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Enjaymo is a brand name for Sutimlimab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Enjaymo is indicated for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease (CAD).
Verbatim from this product's EMA label. Tap a section to expand.
Enjaymo must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological disorders. 4). The recommended dose is based on body weight. For patients weighing 39 kg to less than 75 kg, the recommended dose is 6500 mg and for patients weighing 75 kg or more, the recommended dose is 7500 mg.
Administer Enjaymo intravenously weekly for the first two weeks, with administration every two weeks thereafter. 4). Enjaymo is intended for continuous use as chronic therapy only, unless the discontinuation of Enjaymo is clinically indicated.
3 Missed dose If a dose is missed, the missed dose should be administered as soon as possible. If the duration after the last dose exceeds 17 days, therapy should be reinitiated with weekly administrations for the first two weeks followed by administration every two weeks thereafter.
2). Hepatic impairment No dose adjustment is required in patients with hepatic impairment. Renal impairment No dose adjustment is required in patients with renal impairment. Paediatric population There is no relevant use of Enjaymo in children < 18 years of age in the treatment of CAD.
Method of administration Enjaymo is for intravenous infusion only. Do not administer as an intravenous push or bolus. 6. Following preparation, Enjaymo infusion solution should be administered intravenously at the infusion rate presented in Table 1.
Table 1 Infusion reference table Body weight range Dose (mg) Number of vials needed Volume (mL) Maximum infusion rate Greater than or equal to 39 kg to less than 75 kg 6500 6 130 130 mL/hour 75 kg or greater 7500 7 150 150 mL/hour Patients with cardiopulmonary disease may receive the infusion over 120 minutes.
If an adverse reaction occurs during the administration of Enjaymo, the infusion may be slowed or stopped at the discretion of the physician. If hypersensitivity reactions occur, discontinue Enjaymo and initiate appropriate treatment.
Monitor the patient for at least two hours following completion of the initial infusion for signs or symptoms of an infusion and/or hypersensitivity reaction. Monitor the patient for one hour following completion of subsequent infusions for signs or symptoms of an infusion reaction.
4 Home infusion Home infusions should be performed by a healthcare professional. The decision to consider home infusion should be based on individual clinical characteristics of the patient and individual needs of the patient. Transitioning the infusion from a clinical facility to home administration includes ensuring that adequate infrastructure and resourcing is in place and consistent with treating physician orders.
Summary of safety profile The most frequently reported adverse reactions with Enjaymo in CADENZA and CARDINAL clinical studies were headache, hypertension, urinary tract infection, upper respiratory tract infection, nasopharyngitis, nausea, abdominal pain, infusion-related reactions and cyanosis (reported as acrocyanosis).
Tabulated list of adverse reactions The safety evaluation of Enjaymo in patients with CAD was primarily based on data from 66 patients who participated in the phase 3, randomized, placebo-controlled study (CADENZA) and in an open- label single-arm study (CARDINAL).
Listed in Table 2 are adverse reactions observed in the CADENZA and CARDINAL studies presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 7 Table 2 List of adverse reactions in CADENZA and CARDINAL studies MedDRA System Organ Class Very common Common Infections and infestations Urinary tract infection Cystitis Upper respiratory tract infectionsa Nasopharyngitisb Gastroenteritis Rhinitis Lower respiratory tract infectionsc Urosepsis Escherichia urinary tract infection Urinary tract infection bacterial Cystitis bacterial Oral herpes Herpes simplex viraemia Herpes zoster Herpes simplex General disorders and administration site conditions Pyrexiaf Feeling coldf Infusion related reactionsf Nervous system disorders Headache Auraf Dizzinessf* Vascular disorders Hypertensiond Cyanosis (reported as acrocyanosis) Raynaud’s phenomenon Hypotensionf* Stress cardiomyopathyf Gastrointestinal disorders Abdominal paine Nausea Diarrhoeaf Dyspepsiaf Aphthous ulcerf Respiratory, thoracic and mediastinal disorders Chest discomfortf* Skin and subcutaneous tissue disorders Pruritusf* aUpper respiratory tract infections: upper respiratory tract infection, bronchitis, and viral upper respiratory tract infection bNasopharyngitis: nasopharyngitis, pharyngitis c Lower respiratory tract infections: pneumonia klebsiella, COVID-19 pneumonia, lower respiratory tract infection, respiratory tract infection viral, respiratory tract infection, pneumonia dHypertension: hypertension, blood pressure increased, essential hypertension, hypertensive crisis, white coat hypertension eAbdominal pain: abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness fInfusion related reaction: All occurred within 24 hours of start of Enjaymo infusion.
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. Infections Enjaymo targets the classical complement pathway (CP) specifically binding to complement protein component 1, s subcomponent (C1s) preventing the cleavage of complement protein C4.
Although the lectin and alternate pathways remain unaffected, patients may have an increased susceptibility to serious infections, especially infections caused by encapsulated bacteria such as Neisseria meningitides, Streptococcus pneumoniae, and Haemophilus influenza.
Patients should be vaccinated against encapsulated bacteria before treatment with Enjaymo is started, please see “Vaccinations” below. 8). Enjaymo should not be initiated in patients with active, serious infections. Patients should be monitored for early signs and symptoms of infections and should be informed to seek immediate medical care if such symptoms should occur.
5 Patients with viral hepatitis and HIV were excluded from the clinical studies. Before and during treatment, patients must notify their physician if they have been diagnosed with hepatitis B, hepatitis C, or HIV infection. Be cautious when treating patients with a history of hepatitis B, hepatitis C, or HIV infection.
Vaccinations Vaccinate patients according to the most current local recommendations for patients with persistent complement deficiencies, including meningococcal and streptococcal vaccines. Revaccinate patients in accordance with local recommendations.
Immunize patients without a history of vaccination against encapsulated bacteria at least 2 weeks prior to receiving the first dose of Enjaymo. If urgent Enjaymo therapy is indicated in an unvaccinated patient, administer vaccine(s) as soon as possible.
The benefits and risks of antibiotic prophylaxis for prevention of infections in patients receiving Enjaymo have not been established. Hypersensitivity reactions As with other protein products, administration of Enjaymo may result in hypersensitivity reactions, including anaphylaxis.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Infusion of Enjaymo at home may be considered for patients who have tolerated their infusion well in a clinical facility and have not had infusion related reactions. A patient’s underlying co-morbidities and ability to adhere to the home infusion requirements need to be considered when evaluating the patient for eligibility to receive home infusion.
In addition, the following criteria should be considered: • The patient must have no ongoing concurrent condition that, in the opinion of the physician, may place the patient at greater risk when receiving an infusion in the home setting rather than in the clinic setting.
A comprehensive evaluation should be completed before the initiation of home infusion to ensure that the patient is medically stable. • The patient must have successfully received Enjaymo infusion in a clinical setting (hospital or outpatient) for at least three months under the supervision of a physician or care provider experienced in the management of patients with CAD.
• The patient must be willing and able to comply with home infusion procedures and recommendations of the treating physician or care provider. • The healthcare professional administering the infusion at home should be available at all times during the home infusion and for at least 1 hour after infusion.
4) and the treating physician should be notified. In such cases, the treating physician should decide if subsequent infusions should occur and if so, whether the infusions should be administered in a hospital or supervised outpatient care setting.
*Events suggestive of hypersensitivity reactions are included in the table. 2%) patients. Serious infections listed in the ADR table include respiratory tract infection [pneumonia klebsiella (n=1), respiratory tract infection (n=1), COVID-19 pneumonia (n=1)], urinary tract infection [urosepsis (n=1), urinary tract infection (n=1), urinary tract infection bacterial (n=1)], herpes zoster (n=1).
Sutimlimab was discontinued in one patient due to a serious infection of Klebsiella pneumonia with fatal outcome. No other fatal events of infections were reported. 4 for information on vaccination recommendations for serious infections and for monitoring early signs and symptoms of infections.
8 Immunogenicity Immunogenicity of sutimlimab was assessed in CAD patients in the CARDINAL and CADENZA studies at baseline, during the treatment period, and at end of treatment (Week 26). 3%) enrolled in the CARDINAL study who received at least one dose of sutimlimab developed treatment-emergent ADAs.
3%) developed treatment-emergent ADAs. These ADAs were transient in nature with low titre and were not associated with changes in the pharmacokinetic profile, clinical response, or adverse events. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
In clinical studies, no serious hypersensitivity reactions were observed with Enjaymo. If hypersensitivity reactions occur, discontinue Enjaymo and initiate appropriate treatment. 8). Patients should be monitored for infusion-related reactions, infusion interrupted if a reaction occurs and appropriate treatment initiated.
Systemic lupus erythematosus (SLE) Individuals with inherited classical complement deficiency are at a higher risk for developing SLE. Patients with SLE were excluded from clinical studies with Enjaymo. Patients being treated with Enjaymo should be monitored for signs and symptoms of SLE and evaluated appropriately.
Use Enjaymo with caution in patients with SLE or those who develop signs and symptoms of SLE. Monitoring CAD manifestations after Enjaymo discontinuation The effects on haemolysis diminish after end of treatment. Patients should therefore be monitored for signs and symptoms of haemolysis in case of treatment discontinuation.
85% of the WHO recommended maximum daily intake of 2 g sodium for an adult.