Recommended Topic Related To:

Aranesp

"The U.S. Food and Drug Administration approved a risk management program to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis-Stimulating Agents (ESAs). For patients with cancer, the program "...

Aranesp

Aranesp Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Aranesp (darbepoetin alfa) is used to treat anemia (a lack of red blood cells in the body) in people with long-term serious kidney disease (chronic renal failure) and people receiving chemotherapy for some types of cancer. Aransep belongs to a drug class called erythropoiesis-stimulating agents, or ESAs. Common side effects include headache, body aches, diarrhea, and irritation at the injection site. Aransep may rarely cause very serious side effects, including blood clots, which can be fatal.

The dosage is based on your medical condition, weight, and response to treatment. Aransep is given as an injection under the skin or into a vein, usually once a week or as directed by your doctor. There may be other drugs that can interact with Aransep. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. During pregnancy, Aransep should be used only when prescribed. In some women of child-bearing age, menstrual periods have resumed during treatment with a similar drug (epoetin alfa). If this occurs with Aransep 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.

Our Aranesp Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Aranesp in Detail - Patient Information: Side Effects

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.

Contact your doctor if you feel light-headed or unusually weak or tired. 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;
  • swelling, rapid weight gain;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance; or
  • pain, swelling, warmth, or redness in one or both legs.

Stop using darbepoetin alfa 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;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • 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 side effects may include:

  • stomach pain;
  • mild cough;
  • mild skin rash or redness; 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Aranesp (Darbepoetin Alfa) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Aranesp Overview - Patient Information: Side Effects

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.

Get medical help right away if you have any very serious side effects, including: seizures.

This medication may rarely cause blood clots. Get medical help right away 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, confusion, 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, get medical help right away 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.

Read the entire patient information overview for Aranesp (Darbepoetin Alfa)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Aranesp FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the label:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice.

Patients with Chronic Kidney Disease

Adult Patients

Adverse reactions were determined based on pooled data from 5 randomized, active-controlled studies of Aranesp with a total of 1357 patients (Aranesp 766, epoetin alfa 591). The median duration of exposure for patients receiving Aranesp was 340 days, with 580 patients exposed for greater than 6 months and 360 patients exposed for greater than 1 year. The median (25th, 75th percentiles) weight-adjusted dose of Aranesp was 0.50 mcg/kg (0.32, 0.81). The median (range) age for patients administered Aranesp was 62 years (18 to 88). In the Aranesp group, 55% were male, 72% were white, 83% were receiving dialysis, and 17% were not receiving dialysis.

Table 4 lists adverse reactions occurring in ≥ 5% of patients treated with Aranesp.

Table 4: Adverse Reactions Occurring in ≥ 5% of Patients with CKD

Adverse Reaction Patients Treated With Aranesp
(n = 766)
Hypertension 31%
Dyspnea 17%
Peripheral edema 17%
Cough 12%
Procedural hypotension 10%
Angina pectoris 8%
Vascular access complications 8%
Fluid overload 7%
Rash/Erythema 5%
Arteriovenous graft thrombosis 5%

Rates of adverse reactions with Aranesp therapy were similar to those observed with other recombinant erythropoietins in these studies.

Pediatric Patients

Aranesp was administered to 81 pediatric patients with CKD who had stable hemoglobin concentrations while previously receiving epoetin alfa [see Clinical Studies]. In this study, the most frequently reported serious adverse reactions with Aranesp were hypertension and convulsions. The most commonly reported adverse reactions were hypertension, injection site pain, rash, and convulsions. Aranesp administration was discontinued because of injection site pain in 2 patients and moderate hypertension in a third patient.

Studies have not evaluated the effects of Aranesp when administered to pediatric patients as the initial treatment for the anemia associated with CKD.

Cancer Patients Receiving Chemotherapy

Adverse reactions were based on data from a randomized, double-blind, placebo-controlled study of Aranesp in 597 patients (Aranesp 301, placebo 296) with extensive stage small cell lung cancer (SCLC) receiving platinum-based chemotherapy. All patients were white, 64% were male, and the median age was 61 years (range: 28 to 82 years); 25% of the study population were from North America, Western Europe, and Australia. Patients received Aranesp at a dose of 300 mcg or placebo weekly for 4 weeks then every 3 weeks for a total of 24 weeks, and the median duration of exposure was 19 weeks (range: 1 to 26 weeks).

Adverse reactions were also based on data from 7 randomized, double-blind, placebo-controlled studies, including the SCLC study described above, that enrolled 2112 patients (Aranesp 1203, placebo 909) with non-myeloid malignancies. Most patients were white (95%), male (52%), and the median age was 63 years (range: 18 to 91 years); 73% of the study population were from North America, Western Europe, and Australia. Dosing and schedules varied by study from once weekly to once every 4 weeks, and the median duration of exposure was 12 weeks (range: 1 to 27 weeks).

Table 5: Thrombovascular Adverse Reactions in Patients Receiving Chemotherapy

Adverse Reaction SCLC Study All Placebo-controlled Studies
Aranesp
(n = 301)
Placebo
(n = 296)
Aranesp
(n = 1203)
Placebo
(n = 909)
Thromboembolic Adverse Reactions, n (%) 24 (8.0%) 13 (4.4%) 73 (6.1%) 37 (4.1%)
  Arterial 10 (3.3%) 3 (1.0%) 15 (1.2%) 5 (0.6%)
     Myocardial infarction 5 (1.7%) 0 7 (0.6%) 2 (0.2%)
  Venous 14 (4.7%) 10 (3.4%) 60 (5.0%) 32 (3.5%)
     Pulmonary embolism 5 (1.7%) 3 (1.0%) 16 (1.3%) 6 (0.7%)
  Cerebrovascular disorders* 14 (4.7%) 9(3.0%) 20 (1.7%) 17 (1.9%)
* “Cerebrovascular disorders” encompasses CNS hemorrhages and cerebrovascular accidents (ischemic and hemorrhagic). Events in this category may also be included under “thromboembolic adverse reactions.”

In addition to the thrombovascular adverse reactions, abdominal pain and edema occurred at a higher incidence in patients taking Aranesp compared to patients on placebo. Among all placebo-controlled studies, abdominal pain (13.2% vs. 9.4%) and edema (12.8% vs. 9.7%) were reported more frequently in patients receiving Aranesp compared to the placebo group. In the SCLC study the incidence of abdominal pain (10.3% vs. 3.4%) and edema (5.6% vs. 5.1%) in the Aranesp-treated patients compared to those receiving placebo.

Postmarketing Experience

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been identified during postmarketing use of Aranesp:

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. Neutralizing antibodies to darbepoetin alfa that cross-react with endogenous erythropoietin and other ESAs can result in PRCA or severe anemia (with or without other cytopenias) [see WARNINGS AND PRECAUTIONS].

In clinical studies, the percentage of patients with antibodies to Aranesp was examined using the Biacore® assay. Sera from 1501 patients with CKD and 1159 cancer patients were tested. At baseline, prior to Aranesp treatment, binding antibodies were detected in 59 patients (4%) with CKD and 36 cancer patients (3%). During Aranesp therapy (range: 22 to 177 weeks), a follow-up sample was taken. One additional patient with CKD and 8 additional cancer patients developed antibodies capable of binding Aranesp. None of the patients had antibodies capable of neutralizing the activity of Aranesp or endogenous erythropoietin at baseline or at end of study. No clinical sequelae consistent with PRCA were associated with the presence of these antibodies.

The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Aranesp with the incidence of antibodies to other products may be misleading.

Read the entire FDA prescribing information for Aranesp (Darbepoetin Alfa) »

A A A

Aranesp - User Reviews

Aranesp User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Aranesp sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.


NIH talks about Ebola on WebMD