Enjaymo 50 mg/mL intravenous solution

Generic name:
Sutimlimab - injection

Pronunciation
(soo-TIM-li-mab)

Brand name(s)
Enjaymo

Sutimlimab is used to treat a certain rare blood disorder (cold agglutinin disease). This disease causes your body's immune system to break down red blood cells, which results in anemia. Sutimlimab works by helping to block the body's breakdown of red blood cells. This effect helps lessen symptoms of anemia (such as tiredness) and may reduce the need for blood transfusions.

Read the Medication Guide provided by your pharmacist before you start using sutimlimab and each time you get a treatment. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually once a week for the first 2 doses, then once every 2 weeks after that. The dosage is based on your medical condition, weight, and response to treatment.

Infusion reactions may happen during the infusion of this drug. Tell your doctor right away if you have any symptoms of infusion reactions such as itching, rash, flushing, rapid heartbeat, chest pain, shortness of breath, dizziness/lightheadedness, headache, or nausea. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Do not stop using this medication without consulting your doctor. Your condition may become worse when the drug is stopped. If you do stop using this medication, your doctor will monitor you to make sure your condition does not get worse. Consult your doctor for more details.

Tell your doctor if your condition does not get better or if it gets worse.

See also How to Use section.

Headache, tiredness, swelling hands/ankles/feet, stuffy/runny nose, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• aching/swollen joints
• rash on nose and cheeks
• burning/painful/frequent/urgent urination

This medication may lower your ability to fight infections. This may make you more likely to get serious (possibly fatal) infections such as meningitis or sepsis. Get medical help right away if you develop symptoms such as:

• nausea/vomiting that doesn't stop
• fever
• chills
• severe headache
• stiff neck
• mental/mood changes (such as confusion)
• muscle aches with flu-like symptoms
• eye sensitivity to light

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using sutimlimab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• current/recent infection (including hepatitis, HIV)
• immune system problems (autoimmune disorders such as lupus)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Sutimlimab can make you more likely to get certain infections (such as flu, meningitis, pneumonia). Talk to your doctor for more details.

Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Your doctor may direct you to have any required vaccines at least 2 weeks before starting this medication. Tell your health care professional that you are using sutimlimab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as LDH level, bilirubin level, complete blood count) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.