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WHAT IS ENJAYMO?

ENJAYMO is a chemotherapy-free 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.
*At least 1.5 g/dL increase in hemoglobin from the start of treatment in the double-blind, randomized, placebo-controlled trial, and a return to at least 12 g/dL or at least a 2 g/dL improvement from the start of treatment in the single-arm, open-label trial
†No blood transfusion 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.
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.
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.
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 may lower the ability of your immune system to fight infections. ENJAYMO increases your chance of getting serious infections including those caused by encapsulated bacteria, including Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type B. These serious infections may quickly become life-threatening or cause death if not recognized and treated early.
You must complete or be up to date with the vaccines against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before your first dose of ENJAYMO.
If your healthcare provider decides that urgent treatment with ENJAYMO is needed, you should receive vaccinations as soon as possible.
If you have been vaccinated against these bacteria in the past, you might need additional vaccines before starting ENJAYMO. Your healthcare provider will decide if you need additional vaccines.
Vaccines do not prevent all infections caused by encapsulated bacteria. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious infection:
fever with or without shivers or chills
fever and a rash
fever with chest pain and cough
fever with breathlessness or fast breathing
fever with high heart rate
headache with nausea or vomiting
headache and fever
headache with stiff neck or stiff back
confusion
body aches with flu-like symptoms
clammy skin
eyes sensitive to light
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
nausea
dizziness
decrease in blood pressure
injection site reaction
rash
chest discomfort
flushing
itchy skin
rapid heartbeat
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 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
Rapid heart rate
Shortness of breath
Blood in your urine or dark urine
The most common side effects of ENJAYMO include:
increase in blood pressure
joint pain
dizziness
urinary tract infection
headache
feeling tired or weak
respiratory tract infection
nausea
cough
bacterial infection
runny nose
swelling in lower legs or hands
bluish color to the lips and skin
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.
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.
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