Dosing once every 2 weeks with ENJAYMO1
Patients can receive an infusion 3 ways*
At an infusion center
*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
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
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.
6500 mg FOR PATIENTS 39 kg TO <75 kg
7500 mg FOR PATIENTS ≥75 kg
|Body weight range||Dose||Number of ENJAYMO
|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 should receive the infusion over 120 minutes.
What to know before, during, and after an infusion1
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.
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.
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
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.
- 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
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.
- 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 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.
- In-line infusion warmers may be used, but should not exceed a temperature of 104 °F (40 °C)
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.
- Patients with cardiopulmonary disease should receive the infusion over 2 hours regardless of body weight