Chronic kidney disease ckd in patients on dialysis and patients not on. 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. Aranesp has not been shown to improve quality of life, fatigue, or patient wellbeing 1. Desferal is contraindicated in patients with severe renal disease or anuria, since the drug and the iron. Contraindications known hypersensitivity to the active substance. To reduce the development of drugresistant bacteria and maintain the effectiveness of recarbrio and other antibacterial drugs, recarbrio should be used. Highlights of prescribing information these highlights do not include all the information needed to use aranesp safely and effectively. Insert the needle of the syringe into the histidine diluent vial.
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. The pdfpages package makes it easy to insert pages of external pdf. Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Aortitis has been reported in patients receiving filgrastim products. Sarclisa isatuximabirfc injection, for intravenous use. The recommended starting dose in adults is 100 unitskg as an intravenous or subcutaneous injection 3 times per week. Inject air into the vial and withdraw the quantity required for reconstitution. 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. Anemia secondary to myelodysplastic syndrome mds endogenous serum erythropoietin level of. Highlights of prescribing information these highlights do. Applicable procedure codes j0881 injection, darbepoetin alfa, 1 microgram nonesrd use 1 billable unit applicable ndcs singledose vial singledose prefilled syringe. 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. Aranesp darbepoetin alfa for healthcare professionals. Aranesp is an erythropoiesisstimulating agent esa indicated for the treatment of anemia due to.
Chronic renal failure patients the safety and effectiveness of aranesp have been assessed in multicenter studies. See 17 for patient counseling information and medication. Aranesp is a manmade form of the protein human erythropoietin that is given to reduce or avoid the need for red blood cell transfusions. Aarp health insurance plans pdf download medicare replacement pdf download aarp medicarerx plans united healthcare pdf download. The additional carbohydrate chains increase the approximate molecular weight of the glycoprotein from 30,000 to 37,000 daltons. Aug 3, 2018 dialysis, of the medicare benefits policy manual.
Highlights of prescribing information these highlights do not include all the information needed to use promacta safely and effectively. See 17 for patient counseling information and fda approved patient labeling. Beovu brolucizumabdbll injection, for intravitreal injection. Sections or subsections omitted from the full prescribing information are not listed. 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. Description clinical pharmacology clinical studies. Description clinical pharmacology clinical studies indications and. Retacrit epoetin alfaepbx dosage and administration. Vumerity diroximel fumarate delayedrelease capsules, for oral use. Fasenra benralizumab injection, for subcutaneous use.
Aranespa is a 165amino acid protein that differs from recombinant human erythropoietin in containing 5 nlinked oligosaccharide chains, whereas recombinant human erythropoietin contains 3. 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. Throughout this section of the package insert, the aranesp study numbers in 2 openlabel studies, aranesp or epoetin alfa were administered for the. See full prescribing information for complete boxed warning. Esas increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access and tumor progression or recurrence chronic kidney disease. In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive. 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. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers e.
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. 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. Desferal is not indicated for the treatment of primary hemochromatosis, since phlebotomy is the method of choice for removing excess iron in this disorder. Aranesp is not considered medically necessary for indications other than those listed above due to insufficient evidence of therapeutic value. Patients are calculated based on an estimated annual cumulative dose. People with anemia have a lowerthannormal number of red blood cells rbcs. 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. Tepezza teprotumumabtrbw for injection, for intravenous use.
Highlightsof prescribing information kyprolis safely and. Aranesp darbepoetin alfa is an erythropoiesisstimulating protein that is produced in chinese hamster ovary cho cells by recombinant dna technology. Highlights of prescribing information these highlights do not include all the information needed to use mavyret safely and effectively. Highlights of prescribing information these highlights. Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively.
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. Venofer is indicated for the treatment of iron deficiency anemia in patients. Infed iron dextran injection usp is a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. 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. Skyrizi risankizumabrzaa full prescribing information. Each ml contains the equivalent of 50 mg of elemental iron as an iron dextran complex, approximately 0. 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. Refer to the dexamethasone prescribing information for other information on that product. Comparison of ep2006, a filgrastim biosimilar, to the reference.