Brand Name
Enjaymo
Generic Name
Sutimlimab-Jome
View Brand Information FDA approval date: February 04, 2022
Classification: Classical Complement Pathway Inhibitor
Form: Injection
What is Enjaymo (Sutimlimab-Jome)?
ENJAYMO is a classical complement inhibitor indicated for the treatment of hemolysis in adults with cold agglutinin disease . Cold Agglutinin Disease ENJAYMO is indicated for the treatment of hemolysis in adults with cold agglutinin disease .
Approved To Treat
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Brand Information
Enjaymo (sutimlimab-jome)
1DOSAGE FORMS AND STRENGTHS
Injection: 1,100 mg/22 mL (50 mg/mL) as a clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial.
2CONTRAINDICATIONS
ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients
3ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Serious Infections
- Infusion-Related Reactions
- Risk of Autoimmune Disease
- Recurrent Hemolysis After ENJAYMO Discontinuation
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of ENJAYMO in patients with a confirmed diagnosis of CAD was evaluated in a placebo-controlled study (CADENZA) in Part A (n=42) followed by an open-label single-arm study in Part B (n=39) and an open-label single-arm study (CARDINAL) (n=24)
4DESCRIPTION
Sutimlimab-jome, a classical complement inhibitor, is a humanized monoclonal antibody expressed by recombinant in Chinese hamster ovary (CHO) cells and produced
ENJAYMO (sutimlimab-jome) injection is a sterile, clear to slightly opalescent, colorless to slightly yellow, preservative-free solution for intravenous use. Each single-dose vial contains 1,100 mg sutimlimab-jome at a concentration of 50 mg/mL with a pH of 6.1. Each mL contains 50 mg of sutimlimab-jome and also contains polysorbate 80 (0.2 mg), sodium chloride (8.18 mg), sodium phosphate dibasic heptahydrate (0.48 mg), sodium phosphate monobasic monohydrate (1.13 mg), and Water for Injection, USP.
5PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
6PRINCIPAL DISPLAY PANEL - 1,100 mg/22 mL Vial Carton
NDC 55292-820-01
Enjaymo
1,100 mg/22 mL (50 mg/mL)
For Intravenous Infusion
Attention Pharmacist:
One single-dose vial
RECORDATI
