Enjaymo (Sutimlimab-Jome) for Autoimmune Hemolytic Anemia

Enjaymo (sutimlimab-jome) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for treating hemolysis in adults with cold agglutinin disease (CAD), a type of autoimmune hemolytic anemia (AIHA).

How Enjaymo Works and How It’s Taken

Enjaymo is a type of medicine called a monoclonal antibody. It works by blocking a protein called C1s, which is part of the immune system’s classical complement pathway. In people with cold agglutinin disease, blocking C1s helps prevent the breakdown of red blood cells, also called hemolysis.

Doctors prescribe Enjaymo when an adult has CAD and needs treatment for hemolysis.

Enjaymo is given through an intravenous (IV) infusion.

Typical Dosing for Cold Agglutinin Disease

The recommended dose of Enjaymo for CAD is based on body weight. Infusions typically take one to two hours. The dosing schedule is:

39 kilograms to less than 75 kilograms — Receive 6,500 milligrams by IV infusion on day 0, day 7, and then every two weeks.
75 kilograms or more — Receive 7,500 milligrams by IV infusion on day 0, day 7, and then every two weeks.

This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Enjaymo Side Effects

In clinical studies of Enjaymo in adults with CAD, the following common side effects occurred in at least 18 percent of participants in one or both studies:

Runny nose
Headache
High blood pressure
Bluish color to the lips and skin
Raynaud’s phenomenon (changes in color or sensation in the fingers and toes)
Urinary tract infection
Respiratory tract infection
Bacterial infection
Dizziness
Fatigue
Swelling in the lower legs or hands
Joint pain
Cough
Nausea

Serious Side Effects and Warnings

Enjaymo can cause serious side effects that may require immediate medical attention. These include:

Serious infections — Enjaymo may make it harder for your immune system to fight infections, including serious infections caused by certain bacteria.
Infusion-related reactions — These may happen during or after an infusion and cause trouble breathing, a fast heartbeat, flushing, low blood pressure, rash, itching, or chest discomfort.
Risk of autoimmune disease — The immune system may start attacking the body’s own tissues, potentially causing conditions such as systemic lupus erythematosus (lupus).

Get medical help right away if you think you are having a serious reaction.

How To Save on Enjaymo

Recordati Rare Diseases, the manufacturer of Enjaymo, offers Recordati Rare Diseases Patient Solutions (RRD PS). Eligible people can also ask about the ENJAYMO No Cost Trial Program, which provides 30 days of Enjaymo treatment at no cost.

To learn more, visit the Patient Solutions page or call 833-223-2428.

What To Know Before Taking Enjaymo

Before starting Enjaymo, make sure you are up to date on vaccines against certain encapsulated bacteria, including Streptococcus pneumoniae and Neisseria meningitidis (serogroups A, C, W, Y, and B), at least two weeks before your first dose. If you need urgent treatment, receive these vaccines as soon as possible.

Tell your doctor if you have any allergies to sutimlimab-jome or any ingredients in Enjaymo. Do not receive Enjaymo if you are allergic to sutimlimab-jome or any of its ingredients.

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, and supplements.

Before receiving Enjaymo, tell your healthcare provider about all your medical conditions, including whether you:

Have a fever or infection, or have a history of HIV, hepatitis B, or hepatitis C.
Have an autoimmune disease such as systemic lupus erythematosus (SLE), also known as lupus.

If you miss a dose, get it as soon as possible and then resume dosing every two weeks. If more than 17 days have passed since your last dose, you will need weekly doses for two weeks before returning to dosing every two weeks. Talk to your provider as soon as possible if you miss a dose.

If you are pregnant, planning to become pregnant, or breastfeeding while taking Enjaymo, talk with your doctor about the risks and benefits.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Enjaymo?

In a six-month study of adults with CAD, about 73 percent of people taking Enjaymo met the main treatment goal, compared with 15 percent taking a placebo (an inactive treatment).

In another six-month study, average hemoglobin levels increased by 2.29 grams per deciliter by week 3 and 3.18 grams per deciliter at the treatment assessment time point. That assessment used the average of measurements taken during weeks 23, 25, and 26.

How long does Enjaymo take to work for CAD?

In a clinical study, average hemoglobin levels increased by more than 1 gram per deciliter within the first week after starting Enjaymo, and bilirubin levels fell toward normal. These results suggest that Enjaymo can begin working after the first infusion.

What tests or monitoring are needed with Enjaymo for CAD?

You should be monitored for infusion or allergic reactions for at least two hours after the first infusion and for one hour after later infusions.

If treatment is stopped or interrupted, your healthcare provider will closely monitor you for signs that red blood cell breakdown (hemolysis) has returned. This may include blood tests for total bilirubin, lactate dehydrogenase (LDH), and hemoglobin, along with checking for symptoms such as tiredness, shortness of breath, a rapid heartbeat, or dark urine.

Your healthcare provider will also monitor you for signs and symptoms of serious infections and autoimmune disease.