Enjaymo

ENJAYMO- sutimlimab injection, solution, concentrate
Bioverativ U.S. LLC.

1 INDICATIONS AND USAGE

Cold Agglutinin Disease

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).

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Vaccinations

Vaccinate patients against encapsulated bacteria at least 2 weeks prior to initiation of ENJAYMO therapy according to the most current Advisory Committee on Immunization Practices (ACIP) recommendations for patients with persistent complement deficiencies [see Warnings and Precautions (5.1)]. If urgent ENJAYMO therapy is indicated in an unvaccinated patient, administer vaccine(s) as soon as possible.

2.2 Recommended Dosage Regimen

The recommended dosage of ENJAYMO for patients with CAD is based on body weight. For patients weighing 39 kg to less than 75 kg, the recommended dose is 6,500 mg and for patients weighing 75 kg or more, the recommended dose is 7,500 mg. Administer ENJAYMO intravenously weekly for the first two weeks, with administration every two weeks thereafter. Administer ENJAYMO at the recommended dosage regimen time points, or within two days of these time points.

If a dose is missed, administer as soon as possible; thereafter, resume dosing every two weeks. If the duration after the last dose exceeds 17 days, administer ENJAYMO weekly for two weeks, with administration every two weeks thereafter.

2.3 Preparation and Administration

ENJAYMO is for intravenous infusion only.

Each vial of ENJAYMO is intended for single dose only.

Use aseptic technique to prepare ENJAYMO as follows:

  • To minimize foaming, do not shake ENJAYMO.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • ENJAYMO solution is a clear to slightly opalescent and colorless to slightly yellow solution. Do not administer if discolored or if foreign particulate matter is present.
  • Withdraw the calculated volume of ENJAYMO from the appropriate number of vials based on the recommended dosage (see Table 1). Dilute the calculated volume with 0.9% Sodium Chloride Injection, USP to a total volume of 500 mL.
  • Refer to Table 1 for infusion rate. Administer the infusion over 1 to 2 hours depending on the patient’s body weight. Administer ENJAYMO infusion solution only through a 0.2 micron in-line filter with a polyethersulfone (PES) membrane.
  • 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.
  • If the ENJAYMO infusion solution is not used immediately, store refrigerated at 36°F to 46°F (2°C to 8°C).
  • Once removed from refrigeration, 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. Total time from the time of preparation, including refrigeration, adjustment to room temperature and the expected infusion time should not exceed 36 hours. In-line infusion warmers may be used, do not exceed a temperature of 104°F (40°C).
  • No incompatibilities have been observed between ENJAYMO infusion solution and infusion bags made of Di-(2-ethylhexyl)phthalate (DEHP) plasticized polyvinyl chloride (PVC), Ethyl Vinyl Acetate (EVA) and polyolefin (PO); administration sets made of DEHP-plasticized PVC, DEHP-free polypropylene (PP) and polyethylene (PE); and vial adapters made of polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS).
Table 1: Infusion Reference Table
Body Weight Range Dose Number of ENJAYMO Vials Needed ENJAYMO Volume Volume of NaCl Diluent Total Volume Maximum Infusion Rate
*
Patients with cardiopulmonary disease should receive the infusion over 120 minutes.
39 kg to less than 70 kg 6,500 mg 6 130 mL 370 mL 500 mL 250 mL/hour
70 kg to less than 75 kg 6,500 mg 6 130 mL 370 mL 500 mL 500 mL/hour *
75 kg or greater 7,500 mg 7 150 mL 350 mL 500 mL 500 mL/hour *

Slow or stop the infusion in case of infusion reaction during ENJAYMO administration. Monitor the patient for at least two hours following completion of the initial infusion for signs or symptoms of an infusion and/or hypersensitivity reaction. Monitor the patient for one hour following completion of subsequent infusions for signs or symptoms of an infusion reaction.

3 DOSAGE FORMS AND STRENGTHS

Injection: 1,100 mg/22 mL (50 mg/mL) as a clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial.

4 CONTRAINDICATIONS

ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].

5 WARNINGS AND PRECAUTIONS

5.1 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. These infections included sepsis, respiratory, and skin infections [see Adverse Reactions (6.1)].

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 two 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.

Vaccination reduces, but does not eliminate, the risk of encapsulated bacterial infections.

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. ENJAYMO has not been studied in patients with chronic systemic infections such as hepatitis B, hepatitis C, or HIV. Consider patients’ immune status when initiating treatment with ENJAYMO.

5.2 Infusion-Related Reactions

ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients [see Contraindications (4)]. Administration of ENJAYMO may result in infusion-related reactions. In the CARDINAL study, 2 of 24 patients (8%) treated with ENJAYMO experienced infusion-related reactions (shortness of breath, rapid heartbeat, nausea, flushing, and headache) [see Adverse Reactions (6.1)].

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.

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