Enjaymo

ENJAYMO is a classical complement inhibitor indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD). (

• Vaccinate against encapsulated bacteria at least two weeks prior to treatment. (
  2.1 Recommended Vaccinations for Encapsulated Bacterial Infections

  Vaccinate patients 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 at least 2 weeks prior to initiation of ENJAYMO

  [see Warnings and Precautions (5.1)].

  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.
  )
• Weight-based dosage weekly for two weeks then every two weeks:
  • For patients weighing 39 kg to less than 75 kg: 6,500 mg by intravenous infusion. (
    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.
    )
  • For patients weighing 75 kg or more: 7,500 mg by intravenous infusion. (
    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.
    )
• See Full Prescribing Information for important preparation and administration instructions. (
  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.

  ENJAYMO can either be used as an undiluted or diluted preparation.

  Undiluted preparation of ENJAYMO

  Use aseptic technique to prepare ENJAYMO as follows:

  • Remove ENJAYMO from the refrigerator. To minimize foaming, do not shake ENJAYMO.
  • Inspect vials visually for particulate matter and discoloration prior to administration. ENJAYMO solution is a clear to slightly opalescent and colorless to slightly yellow liquid. Do not administer if discolored or if other 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) and add to an empty infusion bag.
  • Prior to administration, allow the infusion solution to adjust to room temperature (59°F to 77°F (15°C to 25°C). Refer to Table 1 for infusion rate. The infusion should be administered over 1 hour. Administer ENJAYMO infusion solution only through a 0.2 micron in-line filter with a polyethersulfone (PES) membrane.
  • The infusion catheter and tubing should be primed with the dosing solution immediately before infusion and flushed immediately following completion of the infusion with a sufficient quantity (approximately 20 mL) of sterile 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 59°F to 77°F (15°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 for ENJAYMO (undiluted)

  Body Weight Range	Dose	Number of ENJAYMO Vials Needed	ENJAYMO Volume	Maximum Infusion Rate
  Greater than or equal to 39 kg to less than 75 kg	6,500 mg	6	130 mL	130 mL/hourPatients with cardiopulmonary disease may receive the infusion over 120 minutes.
  75 kg or greater	7,500 mg	7	150 mL	150 mL/hour

  Diluted preparation of ENJAYMO

  Use aseptic technique to prepare ENJAYMO as follows:

  • Remove ENJAYMO from the refrigerator. 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 2 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 59°F to 77°F (15°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 2: Infusion Reference Table for ENJAYMO (diluted in 0.9% Sodium Chloride Injection, USP)

  Body Weight Range	Dose	Number of ENJAYMO Vials Needed	ENJAYMO Volume	Volume of NaCl Diluent	Total Volume	Maximum Infusion Rate
  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/hourPatients with cardiopulmonary disease may receive the infusion over 120 minutes.
  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.
  )

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.

There are no available data on ENJAYMO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Human immunoglobulin G (IgG) antibodies are known to cross the placental barrier; therefore, sutimlimab-jome may be transmitted from the mother to the developing fetus. In animal reproduction studies, intravenous administration of sutimlimab-jome to pregnant monkeys during organogenesis at doses 2 to 3 times the maximum recommended human doses did not result in adverse effects on pregnancy or offspring development

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively.