Anemia in Chronic Kidney Disease Market Set for Significant Growth and Innovation by 2034
Anemia in Chronic Kidney Disease (CKD), a common and debilitating complication resulting from reduced erythropoietin production and iron deficiency, continues to pose serious clinical challenges and an economic burden. DelveInsight's comprehensive report on the Anemia in CKD market sheds light on the evolving understanding and management of this condition, which affects a substantial proportion of patients with moderate to advanced CKD.
With improved awareness and screening, earlier diagnosis and intervention are becoming more achievable, especially with the support of emerging biomarkers and treatment guidelines. Innovative therapies such as HIF-PH inhibitors and long-acting erythropoiesis-stimulating agents (ESAs) are shaping a dynamic treatment landscape aimed at improving hemoglobin levels with fewer side effects.
DelveInsight's ' Anemia in Chronic Kidney Disease Market Report ' offers an in-depth analysis of the epidemiology, disease burden, and market outlook across key geographies, including the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. The report highlights current unmet needs, late-stage pipeline therapies, market drivers and barriers, and the key players transforming patient care, making it a vital resource for healthcare stakeholders and innovators in nephrology.
Some of the Key Facts of the Anemia in Chronic Kidney Disease Market Report:
• The anemia in chronic kidney disease is expected to grow at a significant CAGR by 2034.
• In 2023, the United States recorded the highest number of prevalent Anemia in Chronic Kidney Disease (CKD) cases among the 7MM.
• The U.S. also accounted for the highest number of treated cases of Anemia in CKD during the same year.
• A higher prevalence was noted among individuals aged 60 and above compared to those under 60 in the U.S.
• Males with CKD had a 30% higher risk of developing anemia compared to females.
• Among the EU4 and the UK, Spain reported the lowest number of anemia in CKD cases in 2023.
• In Japan, anemia was one of the most frequently documented outcomes, with prevalence rates ranging from 0% to 95%, depending on CKD severity and dialysis status.
• In March 2025, the FDA expanded the approval of Furoscix to include the treatment of edema in patients with chronic kidney disease, including nephrotic syndrome.
• In March 2025, scPharmaceuticals received FDA approval for a supplemental new drug application (sNDA) for Furoscix (furosemide injection). This approval expands the drug's use to treat edema in patients with chronic kidney disease (CKD), marking a significant advancement in scPharmaceuticals' portfolio for cardiorenal conditions.
• In March 2025, the FDA approved an expanded indication for furosemide injection (Furoscix; scPharmaceuticals, Inc.) to treat edema in adult patients with chronic kidney disease (CKD), including nephrotic syndrome. The expanded treatment is expected to be available by April 2025. This approval follows the FDA's acceptance of the supplemental new drug application in July 2024.
• In January 2025, the FDA approved a new indication for semaglutide to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease, according to Novo Nordisk.
• In November 2024, Unicycive Therapeutics (Nasdaq: UNCY) announced that the FDA has accepted its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), with a PDUFA target action date set for June 28, 2025. If approved, OLC has the potential to significantly enhance the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients undergoing dialysis.
• Leading companies in the anemia in chronic kidney disease market include Jiangsu HengRui Medicine, Shenyang Sunshine Pharmaceutical, Biocad, Xenetic Biosciences, Chiasma, Liminal BioSciences, Acceleron Pharma, Celgene Corporation, and others.
• Emerging therapies in the anemia in chronic kidney disease market include DDO-3055, SSS17, BCD-131, BCD-066, Erythropoietin polysialic, CHIP 2, PBI 1402, Sotatercept, and others.
• The rising prevalence of anemia in chronic kidney disease, along with continuous advancements in therapeutic options, is fueling the demand for more effective treatment approaches.
To know in detail about the anemia in chronic kidney disease market outlook, drug uptake, treatment scenario, and epidemiology trends, click here: Anemia In Chronic Kidney Disease Market Forecast
Anemia in Chronic Kidney Disease Overview
Anemia is a frequent and serious complication of Chronic Kidney Disease (CKD), arising as kidney function declines and the body's ability to produce adequate erythropoietin—a hormone essential for red blood cell production, diminishes. CKD impairs the kidneys' filtering ability, leading to the accumulation of waste and fluids, which further contributes to the onset of anemia.
The condition becomes increasingly prevalent in advanced stages of CKD. In the United States, over 37 million adults are estimated to have CKD, and more than one in seven individuals with CKD also suffer from anemia. The risk intensifies as kidney function deteriorates, with nearly all individuals at end-stage kidney failure (when kidney function drops below 15%) experiencing anemia.
Certain populations are more susceptible: individuals with CKD and diabetes are at higher risk of developing anemia earlier and in more severe forms. Additionally, people over the age of 60 are more likely to be affected. The progression of CKD-related anemia is typically gradual and may remain asymptomatic in its early stages, making early detection and management crucial for improving patient outcomes.
Get a free sample of the anemia in chronic kidney disease market report with key insights and emerging therapies here:
Anemia in Chronic Kidney Disease Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.
Anemia in Chronic Kidney Disease Epidemiology Segmentation:
The anemia in chronic kidney disease epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by:
• Total Prevalent Cases of Chronic Kidney Disease
• Diagnosed Cases of Anemia in Chronic Kidney Disease
• Age-Specific Prevalent Cases of Anemia in Chronic Kidney Disease
• Total Prevalent Cases of Anemia in Chronic Kidney Disease
• Total Prevalent Cases of Anemia in Different Stages of Chronic Kidney Disease
• Treatable Cases of Anemia in Chronic Kidney Disease
Download the report to understand which factors are driving anemia in chronic kidney disease epidemiology trends @ Anemia In Chronic Kidney Disease Epidemiology Forecast
The anemia in chronic kidney disease drugs uptake section examines the rate at which newly launched or upcoming potential drugs are being adopted in the anemia in chronic kidney disease market during the study period. This analysis covers drug uptake, patient adoption of therapies, and the sales performance of each drug.
Additionally, the therapeutics assessment section highlights the drugs with the most rapid uptake, shedding light on the factors driving their widespread use. It also provides a comparative analysis of these drugs based on their market share.
The report further delves into the anemia in chronic kidney disease pipeline development activities, offering key insights into various therapeutic candidates in different stages of development and the major companies behind these innovations. It also covers recent collaborations, acquisitions, mergers, licensing agreements, patent details, and other critical information related to emerging therapies.
Anemia in Chronic Kidney Disease Market Strengths
• The availability of novel oral treatment options, such as daprodustat, offers more convenient and effective routes of administration for patients.
• Active research and ongoing clinical trials are enhancing the understanding of the disease and driving innovation in therapeutic strategies.
Anemia in Chronic Kidney Disease Market Weaknesses
• Patients often struggle to recognize or differentiate the symptoms of anemia from CKD or other related conditions, leading to underreporting.
• Healthcare providers, particularly in non-dialysis settings, frequently under-monitor hemoglobin levels and iron stores, resulting in delayed or suboptimal treatment initiation.
Scope of the Anemia in Chronic Kidney Disease Market Report
• Study Period: 2020–2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Anemia In Chronic Kidney Disease Companies: GlaxoSmithKline, Teva Pharmaceuticals, Cipla, Sun Pharmaceuticals, and others.
• Key Anemia In Chronic Kidney Disease Therapies: DDO-3055, SSS17, BCD-131, BCD-066, Erythropoietin polysialic, CHIP 2, PBI 1402, Sotatercept, and others.
• Anemia In Chronic Kidney Disease Therapeutic Assessment: Anemia in chronic kidney disease, currently marketed, and anemia in chronic kidney disease emerging therapies
• Anemia In Chronic Kidney Disease Market Dynamics: Anemia in chronic kidney disease market drivers and anemia in chronic kidney disease market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Anemia In Chronic Kidney Disease Unmet Needs, KOL's views, Analyst's views, Anemia In Chronic Kidney Disease Market Access and Reimbursement
To learn more about the key players and advancements in the anemia in chronic kidney disease treatment landscape, visit the
Table of Contents
1. Anemia In Chronic Kidney Disease Market Report Introduction
2. Executive Summary for Anemia In Chronic Kidney Disease
3. SWOT analysis of Anemia In Chronic Kidney Disease
4. Anemia In Chronic Kidney Disease Patient Share (%) Overview at a Glance
5. Anemia In Chronic Kidney Disease Market Overview at a Glance
6. Anemia In Chronic Kidney Disease Disease Background and Overview
7. Anemia In Chronic Kidney Disease Epidemiology and Patient Population
8. Country-Specific Patient Population of Anemia In Chronic Kidney Disease
9. Anemia In Chronic Kidney Disease Current Treatment and Medical Practices
10. Anemia In Chronic Kidney Disease Unmet Needs
11. Anemia In Chronic Kidney Disease Emerging Therapies
12. Anemia In Chronic Kidney Disease Market Outlook
13. Country-Wise Anemia In Chronic Kidney Disease Market Analysis (2020–2034)
14. Anemia In Chronic Kidney Disease Market Access and Reimbursement of Therapies
15. Anemia In Chronic Kidney Disease Market Drivers
16. Anemia In Chronic Kidney Disease Market Barriers
17. Anemia In Chronic Kidney Disease Appendix
18. Anemia In Chronic Kidney Disease Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
About DelveInsight
DelveInsight is a leading Healthcare Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.
It also offers Healthcare Consulting Services, which benefit from market analysis to accelerate business growth and overcome challenges with a practical approach.
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Website: https://www.delveinsight.com/
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Combined use of bleomycin and ADCETRIS causes pulmonary toxicity. Article content Special Warnings and Precautions Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Article content Progressive multifocal leukoencephalopathy (PML): John Cunningham virus (JCV) reactivation resulting in PML and death can occur in ADCETRIS-treated patients. PML has been reported in patients who received this treatment after receiving multiple prior chemotherapy regimens. PML is a rare demyelinating disease of the central nervous system that results from reactivation of latent JCV and is often fatal. Article content Patients should be closely monitored for new or worsening neurological, cognitive, or behavioral signs or symptoms, which may be suggestive of PML. ADCETRIS should be held for any suspected case of PML. 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Article content Serious infections and opportunistic infections: Serious infections such as pneumonia, staphylococcal bacteremia, sepsis/septic shock (including fatal outcomes), and herpes zoster, cytomegalovirus (CMV) (reactivation) and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS. Patients should be carefully monitored during treatment for the emergence of possible serious and opportunistic infections. Article content Infusion-related reactions (IRR): Immediate and delayed IRR, as well as anaphylaxis, have been reported with ADCETRIS. Article content Patients should be carefully monitored during and after infusion. If an anaphylactic reaction occurs, administration of ADCETRIS should be immediately and permanently discontinued and appropriate medical therapy should be administered. Article content If an IRR occurs, the infusion should be interrupted and appropriate medical management instituted. The infusion may be restarted at a slower rate after symptom resolution. Patients who have experienced a prior IRR should be premedicated for subsequent infusions. Premedication may include paracetamol, an antihistamine and a corticosteroid. Article content IRRs are more frequent and more severe in patients with antibodies to brentuximab vedotin. Article content Tumor lysis syndrome (TLS): TLS has been reported with ADCETRIS. Patients with rapidly proliferating tumour and high tumour burden are at risk of tumour lysis syndrome. These patients should be monitored closely and managed according to best medical practice. Management of TLS may include aggressive hydration, monitoring of renal function, correction of electrolyte abnormalities, anti-hyperuricaemic therapy, and supportive care. Article content Peripheral neuropathy (PN): ADCETRIS may cause peripheral neuropathy, both sensory and motor. ADCETRIS-induced peripheral neuropathy is typically an effect of cumulative exposure to this medicinal product and is reversible in most cases. In clinical trials, the majority of patients had resolution or improvement of their symptoms. Patients should be monitored for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paraesthesia, discomfort, a burning sensation, neuropathic pain or weakness. Patients experiencing new or worsening peripheral neuropathy may require a delay and a dose reduction of ADCETRIS or discontinuation of treatment. Article content Hematological toxicities: Grade 3 or Grade 4 anaemia, thrombocytopenia, and prolonged (≥ 1 week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose. Article content Febrile neutropenia: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection with an absolute neutrophil count < 1.0 x 10 9 /L, fever ≥ 38.5 0 C; ref CTCAE v3) has been reported with treatment with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose of treatment. Patients should be monitored closely for fever and managed according to best medical practice if febrile neutropenia develops. Article content In combination therapy with AVD or CHP, advanced age was a risk factor for febrile neutropenia. When ADCETRIS is administered in combination with AVD or CHP, primary prophylaxis with G-CSF, beginning with the first dose, is recommended for all adult patients regardless of age. In combination therapy with AVD or CHP, advanced age was a risk factor for febrile neutropenia. Article content Severe cutaneous adverse reactions (SCARs): Cases of SCARs, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with ADCETRIS. Fatal outcomes have been reported for SJS and TEN. If SJS, TEN or DRESS occur, ADCETRIS should be discontinued, and appropriate medical therapy should be administered. Article content Gastrointestinal (GI) Complications: GI complications including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation and haemorrhage, some with fatal outcomes, have been reported in patients treated with ADCETRIS. In the event of new or worsening GI symptoms, perform a prompt diagnostic evaluation and treat appropriately. Article content Hepatotoxicity: Hepatotoxicity in the form of elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) has been reported with ADCETRIS. Serious cases of hepatotoxicity, including fatal outcomes, have also occurred. Pre-existing liver disease, comorbidities, and concomitant medications may also increase the risk. Liver function should be tested before initiating the treatment and routinely monitored in patients receiving ADCETRIS. Patients experiencing hepatotoxicity may require a delay, change in dose or discontinuation of ADCETRIS. Article content Hyperglycemia: Hyperglycaemia has been reported during clinical trials in patients with an elevated Body Mass Index (BMI) with or without a history of diabetes mellitus. However, any patient who experiences an event of hyperglycaemia should have their serum glucose closely monitored. Anti-diabetic treatment should be administered as appropriate. Article content Infusion site extravasation: Extravasation during intravenous infusion has occurred. Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible infiltration during drug administration. Article content Renal and Hepatic Impairment: There is limited experience in patients with renal and hepatic impairment. Available data indicate that MMAE clearance might be affected by severe renal impairment, hepatic impairment, and by low serum albumin concentrations. Article content CD30+ CTCL: The size of the treatment effect in CD30 + CTCL subtypes other than mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) is not clear due to lack of high level evidence. In two single arm phase II studies of ADCETRIS, disease activity has been shown in the subtypes Sézary syndrome (SS), lymphomatoid papulosis (LyP) and mixed CTCL histology. These data suggest that efficacy and safety can be extrapolated to other CTCL CD30+ subtypes. Nevertheless, ADCETRIS should be used with caution in other CD30+ CTCL patients after careful consideration of the potential benefit-risk on an individual basis. Article content Sodium content in excipients: This medicinal product contains 13.2 mg sodium per vial, equivalent to 0.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Article content Polysorbate content in excipients: This medicinal product contains 2 mg of polysorbate 80 per vial, equivalent to 0.2 mg/ml. Polysorbates may cause allergic reactions. Article content Interactions Interaction with medicinal products metabolised through CYP3A4 route (CYP3A4 inhibitors/inducers) Co‑administration of brentuximab vedotin with ketoconazole, a strong CYP3A4 and P‑gp inhibitor, increased the exposure to the antimicrotubule agent MMAE by approximately 73%, and did not alter the plasma exposure to brentuximab vedotin. Therefore, co‑administration of brentuximab vedotin with strong CYP3A4 and P‑gp inhibitors may increase the incidence of neutropenia. If neutropenia develops, refer to Tables 1 and 2 for dosing recommendations for neutropenia. Article content Co‑administration of brentuximab vedotin with rifampicin, a strong CYP3A4 inducer, did not alter the plasma exposure to brentuximab vedotin. Though PK data are limited, co‑administration of rifampicin appeared to reduce plasma concentrations of MMAE metabolites that could be assayed. Article content Co‑administration of midazolam, a CYP3A4 substrate, with brentuximab vedotin did not alter the metabolism of midazolam; therefore brentuximab vedotin is not expected to alter the exposure to medicines that are metabolized by CYP3A4 enzymes. Article content Etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD regimen) The pharmacokinetics of ADC and MMAE have not been characterized in the setting of BrECADD. Exposures of brentuximab vedotin and concurrent chemotherapy are not expected to be affected in the BrECADD regimen. Article content Fertility, pregnancy and lactation Women of childbearing potential: Women of childbearing potential should be using two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment. Article content Pregnancy: There are no data from the use of ADCETRIS in pregnant women. Studies in animals have shown reproductive toxicity. ADCETRIS should not be used during pregnancy unless the benefit to the mother outweighs the potential risks to the fetus. If a pregnant woman needs to be treated she should be clearly advised on the potential risk to the fetus. Article content Breast-feeding: There is no data as to whether brentuximab vedotin or its metabolites are excreted in human milk. A risk to the newborn/infant cannot be excluded. A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from this therapy, taking into account a potential risk of breast-feeding for the child and the benefit of therapy for the woman. Article content Fertility: In non-clinical studies, brentuximab vedotin treatment has resulted in testicular toxicity, and may alter male fertility. MMAE has been shown to have anagenic properties. Therefore, men being treated with this medicine are advised to have sperm samples frozen and stored before treatment. Men being treated with this medicine are advised not to father a child during treatment and for up to 6 months following the last dose. Article content Effects on ability to drive and use machines: ADCETRIS may have a moderate influence on the ability to drive and use machines (e.g. dizziness). Article content Undesirable Effects Monotherapy: The most frequent adverse reactions (≥10%) were infections, peripheral sensory neuropathy, nausea, fatigue, diarrhea, pyrexia, upper respiratory tract infection, neutropenia, rash, cough, vomiting, arthralgia, peripheral motor neuropathy, infusion-related reactions, pruritus, constipation, dyspnea, weight decreased, myalgia and abdominal pain. Serious adverse drug reactions occurred in 12% of patients. The frequency of unique serious adverse drug reactions was ≤1%. Adverse events led to treatment discontinuation in 24% of patients. Article content Combination Therapy: In the studies of ADCETRIS as combination therapy in 662 patients with previously untreated advanced HL and 223 patients with previously untreated CD30+ PTCL, the most common adverse reactions (≥ 10%) were: infections, neutropenia, peripheral sensory neuropathy, nausea, constipation, vomiting, diarrhea, fatigue, pyrexia, alopecia, anemia, weight decreased, stomatitis, febrile neutropenia, abdominal pain, decreased appetite, insomnia, bone pain, rash, cough, dyspnea, arthralgia, myalgia, back pain, peripheral motor neuropathy, upper respiratory tract infection, and dizziness. In patients receiving ADCETRIS combination therapy, serious adverse reactions occurred in 34% of patients. Serious adverse reactions occurring in ≥ 3% of patients included febrile neutropenia (15%), pyrexia (5%), and neutropenia (3%). Adverse events led to treatment discontinuation in 10% of patients. Article content In patients receiving ADCETRIS combination therapy, serious adverse reactions occurred in 34% of patients. Serious adverse reactions occurring in ≥ 3% of patients included febrile neutropenia (15%), pyrexia (5%), and neutropenia (3%). Adverse events led to treatment discontinuation in 10% of patients. Article content Adverse events led to treatment discontinuation in 10% of patients. Adverse events that led to treatment discontinuation in ≥ 2% of patients included peripheral sensory neuropathy, and peripheral neuropathy. Article content Combination Therapy (BrECADD regimen): In the HD21 study, 747 patients received BrECADD, and 741 patients received eBEACOPP. The safety profile of ADCETRIS in patients receiving BrECADD remained consistent with other combination therapy (AVD/CHP). Article content Serious adverse reactions occurred in 39.4% patients receiving BrECADD treatment, and 36.4% in patients who received eBEACOPP. The most common serious adverse reactions in patients who received BrECADD (> 3%) were febrile neutropenia (19.3%), pyrexia (3.9%), and neutropenia (3.2%). Article content Serious cardiac adverse reactions occurred in 2.7% of patients receiving BrECADD and 1.1% of patients receiving eBEACOPP. The most common serious cardiac adverse reaction in patients who received BrECADD (>0.5%) was tachycardia (0.9%). Article content Serious adverse events led to treatment discontinuation in 2% of patients in both BrECADD and eBEACOPP arms. The most common serious adverse events that led to discontinuation in the BrECADD arm were febrile neutropenia (0.3%) and cardiac failure (0.3%). Article content CONTRAINDICATION Contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation). Article content Peripheral neuropathy (PN): ADCETRIS causes PN that is predominantly sensory. Cases of motor PN have also been reported. ADCETRIS-induced PN is cumulative. Monitor for symptoms such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay, change in dose, or discontinuation of ADCETRIS. Article content Anaphylaxis and infusion reactions: Infusion-related reactions (IRR), including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an IRR occurs, interrupt the infusion and institute appropriate medical management. If anaphylaxis occurs, immediately and permanently discontinue the infusion and administer appropriate medical therapy. Premedicate patients with a prior IRR before subsequent infusions. Premedication may include acetaminophen, an antihistamine, and a corticosteroid. Article content Hematologic toxicities: Fatal and serious cases of febrile neutropenia have been reported with ADCETRIS. Prolonged (≥1 week) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can occur with ADCETRIS. Article content Administer G-CSF primary prophylaxis beginning with Cycle 1 for adult patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL, and pediatric patients who receive ADCETRIS in combination with chemotherapy for previously untreated high risk cHL. Article content Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses. Article content Serious infections and opportunistic infections: Infections such as pneumonia, bacteremia, and sepsis or septic shock (including fatal outcomes) have been reported in ADCETRIS-treated patients. Closely monitor patients during treatment for infections. Article content Tumor lysis syndrome: Patients with rapidly proliferating tumor and high tumor burden may be at increased risk. Monitor closely and take appropriate measures. Article content Increased toxicity in the presence of severe renal impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with severe renal impairment. Avoid use in patients with severe renal impairment. Article content Increased toxicity in the presence of moderate or severe hepatic impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with moderate or severe hepatic impairment. Avoid use in patients with moderate or severe hepatic impairment. Article content Hepatotoxicity: Fatal and serious cases have occurred in ADCETRIS-treated patients. Cases were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, and occurred after the first ADCETRIS dose or rechallenge. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk. Monitor liver enzymes and bilirubin. Patients with new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of ADCETRIS. Article content PML: Fatal cases of JC virus infection resulting in PML have been reported in ADCETRIS-treated patients. First onset of symptoms occurred at various times from initiation of ADCETRIS, with some cases occurring within 3 months of initial exposure. In addition to ADCETRIS therapy, other possible contributory factors include prior therapies and underlying disease that may cause immunosuppression. Consider PML diagnosis in patients with new-onset signs and symptoms of central nervous system abnormalities. Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed. Article content Pulmonary toxicity: Fatal and serious events of noninfectious pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome, have been reported. Monitor patients for signs and symptoms, including cough and dyspnea. In the event of new or worsening pulmonary symptoms, hold ADCETRIS dosing during evaluation and until symptomatic improvement. Article content Serious dermatologic reactions: Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. If SJS or TEN occurs, discontinue ADCETRIS and administer appropriate medical therapy. Article content Gastrointestinal (GI) complications: Fatal and serious cases of acute pancreatitis have been reported. Other fatal and serious GI complications include perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus. Lymphoma with pre-existing GI involvement may increase the risk of perforation. In the event of new or worsening GI symptoms, including severe abdominal pain, perform a prompt diagnostic evaluation and treat appropriately. Article content Hyperglycemia: Serious cases, such as new-onset hyperglycemia, exacerbation of pre-existing diabetes mellitus, and ketoacidosis (including fatal outcomes) have been reported with ADCETRIS. Hyperglycemia occurred more frequently in patients with high body mass index or diabetes. Monitor serum glucose and if hyperglycemia develops, administer anti-hyperglycemic medications as clinically indicated. Article content Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of this potential risk, and to use effective contraception during ADCETRIS treatment and for 2 months after the last dose of ADCETRIS. Advise male patients with female partners of reproductive potential to use effective contraception during ADCETRIS treatment and for 4 months after the last dose of ADCETRIS. Article content ADVERSE REACTIONS The most common adverse reactions (≥20%) in adult patients are peripheral neuropathy, nausea, fatigue, musculoskeletal pain, constipation, diarrhea, vomiting, pyrexia, upper respiratory tract infection, mucositis, abdominal pain, and rash. The most common laboratory abnormalities (≥20%) in adult patients are decreased neutrophils, increased creatinine, decreased hemoglobin, decreased lymphocytes, increased glucose, increased ALT, and increased AST. Article content The most common Grade ≥3 adverse reactions (≥5%) in combination with AVEPC in pediatric patients were neutropenia, anemia, thrombocytopenia, febrile neutropenia, stomatitis, and infection. Article content DRUG INTERACTIONS Concomitant use of strong CYP3A4 inhibitors has the potential to affect the exposure to monomethyl auristatin E (MMAE). Closely monitor adverse reactions. Article content Please see the full Prescribing Information, including BOXED WARNING, for ADCETRIS here. Article content About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit Article content Important Notice For the purposes of this notice, 'press release' means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ('Takeda') regarding this release. 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Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, 'Takeda' is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words 'we', 'us' and 'our' are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. Article content Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. 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These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s); and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: or at Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results. Article content Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Article content Footnotes: Article content *While late relapse is rare, PFS status after 5 years does not guarantee cure. Patients should be monitored and encouraged to report any return of symptoms as appropriate. Article content References: Article content Borchmann P, Ferdinandus J, Schneider G, et al. Assessing the efficacy and tolerability of PET-guided BrECADD versus eBEACOPP in advanced-stage, classical Hodgkin lymphoma (HD21): a randomised, multicentre, parallel, open-label, phase 3 trial [published correction appears in Lancet. 2024 Nov 30;404(10468):2164. doi: 10.1016/S0140-6736(24)02571-6.]. Lancet. 2024;404(10450):341-352. Bröckelmann PJ, Goergen H, Kohnhorst C, von Tresckow B, Moccia A, Markova J, Meissner J, Kerkhoff A, Ludwig WD, Fuchs M, Borchmann P, Engert A. Late Relapse of Classical Hodgkin Lymphoma: An Analysis of the German Hodgkin Study Group HD7 to HD12 Trials. J Clin Oncol. 2017 May 1;35(13):1444-1450. doi: 10.1200/JCO.2016.71.3289. Epub 2017 Feb 27. PMID: 28240973. Article content Article content Article content Article content Article content Contacts Article content Takeda Media Contacts: Japanese Media Tsuyoshi Tada Article content Article content
