Sutimlimab

Sutimlimab is a prescription medicine used for the treatment of hemolysis in adults with cold agglutinin disease (CAD).

• Sutimlimab is available under the following different brand names: sutimlimab-jome, Enjaymo

Common side effects of Sutimlimab include:

• respiratory tract infection, 
• viral infection, 
• diarrhea, 
• stomach pain or indigestion, 
• cough, 
• joint pain,
• joint inflammation, and
• swelling of the lower legs, ankles, and feet

Serious side effects of Sutimlimab include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• muscle aches, 
• flu-like symptoms, 
• severe swelling, pain and redness around the injection site or a wound, 
• joint pain or swelling, 
• fever,  
• shortness of breath, 
• rapid heartbeat, and
• rash

Rare side effects of Sutimlimab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 50 mg/mL (22 mL/single-dose vial)

Cold Agglutinin Disease

Adult dosage

• 39 to below 75 kg: 6500 mg IV weekly for first 2 weeks, then every 2 weeks thereafter
• Above 75 kg: 7500 mg IV weekly for first 2 weeks, then every 2 weeks thereafter
• Administer at or within 2 days of the scheduled dose

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Sutimlimab has no noted severe interactions with any other drugs.
• Sutimlimab has no noted serious interactions with any other drugs
• Sutimlimab has no noted moderate interactions with any other drugs.
• Sutimlimab has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to sutimlimab or inactive ingredients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sutimlimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sutimlimab?”

Cautions

• Monitor for infusion-related reactions and interrupt if a reaction occurs; discontinue the infusion and institute appropriate supportive measures if signs of hypersensitivity reactions (eg, cardiovascular instability, respiratory compromise) occur
• May potentially increase the risk of developing autoimmune diseases such as systemic lupus erythematosus; monitor for signs and symptoms and manage medically
• Monitor for signs and symptoms of hemolysis such as elevated levels of total bilirubin or lactate dehydrogenase accompanied by decreased hemoglobin, or reappearance of symptoms such as fatigue, dyspnea, palpitations, or hemoglobinuria; consider restarting infusion if signs and symptoms of hemolysis occur after discontinuing
• Serious infections
  • May increase susceptibility to serious infections, including infections caused by encapsulated bacteria such as Neisseria meningitidis (any serogroup), Streptococcus pneumoniae, and Haemophilus influenzae
  • Serious bacterial and viral infections were reported; infections included sepsis and respiratory and skin infections
  • Vaccination reduces but does not eliminate, risk of encapsulated bacterial infections; some infections may become rapidly life-threatening or fatal if not recognized or treated promptly
  • Inform patients of signs and symptoms of infections and steps to be taken to seek immediate care
  • Vaccinate patients for encapsulated bacteria according to the most current ACIP recommendations for patients with persistent complement deficiencies; revaccinate patients in accordance with ACIP recommendations
  • Immunize patients without a history of vaccination against encapsulated bacteria at ≥2 weeks before receiving the initial dose
  • If urgent therapy is indicated in an unvaccinated patient, administer vaccine(s) as soon as possible
  • If administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection
  • Consider treatment interruption in patients undergoing treatment for serious infection
  • Not studied in patients with chronic systemic infections such as hepatitis B, hepatitis C, or HIV

Pregnancy and Lactation

• No data are available on use in pregnant females to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Human immunoglobulin G (IgG) antibodies are known to cross the placental barrier; therefore, sutimlimab-jome may be transmitted from the mother to the developing fetus
• Lactation
  • There are no data on the presence of sutimlimab-jome in human milk, its effects on breastfed children, or its effects on milk production
  • Maternal IgG is known to be present in human milk
  • Effects of local gastrointestinal exposure and limited systemic exposure in breastfed children to sutimlimab-jome are unknown