What is ENJAYMO?

What is ENJAYMO?

The First and Only APPROVED

Treatment in CAD

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 CAD.

ENJAYMO has been studied in a clinical trial

CARDINAL was an open-label (meaning everyone knew what drug they were given), 6-month clinical study in 24 patients with a recent history* of blood transfusions.

*Patients received at least 1 blood transfusion during the 6 months prior to starting the study.

Primary Study
Outcome

The proportion of patients who experienced all of the following:

Hemoglobin Levels Icon

Increases in hemoglobin levels from the start of the study (increase ≥ 2 g/dL or Hb ≥ 12 g/dL at treatment assessment)

No transfusions Icon

No blood transfusions from Week 5 through Week 26 of the study

No Prohibited CAD Medications Icon

No treatment for CAD beyond what was permitted per protocol from Week 5 through Week 26

A primary outcome is the main result measured at the end of the study to see if a given treatment worked.

Defined as the mean value from Weeks 23, 25 and 26.

ENJAYMO Study Results

The CARDINAL Clinical Study of ENJAYMO Met Its Primary Endpoint

54%
Met Primary Outcome
Results of the study showed 54% (13/24) of patients had increases in hemoglobin while remaining transfusion-free and had no additional treatment beyond what was permitted per protocol of the study.
63%
Increase in Hemoglobin
63% (15/24) of patients achieved a hemoglobin level ≥ 12 g/dL or showed an increase in hemoglobin ≥ 2 g/dL.
71%
Transfusion-free for Most Patients
71% (17/24) of patients did not receive a blood transfusion from Week 5 through Week 26.
92%
No Additional Treatments for CAD
92% (22/24) of patients did not receive treatment beyond what was permitted per protocol of the study from Week 5 through Week 26.
Mean Increase in Hemoglobin Level Graphic Mean Increase in Hemoglobin Level Graphic

ENJAYMO Safety Profile

Adverse Reactions (≥5%) in Patients Receiving ENJAYMO in CARDINAL

Adverse Reaction*
ENJAYMO
N=24 (%)
Infections
Respiratory tract infection*
6 (25%)
Viral infection*
3 (13%)
Bladder infection*
2 (8%)
Bacterial infection*
2 (8%)
Vascular disorders
Blue discoloration of the skin
2 (8%)
High blood pressure*
2 (8%)
Gastrointestinal disorders
Diarrhea
3 (13%)
Indigestion*
3 (13%)
Gastroenteritis
2 (8%)
Abdominal pain
2 (8%)
Respiratory, thoracic and mediastinal disorders
Cough*
3 (13%)
Musculoskeletal and connective tissue disorders
Joint inflammation (arthritis)*
3 (13%)
General disorders and administration site conditions
Swelling on the lower legs, ankles, and feet
3 (13%)
Fatigue*
2 (8%)
Infusion reaction
2 (8%)
Nervous system disorders
Headache
2 (8%)

These are not all the possible side effects of ENJAYMO. Call your doctor for medical advice about side effects.

*Events may be counted in more than one grouped term, e.g., viral upper respiratory tract infection is counted in viral infection and respiratory tract infection.

  • You need to be vaccinated against certain bacteria at least 2 weeks before your first dose of ENJAYMO. These bacteria can lower your immune system's ability to fight infections, causing potentially life-threatening infections in your blood, lungs, or in or around your brain.
  • During treatment with ENJAYMO, you may need additional vaccinations.
  • Seek immediate medical care if you have any new symptoms of infection, such as fever, cough, difficulty breathing, flu-like symptoms, severe headache with stiff neck or back, or pain during urination or urinating more often than usual, and pain, redness or swelling of the skin.

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×
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 AND INDICATION
+
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.

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 a part of 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)
  • Arthralgia
  • 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.

Please see Full Prescribing Information, including Medication Guide.

×
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.

IMPORTANT SAFETY INFORMATION AND INDICATION
+
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.

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 a part of 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.

Please see Full Prescribing Information, including Medication Guide.