Sutimlimab

What is Sutimlimab?

• Sutimlimab (Enjaymo) is a classical complement inhibitor used to decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease.

What are the uses of this medicine?

• Sutimlimab (Enjaymo) is a prescription medicine used to decrease the need for red blood cell transfusion due to the breakdown of red blood cells (hemolysis) in adults with cold agglutinin disease (CAD).

How does this medicine work?

• A preparation of autologous CD8+ T lymphocytes targeting SLC45A2, a melanoma-associated antigen, with potential immunomodulating and antineoplastic activities.
• Following peripheral blood mononuclear cell (PBMC) collection and ex vivo expansion of SLC45A2-specific cytotoxic T-lymphocytes (CTLs), sutimlimab is re-infused into the patient, where they target and lyse SLC45A2-expressing tumor cells.
• While SLC45A2 is expressed by approximately 80% of cutaneous melanomas, its expression is limited in mature normal melanocytes, allowing high tumor selectivity and reduced potential for autoimmune toxicity.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted.

Is this medicine FDA approved?

• Sutimlimab was approved for medical use in the United States in February 2022.

How should this medicine be used?

• Vaccinate against encapsulated bacteria at least two weeks prior to treatment.

Recommended dosage:

• The recommended dosage of Enjaymo for patients with CAD is based on body weight.

Weight-based dosage weekly for two weeks then every two weeks:

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

Administration:

• Enjaymo is given through a vein by intravenous (I.V.) infusion, usually over 1 to 2 hours.
• You will usually receive a starting dose of Enjaymo, followed by a second dose of Enjaymo 1 week later. Then 2 weeks after your second dose, you will start to receive an Enjaymo infusion every 2 weeks.
• After your first infusion, you should be monitored for infusion and allergic reactions for at least 2 hours. For all future infusions, you should be monitored for infusion reactions for 1 hour.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 1,100 mg/22 mL (50 mg/mL) in a single-dose vial

This medicine is available in fallowing brand namesː

• Enjaymo

What side effects can this medication cause?

The most common side effects of this medicine include:

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

Enjaymo can cause serious side effects, including:

• Serious infections
• Infusion-related reactions
• Risk of autoimmune disease

What special precautions should I follow?

• Enjaymo may increase susceptibility to serious infections, including infections caused by encapsulated bacteria such as Neisseria meningitides (any serogroup), Streptococcus pneumoniae, and Haemophilus influenzae. Ensure patients are vaccinated against encapsulated bacteria. Monitor patients for early signs and symptoms of infections.
• Enjaymo is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients. Monitor patients for infusion-related reactions, interrupt if reaction occurs, and institute appropriate medical management as needed.
• Based on its mechanism of action, Enjaymo may potentially increase the risk for developing autoimmune diseases such as systemic lupus erythematosus (SLE). Monitor patients for signs and symptoms and manage medically.
• Monitor patients for signs and symptoms of hemolysis if treatment with Enjaymo is interrupted. Consider restarting Enjaymo if signs and symptoms of hemolysis occur after discontinuation.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on Enjaymo use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• It is not known if Enjaymo will harm your unborn baby.

Can this medicine be used in children?

• It is not known if Enjaymo is safe and effective in children.

What are the active and inactive ingredients in this medicine?

• Active ingredient: sutimlimab-jome
• Inactive ingredients: polysorbate 80, sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, and Water for Injection, USP.

Who manufactures and distributes this medicine?

• Manufactured by: Bioverativ USA Inc., Waltham, MA . A SANOFI COMPANY.

What should I know about storage and disposal of this medication?

• Store Enjaymo vials refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
• Do not freeze.
• Do not shake.
• Discard unused portion.

• Dailymed label info on Sutimlimab
• FDA Sutimlimab

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