Generic: SUTIMLIMAB-JOME
Classical Complement Pathway Inhibitor [EPC]
1 INDICATIONS AND USAGE ENJAYMO is a classical complement inhibitor indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD). ( 1 ) Cold Agglutinin Disease ENJAYMO (sutimlimab-jome) is indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD).
5 WARNINGS AND PRECAUTIONS Serious Infections: Ensure patients are vaccinated against encapsulated bacteria. Monitor patients for early signs and symptoms of infections. ( 5.1 ) Infusion-Related Reactions: Monitor patients for infusion-related reactions, interrupt if reaction occurs, and institute appropriate medical management as needed. ( 5.2 ) Risk of Autoimmune Disease: Monitor patients for signs and symptoms and manage medically. ( 5.3 ) Recurrent Hemolysis After ENJAYMO Discontinuation: Mo...
5 WARNINGS AND PRECAUTIONS Serious Infections: Ensure patients are vaccinated against encapsulated bacteria. Monitor patients for early signs and symptoms of infections. ( 5.1 ) Infusion-Related Reactions: Monitor patients for infusion-related reactions, interrupt if reaction occurs, and institute appropriate medical management as needed. ( 5.2 ) Risk of Autoimmune Disease: Monitor patients for signs and symptoms and manage medically. ( 5.3 ) Recurrent Hemolysis After ENJAYMO Discontinuation: Monitor patients for signs and symptoms of hemolysis if treatment with ENJAYMO is interrupted. ( 5.4 ) 5.1 Serious Infections Including Those Caused by Encapsulated Bacteria ENJAYMO, a proximal classical complement C1s inhibitor, increases a patient's susceptibility to serious infections including those caused by encapsulated bacteria e.g. Neisseria meningitidis (any serogroup, including non-groupable strains), Streptococcus pneumoniae , and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. Serious infections (bacterial and viral) were reported in 15% (10/66) of patients receiving ENJAYMO from the two phase 3 studies. These infections included urinary tract infection with sepsis, respiratory tract infection, pneumonia, otomastoiditis, and skin infections One patient (1.5%) died due to klebsiella pneumonia. Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of ENJAYMO, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the chronic duration of therapy with ENJAYMO. Note that, ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent ENJAYMO therapy is indicated in a patient who is not up to date on their vaccines administer vaccine(s) as soon as possible. Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. If ENJAYMO treatment is administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection. Some infections may become rapidly life-threatening or fatal if not recognized and treated promptly. Inform patients of these signs and symptoms and steps to be taken to seek immediate medical care. Consider interruption of ENJAYMO treatment in patients who are undergoing treatment for serious infection. ENJAYMO has not been studied in patients with chronic systemic infections such as hepatitis B, hepatitis C, or HIV. Consider patients' immune status when initiating treatment with ENJAYMO. 5.2 Infusion-Related Reactions ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients [see Contraindications (4) ] . Administration of ENJAYMO may result in infusion-related reactions. In the two phase 3 studies, 19 of 66 (29%) patients treated with ENJAYMO experienced infusion-related reactions (e.g., shortness of breath, rapid heartbeat, nausea, flushing, headache, hypotension, chest discomfort, pruritus, rash, injection site reaction, and dizziness) were reported in patients from the two clinical studies. One patient permanently discontinued ENJAYMO due to an infusion-related reaction. Monitor patients for infusion-related reactions and interrupt if a reaction occurs. Discontinue ENJAYMO infusion and institute appropriate supportive measures if signs of hypersensitivity reactions, such as cardiovascular instability or respiratory compromise, occur. 5.3 Risk of Autoimmune Disease Based on its mechanism of action, ENJAYMO may potentially increase the risk for developing autoimmune diseases such as systemic lupus erythematosus (SLE). Development of systemic lupus erythematosus (SLE) has been associated with inherited classical complement deficiency. Patients with SLE or autoimmune disease with positive anti-nuclear antibody were excluded from clinical trials with ENJAYMO. In clinical trials, 3/66 (4.5%) patients developed a relapse or worsening of preexisting autoimmune disease. Monitor patients being treated with ENJAYMO for signs and symptoms and manage medically. 5.4 Recurrent Hemolysis After ENJAYMO Discontinuation If treatment with ENJAYMO is interrupted, closely monitor patients for signs and symptoms of recurrent hemolysis, e.g., elevated levels of total bilirubin or lactate dehydrogenase (LDH) accompanied by a decrease in hemoglobin, or reappearance of symptoms such as fatigue, dyspnea, palpitations, or hemoglobinuria. Consider restarting ENJAYMO if signs and symptoms of hemolysis occur after discontinuation.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infections [see Warnings and Precautions (5.1) ] Infusion-Related Reactions [see Warnings and Precautions (5.2) ] Risk of Autoimmune Disease [see Warnings and Precautions (5.3) ] Recurrent Hemolysis After ENJAYMO Discontinuation [see Warnings and Precautions (5.4) ] Most common adverse reactions in the CADENZA study (Part A) (incidence โฅ18%) are rh...
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infections [see Warnings and Precautions (5.1) ] Infusion-Related Reactions [see Warnings and Precautions (5.2) ] Risk of Autoimmune Disease [see Warnings and Precautions (5.3) ] Recurrent Hemolysis After ENJAYMO Discontinuation [see Warnings and Precautions (5.4) ] Most common adverse reactions in the CADENZA study (Part A) (incidence โฅ18%) are rhinitis, headache, hypertension, acrocyanosis, and Raynaud's phenomenon. The most common adverse reactions in the CARDINAL study (incidence โฅ25%) are urinary tract infection, respiratory tract infection, bacterial infection, dizziness, fatigue, peripheral edema, arthralgia, cough, hypertension, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ENJAYMO in patients with a confirmed diagnosis of CAD was evaluated in a placebo-controlled study (CADENZA) in Part A (n=42) followed by an open-label single-arm study in Part B (n=39) and an open-label single-arm study (CARDINAL) (n=24) [see Clinical Studies (14) ] . The median duration of treatment exposure to ENJAYMO was 104 weeks (patients randomized to ENJAYMO in CADENZA Part A) and 93 weeks (patients randomized to placebo in CADENZA Part A) and 143 weeks for CARDINAL. CADENZA (Part A) Serious adverse reaction occurred in 2/22 (9%) patients who received ENJAYMO. Serious adverse reactions included Raynaud's phenomenon (n=1) and febrile infection (n=1). Permanent discontinuation of ENJAYMO due to an adverse reaction occurred in 2/22 (9%) patients. Adverse reactions which resulted in permanent discontinuation of ENJAYMO included Raynaud's phenomenon (n=1), acrocyanosis (n=1), and infusion related reactions (n=1). Dosage interruptions of ENJAYMO due to an adverse reaction occurred in 3/22 patients. Adverse reactions which required dosage interruption included nasopharyngitis (n=1) and infusion related reaction (n=1), including pruritis (n=1) and chest discomfort (n=1). The most common adverse reactions (โฅ18%) reported in the CADENZA study were rhinitis, headache, hypertension, acrocyanosis, and Raynaud's phenomenon. Table 3: Adverse Reactions (โฅ10%) in Patients Who Received ENJAYMO with a Difference Between Arms of >5% Compared to Placebo in the CADENZA Study (Part A) Adverse Reactions ENJAYMO (N=22) Placebo (N=20) Headache 5 (23%) 2 (10%) Hypertension 5 (23%) 0 Rhinitis 4 (18%) 0 Acrocyanosis 4 (18%) 0 Raynaud's phenomenon 4 (18%) 0 CARDINAL Serious adverse reactions occurred in 10/24 (42%) patients who received ENJAYMO. The most common adverse reaction (>5%) was acrocyanosis (n=2). A fatal adverse reaction of pneumonia klebsiella occurred in one patient who received ENJAYMO. Permanent discontinuation of ENJAYMO due to an adverse reaction occurred in 2/24 (8%) patients. Adverse reactions which resulted in permanent discontinuation of ENJAYMO included pneumonia klebsiella (n=1) and acrocyanosis (n=2). Dosage interruptions of ENJAYMO due to an adverse reaction occurred in 7/24 patients. Adverse reactions which required dosage interruption included pneumonia, COVID-19 pneumonia, abdominal pain upper, urinary tract infection bacterial, urosepsis, acrocyanosis, viral infection, blood creatinine increased and infusion-related reaction. The most common adverse reaction (โฅ25%) reported in the CARDINAL study were urinary tract infection, respiratory tract infection, bacterial infection, dizziness, fatigue, peripheral edema, arthralgia, cough, hypertension, and nausea. Table 4: Adverse Reactions (โฅ15%) in Patients Receiving ENJAYMO in the CARDINAL Study Adverse Reaction/Body System n (%) (N=24) Please note: if a subject has multiple events in a grouped term the subject is only counted once. The following terms were combined for the analysis: INFECTIONS AND INFESTATIONS Urinary tract infection Urinary Tract Infection includes cystitis, urosepsis 9 (38%) Respiratory tract infection Respiratory tract infection includes upper respiratory tract infection, bronchitis, lower respiratory tract infection, COVID-19 pneumonia 6 (25%) Bacterial infection Bacterial infection includes Escherichia urinary tract infection, urinary tract infection bacteria, cystitis bacterial, Escherichia sepsis, pneumococcal sepsis, pneumonia klebsiella, streptococcal sepsis, wound infection staphylococcal 6 (25%) Nasopharyngitis 5 (21%) Viral infection Viral infection includes oral herpes, herpes zoster, respiratory tract infection viral, viral upper respiratory tract infection, Herpes simplex viraemia 5 (21%) NERVOUS SYSTEM DISORDERS Dizziness Dizziness includes dizziness postural and vertigo 7 (29%) Headache 5 (21%) GENERAL DISORDERS Fatigue Fatigue includes asthenia, malaise, mental fatigue 8 (33%) Peripheral edema Peripheral edema includes peripheral swelling 6 (25%) Pyrexia 5 (21%) MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Arthralgia 6 (25%) VASCULAR DISORDERS Hypertension Hypertension includes, blood pressure increased, essential hypertension 6 (25%) Acrocyanosis 5 (21%) GASTROINTESTINAL DISORDERS Nausea 6 (25%) Abdominal pain Abdominal pain includes abdominal pain upper, abdominal tenderness 5 (21%) RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS Cough Cough includes productive cough 6 (25%) INJURY, POISONING AND PROCEDURAL COMPLICATIONS Infusion-related reaction Infusion related reaction includes stress cardiomyopathy, feeling cold (All occurred within 24 hours of start of ENJAYMO infusion) 4 (17%)
Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.