If your hemoglobin level stays too high or if your hemoglobin goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take Aranesp, even if you do not have an increase in your hemoglobin level.

Aranesp doesn’t improve the quality of life, fatigue, or well-being.

You should not use Aranesp if :

If you have cancer and you will not be receiving chemotherapy that may cause anemia.
If you have a cancer that has a high chance of being cured. Talk with your healthcare provider about the kind of cancer you have.
If your anemia due to chemotherapy treatment can be managed by RBC transfusion.
In place of emergency treatment for anemia (RBC transfusions).
It is not known if Aranesp is safe and effective in children who have cancer.
In patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers: Your tumor may grow faster and you may die sooner if you choose to take Aranesp.
Your healthcare provider will talk with you about these risks.
For all people who take it, including people with cancer or chronic kidney disease:
Serious heart problems, such as heart attack or heart failure, and stroke.

Other Side effects

Blood clots. Blood clots may happen at any time while taking Aranesp. If you are receiving Aranesp® for any reason and are going to have surgery, talk with your healthcare provider about whether you need to take a blood thinner to lessen the chance of blood clots during or following surgery.
Chest pain
Trouble breathing or shortness of breath
Pain or swelling in your legs
A cool or pale arm or leg
confusion, trouble speaking, or trouble understanding others’ speech
numbness or weakness in your face, arm, or leg, especially on one side of your body
trouble in vision
Sudden trouble walking, dizziness, loss of balance or coordination
Loss of consciousness (fainting)
Shortness of breath
Cough
Low blood pressure during dialysis
Abdominal pain
Edema (swelling) of the arms or legs
These are not all the possible side effects of Aranesp®. Tell your healthcare provider about any side effects that bother you or do not go away
If you decide to take Aranesp®, your healthcare provider should prescribe the smallest dose that is necessary to reduce your chance of needing RBC transfusions.
If your hemoglobin level stays too high or goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take Aranesp®, even if you do not have an increase in your hemoglobin level.

Precautions when taking Aranesp

Do not take it if you:

high blood pressure (uncontrolled hypertension).
had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with Aranesp or other erythropoietin medicines.
had a serious allergic reaction to any of the excipients.
Before taking Aranesp, tell your doctor if you: have heart disease; have high blood pressure; have had a seizure or stroke; or if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed.
If you know you are allergic to latex, talk to your healthcare provider before using Aranesp because the needle cover on the prefilled syringe contains latex.
before taking aranesp, tell your doctor if you suffer from cancer.

How should I store Aranesp?

Do not shake Aranesp.
Store Aranesp in the carton it comes in to protect it from light.
Store Aranesp in the refrigerator between 36°F to 46°F (2°C to 8°C).
Do not freeze Aranesp. Do not use Aranesp that has been frozen.
Throw away the Aranesp vial or prefilled syringe after one use. Do not re-use even if there is medicine left.

Keep Aranesp and all medicines out of the reach of children.

Mechanism of Action of Aranesp

Recombinant human erythropoietin with salicylic acid additions to enhance stability; stimulates erythropoiesis via division & differentiation of progenitor cells in bone marrow to induce the release of reticulocytes from the bone marrow into the bloodstream to become erythrocytes.

Pharmacokinetics of Aranesp

Half-Life: 46 hr (SC), 21 hr (IV)

Peak Plasma Time: 34 hr (SC)

Vd: 0.06 L/kg

Absorption: Slow (SC)

Bioavailability: 37% (SC; adults); 54% (SC; children)

Method of administration

IV Administration

May be administered SC or IV bolus

Do not shake; vigorous shaking may denature darbepoetin alfa, rendering it biologically inactive

Do not dilute or administer in conjunction with other drug solutions

Discard any unused portion of the vial

Do not pool unused portions

Discontinue immediately if signs/symptoms of anaphylaxis occur

Special Population

Pregnancy & Lactation

Pregnancy

Limited available data on pregnant women are insufficient to determine a drug-associated risk of major birth defects or miscarriage; in animal reproductive and developmental toxicity studies, drug increased early post-implantation loss at doses approximating clinical recommended starting doses; consider benefits and risks for the mother and possible risks to fetus when prescribing to a pregnant woman.

Lactation

There is no information regarding presence of drug in human milk, effects on breastfed child, or on milk production; the developmental and health benefits of breastfeeding should be consider along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition.