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works cited

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answers to case study

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case study

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types of anemia

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Different types of anemia and their causes include: Iron deficiency anemia. This is the most common type of anemia worldwide. ... Vitamin deficiency anemia. ... Anemia of chronic disease. ... Aplastic anemia. ... Anemias associated with bone marrow disease. ... Hemolytic anemias. ... Sickle cell anemia. ... Other anemias.

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neupogen

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B12

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types of transfusions

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Types of Blood Transfusions | Red Blood Cell, Platelets & Plasma | American Red Cross

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Most donated blood collected by the American Red Cross is used for direct blood transfusions. Learn more about the types of blood transfusions made possible by donated blood.

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fg-4592

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Recent positive drug tests by two cyclists suggest there is a new, cutting-edge substance making its way to athletes looking for performance-enhancement: FG-4592, an experimental drug that increases production of red blood cells but has not yet been approved for human consumption.

Athletes have long found surreptitious means of obtaining banned performance-enhancing drugs, but with FG-4592, there actually may be a far more straightforward way - simply by ordering it from chemical-supply companies online.

And that, said Don Catlin, an expert on testing for banned substances, is something new to him. Athletes have gotten banned drugs from websites in China, he said, but what they receive is not always what they tried to order. The companies selling FG-4592 are not marketing it to athletes or individuals who want to take it; they emphasize that what they are selling is a chemical that is intended only for researchers.

But according to Catlin, a consultant on drug testing and former director of the U.C.L.A. lab that performs drug tests for the Olympics, that may not stop a determined athlete.

"What's amazing to me is that it is out there for sale on the Internet," Catlin said. This is in contrast with similar performance-enhancers such as erythropoietin, which likewise increases red cell production.

One of the cyclists accused of taking FG-4592, Fabio Taborre of Italy, was provisionally suspended on Monday after testing positive. The other, Carlos Oyarzun of Chile, was expelled from this month's Pan American Games for the same reason.

Both cyclists' suspensions were based on a single test; they are awaiting the results of a backup sample. Oyarzun has denied taking FG-4592.

In theory, FG-4592 is available only to participants in clinical trials being conducted by AstraZeneca and FibroGen. The drug is in the final stage of testing, but not approved for sale.

But at least three chemical-supply companies sell FG-4592. A person can simply go to a website, click on FG-4592, add it to a cart, pay with a credit card, and even get it sent via overnight delivery. The hitch, though, is that the buyer has to be a researcher.

"You have to have something in writing saying you will be using it for research purposes," said Jane Lee, a technical-support specialist at Selleck, a company that sells the compound and advertises it to be 99.36 percent pure. Lee added that the compound has to be sent to a university or research facility.

The effective dose depends on a person's size. But Selleck provided a helpful chart listing proper doses according to size and body surface area, for animals as varied as mice and baboons.

Unlike EPO, a blood booster that is injected, FG-4592 is taken as a pill. It spurs the body to make more red blood cells, in part by stimulating the production of EPO, a hormone used in red blood cell production that has been prevalent in professional cycling for years. Athletes know that anything that gives them more oxygen-carrying red blood cells will make them faster and improve their endurance. Their means have run the gamut from the work-intensive and legal (such as altitude tents and training at high altitudes) to the chemical and illegal (such as blood doping and injections of EPO).

The new drug is in a class of substances, known as hypoxia inducible factor stabilizers, that is prohibited by the World Anti-Doping Agency, which tests for it via urine samples. More than 600 sports organizations - including the International Olympic Committee and the International Cycling Union, or U.C.I., which represents cyclists - use the agency's lists to determine which substances to ban.

There is no other drug like FG-4592, said Abigail Bozarth, an AstraZeneca spokeswoman. She added, "We are unable to comment on how an individual might gain access to FG-4592 outside of a clinical trial."

At Cayman Chemical, another company that sells FG-4592, Gregory W. Endres, vice president for chemistry, warned that "it would be highly inadvisable" for a person to buy and then consume the chemical. The reason, he said, is that it is not produced somewhere that is authorized to make drugs for human beings.

"This is a research chemical, for research purposes," Endres said. "Things go through the F.D.A. for a reason." He would not elaborate on what risks someone would take using Cayman's compound, which is considered to be 98 percent pure.

Christopher Kelly, a spokesman for the Food and Drug Administration, said the agency did not deal with the prospect of humans' ingesting drugs sold by chemical-supply companies and intended for research in animals. It is not clear, he said, what risks, if any, they might be taking.

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A Drug Hits Cycling Before It Hits the Market

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Recent positive drug tests by two cyclists suggest there is a new, cutting-edge substance making its way to athletes looking for performance-enhancement: FG-4592, an experimental drug that increases production of red blood cells but has not yet been approved for human consumption.

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oprelavekin

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new drug

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Injectafer New FDA Drug Approval | CenterWatch

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Injectafer (ferric carboxymaltose injection): For the treatment of iron deficiency anemia. New approved drug details including side effects, uses and general information.

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EBA

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Oral vs. Intravenous iron

Most of the studies on iron supplementation have been conducted in populations of patients with CKD, and have provided evidence of a better clinical response with intravenous iron in comparison to the oral route. Less side effects, better absorption, and better compliance to treatment have been described, without the need for the use of erythropoiesis stimulating agents for the hemoglobin target between 11.5 and 12 g/dL to be achieved.

Some studies have reported an absence of response of increase in hemoglobin and/or improvement of cardiac parameters within one year of treatment, whereas others have reported a hematological response between 3 and 6 months.

There are several types of parenteral iron: iron dextran, iron gluconate, iron saccharate, and ferric carboxymaltose. The latter two compounds were used in the two major studies on iron supplementation in HF.

Iron dextran may be administered intravenously or intramuscularly. It is a molecule with high antigenicity and requires a pre-treatment test to evaluate the development of symptoms of allergic or anaphylactic reaction, which occur in 0.5-1% of cases. Late hypersensitivity reactions, i.e., between 24 and 48 hours up to weeks after the administration, can also be observed; these reactions are characterized by fever, malaise, headache, lymphadenomegaly, arthralgia and myalgia, and may occur in more than 10% of the patients treated.

Iron gluconate is a compound more stable than iron dextran, and its administration is associated with the occurrence of severe anaphylactic reaction and late reaction in 0.04% and 0.4% of cases, respectively. This medication has been validated for use in hemodialysis patients, in the treatment of anemia in patients with cancer, and in severely ill patients in intensive care units. However, it is not commercially available in Brazil.

Iron saccharate is a medication with minimum immunogenicity (occurrence of allergic reaction < 1/100,000 infusions). In Brazil, ferric hydroxide saccharate is the only option for the treatment with parenteral iron. It is marketed in vials containing 2 mL and 100 mg of elemental iron for intramuscular use, and vials containing 5 mL and 100 mg of elemental iron for intravenous use. The Ganzoni formula is used for the calculation of the total dose required: [Hb (g/dL) desired - Hb (g/dL) found] x body weight (Kg) x 2.4 + 500. For intravenous administration, it is necessary to observe the maximum dose limit of 200 mg per application (two vials) and the maximum weekly dose of 500 mg. Also, it is necessary to observe the minimum 24-hour interval between applications.

Ferric carboxymaltose has the advantage of enabling the administration of 1,000 mg of iron in only 15 minutes, with a minimum risk of adverse effects. This dose facilitates treatment, and prevents waste of time and the need for several appointments during therapy.

The most frequent adverse effects of these ferric compounds are gastrointestinal disturbances described as nausea, vomiting, abdominal pain, diarrhea or constipation and metallic taste. These side effects are significantly more frequent with oral replacement.

The two major studies corroborating iron supplementation in patients with iron-deficiency anemia are FERRIC-HF, published in 2008, and FAIR-HF, published in 2009 and cited in the updating of the Guideline on Chronic Heart Failure of the Brazilian Society of Cardiology, published in 2012.

The FERRIC-HF study (Effect of Intravenous Iron Sucrose on Exercise Tolerance in Anemic and Nonanemic Patients with Symptomatic Chronic Heart Failure and Iron Deficiency) included 35 patients who were followed up for only 18 weeks, which limits data extrapolation for the clinical practice. However, it was a relevant study given the scarcity of information on this topic. In this study, anemic (Hb < 12.5 g/dL) and nonanemic patients (Hb between 12.5 and 14.5 g/dL) with ferritin < 100 ng/mL or between 100-300 ng/mL when associated with transferrin saturation < 20%, from two European centers, were randomized to receive placebo or intravenous iron sucrose at a 200 mg dose per week to achieve the correction of the calculated iron deficiency. Clinical and laboratorial reassessment of the patients was carried out at weeks 1, 4, 8, 12, 16, and 18. Treatment was discontinued for two weeks if serum ferritin was > 500 ng/mL and/or transferrin saturation > 45% or Hb > 16 g/dL. Treatment was resumed when: ferritin < 500 ng/mL, transferrin saturation < 45% and Hb < 16 g/dL. Among all patients studied, the fatigue score was significantly lower in the group treated in relation to the placebo group. This was the most important finding of that study. A statistically significant improvement in the peak oxygen consumption (VO ₂)/kg and functional capacity was also observed, however with little clinical relevance.

The FAIR-HF study (Ferric Carboxymaltose in Patients with Heart Failure and Iron Deficiency) was a randomized double-blind clinical study which included 459 patients with NYHA functional class (FC) II-III patients with left ventricular ejection fraction ≤ 40% for FC II or ≤ 45% for FC III, iron deficiency (serum ferritin < 100mcg/L or between 100-299 mcg/L if transferring saturation < 20%) and hemoglobin level between 9.5 and 13.5 g/dL. The patients were randomized to receive ferric carboxymaltose either 200 mg or saline solution. The total iron dose was calculated using the Ganzoni formula, and the weekly dose administered was 200 mg. Then, a monthly maintenance iron dose of 200 mg was administered. Clinical and laboratorial reassessment of patients was made at weeks 4, 12, 24 and 26. If ferritin was higher than 800 mcg/L or between 500-800 mcg with transferrin saturation > 50% or Hb > 16 g/L, iron supplementation was discontinued. When ferritin levels dropped to 400 mcg/L, transferrin saturation < 45% and Hb < 16 g/dL, treatment was resumed 45% for FC III, iron deficiency (serum ferritin< 100mcg/L or between 100-299 mcg/L if transferring saturation < 20%) and hemoglobin level between 9.5 and 13.5 g/dL. The patients were randomized to receive ferric carboxymaltose either 200 mg or saline solution. The total iron dose was calculated using the Ganzoni formula, and the weekly dose administered was 200 mg. Then, a monthly maintenance iron dose of 200 mg was administered. Clinical and laboratorial reassessment of patients was made at weeks 4, 12, 24 and 26. If ferritin was higher than 800 mcg/L or between 500-800 mcg with transferrin saturation > 50% or Hb > 16 g/L, iron supplementation was discontinued. When ferritin levels dropped to 400 mcg/L, transferrin saturation < 45% and Hb < 16 g/dL, treatment was resumed .

Assessment of the quality of life and functional capacity at week 24 comprised the primary endpoint and at weeks 4 and 12, the secondary endpoint. With respect to the primary endpoint, among patients who received the ferric compound, 50% reported improvement of their functional capacity in comparison to 28% of those receiving saline solution (OR = 2.51; 95% CI: 1.75-3.6). At week 24, among patients of the ferric carboxymaltose group, 47% reported FC I-II in comparison to 30% of patients of the placebo group (OR = 2.4; 95% CI: 1.55-3.71). In relation to the secondary endpoint, there was a significant improvement in the quality of life and functional capacity at weeks 4 and 12, with stabilization of the distance walked in the 6-minute walking test at week 12. Mortality and adverse events rates were similar between the groups. In this study, the fact that the improvement in the functional capacity was limited to the subgroup with ischemic heart disease is noteworthy. Maybe this finding results from the small number of nonischemic patients included (20%). However, this is a topic that remains to be elucidated in the literature.

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Anemia, Heart Failure and Evidence-Based Clinical management

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Anemia is a prevalent comorbidity and marker of a poorer prognosis in patients with heart failure (HF). Its clinical relevance, as well as its pathophysiology and the clinical management of these patients are important subjects in the specialized literature. ...

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EBA

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Iron Deficiency Anemia: Evaluation and Management

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Iron deficiency is the most common nutritional disorder worldwide and accounts for approximately one-half of anemia cases. The diagnosis of iron deficiency anemia is confirmed by the findings of low iron stores and a hemoglobin level two standard deviations below normal. Women should be screened during pregnancy, and children screened at one year of age.

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hematopoiesis

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safety

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ferrous sulfate

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new drug

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A new type of erythropoietin product may be coming soon for patients with chronic and advanced kidney disease in whom anemia may develop.

AstraZeneca, the second largest pharmaceuticals firm in the United Kingdom, had a dwindling drug pipeline and has completed a deal with FibroGen, a biotechnology company in the United States, for an experimental anemia drug, several news outlets reported recently. AstraZeneca paid for rights to a drug that could be worth more than $815 million.

FG-4592 is the name of the new compound, which is delivered in pill form rather than the conventional injection for anemia brought on by chronic kidney (CKD) disease and end stage renal disease (ESRD).

The treatment is the first of a new type of drug for kidney patients that boosts the production of red blood cells by making the body react as if it is at high altitude and needs more cells for oxygen delivery.

Pharmaceutical researchers believe that such drugs could create a new market in treating anemia and other serious conditions, including circulatory problems and wound damage, Reuters reported. The drug may someday be developed for other anemia conditions, AstraZeneca said on its website.

Right now, AstraZeneca will pay $350 million up front, plus development-related milestone payments of up to $465 million, for a total of $815 million for rights to FG-4592 in the United States, China, and selected markets. The Reuters news service said that there could be additional payments "if use of the drug is expanded beyond the initial target of treating anaemia [sic] in patients with chronic kidney disease and end stage renal disease."

The drug is a small-molecule compound that stops the activity of hypoxia-inducible factor prolyl hydroxylase in anemia patients with CKD. According to AstraZeneca, the drug brings about a natural response to conditions of low oxygen and turns on the process of making red blood cells. FG-4592 has been shown to correct anemia and maintain hemoglobin levels "without the need for supplementation with intravenous iron in CKD patients not yet receiving dialysis and in end stage renal disease patients receiving dialysis," the company noted.

Thomas B. Neff, chief executive officer of FibroGen, said that FG-4592 could offer anemia patients an easier oral therapy "that provides coordinated erythropoiesis [production of red blood cells], that increases natural erythropoietin within the normal physiological range, and that is effective without intravenous iron supplementation and without an increased risk for hypertension."

Neff said that AstraZeneca and FibroGen would make China the first-to-launch country for FG-4592 and that the companies want to innovate in the area of anemia therapy to CKD and ESRD patients in the United States, where clinical trials would be fully funded under the terms of the agreement.

Pascal Soriot, AstraZeneca's chief executive officer, said that the collaboration on FG-4592 is "an important addition to AstraZeneca's growing late-stage portfolio in cardiovascular and metabolic disease," one of the company's core therapy areas. "We know from our research into complications of renal disease that anemia continues to be a challenge for patients with chronic kidney disease, due in part to the inconvenience and complexity of existing injectable and intravenous therapies and the safety concerns associated with them," Soriot said.

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A new type of erythropoietin product may be coming soon for patients with chronic and advanced kidney disease in whom anemia may develop. AstraZeneca, the second largest pharmaceuticals firm in the United Kingdom, had a dwindling drug pipeline and has completed a deal with FibroGen, a biotechnology company in the United States, for an experimental anemia drug, several news outlets reported recently.