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 this medicine is safe and effective in children.

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 lifethreatening 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

See Enjaymo side effects.

Who should not receive Enjaymo?

Do not receive Enjaymo if you are allergic to sutimlimab-jome or any of the ingredients. See the end of this page for a complete list of ingredients.

• Enjaymo is given through a vein by intravenous (I.V.) infusion, usually over 1 to 2 hours.
• You will usually receive a starting dose, followed by a second dose 1 week later. Then 2 weeks after your second dose, you will start to receive an infusion every 2 weeks.
• After your first infusion, you should be monitored for infusion and allergic reactions for at least 2 hours. For all future infusions, you should be monitored for infusion reactions for 1 hour. See Enjaymo side effects.
• 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
• If you miss an infusion, call your healthcare provider right away.

- For patients weighing 39 kg to less than 75 kg: 6,500 mg by intravenous infusion weekly for two weeks then every two weeks.
- For patients weighing 75 kg or more: 7,500 mg by intravenous infusion weekly for two weeks then every two weeks.

Use: to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD).

Do not receive Enjaymo if you are allergic to sutimlimab-jome or any of the ingredients. See the end of this page for a complete list of ingredients.

Before receiving Enjaymo

Before receiving treatment, 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. You should talk to your healthcare provider about the best way to feed your baby during treatment.

Enjaymo can cause serious side effects, including:

• See information important.
• 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 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 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 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

The most common side effects 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. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.