Buy Enjaymo (sutimlimab)

What is Enjaymo (sutimlimab) for?

Enjaymo (sutimlimab) is a classical complement inhibitor indicated to decrease the need for red blood cell transfusion due to hemolysis (red blood cell destruction) in adults with cold agglutinin disease (CAD).^[1]

It is available as a single-dose vial each containing 1,100 mg/22 mL (50 mg/mL) sutimlimab.^[1]

How does Enjaymo (sutimlimab) work?

CAD is an autoimmune disorder in which red blood cells are destroyed by the patient’s own body. Patients suffer from anemia (a decreased number of red blood cells) and cold-induced circulatory symptoms, such as pain and discoloration of fingers or toes.^[2]

Sutimlimab, the active ingredient in Enjaymo, is a monoclonal antibody that can bind to and inhibit the protein C1s, which is a part of the classical complement pathway. This pathway is involved in activating immune cells and promoting inflammation.^[2,3]

By blocking C1s, Enjaymo can inhibit the complement pathway, thereby blocking C1-activated hemolysis (red blood cell destruction).^[3]

Where has Enjaymo (sutimlimab) been approved?

Enjaymo (sutimlimab) was approved for the treatment of people with CAD by:

• The Food and Drug Administration (FDA), USA on February 4, 2022.^[4]

Enjaymo (sutimlimab) was granted orphan drug designation, breakthrough therapy designation and priority review.^[4]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Enjaymo (sutimlimab) taken?

The standard dosage is based on body weight:^[1]

• For patients weighing 39 kg to less than 75 kg: 6,500 mg
• For patients weighing 75 kg or more: 7,500 mg

Enjaymo is given through a vein by intravenous (I.V.) infusion. You will be given a starting dose, and 1 week thereafter a second dose. After the second dose, you will receive a dose every 2 weeks. The dosage should be given at the exact time points, or within two days of these time points.^[1]

If you have missed a dose, you should receive the dosage as soon as possible, and resume dosing every two weeks. If the duration after the last dose is more than 17 days, you should receive Enjaymo once a week for two weeks, and every two weeks thereafter.^[1]

Complete information about Enjaymo (sutimlimab) dosage and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Enjaymo (sutimlimab)?

Common adverse reactions

The most common side effects (≥10% of patients) listed in the prescribing information include:^[1]

• Respiratory tract infection
• Viral infection
• Diarrhea
• Dyspepsia
• Cough
• Arthralgia
• Arthritis
• Peripheral edema

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• Serious infections
• Infusion-related reactions
• Increased risk for developing autoimmune diseases such as systemic lupus erythematosus (SLE)
• Recurrent hemolysis after you stop treatment

Use in a specific population

It is not known if Enjaymo will harm your unborn baby or whether it passes into your breast milk. Talk to you treating doctor if you are pregnant or planning to be pregnant or if you are breastfeeding.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [FDA]: Enjaymo (sutimlimab) [PDF] Sanofi, Feb 2022

2. FDA approves Enjaymo™ (sutimlimab-jome), first treatment for use in patients with cold agglutinin disease
Sanofi press release, Feb 2022

3. Sutimlimab in Cold Agglutinin Disease
Röth, A et al., NEJM, Apr 2021

4. FDA approves treatment for adults with rare type of anemia
FDA press release, Feb 2022