ZIKV IG(Emergent BioSolutions)

OSAKA, Japan & CAMBRIDGE, Mass.--( BUSINESS WIRE )--Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA ® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults. HYQVIA first received approval in the U.S. in 2014 for the treatment of primary immunodeficiency (PI) in adults, which has since been expanded to include children 2-16 years old. 1 HYQVIA is the only FDA-approved combination of immunoglobulin (IG) and hyaluronidase, which makes it a facilitated subcutaneous immunoglobulin (SCIG) infusion. For adults with CIDP, HYQVIA can be infused up to once monthly (every two, three or four weeks) due to the hyaluronidase component, which facilitates the dispersion and absorption of large IG volumes in the subcutaneous space between the skin and the muscle. Because it is delivered subcutaneously, HYQVIA can be administered by a healthcare professional in a medical office, infusion center or at a patient’s home. In addition, it can be self-administered after appropriate patient or caregiver training. 1 “ With the FDA approval of HYQVIA for CIDP, which builds on our expertise in rare neuroimmunological and neuromuscular disorders, we can now offer a personalized maintenance treatment option for adults with this debilitating disease,” said Giles Platford, president of Takeda’s Plasma-Derived Therapies Business Unit. “ Research and clinical experience have shown that IG therapy is effective as maintenance treatment in adults with CIDP, and we hope that this approval for HYQVIA is the first of several around the world as we strive to deliver our broad and diverse IG portfolio to more people with complex neuroimmunological diseases.” This approval is based on results from a randomized, double-blinded, placebo-controlled study (ADVANCE-CIDP 1) and a single-arm, open-label, extension study (ADVANCE-CIDP 3) that evaluated the efficacy and safety of HYQVIA as a maintenance therapy in adults with CIDP. The efficacy evaluation included 122 adults from ADVANCE-CIDP 1 with a confirmed diagnosis of CIDP and who had remained on a stable dosing regimen of intravenous immunoglobulin (IVIG) therapy for at least three months prior to screening. The analysis of the primary endpoint demonstrated a statistically significant difference between the relapse rates in the HYQVIA group (N=57, 14.0%) compared to the placebo group (N=65, 32.3%) (p=0.0314). The treatment difference of -18.3% (two-sided 95% CI: -32.1%, -3.1%) indicated that HYQVIA demonstrated superiority over placebo in preventing relapse of CIDP. 1 The safety of HYQVIA in adults with CIDP was evaluated across ADVANCE-CIDP 1 (N=62) and ADVANCE-CIDP 3 (N=79). The most common adverse reactions observed in >5% of study subjects in clinical studies of HYQVIA for CIDP were local reactions, headache, pyrexia, nausea, fatigue, erythema, pruritus, increased lipase, abdominal pain, back pain, and pain in extremity. 1 CIDP is a rare, acquired, immune-mediated neuromuscular disorder affecting the peripheral nervous system. 2,3 It is typically characterized by progressive, symmetric symptoms such as weakness, tingling or loss of feeling in distal and proximal limbs, loss of reflexes and difficulty walking. 3 Because its symptoms may overlap with other rare, neuromuscular conditions, CIDP is often misdiagnosed. 4 The mechanism of action of IG in the treatment of CIDP in adults has not been fully elucidated but may include immunomodulatory effects. 1 The role of IG therapy as maintenance treatment in CIDP has been well-established and is the guidelines-based standard of care for this complex and heterogeneous condition. 5 However, there are aspects of IVIG treatment that can be challenging for patients such as long treatment duration associated with high IG volumes, potential for venous access challenges, and infusion setting limitations. 5 “ While it is considered the standard-of-care for maintenance treatment of adults with CIDP, IVIG infusions may be challenging for some patients and their caregivers,” said Lisa Butler, executive director, GBS-CIDP Foundation International. “ We’re excited that this therapy could offer some adults with CIDP an alternative subcutaneous option that may address some of these challenges and help personalize treatment.” HYQVIA is now available as a maintenance therapy for adult patients with CIDP in the U.S. In December 2023, Takeda announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA as maintenance therapy in patients with CIDP after stabilization with IVIG. The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for HYQVIA for CIDP throughout the European Union. 6 About HYQVIA HYQVIA ® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulin (IG) and is approved in the U.S. to treat adults and children two years of age and older with primary immunodeficiency (PI), and as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adult patients with CIDP. It is also approved by the European Medicines Agency (EMA) as a replacement therapy in adults, children and adolescents with PI and with secondary immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure (PSAF) or serum IgG level of <4 g/L. HYQVIA is infused under the skin into the fatty subcutaneous tissue. HYQVIA contains IG collected from human plasma. IG are antibodies that maintain the body’s immune system. The hyaluronidase part of HYQVIA facilitates the dispersion and absorption of IG in the subcutaneous space between the skin and the muscle. HYQVIA is infused up to once a month (every two, three or four weeks for CIDP; every three or four weeks for PI). About ADVANCE-CIDP 1 and ADVANCE-CIDP 3 ADVANCE-CIDP 1 was a Phase 3, multicenter, placebo-controlled, double-blinded study evaluating the safety, efficacy and tolerability of HYQVIA. The primary endpoint of the ADVANCE-CIDP 1 clinical trial was the proportion of subjects who experienced a relapse, defined as an increase of ≥1 point relative to the pre-subcutaneous (SC) treatment baseline score in two consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scores obtained less than seven days apart. Patients were randomized to receive either HYQVIA or placebo at the same dose and infusion frequency as their prior IVIG treatment (every two, three or four weeks) for six months or until withdrawal or relapse. Those who remained relapse free were offered HYQVIA treatment as part of ADVANCE-CIDP 3, which was an open-label extension clinical trial to assess the long-term safety, tolerability and immunogenicity of HYQVIA in participants with CIDP who completed ADVANCE-CIDP 1. Further information about the ADVANCE-CIDP 1 and ADVANCE-CIDP 3 clinical trials is available at ClinicalTrials.gov under study identifiers NCT02549170 and NCT02955355 , respectively. HYQVIA U.S. Indication HYQVIA is indicated for the treatment of primary immunodeficiency (PI) in adults and pediatric patients two years of age and older and for chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults. HYQVIA is for subcutaneous use only. HYQVIA U.S. Important Safety Information WARNING: THROMBOSIS Thrombosis may occur with immune globulin (IG) products, including HYQVIA. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer HYQVIA at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity. Contraindications History of anaphylactic or severe systemic hypersensitivity reactions to human IG IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to human IG Known systemic hypersensitivity to hyaluronidase including Recombinant Human Hyaluronidase of HYQVIA Known systemic hypersensitivity to human albumin (in the hyaluronidase solution) Warnings and Precautions Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with human IG. If a hypersensitivity reaction occurs, discontinue infusion immediately and institute appropriate treatment. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity reactions, including anaphylaxis. Thrombosis: Has been reported to occur following treatment with IG products, including HYQVIA and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Immunogenicity of Recombinant Human Hyaluronidase (rHuPH20): Non-neutralizing antibodies to the Recombinant Human Hyaluronidase component can develop. The clinical significance of these antibodies or whether they interfere with fertilization in humans is unknown. Aseptic Meningitis Syndrome: Has been reported with use of IG, including HYQVIA and may occur more frequently in females. The syndrome usually begins within several hours to two days following IG treatment. Conduct a thorough neurological exam on patients exhibiting signs and symptoms, to rule out other causes of meningitis. Discontinuing IG treatment has resulted in remission within several days without sequelae. Hemolysis: HYQVIA contains blood group antibodies which may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for signs and symptoms of hemolysis and delayed hemolytic anemia and, if present, perform appropriate confirmatory lab testing. Renal Dysfunction/Failure: Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, and death may occur with intravenous (IV) use of IG products, especially those containing sucrose. Ensure patients are not volume depleted prior to infusion. In patients at risk due to pre-existing renal insufficiency or predisposition to acute renal failure, assess renal function before initiation and throughout treatment, and consider lower, more frequent dosing. If renal function deteriorates, consider discontinuation. Spread of Localized Infection: Do not infuse HYQVIA into or around an infected area due to potential risk of spreading a localized infection. Transfusion-Related Acute Lung Injury: Non-cardiogenic pulmonary edema may occur with IV administered IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil and anti-HLA antibodies in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support. Transmittable Infectious Agents: Because HYQVIA is made from human plasma, it may carry a risk of transmitting infectious agents (e.g. viruses, other pathogens). No cases of transmission of viral diseases or variant Creutzfeldt-Jakob disease (vCJD) have been associated with HYQVIA. Interference with Lab Tests: False positive serological test results and certain assay readings, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies. Adverse Reactions The most common adverse reactions observed in >5% of patients in the clinical trials were: Primary Immunodeficiency (PI) : local adverse reactions including pain, erythema, edema, and pruritus, and systemic adverse reactions including, headache, antibody formation against Recombinant Human Hyaluronidase (rHuPH20), fatigue, nausea, pyrexia, and vomiting. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) : local reactions, headache, pyrexia, nausea, fatigue, erythema, pruritus, increased lipase, abdominal pain, back pain, and pain in extremity. Drug Interactions Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella). Use In Specific Populations Pregnancy : Limited human data are available on the use of HYQVIA during pregnancy. The effects of antibodies to the Recombinant Human Hyaluronidase on the human embryo or fetal development are unknown. It is not known whether HYQVIA can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. HYQVIA should be given to a pregnant woman only if clearly needed. For Full U.S. Prescribing Information, please visit: https://www.shirecontent.com/PI/PDFs/HYQVIA_USA_ENG.pdf For European Union Summary of Product Characteristics, please visit: https://www.ema.europa.eu/en/medicines/human/EPAR/hyqvia 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 www.takeda.com . 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. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). 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. 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: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov . 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. 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. _______________________ 1 HYQVIA ® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] U.S. Prescribing Information. 2 GBS CIDP Foundation International. Voice of the Patient Report. August 26, 2022. www.gbs-cidp.org . Accessed August 2022. 3 Dalakas MC. Nat Rev Neurol . 2011;7(9):507–17. 4 Broers MC, Bunschoten C, Nieboer D, Lingsma HF, Jacobs BC. Eur J Neurol . 2021;28(6):2065–2073. 5 Van den Bergh P, Van Doorn PA, Hadden RD, et al. Eur J Neurol . 2021;28(11):3556–3583. 6 European Medicines Agency. HyQvia 100 mg/mL solution for infusion for subcutaneous use Summary of Product Characteristics. https://www.ema.europa.eu/en/documents/product-information/hyqvia-epar-product-information_en.pdf .

OSAKA, Japan & CAMBRIDGE, Mass.--( BUSINESS WIRE )--Takeda ( TSE:4502/NYSE:TAK ) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA ® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous immunoglobulin therapy (IVIG). The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for HYQVIA for CIDP throughout the European Union. “ Takeda is focused on bringing its differentiated immunoglobulin therapies to patients with neuroimmunological disorders, providing treatment options that address the needs of a broad range of patients,” said Kristina Allikmets, senior vice president and head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit. “ This positive CHMP opinion is a crucial step towards bringing patients with CIDP and their caregivers an effective therapy that, if approved, may offer maintenance treatment personalization through up to once-monthly facilitated subcutaneous administration at home or in office.” CIDP is an acquired, immune-mediated condition affecting the peripheral nervous system that is characterized by progressive, symmetric weakness in distal and proximal limbs and impaired sensory function in extremities. 2 The role of IGs as maintenance therapy for this rare, debilitating and slowly progressing or relapsing disease has been well-established and is considered a standard of care for this complex and heterogeneous condition in guidelines from the European Academy of Neurology and Peripheral Nerve Society due to its broad immunomodulatory and anti-inflammatory effects. 3,4 However, the high volume and frequency of treatment required to effectively manage this disease means that treatment can be a challenge for patients and their health care providers. This proposed extension of indication for HYQVIA is based on data from the pivotal Phase 3 ADVANCE-CIDP 1 clinical trial, which investigated HYQVIA as maintenance therapy in adult patients with CIDP. HYQVIA is also under regulatory review in the United States for use as a maintenance therapy in adult patients with CIDP. About HYQVIA ® HYQVIA ® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins (Ig) and is approved by the European Medicines Agency (EMA) as a replacement therapy in adults, children and adolescents with primary immunodeficiency (PI) and with secondary immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure (PSAF) or serum IgG level of <4 g/L. It is also approved in the United States to treat adults and children two years of age and older with PI. HYQVIA is infused under the skin into the fatty subcutaneous tissue. HYQVIA contains immunoglobulins collected from human plasma. Immunoglobulins are antibodies that maintain the body’s immune system. The hyaluronidase part of HYQVIA helps more of the Ig get absorbed into the body. HYQVIA is infused up to once a month (every three or four weeks). About the ADVANCE Clinical Program ADVANCE-CIDP 1 was a Phase 3, multicenter, placebo-controlled, double-blinded study to evaluate the efficacy, safety and tolerability of HYQVIA ® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as a maintenance therapy to prevent relapse in chronic inflammatory demyelinating polyneuropathy (CIDP). The global study included 132 adults with a confirmed diagnosis of CIDP and who had remained on a stable dosing regimen of intravenous immunoglobulin (IVIG) therapy for at least three months prior to screening. The primary endpoint of the clinical trial was the proportion of subjects who experienced a worsening of functional disability, defined as an increase of ≥1 point relative to the pre-subcutaneous (SC) treatment baseline score in two consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scores. The primary efficacy analysis compared relapse rates using a continuity-corrected χ2 test conducted at the 5% level of statistical significance, with missing data imputed as no relapse. Some of the secondary endpoints included time to relapse as defined by relapse probability, effect on activities of daily living (ADL), safety and tolerability. Patients were randomized to receive either HYQVIA or placebo at the same dose and infusion frequency as their prior IVIG treatment (every two, three or four weeks) for six months or until relapse. Patients who relapsed were offered IVIG treatment as rescue therapy for a period of up to six months. Those who remained relapse free were offered to continue HYQVIA treatment as part of ADVANCE-CIDP 3, an open-label extension clinical trial to assess the long-term safety, tolerability and immunogenicity of HYQVIA in participants with CIDP who completed ADVANCE-CIDP 1. Further information about the ADVANCE-CIDP 1 clinical trial is available at ClinicalTrials.gov under study identifier NCT02549170 . HyQvia® (Human normal immunoglobulin) 100 mg/ml solution for infusion for subcutaneous use PRESCRIBING INFORMATION Always refer to the Summary of Product Characteristics (SmPC) and the local prescribing information of your country before prescribing. Presentation: HyQvia is a dual vial unit consisting of one vial of 10% human normal immunoglobulin (IG) and one vial of recombinant human hyaluronidase (see the SmPC for details). Indications: Replacement therapy in adults, children and adolescents (0-18 years) in: primary immunodeficiency syndromes with impaired antibody production; secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF) or serum IgG level of 6 g/l). PSAF is a failure to mount at least a 2- fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines. Dosage and administration: For subcutaneous use only. Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency. The product should be brought to room temperature before use. Inspect both vials for discolouration and particulate matter before administration. Do not use heating devices including microwaves. Do not shake or mix the components of the two vials. Suggested infusion site(s) are the middle to upper abdomen and thighs. The two components of the medicinal product must be administered sequentially through the same needle beginning with the recombinant human hyaluronidase followed by IG 10%. Please see the SmPC for infusion rates. The full contents of the recombinant human hyaluronidase vial should be administered regardless of whether the full contents of the IG 10% vial is administered. Longer needles may be used under medical supervision to prevent infusion site leakage. Home treatment should be initiated and monitored by a physician experienced in the guidance of patients for home treatment. Posology : Dose and dosage regimen may need to be individualised for each patient dependent on the response. Dose based on body weight may require adjustment in underweight or overweight patients. Patients naïve to IG therapy : The dose required to achieve a trough level of 6 g/l is approximately 0.4-0.8 g/kg body weight/month. The dosage interval to maintain steady state levels varies from 2-4 weeks. Trough levels should be measured and assessed in conjunction with the incidence of infection. To reduce the rate of infection, it may be necessary to increase the dosage and aim for higher trough levels (>6 g/l). At the initiation of therapy, it is recommended that the treatment intervals for the first infusions be gradually prolonged from a 1-week dose to up to a 3- or 4-week dose. Patients previously treated with IG administered intravenously (IV): For patients switching directly from IV IG, or who have had a previous IV dose of IG that can be referenced, the medicinal product should be administered at the same dose and at the same frequency as their previous IV IG treatment. Patients previously treated with IG administered subcutaneously: For patients currently being administered IG subcutaneously, the initial dose of HyQvia is the same as for subcutaneous treatment but may be adjusted to 3- or 4-week intervals. For patients switching directly from an IG treatment administered subcutaneously, the first infusion of HyQvia should be given one week after the last treatment with the previous IG. Secondary immunodeficiencies: The recommended dose is 0.2-0.4 g/kg every three to four weeks. Trough levels should be measured and assessed in conjunction with the incidence of infection. Dose should be adjusted as necessary to achieve optimal protection against infections, an increase may be necessary in patients with persisting infection; a dose decrease can be considered when the patient remains infection free. Children and adolescents (0-18 years): Follow adult dosage guidance. Contraindications: Hypersensitivity to any ingredient or human IG especially in patients with antibodies against IgA; systemic hypersensitivity to hyaluronidase or human recombinant hyaluronidase; HyQvia must not be given IV or intramuscularly. Warnings and precautions: If HyQvia is accidentally administered into a blood vessel, patients could develop shock. The recommended infusion rate given in the SmPC should be adhered to. Infuse slowly and monitor closely throughout the infusion period, particularly patients starting therapy. Patients may require monitoring for up to 1 hour after administration. Manage infusion related events by slowing the infusion rate or stopping the infusion. Treatment will depend on the nature and severity of the adverse event. Patients should be reminded to report chronic inflammation and nodules which occur at the infusion site or other locations. For home treatment, patients should have the support of another responsible person in case of adverse reactions. Record treatment with HyQvia and batch number in patients’ notes. Hypersensitivity: Hypersensitivity reactions are possible in patients with anti-IgA antibodies who should only be treated with HyQvia if alternative treatments are not possible and under close medical supervision. In case of hypersensitivity, shock or anaphylactic-like reactions, discontinue the infusion immediately and treat the patient for shock. Rarely, human normal IG can induce a fall in blood pressure with anaphylactic reaction. In high-risk patients HyQvia should only be administered where supportive care is available for life threatening reactions. Patients should be informed of the early signs of anaphylaxis/ hypersensitivity. Pre-medication may be used as a preventative measure. Hypersensitivity to recombinant human hyaluronidase: Any suspicion of allergic or anaphylactic like reactions following recombinant human hyaluronidase administration requires immediate discontinuation of the infusion and standard medical treatment should be administered, if necessary. Immunogenicity of recombinant human hyaluronidase: development of non-neutralising antibodies to the recombinant human hyaluronidase component has been reported in patients receiving HyQvia in clinical studies. Thromboembolism: Thromboembolic events including myocardial infarction, stroke, deep venous thrombosis and pulmonary embolism have been observed with IG treatment and cannot be excluded with use of HyQvia. Ensure adequate hydration prior to treatment. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk. Patients should be informed about initial symptoms and advised to contact their physician immediately upon onset. Haemolytic anaemia: IG products contain antibodies to blood groups (e.g. A, B, D) which may act as haemolysins. Monitor for signs and symptoms of haemolysis. Acute renal failure: Severe renal adverse reactions have been reported in patients receiving IV IG. Aseptic meningitis syndrome: has been reported, symptoms usually begin within several hours to 2 days following treatment. Patients should be informed about initial symptoms. Discontinuation of IG treatment may result in remission within several days without sequelae. Transmissible agents: Infectious diseases due to the transmission of infective agents cannot be totally excluded. Sodium content: The recombinant human hyaluronidase component contains 4.03 mg sodium/mL. To be taken into consideration by patients on a controlled sodium diet. Traceability: The name and the batch number of the administered product should be clearly recorded. Interactions: Live attenuated virus vaccines – postpone vaccination for 3 months after treatment with HyQvia. For measles vaccine, impairment may persist for up to 1 year, so check antibody status. Please see the SmPC for details. Fertility, pregnancy and lactation: Safety during pregnancy has not been established and immunoglobulins are excreted into the milk, therefore use with caution in pregnant and breastfeeding mothers. Effects on ability to drive and use machines: HyQvia has no or negligible influence on the ability to drive and use machines, e.g. dizziness. Please see the SmPC for details. Undesirable effects: Very common (≥1/10 patients) : Feeling hot, infusion site paraesthesia, infusion site pain (including discomfort, tenderness, groin pain). Common (≥1/100, < 1/10 patients) : Vomiting, nausea, abdominal pain (including abdominal upper and lower pain and tenderness), diarrhoea, infusion site erythema, infusion site swelling (including local swelling and oedema), infusion site pruritus (including vulvovaginal pruritus), pyrexia, asthenic conditions (including asthenia, fatigue, lethargy, malaise), myalgia, musculoskeletal chest pain, headache. Other serious undesirable effects (rare or unknown frequency): Direct Coombs’ test positive, meningitis aseptic. Refer to the SmPC for details on full side effect and interactions. Marketing Authorisation (MA) numbers : 2.5g EU/1/13/840/001, 5g EU/1/13/840/002, 10g EU/1/13/840/003, 20g EU/1/13/840/004, 30g EU/1/13/840/005. Name and address of MA holder: Baxalta Innovations GmbH, Industriestrasse 67, A-1221 Vienna, Austria. HyQvia is a registered trade name. PI approval code : pi-02539 Date of preparation : June 2023. Further information is available on request. Adverse events should be reported to the authorities in your country as required by local law. Adverse events should also be reported to Takeda at: GPSE@takeda.com This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8. of the SmPc for how to report adverse reactions. For Full U.S. Prescribing Information, please visit: https://www.shirecontent.com/PI/PDFs/HYQVIA_USA_ENG.pdf 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 www.takeda.com . 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. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). 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. 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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Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. ______________________________________ 1 Bril V, Hadden RDM, Brannagan TH 3rd, Bar M, Chroni E, Rejdak K, Rivero A, Andersen H, Latov N, Levine T, Pasnoor M, Sacconi S, Souayah N, Anderson-Smits C, Duff K, Greco E, Hasan S, Li Z, Yel L, Ay H. Hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: The ADVANCE-CIDP 1 randomized controlled trial. J Peripher Nerv Syst. 2023 Sep;28(3):436-449. doi: 10.1111/jns.12573. Epub 2023 Jul 6. PMID: 37314318. 2 Dalakas MC. Nat Rev Neurol. 2011;7(9):507–17. 3 Eftimov F, et al. Cochrane Database Syst Rev. 2013;12:CD001797. 4 Van den Bergh, P. Y. (2021). European Academy of Neurology/Peripheral Nerve Society guideline on diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy: Report of a joint task force—second revision. European Journal of Neurology, 28(11), 3556–3583. https://doi-org.libproxy1.nus.edu.sg/10.1111/ene.14959