Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Aranesp (Darbepoetin-alfa). If you are concerned about side effects, discuss the risks and benefits of Aranesp (Darbepoetin-alfa) with your doctor.

The following side effects have been reported by at least 1% of people taking Aranesp (Darbepoetin-alfa). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• general feeling of tiredness or weakness
• pain, stinging, redness, or swelling around the injection site

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• clotting of the vascular access site (for people on hemodialysis)
• dehydration
• Diarrhea
• edema (swelling of the face, fingers, ankles, feet, or lower legs)
• headache
• increased or decreased blood pressure, dizziness, or feeling faint
• muscle aches and pain
• nausea
• signs of infection (symptoms may include Fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• chest pain
• signs of allergic reaction (symptoms may include skin rash or Hives, trouble breathing, sweating, abnormal heart rate, or decreased blood pressure)
• signs of Blood Clots (pain or swelling in the legs, worsening shortness of breath)
• signs of Stroke (confusion, severe headache, sudden weakness, dizziness, trouble speaking, or vision problems)
• seizures

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Aranesp (Darbepoetin-alfa).

SingleJect Prefilled Syringes and Single-use Prefilled SureClickTM Autoinjector

Each Single Ject, prefilled syringe, or single-use, prefilled SureClickTM autoinjector contains: darbepoetin alfa as 10 µg, 15 µg, 20 µg, 30 µg, 40 µg, 50 µg, 60 µg, 80 µg, 100 µg, 130 µg, 150 µg, 200 µg, 250 µg, 300 µg, 400 µg, 500 µg per syringe in the following concentrations and fill volumes: 25 µg/mL in 0.4 mL; 40 µg/mL in 0.38 mL and 0.5 mL; 100 µg/mL in 0.3 mL, 0.4 mL and 0.5 mL; 200 µg/mL in 0.3 mL, 0.4 mL, 0.5 mL and 0.65 mL; 500 µg/mL in 0.3 mL, 0.4 mL, 0.5 mL, 0.6 mL, 0.8 mL and 1 mL. Nonmedicinal ingredients: polysorbate 80, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate and sterile water for injection, USP. pH of polysorbate solution is 6.2±0.2. The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex).

To reduce the risk of accidental needle sticks to users, each prefilled syringe is equipped with an UltraSafe Needle Guard that is manually activated to cover the needle during disposal.

The autoinjector has a needle cover that automatically extends as the autoinjector is removed from the injection site after completion of the injection.

Single-dose Vials

Each single-dose vial, contains: darbepoetin alfa as 15 µg, 25 µg, 40 µg, 60 µg, 100 µg, 200 µg, 325 µg, 500 µg per vial in the following concentration and fill volumes: 15 µg/mL in 1 mL; 25 µg/mL in 1 mL; 40 µg/mL in 1 mL; 60 µg/mL in 1 mL; 100 µg/mL in 1 mL; 200 µg/mL in 1 mL; 325 µg/mL in 1 mL; 500 µg/mL in 1 mL. Nonmedicinal ingredients: polysorbate 80, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate and sterile water for injection, USP. pH of polysorbate solution is 6.2±0.2.

Do not use Aranesp (Darbepoetin-alfa) if you:

• are allergic to darbepoetin alfa or any ingredients of the medication
• are allergic to medications made from mammalian cells
• have developed a condition called pure red cell aplasia (PRCA), after using erythropoiesis-stimulating proteins (e.g., darbepoetin alfa, epoetin alfa)
• have uncontrolled high blood pressure

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take Aranesp (Darbepoetin-alfa).

Allergies: Aranesp (Darbepoetin-alfa) can cause severe allergic reactions. Contact your doctor immediately if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

Blood clots: Aranesp (Darbepoetin-alfa) may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities, and which in some cases can cause death. Your doctor will monitor your hemoglobin level closely with blood tests during treatment with Aranesp (Darbepoetin-alfa). If you experience symptoms such as sharp pain and swelling in the leg, or difficulty breathing, contact your doctor immediately.

Cancer: Darbepoetin alfa is used to treat anemia caused by chemotherapy treatment of non-myeloid cancers. It is not used to treat anemia that is due to the cancer itself. Under some conditions, Aranesp (Darbepoetin-alfa) may cause tumours to progress or reoccur more quickly than for people who are not using darbepoetin alfa.

Cardiovascular disease: Aranesp (Darbepoetin-alfa) often affects blood pressure and can contribute to symptoms of heart disease. If you have high blood pressure, heart disease such as heart failure, Angina, or a previous Heart Attack, discuss with your doctor how Aranesp (Darbepoetin-alfa) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aranesp (Darbepoetin-alfa), and whether any special monitoring is needed. If you are taking blood pressure pills to control blood pressure, it is important to continue taking them regularly while you are on darbepoetin alfa. Your doctor will monitor your hemoglobin (the protein in red blood cells that carry oxygen) until an appropriate dose of darbepoetin alfa has been determined.

Kidney disease: Aranesp (Darbepoetin-alfa) may be used by people with chronic kidney disease who are receiving dialysis and who are not receiving dialysis - the dose may be different for each. Your doctor will monitor you closely for your response to the medication.

Pure red cell aplasia: Cases of pure red cell aplasia (PRCA) have been reported among people treated with darbepoetin alfa. PRCA is a condition in which a person's bone marrow stops producing red blood cells, leading to severe anemia. People who develop PRCA may experience a new or worsening feeling of tiredness or shortness of breath. If you are experiencing such symptoms, call your doctor as soon as possible. Do not stop your medication without contacting your doctor first.

Seizure: Aranesp (Darbepoetin-alfa) may contribute to an increase in seizures although the relationship between darbepoetin and seizures is not clear. If you experience seizures or have a history of seizure disorder, discuss with your doctor how Aranesp (Darbepoetin-alfa) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aranesp (Darbepoetin-alfa), and whether any special monitoring is needed.

Stroke: Darbepoetin can increase the risk of blood clots forming in the blood vessels. If you have a past history of stroke, discuss with your doctor how Aranesp (Darbepoetin-alfa) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aranesp (Darbepoetin-alfa), and whether any special monitoring is needed.

If you experience signs and symptoms of a stroke, blurred vision or difficulty speaking, sudden headache or loss of coordination, contact your doctor immediately.

Pregnancy: Aranesp (Darbepoetin-alfa) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Aranesp (Darbepoetin-alfa), contact your doctor immediately.

Breast-feeding: It is not known if darbepoetin alfa passes into breast milk. If you are a breast-feeding mother and are taking Aranesp (Darbepoetin-alfa), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Aranesp (Darbepoetin-alfa) have not been established for children.