Sutimlimab-jome (soo-TIM-li-mab - jome)

Treats the breakdown of red blood cells (hemolysis) in patients with cold agglutinin disease (CAD).

Brand Name(s):

Enjaymo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. It must be injected slowly, so your IV will need to stay in place for 1 to 2 hours.
• A nurse or other health provider will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have lupus, any type of infection, or a history of HIV infection or hepatitis B or C.
• This medicine may cause the following problems:
  • Infusion-related reactions
  • Increase risk of autoimmune disease, including systemic lupus erythematosus (SLE)
• This medicine can increase your risk for serious infections, including meningitis, pneumonia, and influenza. You will need to be vaccinated against bacterial infections at least 2 weeks before you start treatment with this medicine. You may also receive additional vaccines during treatment with this medicine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Back pain, fast heartbeat, headache, nausea, trouble breathing
• Blisters or itching, chest pain, hair loss, muscle or joint pain, swollen glands
• Chest pain, confusion, drowsiness, loss of appetite, unusual tiredness or weakness, vomiting
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Stomach upset

If you notice other side effects that you think are caused by this medicine, tell your doctor

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