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WHAT IS ENJAYMO?

ENJAYMO Is a breakthrough treatment that has been proven to help address the impact of cad
The safety and effectiveness of ENJAYMO was studied in a placebo-controlled clinical trial in 42 patients with CAD.
73% (16/22) OF PATIENTS RESPONDED TO TREATMENT WITH ENJAYMO VS 15% (3/20) ON PLACEBO
Responders:
Had improved hemoglobin*
73% (16/22) of patients taking ENJAYMO (vs 15.0% [3/20] of patients taking placebo) showed an increase in hemoglobin of at least 1.5 g/dL.
REMAINED Transfusion-Free
82% (18/22) of patients taking ENJAYMO (vs 80.0% [16/20] of patients taking placebo) did not receive a blood transfusion from Week 5 through Week 26.
Did not need other Medications for cad
86% (19/22) of patients taking ENJAYMO (vs 100% [20/20] of patients taking placebo) did not receive treatment beyond what was permitted per protocol of the study from Week 5 through Week 26.
Significant Improvement in Fatigue
Patients on ENJAYMO were asked about the impact of fatigue on a scale of 0 (not at all) to 4 (very much so) for a total of 52 points. This 13 item survey (FACIT) included questions like:
• How fatigued they felt
• How weak and tired they felt
• Ability to do usual activities
• Need to take a nap to get through
the day
• Frustration because of tiredness
In the clinical trial, patients on ENJAYMO had an average 11-point improvement from baseline (improving from an average baseline score of 31.67 points to an average score at treatment assessment of 42.5 points) vs a 2-point improvement in patients on placebo. Higher scores on the survey meant a person felt less fatigue.
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ENJAYMO Offered Fast and lasting improvement of hemoglobin levels during the study
See the difference ENJAYMO makes in helping raise hemoglobin levels, compared with placebo.
hemoglobin level chart
The average hemoglobin level at the start of the study was 9.15 g/dL for patients on ENJAYMO and 9.33 g/dL for patients on placebo.
This graph shows the average change in hemoglobin levels from baseline 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.
Enjaymo Returned bilirubin levels to normal
Among 17 patients taking ENJAYMO who had levels of bilirubin measured at baseline and the treatment assessment (the average value from Weeks 23, 25 and 26), bilirubin returned to normal (0.71 mg/dL from a baseline level of 2.41±1.59 mg/dL). Meanwhile, among 18 patients taking placebo who had bilirubin levels measured at baseline and the treatment assessment, bilirubin levels lowered minimally (1.99 mg/dL from a baseline level of 2.09±.69 mg/dL).
WHAT IS BILIRUBIN?
IMPROVED HEMOGLOBIN AND FATIGUE
At the end of the study, patients taking ENJAYMO had:
Improved hemoglobin levels vs patients on placebo
Improvement in self-reported fatigue scores vs patients on placebo
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 treat 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 meningitidis, 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
decrease in blood pressure
chest discomfort
rapid heartbeat
nausea
injection site reaction
flushing
headache
dizziness
rash
itchy skin
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 the return of your symptoms after you stop ENJAYMO. Stopping ENJAYMO may cause the breakdown of your red blood cells due to CAD 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:
increase in blood
pressure
urinary tract infection
respiratory tract
infection
bacterial infection
swelling in lower legs
or hands
joint pain
headache
nausea
runny nose
bluish color to
the lips and skin
dizziness
feeling tired or weak
cough
changes in color or
sensation in the fingers
and toes (Raynaud's
phenomenon)
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.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
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