if you have chest pain, weakness, pain spreading to the arm or shoulder, shortness of breath, slurred speech, or problems with vision or balance. You should not use Aranesp if you have untreated or uncontrolled high blood pressure, if you are allergic to darbepoetin alfa or epoetin alfa (Epogen or Procrit), or if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using either of these two drugs.

Before using Aranesp, tell your doctor if you have heart disease, high blood pressure, kidney disease, a blood cell or clotting disorder, cancer, a seizure disorder, a latex allergy, or a history of stroke, heart attack, or blood clots.

To be sure Aranesp is helping your condition, your blood may need to be tested often. Your blood pressure will also need to be checked. Visit your doctor regularly.

Contact your doctor if you feel light-headed or unusually weak or tired. These may be signs that your body has stopped responding to Aranesp. Some women using Aranesp have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

Aranesp is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using Aranesp.

Before using Aranesp

You should not use Aranesp if you are allergic to darbepoetin alfa or epoetin alfa (Epogen or Procrit), or if you have:

• untreated or uncontrolled high blood pressure; or
• if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using darbepoetin alfa or epoetin alfa.

To make sure you can safely take Aranesp, tell your doctor if you have any of these other conditions:

• heart disease, high blood pressure;
• kidney disease (or if you are on dialysis);
• a history of stroke, heart attack, or blood clots;
• a blood cell or clotting disorder, such as sickle cell anemia or hemophilia;
• cancer;
• a seizure disorder; or
• if you are allergic to latex.

Aranesp is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using Aranesp.

It is not known whether Aranesp will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether darbepoetin alfa passes into breast milk or if it could harm a nursing baby. Do not use Aranesp without telling your doctor if you are breast-feeding a baby. Some women using Aranesp have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need to use birth control while you are using Aranesp.

Aranesp may shorten remission time in some people with head and neck cancer who are also being treated with radiation. Aranesp may also shorten survival time in certain people with breast cancer, non-small cell lung cancer, head and neck cancer, cervical cancer, or lymphoid cancer. Talk with your doctor about your individual risk.

How to use Aranesp

Use Aranesp exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Aranesp is injected under the skin or into a vein. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Do not shake the Aranesp medication bottle or you may ruin the medicine. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure Aranesp is helping your condition, your blood may need to be tested often. Your blood pressure will also need to be checked. Visit your doctor regularly.

Store Aranesp in the refrigerator and do not allow it to freeze. Protect from light. Throw away any Aranesp that has become frozen or has been exposed to light.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of Aranesp.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while using Aranesp?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Aranesp side effects

Contact your doctor if you feel light-headed or unusually weak or tired. These may be signs that your body has stopped responding to Aranesp.

Aranesp can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Aranesp. Seek emergency medical help if you have symptoms of heart or circulation problems, such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• feeling short of breath, even with mild exertion;
• swelling, rapid weight gain;
• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• chest pain with sudden cough, wheezing, rapid breathing, fast heart rate;
• cold feeling or pale appearance in an arm or leg; or
• pain, swelling, warmth, or redness in one or both legs.

Get emergency medical help if you have any of these signs of an allergic reaction to Aranesp: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Aranesp and call your doctor at once if you have other serious side effects such as:

• fever, chills, body aches, flu symptoms;
• feeling like you might pass out;
• seizure (black-out or convulsions); or
• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious Aranesp side effects may include:

• mild skin rash;
• dizziness, mild headache;
• muscle spasm, joint pain;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• nausea, vomiting, diarrhea, stomach pain, constipation; or
• pain, bruising, swelling, warmth, redness, oozing, or bleeding where the IV needle is placed.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Aranesp?

There may be other drugs that can interact with Aranesp. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.