What form(s) does this medication come in? Rockville, MD; 2007 Mar 12. 1998; 339:584-90. http://www.ncbi.nlm.nih.gov/pubmed/9718377?dopt=AbstractPlus, 46. Graf H, Lacombe JL, Braun J et al. Read it again each time Aranesp (darbepoetin alfa prefilled syringes) is Drug Type: Darbepoetin alfa is a biologic response modifier. This medication may also be given by infusion into a vein (intravenously, IV). This is not a list of all drugs or health problems that interact with Aranesp (darbepoetin alfa prefilled syringes). Development and characterization of novel erythropoiesis stimulating protein (NESP). Talk with the doctor. B12, renal function, electrolytes, fluid balance, and for premonitory neurological symptoms. Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. Call your doctor for medical Thomas G, Ali S, Hoebers FJP et al. Cancer: initially 2.25mcg/kg SC once weekly or 500mcg SC once every 3 weeks. Your doctor may need to adjust the dose according to your body's response to the medication. Medically reviewed by Drugs.com. Amended economic impact analysis of final rule requiring use of labeling on natural rubber containing devices. Darbopoetin alfa should be used with caution in people with high blood pressure. 3. Generic Name: Darbepoetin Alfa Prefilled Syringes (dar be POE e tin AL fa)Brand Name: Aranesp. 11. ), Contraindicated in patients with uncontrolled hypertension; BP should be under control before initiation of therapy.1 Monitor and control BP during therapy.1 If BP becomes difficult to control, reduce dosage of or withhold darbepoetin alfa.1, Seizures and hypertensive encephalopathy reported; risk appears greater in patients with CKD.1 Monitor closely for premonitory neurologic symptoms during the first several months of therapy.1 (See Advice to Patients. Check with your doctor as soon as possible if any of the following side effects occur: Stop taking the medication and seek immediate medical attention if any of the following occur: Some people may experience side effects other than those listed. Rockville, MD; Feb 16, 2010. Erythropoiesis-stimulating agents—time for a reevaluation. 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. pH of polysorbate solution is 6.2±0.2. If you think there has been an overdose, call your poison control center or get medical care right away. Patients on hemodialysis: IV route is recommended. 2004; 19:1224-30. http://www.ncbi.nlm.nih.gov/pubmed/14993489?dopt=AbstractPlus. FDA public health advisory regarding erythropoiesis-stimulating agents (ESAs): epoetin alfa (marketed as Procrit, Epogen), darbepoetin alfa (marketed as Aranesp). American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. 57. FDA has issued public health advisories regarding these risks.19 20 21 22 23 24 25 38 39 40 624 Weigh potential benefits of ESAs in reducing RBC transfusions against risk of serious cardiovascular events in patients with CKD.1 624 Individualize therapy and use lowest possible dosage that will reduce the need for transfusion.1 624, Not intended for patients with CKD who require acute correction of severe anemia; do not use as a substitute for emergency transfusion.1, Not established that ESAs improve quality of life, fatigue, or patient well-being.1, Treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies in whom chemotherapy is planned for at least 2 additional months;1 used to decrease the need for blood transfusions in such patients.1 14 62, ESAs not indicated in patients with chemotherapy-induced anemia when the anticipated outcome is cure of the underlying malignancy.1 54 ESAs not shown to improve outcomes of cancer chemotherapy (e.g., in terms of greater tumor shrinkage, delayed tumor progression, increased survival).1 24 25 34 35 38 39 40 43 44 49 Not established that ESAs improve quality of life, fatigue, or patient well-being.1, Not intended for patients who require acute correction of severe anemia; do not use as a substitute for emergency transfusion.1, Darbepoetin alfa and other ESAs not indicated for use in anemic patients with active malignant disease who are not receiving cancer chemotherapy†.1 28 29 ESAs have been shown to decrease overall survival in certain cancer patients not receiving chemotherapy or radiation therapy.1, In controlled trials of patients with CKD, ESA therapy targeted to hemoglobin concentrations >11 g/dL did not provide additional benefit beyond that achieved with lower targets and was associated with greater risk of death, stroke, and serious adverse cardiovascular events; no trial to date has identified a target hemoglobin, ESA dosage, or dosing strategy that decreases these risks.1 624 (See Boxed Warning.) Washington, DC; 2010 Mar 11. 2001; 43:109-10. http://www.ncbi.nlm.nih.gov/pubmed/11740411?dopt=AbstractPlus. 2006; 355:2071-84. Do not share your drugs with others and do not take anyone else's drugs. We comply with the HONcode standard for trustworthy health information -, Drug class: recombinant human erythropoietins, Anemia Associated with Chronic Renal Failure. The contents herein are for informational purposes only. There are many options to help minimize or prevent side effects. In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. Before starting darbepoetin alfa treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Under some conditions, this medication may cause tumours to progress or reoccur more quickly than for people who are not using darbepoetin alfa. Use lowest dose sufficient to avoid red blood cell transfusion. Do not stop using this medication without consulting your doctor. In some cases, doses can be given once every 2 weeks. Paper presented at 33rd American Society of Nephrology annual meeting. Fernandes M, Sawa H, Bellini G. Haemoglobin concentrations in chronic kidney disease.Lancet. Have your blood pressure checked as you have been told by your doctor. Nonmedicinal ingredients: polysorbate 80, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate and sterile All material copyright MediResource Inc. 1996 – 2020. ), Patients on dialysis: Initially, 0.45 mcg/kg administered IV or sub-Q once weekly or 0.75 mcg/kg administered IV or sub-Q once every 2 weeks as appropriate; IV administration recommended in patients undergoing hemodialysis.1 9 Initiate therapy when hemoglobin concentration <10 g/dL.1 624 Reduce or interrupt therapy if hemoglobin approaches or exceeds 11 g/dL.1 (See Boxed Warning. D’Ambra MN, Gray RJ, Hillman R et al. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy. Aranesp ® is a prescription medicine used to treat a lower than normal number of red blood cells (anemia) caused by chemotherapy that will be used for at least two months after starting Aranesp ®. An official website of the United States government, : Rockville, MD; November 8, 2007. If you have high blood pressure, heart disease such as heart failure, angina, or a previous heart attack, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more. If your symptoms or health problems do not get better or if they become worse, call your doctor. Food and Drug Administration. From FDA website. Reduce or interrupt dose if Hgb >10g/dL (not on dialysis) or >11g/dL (on dialysis). Your doctor will monitor your hemoglobin level closely with blood tests during treatment with this medication. Amgen, Thousand Oaks, CA: Personal communication. These medications are used to replace the erythropoietin that is lacking in people whose own body cannot produce enough. Do not freeze or shake this medication. Converting from epoetin alfa, and for dose adjustments: see full labeling. Cancer: abdominal pain, edema, thrombovascular events. You may experience some nausea and vomiting within days of receiving this drug, but small frequent meals, chewing hum, lozenges, and good mouth care may help. J Clin Oncol. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Practical guidelines for the use of NESP in treating renal anaemia. 2001; 16(Suppl 3):22-8. Do not switch to another ESA.1 16 56, Risk of severe allergic reactions, including anaphylactic reactions, angioedema, respiratory symptoms, skin rash, and urticaria.1 If a serious hypersensitivity or anaphylactic reaction occurs, discontinue immediately and institute appropriate therapy; do not reinitiate.1, The needle cover of the prefilled syringe contains natural latex proteins in the form of dry natural rubber (latex).1 51 52 53 Individuals sensitive to latex should not handle the needle cover.1 51 52 53 Rarely, hypersensitivity reactions to natural latex proteins have been fatal.52 53, Evaluate patients who fail to respond or experience a loss of hemoglobin response for potential causative factors (e.g., iron deficiency, infection, inflammation, bleeding).1, In the absence of another etiology, evaluate for evidence of PRCA and test for presence of antibodies to erythropoietins.1 (See Pure Red Cell Aplasia under Cautions. People who receive the medication under the skin can usually be taught to give themselves the injection. ARANESP prescription and dosage sizes information for physicians and healthcare professionals. Anemia is caused by chemotherapy cancer treatment. FDA public health advisory regarding epoetin alfa (marketed as Procrit, Epogen) and darbepoetin alfa (marketed as Aranesp). 1997; 64:1686-93. Toronto, Canada: 2000 Oct. Abstract 1326. Children: The safety and effectiveness of using this medication have not been established for children. VA Class: BL400 The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex). 1996; 61:32617-21. Anon. Initiate only when hemoglobin (Hgb) <10g/dL. They can prescribe medications and/or offer other suggestions that are effective in managing such problems. Mortality and target haemoglobin concentrations in anaemic patients with chronic kidney disease treated with erythropoietin: a meta-analysis. Do not flush down a toilet or pour down a drain unless you are told to do so. 2008; 108:317-25 http://www.ncbi.nlm.nih.gov/pubmed/18037478?dopt=AbstractPlus, 43. When Aranesp was administered intravenously during organogenesis to pregnant rats (gestational days 6 to 15) and rabbits (gestational days 6 to 18), there was no evidence of embryofetal toxicity or other adverse outcomes at intravenous doses tested, up to 20 mcg/kg/day; no significant placental transfer was observed in rats; placental transfer was not evaluated in rabbits ; In a peri/postnatal development …

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