Enjaymo
Generic: SUTIMLIMAB-JOME
Basic Information
Manufacturer
Recordati Rare Diseases, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
0a25363a-7781-d9f8-cb1c-be22987bf03b
Indications & Usage
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).
( 1 ) Cold Agglutinin Disease ENJAYMO (sutimlimab-jome) is indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD).
Adverse Reactions
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 ≥18%) are rhinitis, headache, hypertension, acrocyanosis, and Raynaud's phenomenon.
The most common adverse reactions in the CARDINAL study (incidence ≥25%) 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 (≥18%) reported in the CADENZA study were rhinitis, headache, hypertension, acrocyanosis, and Raynaud's phenomenon.
Table 3: Adverse Reactions (≥10%) 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 (≥25%) 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 (≥15%) 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%)
The most common adverse reactions in the CARDINAL study (incidence ≥25%) 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 (≥18%) reported in the CADENZA study were rhinitis, headache, hypertension, acrocyanosis, and Raynaud's phenomenon.
Table 3: Adverse Reactions (≥10%) 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 (≥25%) 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 (≥15%) 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%)