Dosing once every 2 weeks with ENJAYMO1
Patients can receive an infusion 3 ways*
At an infusion center
*Subject to coverage requirements and physician 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
Chronic hemolysis and anemia 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.
‡Mean hemoglobin levels decreased 2.41 g/dL [SE: 0.373].
§Mean bilirubin increased 1.27 mg/dL.
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. ENJAYMO can either be administered via an undiluted or diluted preparation.
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
|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
|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.
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, 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.
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 clinical trials receiving ENJAYMO 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.2
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 by weight in the dosing and infusion rate reference table.
- 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
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.
- 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 may receive the infusion over 2 hours regardless of body weight
- Monitor for signs of infusion and/or hypersensitivity reactions per recommendations