Four simple steps to get started with ENJAYMO
Here's how to start your appropriate patients on their ENJAYMO treatment journey
For U.S. Healthcare Professionals Only
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
STEP 1:
Identify if ENJAYMO is an appropriate treatment for your patients
Consider enrolling your patients in Recordati Rare Diseases (RRD) Patient Solutions
Recordati Rare Diseases (RRD) Patient Solutions* is here to support your patients from the start and throughout ENJAYMO treatment
PATIENT SUPPORT SERVICES
Patient Support Services may be able to provide your patients with education services, reimbursement support, and related materials
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FINANCIAL ASSISTANCE PROGRAMS
Recordati Rare Diseases (RRD) Financial Assistance Programs may be able to help with the cost of treatment. Access to ENJAYMO at no cost may be available to eligible patients who are uninsured or underinsured. Co-pay assistance may be available for out-of-pocket co-pay or co-insurance costs related to ENJAYMO prescription for eligible patients*
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- *The Recordati Rare Diseases (RRD) Patient Solutions Co-Pay Program (the “Program”) is not valid for prescriptions covered by or submitted for reimbursement under Medicare, Medicaid, VA, DoD, TRICARE, or similar federal or state programs including any state pharmaceutical assistance programs. The Program is not valid where prohibited by law, and savings may vary depending on patients’ out-of-pocket costs. Recordati Rare Diseases reserves the right to modify or terminate the Program at any time without notice. Patients will receive all Program details upon registration. Approval is not guaranteed. Additional terms and conditions apply.
- DoD=Department of Defense; VA=Department of Veterans Affairs.
Recordati Rare Diseases (RRD) Patient Solutions help is available to you and your patients
Monday through Friday, 8 AM to 8 PM ET, by calling 1-833-223-2428 or enrolling today
STEP 2:
Complete vaccination against encapsulated bacteria1
Complete or update vaccination against encapsulated bacteria, including Streptococcus pneumoniae and Neisseria meningitidis (serogroups A, C, W, Y and B), according to current Advisory Committee on Immunization Practices (ACIP) recommendations for patients receiving complement inhibitors at least 2 weeks prior to initiation of ENJAYMO.
IMMUNIZE AT LEAST 2 WEEKS BEFORE FIRST DOSE OF ENJAYMO—if urgent ENJAYMO therapy is indicated in a patient who is not up to date on their vaccines, administer vaccine(s) as soon as possible.
STEP 3:
Determine your patients’ ENJAYMO infusion plan
Patients can receive an infusion 3 ways, subject to coverage requirements and physician determination:
IN OFFICE
AT AN INFUSION CENTER
AT HOME
Receiving ENJAYMO at home by a nurse may be possible for your patients at no cost. Contact Recordati Rare Diseases Patient Solutions at 1-833-223-2428 for more information and to review eligibility requirements
STEP 4:
Acquire ENJAYMO for your patients
ENJAYMO is available through the following authorized specialty distributors
For more information and ENJAYMO dosing and administration, click here
No Cost Trial Program
Your eligible patients can experience 30 days of ENJAYMO (sutimlimab-jome) treatment at no cost
The ENJAYMO No Cost Trial Program is available regardless of your patient's insurance coverage or current treatment
Enroll your eligible patients* in the No Cost Trial Program
To get started:
*Program Overview
- The No Cost Trial Program can provide a 30-day supply of ENJAYMO at no cost to eligible patients.
- Eligibility for the No Cost Trial Program is contingent on patient enrollment in RRD Patient Solutions.
- There is no obligation for your patient to continue use of ENJAYMO after the No Cost Trial Program has been completed.
- Patients are eligible for the No Cost Trial Program only once per lifetime.
- Shipment of the No Cost Trial Program product is contingent on patients receiving recommended vaccinations and scheduling the first infusion.
- The provision of the No Cost Trial Program product may be disclosed in accordance with transparency reporting requirements in certain states (e.g., VT).
- Recordati Rare Diseases reserves the right to change, modify, or discontinue this program at any time without notice.
For more information about getting started, contact a representative
ENJAYMO HCP Indication and Important Safety Information
INDICATION
ENJAYMO® (sutimlimab-jome) is indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD).
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients.
WARNINGS AND PRECAUTIONS
Serious Infections Including Those Caused by Encapsulated Bacteria
- ENJAYMO, a proximal classical complement C1s inhibitor, increases susceptibility to serious infections, including those caused by encapsulated bacteria e.g. Neisseria meningitidis (any serogroup, including non-groupable strains), Streptococcus pneumoniae, and Haemophilus influenzae type B.
- Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors.
- Serious infections (bacterial and viral) were reported in 15% (10/66) of patients receiving ENJAYMO in the two phase 3 trials. These infections included urinary tract infection with sepsis, respiratory tract infection, pneumonia, otomastoiditis, and skin infections. One patient (1.5%) died due to Klebsiella pneumoniae.
- Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of ENJAYMO, according to the most current ACIP recommendations for patients receiving a complement inhibitor.
- If urgent ENJAYMO therapy is indicated in a patient who is not up to date on their vaccine(s), administer as soon as possible.
- Vaccination does not eliminate the risk of serious encapsulated bacterial infections. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected.
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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 two phase 3 trials, 29% (19/66) of patients treated with ENJAYMO experienced infusion-related reactions. One patient permanently discontinued ENJAYMO due to an infusion-related reaction.
- 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.
- In clinical trials, 4.5% (3/66) of patients developed a relapse or worsening of previously diagnosed autoimmune disease.
- Monitor ENJAYMO patients 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, eg, 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 in the CADENZA trial (Part A) (incidence ≥18%) are rhinitis, headache, hypertension, acrocyanosis, and Raynaud’s phenomenon. The most common adverse reactions in the CARDINAL trial (incidence ≥25%) are urinary tract infection, respiratory tract infection, bacterial infection, dizziness, fatigue, peripheral edema, arthralgia, cough, hypertension, and nausea.
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References:
- ENJAYMO. Prescribing information. Recordati Rare Diseases Inc.; 2024.
