Aranesp

DRUG DESCRIPTION

Aranesp (darbepoetin alfa) is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Aranesp is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons.

Aranesp is formulated as a sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each 1 mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 0.2).

What are the possible side effects of darbepoetin alfa (Aranesp, Aranesp Albumin Free, Aranesp SureClick)?

Contact your doctor if you feel weak, light-headed, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to darbepoetin alfa.

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

  • chest pain or heavy feeling,...

Read All Potential Side Effects and See Pictures of Aranesp

What are the precautions when taking darbepoetin alfa (Aranesp)?

Before using darbepoetin alfa, tell your doctor or pharmacist if you are allergic to it; or to other drugs that cause more red blood cells to be made (e.g., epoetin alfa); or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients (such as polysorbate, latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled high blood pressure.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure (treated/controlled), blood disorders (e.g., sickle cell...

Read All Potential Precautions of Aranesp


Aranesp Consumer (continued)

SIDE EFFECTS: Headache, body aches, diarrhea, and irritation at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Darbepoetin alfa may sometimes cause or worsen high blood pressure, especially in patients with long-term kidney failure. This effect may be caused by the number of red blood cells increasing too quickly, usually within the first 3 months of starting treatment. If you have high blood pressure, it should be adequately controlled before beginning treatment with this medication. Your blood pressure should be checked frequently. Ask your doctor if you should learn how to monitor your own blood pressure. If high blood pressure develops or worsens, follow your doctor's instructions about diet changes and starting or adjusting your high blood pressure medication. Lowering high blood pressure helps prevent strokes, heart attacks, and further kidney problems. Keep all laboratory appointments to have your blood count tested regularly to reduce the chance of this side effect.

Tell your doctor immediately if any of these unlikely but serious side effects occur: seizures, confusion, loss of consciousness.

This medication may rarely cause blood clots. Seek immediate medical attention if you notice any of the following rare but very serious side effects: pain/redness/swelling/weakness of the arms or legs, calf pain/swelling that is warm to the touch, new/worsening shortness of breath, coughing up blood, sudden vision changes, slurred speech, weakness on one side of the body, sudden severe headache, chest/jaw/left arm pain, irregular heartbeat, fainting, blood clots in your hemodialysis vascular access site.

Rarely, this medication may suddenly stop working well after a period of time because your body may make antibodies that reduce the effectiveness of darbepoetin alfa, and a very serious anemia can result. Tell your doctor immediately if symptoms of anemia return (e.g., increased tiredness, low energy, pale skin color, shortness of breath).

Though very unlikely to occur, this product may contain substances such as viruses that could cause infections because it may contain albumin from human blood. Careful screening of blood donors, special manufacturing methods, and tests are all used to reduce this risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor immediately if you develop any signs of an infection (e.g., persistent fever/sore throat, increased tiredness, yellowing eyes/skin, dark urine).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using darbepoetin alfa, tell your doctor or pharmacist if you are allergic to it; or to other drugs that cause more red blood cells to be made (e.g., epoetin alfa); or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients (such as polysorbate, latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled high blood pressure.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure (treated/controlled), blood disorders (e.g., sickle cell anemia, white blood cell or platelet problems, bone marrow problems), bleeding/clotting problems, blood vessel problems, heart problems (e.g., angina, heart failure), seizure disorder, a certain metabolic disorder (porphyria), certain vitamin deficiencies (folic acid, vitamin B12).

Infrequently, patients with long-term kidney failure on dialysis may be at increased risk of seizures during the first 3 months of treatment with this medication, possibly caused by the number of red blood cells increasing too quickly. Therefore, these patients should use caution and avoid activities such as driving or using machinery during this period. Limit alcoholic beverages because alcohol may also increase the risk of seizures.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. In some women of child-bearing age, menstrual periods have resumed during treatment with a similar drug (epoetin alfa). If this occurs with darbepoetin alfa treatment, it may be possible to get pregnant while using this medication. Discuss the need for birth control with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Aranesp Patient Information Including Side Effects

Brand Names: Aranesp, Aranesp Albumin Free, Aranesp SureClick

Generic Name: darbepoetin alfa (Pronunciation: DAR be POE e tin AL fa)

  • What is darbepoetin alfa (Aranesp)?
  • What are the possible side effects of darbepoetin alfa (Aranesp)?
  • What is the most important information I should know about darbepoetin alfa (Aranesp)?
  • What should I discuss with my healthcare provider before using darbepoetin alfa (Aranesp)?
  • How should I use darbepoetin alfa (Aranesp)?
  • What happens if I miss a dose (Aranesp)?
  • What happens if I overdose (Aranesp)?
  • What should I avoid while using darbepoetin alfa (Aranesp)?
  • What other drugs will affect darbepoetin alfa (Aranesp)?
  • Where can I get more information?

What is darbepoetin alfa (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.

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

Darbepoetin alfa may also be used for other purposes not listed in this medication guide.

What are the possible side effects of darbepoetin alfa (Aranesp)?

Contact your doctor if you feel weak, light-headed, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to darbepoetin alfa.

Darbepoetin alfa can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use darbepoetin alfa. 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;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance; or
  • pain or swelling in one or both legs.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using darbepoetin alfa and call your doctor at once if you have any of these serious side effects:

  • feeling short of breath, even with mild exertion;
  • swelling of your ankles or feet;
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • feeling light-headed, fainting; or
  • seizure (black-out or convulsions).

Less serious side effects may include:

  • dizziness, mild headache;
  • fever, sore throat, body aches, flu symptoms;
  • joint or muscle pain;
  • nausea, vomiting, diarrhea, stomach pain, constipation; or
  • 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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about darbepoetin alfa (Aranesp)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use darbepoetin alfa. 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, shortness of breath, slurred speech, or problems with vision or balance.

Do not use darbepoetin alfa if you have high blood pressure (hypertension) that is not controlled by diet and/or medication.

Before using darbepoetin alfa, tell your doctor if you have heart disease, congestive heart failure, high blood pressure, kidney disease, a blood cell or clotting disorder, cancer, epilepsy or another seizure disorder, or a history of stroke, heart attack, or blood clots.

To be sure this medication is helping your body produce red blood cells, your blood will need to be tested on a regular basis. You may also need to check your blood pressure during treatment. Do not miss any scheduled appointments.

Contact your doctor if you feel weak, light-headed, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to darbepoetin alfa.

Some women using darbepoetin alfa 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.

Darbepoetin alfa is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

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