Enjaymo

2 DOSAGE AND ADMINISTRATION Vaccinate against encapsulated bacteria at least two weeks prior to treatment. ( 2.1 ) 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 ) For patients weighing 75 kg or more: 7,500 mg by intravenous infusion. ( 2.2 ) See Full Prescribing Information for important preparation and administration instructions. ( 2.2 , 2.3 ) 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. 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/hour Patients 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/hour Patients 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.

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