Aranesp darbepoetin alfa is used to treat a lower than normal number of red blood cells anemia caused by chronic kidney disease in patients on dialysis and not on dialysis and anemia caused by chemotherapy that will be used for at least two months after starting aranesp. Chronic kidney disease ckd in patients on dialysis and patients not on. Venofer is indicated for the treatment of iron deficiency anemia in patients. Aranesp package insert pdf throughout this section of the package insert, the aranesp study numbers in 2 openlabel studies, aranesp or epoetin alfa were administered for the. To reduce the development of drugresistant bacteria and maintain the effectiveness of recarbrio and other antibacterial drugs, recarbrio should be used. The pdfpages package makes it easy to insert pages of external pdf. Retacrit epoetin alfaepbx dosage and administration. Refer to the dexamethasone prescribing information for other information on that product. Aug 3, 2018 dialysis, of the medicare benefits policy manual. Esas increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access and tumor progression or recurrence chronic kidney disease. Fasenra benralizumab injection, for subcutaneous use.
Insert the needle of the syringe into the histidine diluent vial. Chronic renal failure patients the safety and effectiveness of aranesp have been assessed in multicenter studies. Aranesp darbepoetin alfa for healthcare professionals. Tepezza teprotumumabtrbw for injection, for intravenous use. Highlights of prescribing information these highlights do not include all the information needed to use aranesp safely and effectively. Description clinical pharmacology clinical studies. Desferal is not indicated for the treatment of primary hemochromatosis, since phlebotomy is the method of choice for removing excess iron in this disorder.
Throughout this section of the package insert, the aranesp study numbers in 2 openlabel studies, aranesp or epoetin alfa were administered for the. Granix is a prescription medicine used in people one month and older with certain types of cancer nonmyeloid malignancies, who are receiving chemotherapy that affects the bone marrow. Aranesp darbepoetin alfa is an erythropoiesisstimulating protein that is produced in chinese hamster ovary cho cells by recombinant dna technology. The additional carbohydrate chains increase the approximate molecular weight of the glycoprotein from 30,000 to 37,000 daltons. Description clinical pharmacology clinical studies indications and. Aarp health insurance plans pdf download medicare replacement pdf download aarp medicarerx plans united healthcare pdf download medicare benefits pdf download medicare coverage pdf download medicare part d pdf download medicare part b pdf download aranesp package insert. See full prescribing information for complete boxed warning. Aranesp is a 165amino acid protein that differs from recombinant human erythropoietin in containing 5 nlinked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. Inject air into the vial and withdraw the quantity required for reconstitution. Aarp health insurance plans pdf download medicare replacement pdf download aarp medicarerx plans united healthcare pdf download medicare benefits pdf download medicare coverage pdf download medicare part d pdf download medicare part b pdf download aranesp fda. Highlights of prescribing information these highlights do. Sections or subsections omitted from the full prescribing information are not listed. Highlights of prescribing information these highlights do not include all the information needed to use mavyret safely and effectively.
Beovu brolucizumabdbll injection, for intravitreal injection. Aranespa is a 165amino acid protein that differs from recombinant human erythropoietin in containing 5 nlinked oligosaccharide chains, whereas recombinant human erythropoietin contains 3. Each ml contains the equivalent of 50 mg of elemental iron as an iron dextran complex, approximately 0. Highlights of prescribing information these highlights. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesisstimulating agents esas to target a hemoglobin levelof greater than 11 gdl5.
Anemia secondary to myelodysplastic syndrome mds endogenous serum erythropoietin level of. Highlights of prescribing information these highlights do not include all the information needed to use promacta safely and effectively. December 24, 2019 throughout this section of the package insert, the aranesp study numbers in 2 openlabel studies, aranesp or epoetin alfa were administered for the. Sarclisa isatuximabirfc injection, for intravenous use. Hemlibra emicizumabkxwh injection, for subcutaneous use. See 17 for patient counseling information and medication. Vumerity diroximel fumarate delayedrelease capsules, for oral use. Patients are calculated based on an estimated annual cumulative dose. In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive. Infed iron dextran injection usp is a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. In controlled trials, patients experienced greater risks. Aortitis has been reported in patients receiving filgrastim products. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers e. Aarp health insurance plans pdf download medicare replacement pdf download aarp medicarerx plans united healthcare pdf download.
Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Highlightsof prescribing information kyprolis safely and. Twice weekly 2056mgm2 regimen by 30minute infusion kyprolis is administered intravenously as a 30minute infusion on two consecutive days, each week for threeweeks followed by a 12day rest period as shown in table2. Aranesp is an erythropoiesisstimulating agent esa indicated for the treatment of anemia due to. The recommended starting dose in adults is 100 unitskg as an intravenous or subcutaneous injection 3 times per week. Aranesp is indicated for the treatment of anemia in patients with nonmyeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. Applicable procedure codes j0881 injection, darbepoetin alfa, 1 microgram nonesrd use 1 billable unit applicable ndcs singledose vial singledose prefilled syringe. Comparison of ep2006, a filgrastim biosimilar, to the reference. See 17 for patient counseling information and fda approved patient labeling. Contraindications known hypersensitivity to the active substance. Nplate product monograph page 6 of 67 of the 630 adult patients who received nplate in itp clinical studies, the study duration adjusted thromboticthromboembolic rate in subjects with age 65 years and over was 10 per 100.
Aranesp has not been shown to improve quality of life, fatigue, or patient wellbeing 1. Throughout this section of the package insert, the aranesp study numbers associated with the nephrology and cancer clinical programs are designated with the letters n and c, respectively. People with anemia have a lowerthannormal number of red blood cells rbcs. Aranesp is not considered medically necessary for indications other than those listed above due to insufficient evidence of therapeutic value. Skyrizi risankizumabrzaa full prescribing information. If hemoglobin does not increase after 8 weeks of therapy, increase retacrit dose by approximately 50 to 100 unitskg at 4 to 8week intervals until hemoglobin reaches a level needed to avoid rbc transfusions or. Aranesp is a manmade form of the protein human erythropoietin that is given to reduce or avoid the need for red blood cell transfusions. Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively.
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