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Company
AstraZeneca takes back local sales from GC and Daewoong
by
Eo, Yun-Ho
Nov 21, 2019 11:40pm
AstraZeneca is taking back some local sales rights from GC Pharma and Daewoong Pharmaceutical. According to pharmaceutical industry source on Nov. 1, AstraZeneca Korea has recently decided to retrieve local sales and distribution rights of a high blood pressure treatment, Atacand (candesartan) from GC Pharma, and of chronic obstructive pulmonary disease (COPD) treatment, Eklira (aclidinium) and Duaklir (formoterol and aclidinium) from Daewoong Pharmaceutical. So from next year at latest, AstraZeneca would directly operate marketing and sales of the three items in Korea. Cardiovascular, Renal and Metabolism (CVRM) Department, currently responsible for antidiabetic treatment Farxiga (dapagliflozin), would probably take in Atacand, and Respiratory Department with Daxas (roflumilast) and Symbicort (budesonide and formoterol) would absorb Eklira and Duaklir back. The two types of medicines are under different circumstances. Atacand, under angiotensin receptor blockers (ARBs) class, has an expired patent, but it sold around 25 billion won as outpatient prescription drug last year. AstraZeneca had a joint local sales and distribution deal with GC Pharma since 2011. Eklira and Duaklir’s actual sales figures are not too significant. But retrieving those back would reinforce single-component long-acting muscarinic antagonists (LAMA) and long-acting beta-agonist (LABA) and LAMA combination pipelines at AstraZeneca’s Respiratory Department. The two COPD medicines entered the Korean market as Daewoong Pharmaceutical signed a local sales deal with Spain-based pharmaceutical company, Almirall, in 2004. But AstraZeneca now owns the medicine as it acquired the respiratory pipeline later. Meanwhile, domestic sales contract on Farxiga and a hyperlipidemia treatment, Crestor (rosuvastatin), with Daewoong Pharmaceutical would be maintained as they are.
Company
Oral GLP-1 competitiveness depends on price and convenience
by
Nho, Byung Chul
Nov 20, 2019 11:50pm
Although an oral GLP-1 drug, Rybelsus has attracted heightened attention from its market since its recent approval by the U.S. Food and Drug Administration (FDA), it faces some barriers to overcome like inconvenient high-dose regimen and expensive price. Reportedly, once-daily Rybelsus’ effect of glucose control and weight loss is not as effective as once-weekly injection, despite the oral drug’s dosage is hundred times higher than the injection. And also the drug’s price is expected to be higher than other existing oral drugs. Well aware of the concerns, Novo Nordisk (“Novo”) official spoke at a recently held third quarter 2019 earnings presentation and explained that competitors of Rybelsus would not be an once-weekly injection, but other existing oral antidiabetic treatments and Novo’s own once-daily injection, Victoza. Rybelsus is an oral version of Novo’s once-weekly GLP-1 injection, Ozempic, and 7mg and 14mg doses of Rybelsus were approved by FDA in last September for type 2 diabetic patients, who needs to control glucose level with drug as they cannot self-control it by diet or exercise. The biggest risk factor of Rybelsus is in effectiveness. Rybelsus’ glycated hemoglobin reduction rate, which measures treatment effect on diabetic patients, demonstrated similar level of effectiveness as Novo’s own once-daily injection, Victoza. However, the rate was less promising than Novo’s other once-weekly antidiabetic injection Ozempic. According to Novo’s clinical data, taking 14mg of Rybelsus daily for 52 weeks would reduce 1.3 percent of hemoglobin level, whereas 26 weeks of taking 1.8mg of Victoza daily reduces 1.3 percent, and 40 weeks of 1mg of Ozempic weekly reduces 1.8 percent. Treatments in GLP-1 class take a certain period of time to find patient’s adequate dose to minimize the treatment’s well-known adverse reaction, gastrointestinal side effects. For Rybelsus, it takes about eight weeks. Other injectable Saxenda by Novo, Trulicity by Eli Lilly, and efpeglenatide by Sanofi take about four weeks or less. Unlike the Korean market, market expectation on Rybelsus is also lowered by diabetic patients in the U.S. and other European countries not minding so much of pen-type injection device. Clinical trial on single-dose prefilled pen-type injection conducted by Eli Lilly found 99 percent of subject patients completed administration for the target period of four weeks, and 97 percent of them were positive about continuous use of the treatment type. Moreover, Rybelsus’ 14mg high-dose daily regimen is another issue the treatment faces, because such high dosage could lead patient’s pharmaceutical expense to rise. In fact, Rybelsus’ injectable version, Ozempic’s treatment dosage is 1mg per week, but patients taking Rybelsus has to take 98mg (14mg per day) a week of the exact same substance, which is close to a hundredfold of Ozempic. The industry accordingly expects the extensively higher dosage of the drug would inevitably increase patient’s drug expense. “Rybelsus is ‘just another option of oral antidiabetic treatments’ and it is expected to take its unique place in the market. But it has some problems to overcome, compared to an existing once-weekly injection. Rybelsus’ competitors would likely to be other options of oral antidiabetic treatments or once-daily injection like Victoza. Whichever product demonstrates the most outstanding effect, benefit, convenience and safety among once-weekly injections would lead the market, eventually,” a pharmaceutical industry insider commented.
Opinion
[Reporter's view] The Korean bio-health industry in Anomie
by
Lee, Jeong-Hwan
Nov 20, 2019 11:50pm
World-class standards of medical technology is Korea's long-standing pride. Advanced bio-new drugs are the future growth fuel that the world pursues, and the Korean pharmaceutical industry is gradually shifting its development focus from generics to new drugs with technology. Expectations and concerns coexist in the public's spotlight toward the medical and biopharmaceutical industries that will affect the future of Korea. It is rare to oppose the achievement of 'high-tech medical and bio-new drugs' that will lower regulatory barriers, speed up the introduction of new technologies, and ultimately directly benefit society and the public. On the other hand, the question of whether to agree to the provision of personal health information necessary for the development of advanced medical and biologic new drugs is not easily nodded in assent. The order to make high-tech medical and new medicine without medical big data is to offer the best dinner without high quality and abundant raw materials. In this respect, The Korean bio-health Industry fell in Anomi. New norms and social values appropriate for advanced medical and biologic drugs and the fourth industrial revolution must be established, but it is the current status of our society that existing traditional norms and values rarely innovate. In other words, the social values, which are essential for the high-level medical care and advanced new drug industrialization, are in a state of confusion and irregularity. Recently, the 4th Industrial Revolutionary Committee urged the government to advance laws and regulations, and to strengthen the capacity for review and licensing. Specifically, the government said that it would reduce social unrest by strengthening public relations about the objective scientific achievements that the biohealth industry would bring along with the revision of the Personal Information Protection Act, medical law, and bioethics law. KIET stated that the Korean bio, IT, and AI industries with excellent technology have fallen into ‘the prisoner's dilemma’, pursuing their own interests among medical world, civil society, and the government. It is a diagnosis that civil society, which has high technology development and government-industrial distrust, is not able to agree on providing sensitive health and medical personal information, and is hindering the development of telemedicine or biomedicine. After all, how to rescue Korea's bio-health industry in an anomalous state is the solution for advanced medical and biomedicine drugs. Citizen anxiety is likely to grow as regulatory innovations take place, and it can create fear that personal information is being used by government or some industries for other purposes. The government should work with expert groups to make concrete plans to break down civil distrust, and quickly resolve the public's lack of cutting-edge bio-information through various public participation external events. Regulatory innovation and industrial development should not be focused on keywords, it made The public, the government, and the industry struggling with each other, and darken the state-of-the-art medical and biopharmaceuticals the future We should be able to explain transparently and specifically how my medical information is used and protected in the development of the biohealth industry and how the individual can finally benefit. Also, it is time to break down chaos and anomie by creating a way for individuals to participate in the biohealth industry.
Company
JW Pharmaceutical’s R&D generates fruitful return
by
Chon, Seung-Hyun
Nov 20, 2019 06:14pm
For this year’s third quarter, JW Pharmaceutical recognized total 6.6 billion won made from exporting drug candidate technology. The amount includes upfront fees received from technology transfer deal from last year over atopic dermatitis drug candidate, and from technology export deal on anti-gout drug candidate made last September. The industry evaluates it was fruitful return from R&D investment. JW Pharmaceutical reported on Nov. 19 that the company’s accumulated profit from technology export payment in the third quarter reached 6.6 billion won. The figure reflects upfront payment from two technology transfer deals signed last year and this year. In August last year, JW Pharmaceutical shook hands with Demark-based multinational pharmaceutical company, Leo Pharma agreeing to export atopic dermatitis pipeline, 'JW1601'. Including USD 17 million upfront payment, the deal is worth total 402 million dollars. And in August, the company made a deal with China-based Simcere Pharmaceutical for exporting an anti-gout drug candidate 'URC102'. The deal is worth 70 million dollars, including five-million-dollar upfront payment. But it is quite different as to how these two deals were reflected on the account. The upfront fee on JW1601, 17 million dollars (about 19 billion won), was received September last year. But JW Pharmaceutical decided to recognize 17 billion won at once in August last year, and recognize the rest of 1.3 billion won in 20-month installment from August last year to March next year. So payment of 66.41 million won would be reflected on the account every month until March next year. And up to September this year, payment of about 600 million won (66.41 million won reflected for nine months) was recognized. On the other hand, payment from URC102 deal was recognized all at once. The payment of six billion won was reflected on the third quarter account. However, the actual payment was not transferred in the third quarter. JW Pharmaceutical clarified on the quarterly report that “The payment is to be received in November”. The company, in fact, stated early this month that it has received the payment. A JW Pharmaceutical insider commented, “The payment from the August deal was reflected on the third quarter account as the agreement was finalized then”. Reflecting payments from the two drug candidate technology deals, JW Pharmaceutical has made total of 6.6 billion won profit in the third quarter. The profit from the deals actually helped the company’s overall performance. JW Pharmaceutical generated operating profit of 2.6 billion won in the third quarter, which means it would have made deficit if the technology transfer deal was not reflected. The company may have risked overall earnings with increased R&D expense, but R&D performance is also contributing back to the company’s earnings. JW Pharmaceutical’s earnings were recently worsened due to increased R&D expense. The accumulated R&D expense up to the third quarter was 29.7 billion won, surged by 23.5 percent than the same time year before. The company insider commented, “R&D investment amount was significantly increased recently, as clinical trials for the exported drug candidates have initiated”. The industry sees that the company is well on its way to create a positive cycle of dedicated R&D effort contributing back to the company’s return. Also in last year, JW Pharmaceutical received payment of 4.8 billion won for exporting total parenteral nutrition (TPN) product. JW Holdings signed a licensing-out and export contract with Baxter in July 2013, granting the multinational company rights to supply the TPN product, Winuf to the U.S., Europe and all around the world. The contract is worth total of 35 million dollars, including 25-million-dollar upfront payment and ten-million-dollar milestone payment. With European health regulator giving a green light on Finomel (Winuf’s brand name in Europe), JW Holdings received promised milestone payment of four million dollars last year. The rest of milestone payment, six million dollars is expected to be paid out when the product gets approved in other regions.
Policy
Dupixent, reimbursement in next January upon settlement
by
Lee, Hye-Kyung
Nov 20, 2019 06:33am
Treatment for severe atopic dermatitis, Dupixent are under drug price negociations. NHIS(National Health Insurance Services) recently released this fact on its website. NHIS concluded pre-negotiation with Sanofia aventis before entering into drug price negotiations. Drug negotiations will last up to 60 days. If the drug price negotiations between the NHIS and pharmaceutical companies proceed smoothly, the reimbursement is expected to be secured in next January. Dupixent passed the HIRA's Pharmaceutical Evaluation Committee on October 11th. After negotiating a drug price agreement with the HIRA, it is necessary to put a name on the final list of reimbursement after deliberation by the MOHW Insurance Policy Review Committee. Dupixent will follow the RSA process as a treatment for serious diseases through ‘the detailed evaluation criteria of new drugs’ in August. Once the price negotiations are concluded, they will be the first beneficiaries of the expansion of RSA. The existing RSA system was only applicable to drugs for cancer and rare patients. However, due to its high price, Dupixent was also a target of RSA in that there were some broken cases when there is too much finance.
Policy
All prescription drugs to hand in bioequivalence test result
by
Lee, Tak-Sun
Nov 20, 2019 06:33am
Subject for bioequivalence test is to expand out to all prescription drugs. Also, drug specification with test criteria and procedure would be required, as well as Good Manufacturing Practice (GMP) evaluation result from external contract manufacturing companies. Korean Ministry of Food and Drug Safety (MFDS) announced on Nov. 18 its plan to enact partially revised ‘Regulation on Pharmaceutical Safety’, as a follow-up to the excessive commercialization of generics and last year’s valsartan incident with carcinogen contamination. The ministry is to accept public opinion on the matter until Jan. 20, 2020. For Korean pharmaceutical industry that bases most of business off of generic products, the revised regulation is the most detrimental level of regulation to hinder the industry. Some of regulations were previously alleviated on a moderate level, but they are now tightened back again. ◆ Bioequivalence test for all prescription drugs: First, all prescription drugs are to be gradually obligated to hand in bioequivalence test data. Currently only prescribed tablet, capsule, suppository and other specific drugs designated to provide bioequivalence test result were required to submit the material. About 60 percent of prescription drugs are included in the said subject group. But from now on, the applicable drug regimen types would expand out to all kinds. The administration method types required to provide bioequivalence test material would expand on oral in 2020, aseptic techniques including injection in 2021, and all the other types in 2022. Based on its cost-benefit analysis, MFDS projects affected pharmaceutical companies would spend about 164.4 billion won according to the revised regulation. The analysis estimated a single case of bioequivalence test would cost about 220 million won. ◆ Specification submission exemption removed: All prescription drugs would be obligated to hand in specification material. Specification, containing pharmaceutical test procedures and acceptance criteria for new drug, is to provide information on the drug’s manufacturing and test methodology and criteria for quality control, which also includes evidence and test performance data. Except for biopharmaceuticals, currently a drug listed on an official compendium, such as Korean Pharmacopoeia, was exempted from the material submission. Some officially recognized compendium include Korean Pharmacopoeia, Korean Herbal Pharmacopoeia, Good Manufacturing Practice criteria, and other official compendium or pharmacopoeia acknowledged by Minister of Food and Drug Safety (i.e. U.S. Pharmacopeia, Japanese Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia, German Pharmacopoeia, and French Pharmacopoeia). However, there would be no exception from now on. As of 2017, 51 percent of prescription drugs applying for approval were listed on the official compendium. MFDS suspects additional cost would be spent on evaluation service fee, as companies would already have documented specification related materials. The industry is expected to spend about 3.2 billion won, due to the revised regulation. ◆ CMOs to hand in GMP evaluation results: Besides the bioequivalence test, MFDS is also requiring contract manufacturing organizations (CMOs) to submit GMP status report and evaluation results. At the moment, the submission is exempted for drugs wholly manufactured in contracted manufacturer. GMP status report and evaluation result should include manufacturing plant floor plan, plant facility and environment management information, GMP-dedicated organization chart and related documentation rules, product specification related to applicant item, record of product and quality control, and copy of validation result. MFDS analyzed that annually 738 items are manufactured by CMOs. The ministry deduced the average number based on approved CMO products from 2012 to 2017, assuming items sharing joint bioequivalence test result are entirely manufactured in external facility. The health authority estimated the revised regulation would have companies to spend about total of 3.7 billion won. MFDS also clarified no additional documentation on GMP evaluation is required other than the materials filed by the client company, but explained additional cost would be probably spent on human resources and evaluation service fee.
Company
Boycott against Japan makes no impact on drug sector
by
Kim, Jin-Gu
Nov 20, 2019 06:33am
Although this year’s deficit generated from trade with Japan is expected to hit the lowest point, the pharmaceutical sector has not been affected on a notable level. For last six years, Japanese drug import volume skyrocketed by around 57 percent. The import volume easily overwhelmed the Korean export volume, resulting in inevitable heavy deficit. In general, Korean boycott movement against Japanese goods, started spreading since June, seems not to have affected Japanese drug as much. According to Ministry of Trade, Industry and Energy (MOTIE) and Korea Customs Service (KCS) on Nov. 18, South Korea’s total trade deficit with Japan from January to October this year was USD 16.37 billion, which has gone down by 20.6 percent than same time last year at 20.61 billion dollars. As far as total deficit made from January to October goes, this year’s deficit has been the least ever since 2003 with 15.57 billion dollars. If the trend continues until the end of the year, Korea’s total deficit with Japan would be under 20 billion dollars for the first time in 16 years. It would be about the half of highest volume marked in 2010 at 36.12 billion dollars. However, the pharmaceutical sector seems to be an exception to the trend. Until last October, Korea marked trade deficit with Japanese pharmaceutical products of 132.3 million dollars. Deficit from January to October has hit the lowest figure since three years ago in 2016 (deficit of 120.63 million dollars). But considering average deficit in five years from 2014 to 2018 (accumulated from January to October) was around 95.71 million dollars, this year’s improvement on deficit is hardly remarkable. In the same time, Korea’s export volume to Japan has surged by 51.6 percent from 127.69 million dollars to 197.83 million dollars, but the import volume also surged by 56.6 percent from 185 million dollars to 330.13 million dollars. The increase in import rose over the increase in export, generating the total net deficit as a result. Jan. to Oct. drug trade trend by year (unit: USD 1,000). Red shows this year’s trade volume. Figure improved the most since last 3 years (2017-2019) but still deficit reached higher than before. Even when the boycott movement took off July, the changes of pharmaceutical import and export volume by month did not leave a notable change in trend. As for July, Korea made a deficit of 22.19 million dollars. The country exported 23.97 million dollars of pharmaceutical products and imported 46.16 million dollar-worth of goods. July had the heaviest deficit of the year. The deficit was lowered to 5.56 million dollars in August, but it is getting larger again after generating 10.11 million dollars and 14.57 million dollars of deficit in September and October, respectively. Analyzing last three years of monthly trade deficit, the boycott movement did not make a clear mark on the graph. The result is quite contrasting from major consumer goods, such as automobile, apparel, alcohol beverages and electronics that got struck by the boycott against Japanese goods. Drug trade volume trend by month in last 3 years (unit: USD 1,000) Red shows trade volume in July-Oct. after boycott, but no special tendency found
Policy
Consigned items duty to produce on the rise, Overregulation
by
Lee, Tak-Sun
Nov 20, 2019 06:33am
As the MFDA foretells the resurgence of mandatory production of three batches of consignment items as a solution to the problem of generic stagnation, the pharmaceutical industry is pushing for excessive regulation. It is dissatisfied that consignment production is bound to be stopped if mandatory production of consignment items is obligated while abolishing consignment. The MFDA included these details when it announced legislation on the revision of some of the rules on safety of medicines and others. In addition, it is necessary to submit data on the evaluation of the GMP implementation status in the future manufacturing process. The GMP implementation assessment data also includes validation data to verify the uniformity of the product. Validation data is pre-checked through three batch productions. In other words, a drug produced at another plant will have to produce three batches of data from the plant when approved. Depending on the manufacturing facilities, as many as 100,000 tablets are produced per batch. When placed three times, 300,000 tablets are made. Pharmaceutical companies will not lose money if they sell 300,000 tablets produced for permits. In addition, submission of GMP data will also lengthen the license period. This is a big burden for the consignment company. Of course, trustees can benefit from additional production. However, most pharmaceutical companies are expected to suffer damage in the midst of active consignment production. In addition, the MFDA's stance is to phase out the allowance for joint and consigned living. The MFDA announced in a regulation notice that, starting from next June, the number of items allowed for joint and entrusted livelihood will be limited to three companies, and not allowed from June 2023. In addition, the MFDA is in a position to lower drug prices for consignment and joint livestock products. In the meantime, if consigned drugs are reinstated to become mandatory to produce three batches, the counterfeiting transaction between pharmaceutical companies will be markedly reduced. The provision of mandatory production data for three batches of consignment manufacturing items disappeared following the introduction of the 2014 GMP Conformity Decision. The revival will bring back regulation in almost five years An official in the pharmaceutical industry said, "In the event of last year's Valsartan, there was an opinion that we would revive the production of three batches of consignment items without leaving the co-provisioning regulations." The MFDA announced the revision of the rules on safety, such as the drugs, as well as mandating the production of three batches of consigned drugs, and expanding the subjects for submitting biotest data to all specialty drugs, and eliminating the exemptions for submitting the law. In addition, it will revise the report on overseas safety measures related to the suspension or withdrawal within from 15 days to 3 days, and the burden on pharmaceutical companies is expected to increase further.
Policy
Annual sales↑to ₩6.5 billion by generic exclusivity
by
Lee, Tak-Sun
Nov 20, 2019 06:32am
Myung-jin Chung, director of KHIDI, is announcing the results of the impact assessment on the patent linkage According to a survey result, the drug costs in 2018 were reduced by up to ₩4.8 billion due to generic drug exclusivity. Sales of generic pharmaceutical companies increased by up to ₩6.5 billion while the original company's drug costs were reduced by ₩11.3 billion. Myung-jin Chung, general manager of KHIDI, announced the results of the four-year impact assessment of the Patent linkage at the '2019 Drug Licensing Patent Linked System Policy Forum' held at the Four Points Hotel, Seoul Guro on the 19th. The impact assessment of the patent linkage began in 2016 under the applicable Act and was the fourth time this year. The study period was from April to October of this year, and the study was conducted on drugs that received prohibition of sale or generic exclusivity from January 2018 to December 2018, and their disposal were terminated (expiration of the period, expiration of effect, etc.). During this period, there were 29 items in generic exclusivity, and the targeted brand listed drugs were 5 items. The representative generic exclusivity drugs include 10 generic products of the osteoarthritis named “Layla” and 14 generic products of the hepatitis B named “Viread”. As a result, early entry effect of late drug market was 1.3 ~ 4.6 months. Early entry effect was based on 9 months from the date of notification to the original company following the application for the permission of generic exclusivity. If the original company asks for a prohibition of sale under the patent linkage system, it will not be able to enter the market for 9 months. The sales of generic companies, which acquired the generic exclusivity, increased from ₩5.696 billion to ₩6.473 billion. On the other hand, targeted pharmaceutical companies with the original listed drugs declined from a minimum of ₩9.9 billion to sales of ₩11.3 billion. In the case of Viread, pharmaceutical companies with listed drugs declined from ₩6.2 billion to ₩7.6 billion. On the other hand, Generics sales increase from ₩3.4 billion to ₩4.2 billion. As a result, the drug costs have been reduced from ₩4.53 billion to ₩4.76 billion. The indirect effect of generic exclusivity items is an increase in the research development costs and employment. According to the research results, the R & D expenditure increased from minimum of ₩180 million to maximum of ₩360 million. Employment also increased from a minimum of 19 people to a maximum of 38 people. Myung-Jin Chung said, "Prior to the 4th year after the implementation of the system, the approval of generic exclusivity has had a positive effect on the domestic pharmaceutical industry and health policy." He added. “Unlike concerns when introducing the system, original companies don't apply the prohibition of sale much. Activation of the genetic exclusivity has led to a rise in sales of domestic pharmaceutical companies.
Company
Ferinject for bloodless surgery, reimbursement started up
by
Nho, Byung Chul
Nov 20, 2019 06:19am
It is noted whether high dose iron injection, Ferinject may be included as insurance reimbursement for bloodless surgery (Minimal Transfusion). According to the industry, JW Pharmaceutical applied for a non-reimbursement item, Ferinject, to HIRA on the 18th. High-dose iron is effective as a transfusion replacement therapy for surgical patients who need to increase hemoglobin levels in a short time, and for mothers who have bleeding from childbirth. Introduced by Swiss company, Vifor in 2011, JW Pharmaceutical is currently generating sales of about ₩10 billion. This product is a 500mg high iron injection that can be replenished quickly by administering up to 1000mg of iron per day for 15 minutes. Conventional intravenous iron injections are difficult to administer high doses, so many visits are needed to the hospital. It took more than 40 minutes in a single dose, but Ferinject can be administered up to 5 times faster (in 3 to 5 minutes). Clinical data shows that Ferinject 500mg high-injection iron injection has the same effect as 2 packs of blood 420ml. In addition, it has been evaluated as a safe iron with reduced side effects and vascular pain compared to conventional intravenous iron injection. Ferinject is an effective iron deficiency treatment that can improve the side effects of oral iron containing products with high absorption rate and stability of 99%, and can be administered faster than the existing intravenous iron products. It elevates patient compliance and reduces overload of nurse and hospital work. It is also a safe, high-dose iron infusion that can be used for patients 14 years of age and older, demonstrating safety in pregnant women. Therefore, iron, which is lacking in blood with minimal blood transfusion to surgery patients or anemia patients, has recently emerged as a minimal transfusion treatment supplemented with iron injections, which will greatly contribute to improving the quality of life of patients. High-capacity iron injections are priced at ₩150,000 ~ 200,000 per 500mg of 1 ampule. The reimbursement price is expected to be around ₩70,000 ~ 90,000. The single daily dose is 1000 mg and the maximum maximum dose is 1000 mg or 20 mg / kg. It is contraindicated as follows. Patients with hypersensitivity to Ferinject or its components, patients with known significant hypersensitivity to other parenteral iron preparations, patients with anemia other than iron deficiency (microcytic anaemia), iron overdose or iron impairment. or patients with bacteraemia should be avoided. Adverse events (1% to 10%) are usually headache, dizziness, high blood pressure, nausea, injection site reactions, increased ALT, and hypophosphatemia.
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