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