Is Sutimlimab approved by the FDA?

The FDA approved Sutimlimab (Enjaymo) on February 4, 2022. This approval marked an important development for patients with CAD, offering a targeted treatment to manage hemolysis associated with the disease.

How Sutimlimab Works

Sutimlimab works by inhibiting a component of the immune system called the classical complement pathway, which plays a role in the destruction of red blood cells in CAD patients. By blocking this pathway, Sutimlimab helps prevent hemolysis and the associated symptoms.

Usage and Dosage

Sutimlimab is administered as an intravenous (IV) infusion. The dosing regimen is based on the patient's weight:

• For patients weighing 39 to less than 75 kg:
  • Initial dose: 6500 mg IV once a week for the first 2 weeks.
  • Maintenance dose: 6500 mg IV every 2 weeks thereafter.
• For patients weighing at least 75 kg:
  • Initial dose: 7500 mg IV once a week for the first 2 weeks.
  • Maintenance dose: 7500 mg IV every 2 weeks thereafter.

Administration and Monitoring

Sutimlimab infusions are administered by a healthcare provider over 1 to 2 hours. Patients are monitored closely during and after the infusion for any adverse reactions. Regular medical tests and examinations are required to monitor the patient's response and manage any potential side effects.

Side Effects

Common side effects of Sutimlimab include:

• Dizziness, feeling tired or weak.
• Cold symptoms such as stuffy or runny nose, sneezing, sore throat, cough.
• Headache, nausea.
• Blue-colored lips and skin.
• Joint pain.
• Increased blood pressure.
• Pain and burning during urination.
• Numbness, cold feeling, or pale appearance of fingers or toes.
• Swelling in hands or lower legs.
• Infection.

Serious side effects requiring immediate medical attention include:

• Allergic reactions (hives, difficulty breathing, swelling of face, lips, tongue, or throat).
• Symptoms during the injection (dizziness, nausea, light-headedness, itching, sweating, headache, chest tightness, back pain, trouble breathing, swelling in the face).
• Signs of infection (fever, chills, sore throat, mouth sores, red or swollen gums, pale skin, easy bruising, unusual bleeding, chest discomfort, wheezing, dry cough, rapid weight loss).
• Symptoms of lupus (joint pain or swelling with fever, headaches, chest pain, shortness of breath, skin rash on face or arms that worsens in sunlight).

Warnings and Precautions

Patients may become more susceptible to infections while receiving Sutimlimab. It's important to be current on all vaccinations that protect against serious bacterial infections at least 2 weeks before starting treatment. Additional vaccinations or booster doses may be required during treatment.

Patients should inform their doctor if they have:

• Chronic or recent infections.
• Fever.
• HIV, hepatitis B or C.
• An autoimmune disease such as lupus.
• Recently received a vaccine or are scheduled to receive a vaccine.

Conclusion

Sutimlimab (Enjaymo) is FDA approved as of February 4, 2022, for the treatment of hemolysis in adults with cold agglutinin disease. This targeted therapy offers a significant advancement for managing CAD, providing relief from hemolysis and its associated symptoms. Regular monitoring and adherence to the treatment regimen are crucial for optimizing outcomes and managing side effects.

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