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WHAT IS ENJAYMO?

ENJAYMO Is a breakthrough treatment that has been proven to help address the impacts of cad
The safety and effectiveness of ENJAYMO was studied in 24 patients with CAD and a history of transfusion in the last 6 months in a 6-month open-label clinical trial. This means that both participants and researchers knew what drug was being given.
Overall, 54% of patients met all three of the following criteria:
Significant improvement in hemoglobin levels
Overall 63% of patients (n=15) had hemoglobin return to normal levels (≥12 g/dL) or at least a 2 g/dL improvement from the start of treatment (from a baseline haemoglobin level of 8.6±1.2 g/dL)
Freedom from transfusions
Overall 71% of patients (n=17) avoided the need for transfusions from Weeks 5 to 26 of treatment with ENJAYMO.*
*Average transfusions at baseline: 3.2 within the last 6 months; 4.8 within the last 12 months.
No additional medications for CAD
Overall 92% of patients (n=22) did not need additional medications for their CAD.
ENJAYMO Offered Fast and lasting improvement of hemoglobin levels during the study
Increasing hemoglobin may help you stay in control of anemia and decrease the need of transfusions in CAD. ENJAYMO led to an increase in average hemoglobin levels in the CARDINAL clinical study.
hemoglobin level chart
This graph shows the average hemoglobin levels at each time point from the start to the end of the study. Consider that these data come from a small number of patients and that the clinical trial was not designed to determine the statistical significance of these results.
Defined as the average value from Weeks 23, 25, and 26.
Enjaymo Returned bilirubin levels to normal
Bilirubin (a marker of hemolysis) returned to normal (0.91 mg/dL from a baseline level of 3.1±1.4 mg/dL) in the 14 patients who had bilirubin levels measured at baseline and the treatment assessment (the average value from Weeks 23, 25 and 26)
HOW WAS SUCCESS MEASURED?
Treatment was considered successful in patients who achieved all three of the following goals:
Average improvement in hemoglobin level at treatment assessment
Avoidance of transfusions from Week 5
No additional treatments for CAD initiated from Week 5 onward
Additional endpoints studied looked at the impact on hemoglobin and laboratory measures of hemolysis. More specifically, the average change from baseline in bilirubin and lactate dehydrogenase (LDH) at the point in which treatment was assessed.¥
A majority of patients entered a follow-up study, which continues to monitor the long-term effectiveness and safety of treatment.
¥Defined as an increase from baseline in hemoglobin level ≥2 g/dL or a hemoglobin level ≥12 g/dL on average across Weeks 23, 25, and 26.
The science behind enaymo
See how ENJAYMO is designed to help stop the destruction of red blood cells (hemolysis) before it starts.
INDICATION
ENJAYMO is a prescription medicine used to decrease the need for red blood cell transfusion due to the breakdown of red blood cells (hemolysis) in adults with cold agglutinin disease (CAD).

It is not known if ENJAYMO is safe and effective in children
INDICATION & IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
Do not receive ENJAYMO if you are allergic to sutimlimab-jome or any of the ingredients in ENJAYMO.
ENJAYMO can cause serious side effects, including:
Serious Infections: ENJAYMO is a prescription medicine that affects your immune system. ENJAYMO can lower the ability of your immune system to fight infections. People who take ENJAYMO may have an increased risk of getting infections caused by certain kinds of bacteria such as Neisseria meningitides, Streptococcus pneumoniae , and Haemophilus influenzae . These infections may be serious or life-threatening. Some infections may quickly become life-threatening or cause death if not recognized and treated early.
You need to receive vaccinations against infections caused by certain kinds of bacteria at least 2 weeks before your first dose of ENJAYMO. You may need to have additional vaccinations during treatment
If your healthcare provider decides that urgent treatment with ENJAYMO is needed, you should receive vaccinations as soon as possible.
Vaccinations may reduce the risk of these infections, but do not prevent all infections. Call your healthcare provider or get medical help right away if you get any new signs and symptoms of an infection, including:
fever
severe headache with stiff neck or back
pain during urination or urinating more often than usual
cough or difficulty breathing
flu-like symptoms
pain, redness or swelling of the skin
Infusion-related reactions: Treatment with ENJAYMO may cause infusion-related reactions, including allergic reactions that may be serious or life-threatening. Your healthcare provider may slow down or stop your ENJAYMO infusion if you have an infusion-related reaction, and will treat your symptoms if needed. Tell your healthcare provider right away if you develop symptoms during your ENJAYMO infusion that may mean you are having an infusion-related reaction, including:
shortness of breath
rapid heartbeat
nausea
flushing
headache
Risk of autoimmune disease: ENJAYMO may increase your risk for developing an autoimmune disease such as systemic lupus erythematosus (SLE). Tell your healthcare provider and get medical help if you develop any symptoms of SLE, including:
joint pain or swelling
rash on the cheeks and nose
unexplained fever
If you have CAD and you stop receiving ENJAYMO, your healthcare provider should monitor you closely for return of your symptoms after you stop ENJAYMO. Stopping ENJAYMO may cause the breakdown of your red blood cells due to CAD to return. Symptoms or problems that can happen due to red blood cell breakdown include:
tiredness
shortness of breath
rapid heart rate
blood in your urine or dark urine
The most common side effects of ENJAYMO include:
respiratory tract infection
viral infection
diarrhea
indigestion
cough
joint pain
joint inflammation (arthritis)
swelling of the lower legs, ankles, and feet
These are not all the possible side effects of ENJAYMO. Call your doctor for medical advice about side effects.
Before receiving ENJAYMO, tell your healthcare provider about all of your medical conditions, including if you:
have a fever or infection, including a history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
have an autoimmune disease such as systemic lupus erythematosus (SLE), also known as lupus.
are pregnant or plan to become pregnant. It is not known if ENJAYMO will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if ENJAYMO passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
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