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:

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.