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
Dosing once every 2 weeks with ENJAYMO1
Patients can receive an infusion 3 ways*
In office
At an infusion center
At home
*Subject to coverage requirements and physician determination.
Receiving ENJAYMO at home by a nurse may be possible at no cost. Contact Recordati Rare Diseases Patient Solutions (RRD PS) to find out how.
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
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
Dosing every 2 weeks makes a difference—discontinuing ENJAYMO led to recurrent hemolysis
In the CADENZA study, chronic hemolysis returned after discontinuing ENJAYMO (n=39)
- †Upon completion of Part B of CADENZA, a follow-up visit was completed 9 weeks after administration of the last dose of ENJAYMO. CADENZA is a 6-month, phase 3, placebo-controlled, global, multicenter, randomized, double-blind trial of ENJAYMO in 42 patients with CAD and no transfusion history, followed by Part B, a minimum 1-year cross-over extension phase.
- ‡Mean hemoglobin levels decreased 2.41 g/dL (SE: 0.373). Mean Hb at last visit (n=35): 11.87 g/dL.2
- §Mean bilirubin increased 1.27 mg/dL (SE: 0.182). Mean bilirubin at last visit (n=34): 0.88 mg/dL.2
Administration of ENJAYMO
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. ENJAYMO can either be administered via an undiluted or diluted preparation.
WEIGHT-BASED INFUSION
6500 mg FOR PATIENTS 39 kg TO <75 kg
7500 mg FOR PATIENTS ≥75 kg
Dosing and infusion rate reference table for ENJAYMO undiluted
| Body weight range | Dose | ENJAYMO vials needed |
ENJAYMO volume |
Maximum infusion rate |
|---|---|---|---|---|
| 39 kg to <75 kg | 6500 mg | 6 | 130 mL | 130 mL/hour‖ |
| ≥75 kg | 7500 mg | 7 | 150 mL | 150 mL/hour‖ |
Dosing and infusion rate reference table for ENJAYMO diluted in saline
| Body weight range |
Dose | ENJAYMO vials needed |
ENJAYMO volume |
NaCl diluent Volume |
Total volume |
Maximum infusion rate |
|---|---|---|---|---|---|---|
| 39 kg to <70 kg | 6500 mg | 6 | 130 mL | 370 mL | 500 mL | 250 mL/hour |
| 70 kg to <75 kg | 6500 mg | 6 | 130 mL | 370 mL | 500 mL | 500 mL/hour‖ |
| ≥75 kg | 7500 mg | 7 | 150 mL | 350 mL | 500 mL | 500 mL/hour‖ |
‖Patients with cardiopulmonary disease may 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 INITIATION
Complete or update vaccination against encapsulated bacteria, including Streptococcus pneumoniae and Neisseria meningitidis (serogroups A, C, W, Y and B), according to current ACIP recommendations for patients receiving complement inhibitors at least 2 weeks prior to initiation of ENJAYMO.
If urgent ENJAYMO therapy is indicated in a patient who is not up to date with vaccines for Streptococcus pneumoniae and Neisseria meningitidis, administer these vaccines as soon as possible.
Vaccination does not eliminate the risk of serious encapsulated bacterial infections.
Click here to download the Enjaymo Vaccination guide.
DURING INFUSION
Advise patients that administration of ENJAYMO may result in infusion-related reactions, including hypersensitivity reactions that may be serious or life threatening (eg, anaphylaxis). Educate patients on symptoms of infusion-related reactions and advise them to seek medical attention if symptoms occur.
Monitor for infusion-related reactions like shortness of breath, rapid heartbeat, nausea, flushing, headache, hypotension, chest discomfort, pruritus, rash, injection-site reaction, and dizziness.
Slow or stop the infusion if an infusion reaction occurs and institute appropriate supportive measures if signs of hypersensitivity occur.
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.
Infusion-related reactions occurred in 29% (19/66) of patients treated with ENJAYMO in the two phase 3 trials. One patient permanently discontinued ENJAYMO due to an infusion-related reaction.
4 steps to infusing ENJAYMO1
STEP 1: 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 by weight in the dosing and infusion rate reference table.
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
- If preparing ENJAYMO for undiluted administration, the appropriate amount of ENJAYMO should be added to an empty infusion bag (130 mL or 150 mL depending on the dose)
- If preparing ENJAYMO for diluted administration, dilute with 0.9% sodium chloride to a total volume of 500 mL
- Discard unused portion of ENJAYMO
STEP 2: Allow the ENJAYMO infusion solution to adjust to room temperature 59 °F to 77 °F (15 °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 shake
- 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
STEP 3: 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)
STEP 4: 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 Reminders
- Patients with cardiopulmonary disease may receive the infusion over 2 hours regardless of body weight
- Monitor for signs of infusion and/or hypersensitivity reactions per recommendations
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.
-
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.
ACIP=Advisory Committee on Immunization Practices; CAD=Cold Agglutinin Disease; Hb=hemoglobin; PES=polyethersulfone; USP=United States Pharmacopeia.
References:
- ENJAYMO. Prescribing information.
- Data on file.
