Pronunciation:

soo-TIM-li-mab - jome

Brand Names:

• Enjaymo

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Sutimlimab

Uses of This Medicine:

Sutimlimab-jome injection is used to treat the breakdown of red blood cells (hemolysis) in patients with cold agglutinin disease (CAD).

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of sutimlimab-jome injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sutimlimab-jome injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hepatitis B or C or
• HIV infection or
• Serious infections or
• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for over 1 to 2 hours.

You will usually receive a starting dose of this medicine, followed by a second dose one week later. Then 2 weeks after your second dose, you will receive this medicine every 2 weeks.

You may receive vaccines against bacterial infections at least 2 weeks before receiving this medicine. You may also receive additional vaccines during treatment with this medicine.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have questions.

Missed dose—

Call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely and at regular visits to make sure this medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious infections (eg, meningitis, pneumonia, influenza). Check with your doctor right away if you have chest pain or tightness, chills, confusion, cough, drowsiness, fever, general feeling of illness, joint pain, loss of appetite, muscle aches and pains, nausea, runny nose, severe headache, sore throat, stiff neck, sweating, trouble breathing, unusual tiredness or weakness, or vomiting.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have back pain, chest tightness, chills, fast heartbeat, fever, flushing, headache, nausea, trouble breathing, or weakness.

Using this medicine may increase your risk of having autoimmune disease (eg, systemic lupus erythematosus). Check with your doctor right away if you have blisters or itching, chest pain, fever and chills, general feeling of discomfort or illness, hair loss, headache, muscle or joint pain, skin rash, sore throat, swollen glands, or trouble breathing.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Bladder pain

bloody or cloudy urine

bluish color of the fingernails, lips, skin, palms, or nail beds

blurred vision

chest pain

chills

cough

diarrhea

difficult, burning, or painful urination

dizziness

ear congestion or pain

fever

frequent urge to urinate

head congestion

hoarseness or other voice changes

loss of appetite

lower back or side pain

muscle aches

nausea

nervousness

pounding in the ears

slow or fast heartbeat

stomach pain

stuffy or runny nose

sneezing

sore throat

swelling of the hands, ankles, feet, or lower legs

weakness

Incidence not known

Back pain

blisters or itching

dark urine

decreased urination

general feeling of discomfort or illness

hair loss

skin rash

swollen glands

tiredness

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

difficulty in moving

heartburn

indigestion

muscle pain or stiffness

pain, swelling, or redness in the joints

stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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