Enjaymo
Enjaymo (sutimlimab or sutimlimab-jome) is a newly-approved medication used to lower the need for blood transfusions in adults with a rare form of anemia called cold agglutinin disease (CAD). It's given as an infusion into the veins by a healthcare provider.
What is Enjaymo (sutimlimab)?
What is Enjaymo (sutimlimab) used for?
- Cold agglutinin disease (CAD)
How Enjaymo (sutimlimab) works
Enjaymo (sutimlimab) is a complement inhibitor. It works by attaching to certain proteins in your immune system. This prevents them from being activated so your immune system can't attack your own red blood cells by mistake, which is what happens in CAD. This helps treat symptoms of CAD.
Drug facts
Side effects of Enjaymo (sutimlimab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Respiratory tract infection (25%)
- Viral infection (13%)
- Cough (13%)
- Joint pain (13%)
- Swelling in arms or legs (13%)
- Diarrhea (13%)
- Upset stomach (13%)
Less Common Side Effects
- Feeling tired
- Headache
- Infusion reaction
- Urinary tract infection (UTI)
- High blood pressure
Enjaymo (sutimlimab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious infections: fever, difficulty breathing, headache, weakness, confusion, sweating, chills, stiff neck, fast heart rate, muscle aches, diarrhea
- Severe allergic reaction: hives; swelling of the lips, tongue, or face; difficulty breathing; chest pain
- Infusion reaction: shortness of breath, fast heartbeat, flushing, headache, nausea
The following Enjaymo (sutimlimab) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
- Lupus-like syndrome—joint pain, swelling, or stiffness, butterfly-shaped rash on the face, rashes that get worse in the sun, fever, unusual weakness or fatigue
- Raynaud's—cool, numb, or painful fingers or toes that may change color from pale, to blue, to red
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Dizziness
- Headache
- Increase in blood pressure
- Nausea
- Swelling of the ankles, hands, or feet
Pros and cons of Enjaymo (sutimlimab)
Pros
- Given every 2 weeks (after the first 2 doses)
- Works well to raise hemoglobin levels
- Can lower the number of blood transfusions needed in people with CAD
Cons
- Needs to be given by a healthcare provider as an IV infusion
- Requires monitoring for up to 2 hours after each infusion for allergic reactions
- Hasn't been studied in children younger than 18 years old
Pharmacist tips for Enjaymo (sutimlimab)
- Mark your appointments on your calendar to help you remember to receive your Enjaymo (sutimlimab) infusions on time and get lab work done when instructed. By doing so, your provider can properly monitor how well Enjaymo (sutimlimab) is working for you and if you're having any side effects.
- Try to avoid missing any appointments for your Enjaymo (sutimlimab) infusions so the medication can work the best it can for you. If you happen to miss an infusion, call your provider right away to reschedule.
- Bring a book or something to pass the time during your Enjaymo (sutimlimab) infusion appointments since it can take a few hours until you're finished.
- Make sure to keep a record of all your immunizations, and show it to your provider before starting Enjaymo (sutimlimab). This is helpful for your provider to see what vaccines you still need before starting treatment. Getting the appropriate vaccines before starting Enjaymo (sutimlimab) can help prevent serious infections from happening while you take the medication.
- Don't stop taking Enjaymo (sutimlimab) without speaking with your provider first. If you stop taking Enjaymo (sutimlimab) too suddenly, your symptoms could come back.
Common questions about Enjaymo (sutimlimab)
Cold agglutinin disease (CAD) is a rare, autoimmune form of anemia. This blood condition happens when your immune system attacks and destroys your red blood cells by mistake. In CAD, the term "cold" is used because the attack on your red blood cells specifically happens when you're exposed to cold temperatures (about 32 to 50 degrees Fahrenheit). Symptoms of CAD include feeling tired, weakness, pale skin, joint pain, and bluish or reddish color of skin. Enjaymo (sutimlimab) helps treat CAD by lowering the activity of your immune system so that it doesn't mistakenly attack your red blood cells.
In general, you can expect your Enjaymo (sutimlimab) infusion to take about 1 to 2 hours. The exact amount of time depends on your dose, body weight, and how well you're tolerating the medication. After your infusion is complete, you'll need to stay at your provider's office for another 1 to 2 hours so your provider can watch for signs and symptoms of severe infusion or allergic reactions.
If you haven't already done so, you'll need to receive vaccines for protection against three bacteria: Streptococcus pneumoniae (pneumonia vaccine), Neisseria meningitidis (meningitis vaccine), and Haemophilus influenzae (Hib vaccine). This is because Enjaymo (sutimlimab) can raise your risk for serious infections. You must receive these vaccines at least 2 weeks before starting Enjaymo (sutimlimab) treatment. If your provider decides you need to start Enjaymo (sutimlimab) right away, it's important to get these vaccines as soon as possible to prevent infections.
In clinical studies, 63% of people taking Enjaymo (sutimlimab) for 26 weeks had higher hemoglobin levels (a protein in your red blood cells that carries oxygen). Additionally, 71% of people taking Enjaymo (sutimlimab) didn't need to receive any blood transfusions from week 5 through 26 weeks of treatment.
There haven't been any studies looking at how Enjaymo (sutimlimab) affects humans during pregnancy, so it's not known how safe it is. In animal studies, Enjaymo (sutimlimab) didn't cause harm to mothers or babies when pregnant mothers received doses higher than the typical human dose. It's important to note that what happens in animals might not always happen in humans. If you're pregnant or thinking of becoming pregnant, talk to your provider about the risks and benefits of Enjaymo (sutimlimab) before starting treatment.
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Risks and warnings for Enjaymo (sutimlimab)
Enjaymo (sutimlimab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious infections
Enjaymo (sutimlimab) can affect your body's ability to fight off infections. This can raise your risk of serious or life-threatening infections like pneumonia, meningitis (infection of brain and spinal cord), and Hib disease. To lower your risk of infection, you'll need to get the pneumonia (or pneumococcal) vaccine, the meningitis (or meningococcal) vaccine, and the Hib vaccine at least 2 weeks before starting Enjaymo (sutimlimab). Your provider will routinely monitor you for infections before and during treatment. If you get an infection, you might have to stop taking Enjaymo (sutimlimab) so your body can fight it off with proper treatment. Get medical help right away if you have symptoms of an infection such as fever, cough, difficulty breathing, weakness, sweating, chills, or diarrhea while taking Enjaymo (sutimlimab).
Allergic or infusion reactions
Severe allergic reactions to Enjaymo (sutimlimab) are possible, including life-threatening reactions like facial swelling, hives, and anaphylaxis (e.g., closing of the throat). Enjaymo (sutimlimab) can also cause infusion reactions. If you notice dizziness; fast heartbeat; headache; nausea; flushing; swelling around your eyes, lips, or tongue; or difficulty breathing at any time during Enjaymo (sutimlimab) treatment, get medical attention right away. Your provider will monitor you for up to 2 hours after each infusion to make sure you don't have any serious reactions.
Autoimmune problems
Based on how Enjaymo (sutimlimab) works, it's possible that the medication can raise your risk for other autoimmune problems, such as lupus. Your provider will monitor you for other autoimmune problems while you're taking Enjaymo (sutimlimab).
Return of CAD symptoms
After your provider determines you no longer need to take Enjaymo (sutimlimab), you'll still need to see your provider and be monitored to make sure your CAD symptoms don't come back. Contact your provider if you notice you're having CAD symptoms (e.g., feeling tired, shortness of breath, bloody or dark urine, racing heart, bluish or reddish color of skin). You might have to restart Enjaymo (sutimlimab).
Enjaymo (sutimlimab) dosage
Typical dosage for Enjaymo (sutimlimab)
Dosing depends on your body weight.
- 85 lbs to less than 165 lbs: The typical dose is 6,500 mg injected into the veins (intravenous or IV) once per week for 2 weeks, then every 2 weeks thereafter.
- 165 lbs or greater: The typical dose is 7,500 mg given IV once per week for 2 weeks, then every 2 weeks thereafter.
Enjaymo (sutimlimab) images
