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ARANESP

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Overview

What is ARANESP?

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 does ARANESP look like?



What are the available doses of ARANESP?

Single

-

dose vials

Single

-

dose

prefilled

syringes

What should I talk to my health care provider before I take ARANESP?

How should I use ARANESP?

Aranesp is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.

Evaluation of Iron Stores and Nutritional Factors

Evaluate the iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy.  

Monitoring

of

Response to Therapy

Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Aranesp  . Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion.


What interacts with ARANESP?

Sorry No Records found


What are the warnings of ARANESP?

Sorry No Records found


What are the precautions of ARANESP?

Sorry No Records found


What are the side effects of ARANESP?

Sorry No records found


What should I look out for while using ARANESP?

Aranesp is contraindicated in patients with:

Chronic Kidney Disease:

Cancer:


What might happen if I take too much ARANESP?

Aranespoverdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Aranesp dosage and/or with phlebotomy, as clinically indicated .  Cases of severe hypertension have been observed following overdose with ESAs


How should I store and handle ARANESP?

Store lyophilized Activase at controlled room temperature not to exceed 30°C (86°F), or under refrigeration (2-8°C/36-46°F). Protect the lyophilized material during extended storage from excessive exposure to light. If stored between 2-30°C (36-86°F), Activase may be used within 8 hours following reconstitution. Discard any unused solution after administration is complete.Do not use beyond the expiration date stamped on the vial.Store lyophilized Activase at controlled room temperature not to exceed 30°C (86°F), or under refrigeration (2-8°C/36-46°F). Protect the lyophilized material during extended storage from excessive exposure to light. If stored between 2-30°C (36-86°F), Activase may be used within 8 hours following reconstitution. Discard any unused solution after administration is complete.Do not use beyond the expiration date stamped on the vial.Store at 36ºF to 46ºF (2ºC to 8ºC). Do not freeze.Do not shake. Protect from light; store Aranesp in the carton until use.Do not use Aranesp that has been shaken or frozen.Aranesp is available in the following packages:Single-dose VialSingle-dose Prefilled Syringe (SingleJect)Store at 36ºF to 46ºF (2ºC to 8ºC). Do not freeze.Do not shake. Protect from light; store Aranesp in the carton until use.Do not use Aranesp that has been shaken or frozen.Aranesp is available in the following packages:Single-dose VialSingle-dose Prefilled Syringe (SingleJect)Store at 36ºF to 46ºF (2ºC to 8ºC). Do not freeze.Do not shake. Protect from light; store Aranesp in the carton until use.Do not use Aranesp that has been shaken or frozen.Aranesp is available in the following packages:Single-dose VialSingle-dose Prefilled Syringe (SingleJect)Store at 36ºF to 46ºF (2ºC to 8ºC). Do not freeze.Do not shake. Protect from light; store Aranesp in the carton until use.Do not use Aranesp that has been shaken or frozen.Aranesp is available in the following packages:Single-dose VialSingle-dose Prefilled Syringe (SingleJect)Store at 36ºF to 46ºF (2ºC to 8ºC). Do not freeze.Do not shake. Protect from light; store Aranesp in the carton until use.Do not use Aranesp that has been shaken or frozen.Aranesp is available in the following packages:Single-dose VialSingle-dose Prefilled Syringe (SingleJect)Store at 36ºF to 46ºF (2ºC to 8ºC). Do not freeze.Do not shake. Protect from light; store Aranesp in the carton until use.Do not use Aranesp that has been shaken or frozen.Aranesp is available in the following packages:Single-dose VialSingle-dose Prefilled Syringe (SingleJect)Store at 36ºF to 46ºF (2ºC to 8ºC). Do not freeze.Do not shake. Protect from light; store Aranesp in the carton until use.Do not use Aranesp that has been shaken or frozen.Aranesp is available in the following packages:Single-dose VialSingle-dose Prefilled Syringe (SingleJect)Store at 36ºF to 46ºF (2ºC to 8ºC). Do not freeze.Do not shake. Protect from light; store Aranesp in the carton until use.Do not use Aranesp that has been shaken or frozen.Aranesp is available in the following packages:Single-dose VialSingle-dose Prefilled Syringe (SingleJect)Store at 36ºF to 46ºF (2ºC to 8ºC). Do not freeze.Do not shake. Protect from light; store Aranesp in the carton until use.Do not use Aranesp that has been shaken or frozen.Aranesp is available in the following packages:Single-dose VialSingle-dose Prefilled Syringe (SingleJect)Store at 36ºF to 46ºF (2ºC to 8ºC). Do not freeze.Do not shake. Protect from light; store Aranesp in the carton until use.Do not use Aranesp that has been shaken or frozen.Aranesp is available in the following packages:Single-dose VialSingle-dose Prefilled Syringe (SingleJect)Store at 36ºF to 46ºF (2ºC to 8ºC). Do not freeze.Do not shake. Protect from light; store Aranesp in the carton until use.Do not use Aranesp that has been shaken or frozen.Aranesp is available in the following packages:Single-dose VialSingle-dose Prefilled Syringe (SingleJect)


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Aranesp stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.

Non-Clinical Toxicology
Aranesp is contraindicated in patients with:

Chronic Kidney Disease:

Cancer:

Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic antidepressants, and other drugs with anticholinergic effects. Concomitant administration with antacids may interfere with the absorption of methscopolamine bromide.

The design and overall results of the 3 large trials comparing higher and lower hemoglobin targets are shown in Table 3.

Patients with

Chronic

Kidney Disease

Normal Hematocrit Study (NHS): A prospective, randomized, open-label study of 1265 patients with chronic kidney disease on dialysis with documented evidence of congestive heart failure or ischemic heart disease was designed to test the hypothesis that a higher target hematocrit (Hct) would result in improved outcomes compared with a lower target Hct. In this study, patients were randomized to epoetin alfa treatment targeted to a maintenance hemoglobin of either 14 ± 1 g/dL or 10 ± 1 g/dL.  The trial was terminated early with adverse safety findings of higher mortality in the high hematocrit target group. Higher mortality (35% vs. 29%) was observed for the patients randomized to a target hemoglobin of 14 g/dL than for the patients randomized to a target hemoglobin of 10 g/dL.  For all-cause mortality, the HR = 1.27; 95% CI (1.04, 1.54); p=0.018.  The incidence of nonfatal myocardial infarction, vascular access thrombosis, and other thrombotic events was also higher in the group randomized to a target hemoglobin of 14 g/dL.

CHOIR: A randomized, prospective trial, 1432 patients with anemia due to CKD who were not undergoing dialysis and who had not previously received epoetin alfa therapy were randomized to epoetin alfa treatment targeting a maintenance hemoglobin concentration of either 13.5 g/dL or 11.3 g/dL.  The trial was terminated early with adverse safety findings. A major cardiovascular event (death, myocardial infarction, stroke, or hospitalization for congestive heart failure) occurred in 125 of the 715 patients (18%) in the higher hemoglobin group compared to 97 of the 717 patients (14%) in the lower hemoglobin group [hazard ratio (HR) 1.34, 95% CI: 1.03, 1.74; p = 0.03].

TREAT: A randomized, double-blind, placebo-controlled, prospective trial of 4038 patients with CKD not on dialysis (eGFR of 20 – 60 mL/min), anemia (hemoglobin levels ≤ 11 g/dL), and type 2 diabetes mellitus, patients were randomized to receive either Aranesp treatment or a matching placebo.  Placebo group patients also received Aranesp when their hemoglobin levels were below 9 g/dL.  The trial objectives were to demonstrate the benefit of Aranesp treatment of the anemia to a target hemoglobin level of 13 g/dL, when compared to a "placebo" group, by reducing the occurrence of either of two primary endpoints: (1) a composite cardiovascular endpoint of all-cause mortality or a specified cardiovascular event (myocardial ischemia, CHF, MI, and CVA) or (2) a composite renal endpoint of all-cause mortality or progression to end stage renal disease.  The overall risks for each of the two primary endpoints (the cardiovascular composite and the renal composite) were not reduced with Aranesp treatment (see Table 3), but the risk of stroke was increased nearly two-fold in the Aranesp-treated group versus the placebo group: annualized stroke rate 2.1% vs. 1.1%, respectively, HR 1.92; 95% CI: 1.38, 2.68; p < 0.001. The relative risk of stroke was particularly high in patients with a prior stroke: annualized stroke rate 5.2% in the Aranesp treated group and 1.9% in the placebo group, HR 3.07; 95% CI: 1.44, 6.54.  Also, among Aranesp-treated subjects with a past history of cancer, there were more deaths due to all causes and more deaths adjudicated as due to cancer, in comparison with the control group.

Patients with Cancer

An increased incidence of thromboembolic reactions, some serious and life-threatening, occurred in patients with cancer treated with ESAs.

In a randomized, placebo-controlled study (Study 2 in Table 4  ) of 939 women with metastatic breast cancer receiving chemotherapy, patients received either weekly epoetin alfa or placebo for up to a year. This study was designed to show that survival was superior when epoetin alfa was administered to prevent anemia (maintain hemoglobin levels between 12 and 14 g/dL or hematocrit between 36% and 42%). This study was terminated prematurely when interim results demonstrated a higher mortality at 4 months (8.7% vs. 3.4%) and a higher rate of fatal thrombotic reactions (1.1% vs. 0.2%) in the first 4 months of the study among patients treated with epoetin alfa. Based on Kaplan-Meier estimates, at the time of study termination, the 12-month survival was lower in the epoetin alfa group than in the placebo group (70% vs. 76%; HR 1.37, 95% CI: 1.07, 1.75; p = 0.012).

Patients Having Surgery

Aranespis not approved for reduction of RBC transfusions in patients scheduled for surgical procedures.

An increased incidence of DVT in patients receiving epoetin alfa undergoing surgical orthopedic procedures was demonstrated. In a randomized, controlled study, 680 adult patients, not receiving prophylactic anticoagulation and undergoing spinal surgery, received epoetin alfa and standard of care (SOC) treatment (n = 340) or SOC treatment alone (n = 340).  A higher incidence of DVTs, determined by either color flow duplex imaging or by clinical symptoms, was observed in the epoetin alfa group (16 [4.7%] patients) compared with the SOC group (7 [2.1%] patients). In addition to the 23 patients with DVTs included in the primary analysis, 19 [2.8%] patients experienced 1 other thrombovascular event (TVE) each (12 [3.5%] in the epoetin alfa group and 7 [2.1%] in the SOC group).

Increased mortality was observed in a randomized, placebo-controlled study of epoetin alfa in adult patients who were undergoing CABG surgery (7 deaths in 126 patients randomized to epoetin alfa versus no deaths among 56 patients receiving placebo). Four of these deaths occurred during the period of study drug administration and all 4 deaths were associated with thrombotic events.

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

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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