JOIN US AT THE ASH ANNUAL MEETING FOR A PRESENTATION ON ENJAYMO  |  MONDAY 12/12 @ 8 am

Not an official event of the 64th ASH Annual Meeting and Exposition. This presentation is not sponsored or endorsed by ASH. Not CME-accredited. MAT-US-2208046-v1.0-11/2022

VISIT US AT ASH  |  DECEMBER 10-13  |  BOOTH #643

Not an official event of the 64th ASH Annual Meeting and Exposition. This presentation is not sponsored or endorsed by ASH. Not CME-accredited. MAT-US-2208046-v1.0-11/2022

Dosing once every 2 weeks with ENJAYMO1

Patients can receive an infusion 3 ways*

in office

In office

infusion center

At an infusion center

home

At home

*Subject to coverage requirements and physical determination.

The recommended dosing regimen for adults with Cold Agglutinin Disease (CAD) consists of an initial dose and a dose 1 week later, followed by 1 dose every 2 weeks. ENJAYMO is for IV infusion only.

Administer ENJAYMO at the recommended dosage regimen time points or within 2 days of these time points

ENJAYMO dosing

Interruptions in ENJAYMO treatment

  • If a dose is missed, administer as soon as possible and resume dosing every 2 weeks
  • If the duration after the last dose exceeds 17 days, administer weekly for 2 weeks, with administration every 2 weeks thereafter
Recurrence of chronic hemolysis has been observed with discontinuation of ENJAYMO2

Administration of ENJAYMO1

The dose for ENJAYMO infusion is weight based. ENJAYMO is supplied as one 1100 mg/22 mL (50 mg/mL) single-dose vial per carton.

scale

WEIGHT-BASED INFUSION

6500 mg FOR PATIENTS 39 kg TO <75 kg
7500 mg FOR PATIENTS 75 kg

Body weight range 39 kg to <70 kg 70 kg to <75 kg 75 kg
Dose 6500 mg 6500 mg 7500 mg
Number of ENJAYMO
vials needed
6 6 7
ENJAYMO
volume
130 mL 130 mL 150 mL
Volume of
NaCl diluent
370 mL 370 mL 350 mL
Total volume 500 mL 500 mL 500 mL
Maximum
infusion rate
250 mL/hour 500 mL/hour 500 mL/hour

Patients with cardiopulmonary disease should receive the infusion over 120 minutes.

Slow or stop the infusion in case of an infusion reaction during ENJAYMO administration

What to know before, during, and after an infusion1

Before: vaccinate
BEFORE INITIATION

Ensure vaccination status aligns with ACIP recommendations for persistent complement deficiencies. If urgent ENJAYMO therapy is indicated in an unvaccinated patient, administer vaccine(s) as soon as possible.

Immunize at least 2 weeks before first dose of ENJAYMO.

Vaccination reduces, but does not eliminate, infection risk.

During: infuse
DURING INFUSION

Monitor for infusion-related reactions like shortness of breath, rapid heartbeat, nausea, flushing, and headache.

Slow or stop the infusion if an infusion reaction occurs and institute appropriate supportive measures.

After: Monitor
AFTER INFUSION

Following initial infusion, monitor for 2 hours for signs or symptoms of an infusion and/or hypersensitivity reaction.

For subsequent ENJAYMO infusions, monitor for 1 hour for signs of an infusion reaction.

Patients in CARDINAL were given the following vaccinations if they did not have documentation of vaccination in the 5 years prior to enrollment: meningococcal conjugate vaccine (MenACWY), meningococcal type B vaccine (MenB), Streptococcus pneumoniae vaccination, and Haemophilus influenzae.

4 steps to infusing ENJAYMO1

Prepare ENJAYMO

Use aseptic technique to prepare ENJAYMO. Withdraw the calculated volume of ENJAYMO from the appropriate number of single-use vials based on the recommended dosage and dilute with 0.9% Sodium Chloride Injection, USP to a total volume of 500 mL.

Key Reminders

  • To minimize foaming, do not shake ENJAYMO
  • ENJAYMO is a clear to slightly opalescent and colorless to slightly yellow solution. Do not administer if discolored or if foreign particulate matter is present
  • Discard unused portion of ENJAYMO
Administer within 8 hours

Allow the ENJAYMO infusion solution to adjust to room temperature 68 °F to 77 °F (20 °C to 25 °C) and administer within 8 hours.

Key Reminders

  • 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 shake1
  • If the ENJAYMO infusion solution is not used immediately, store refrigerated at 36 °F to 46 °F (2 °C to 8 °C)
  • Total time from the time of preparation, including refrigeration, adjustment to room temperature, and the expected infusion time, should not exceed 36 hours1
Prime infusion tube

Prime the infusion tubing with the dosing solution immediately before infusion and flush immediately following completion of the infusion with a sufficient quantity (approximately 20 mL) of 0.9% Sodium Chloride Injection, USP.

Key Reminder

  • In-line infusion warmers may be used, but should not exceed a temperature of 104 °F (40 °C)
infuse over 1 to 2 hours

Administer the ENJAYMO infusion over 1 to 2 hours (depending on the patient’s body weight) and only administer through a 0.2 micron in-line filter with a PES membrane.

Key Reminder

  • Patients with cardiopulmonary disease should receive the infusion over 2 hours regardless of body weight

IMPORTANT SAFETY INFORMATION AND INDICATION

CONTRAINDICATIONS

ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients.

WARNINGS AND PRECAUTIONS

Serious Infections

  • ENJAYMO may increase susceptibility to serious infections, including infections caused by encapsulated bacteria such as Neisseria meningitides (any serogroup), Streptococcus pneumoniae, and Haemophilus influenzae.
  • Serious infections (bacterial and viral) were reported in 17% (4/24) of patients receiving ENJAYMO in a single-arm open-label clinical trial.
  • 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 least 2 weeks prior to receiving the first dose of ENJAYMO. If urgent ENJAYMO therapy is indicated in an unvaccinated patient, administer vaccine(s) as soon as possible.
  • If ENJAYMO treatment is administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection. Some infections may become rapidly life-threatening or fatal if not recognized and treated promptly. Inform patients of these signs and symptoms and steps to be taken to seek immediate medical care.
    • Consider interruption of ENJAYMO treatment in patients who are undergoing treatment for serious infection.
    • Consider patients’ immune status when initiating treatment with ENJAYMO.

Infusion-Related Reactions

  • Administration of ENJAYMO may result in infusion-related reactions. In the CARDINAL study, 8% (2/24) of patients treated with ENJAYMO experienced infusion-related reactions.
  • Monitor patients for infusion-related reactions and interrupt if a reaction occurs.
  • Discontinue ENJAYMO infusion and institute appropriate supportive measures if signs of hypersensitivity reactions, such as cardiovascular instability or respiratory compromise, occur.

Risk of Autoimmune Disease

  • Based on its mechanism of action, ENJAYMO may potentially increase the risk for developing autoimmune diseases such as systemic lupus erythematosus (SLE). Development of SLE has been associated with inherited classical complement deficiency.
  • Monitor patients being treated with ENJAYMO for signs and symptoms and manage medically.

Recurrent Hemolysis After ENJAYMO Discontinuation

  • If treatment with ENJAYMO is interrupted, closely monitor patients for signs and symptoms of recurrent hemolysis, e.g., elevated levels of total bilirubin or lactate dehydrogenase (LDH) accompanied by a decrease in hemoglobin, or reappearance of symptoms such as fatigue, dyspnea, palpitations, or hemoglobinuria. Consider restarting ENJAYMO if signs and symptoms of hemolysis occur after discontinuation.

ADVERSE REACTIONS

  • The most common adverse reactions (10%) with ENJAYMO were respiratory tract infection, viral infection, diarrhea, dyspepsia, cough, arthralgia, arthritis, and peripheral edema.

INDICATION

ENJAYMO (sutimlimab-jome) is indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD).


Please see full Prescribing Information.

See the full Medication Guide.

Learn more about Sanofi’s commitment to fighting counterfeit drugs.

ACIP=Advisory Committee on Immunization Practices; CAD=Cold Agglutinin Disease; IV=intravenous; PES=polyethersulfone; USP=United States Pharmacopeia.
References:
  1. ENJAYMO. Prescribing information. Genzyme Corporation.
  2. Röth A, Barcellini W, D’Sa S, et al. Sutimlimab in Cold Agglutinin Disease. N Engl J Med. 2021;384(14):1323-1334. doi:10.1056/NEJMoa2027760
expand arrow

IMPORTANT SAFETY INFORMATION AND INDICATION

CONTRAINDICATIONS

ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients.

WARNINGS AND PRECAUTIONS

Serious Infections

  • ENJAYMO may increase susceptibility to serious infections, including infections caused by encapsulated bacteria such as Neisseria meningitides (any serogroup), Streptococcus pneumoniae, and Haemophilus influenzae.
  • Serious infections (bacterial and viral) were reported in 17% (4/24) of patients receiving ENJAYMO in a single-arm open-label clinical trial.
  • 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 least 2 weeks prior to receiving the first dose of ENJAYMO. If urgent ENJAYMO therapy is indicated in an unvaccinated patient, administer vaccine(s) as soon as possible.
  • If ENJAYMO treatment is administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection. Some infections may become rapidly life-threatening or fatal if not recognized and treated promptly. Inform patients of these signs and symptoms and steps to be taken to seek immediate medical care.
    • Consider interruption of ENJAYMO treatment in patients who are undergoing treatment for serious infection.
    • Consider patients’ immune status when initiating treatment with ENJAYMO.

Infusion-Related Reactions

  • Administration of ENJAYMO may result in infusion-related reactions. In the CARDINAL study, 8% (2/24) of patients treated with ENJAYMO experienced infusion-related reactions.
  • Monitor patients for infusion-related reactions and interrupt if a reaction occurs.
  • Discontinue ENJAYMO infusion and institute appropriate supportive measures if signs of hypersensitivity reactions, such as cardiovascular instability or respiratory compromise, occur.

Risk of Autoimmune Disease

  • Based on its mechanism of action, ENJAYMO may potentially increase the risk for developing autoimmune diseases such as systemic lupus erythematosus (SLE). Development of SLE has been associated with inherited classical complement deficiency.
  • Monitor patients being treated with ENJAYMO for signs and symptoms and manage medically.

Recurrent Hemolysis After ENJAYMO Discontinuation

  • If treatment with ENJAYMO is interrupted, closely monitor patients for signs and symptoms of recurrent hemolysis, e.g., elevated levels of total bilirubin or lactate dehydrogenase (LDH) accompanied by a decrease in hemoglobin, or reappearance of symptoms such as fatigue, dyspnea, palpitations, or hemoglobinuria. Consider restarting ENJAYMO if signs and symptoms of hemolysis occur after discontinuation.

ADVERSE REACTIONS

  • The most common adverse reactions (10%) with ENJAYMO were respiratory tract infection, viral infection, diarrhea, dyspepsia, cough, arthralgia, arthritis, and peripheral edema.

INDICATION

ENJAYMO (sutimlimab-jome) is indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD).


Please see full Prescribing Information.

See the full Medication Guide.

Learn more about Sanofi’s commitment to fighting counterfeit drugs.