Sutimlimab
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From MedlinePlus, U.S. National Library of Medicine
Classical Complement Pathway Inhibitor
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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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). [See table below.] 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). [See table below.] 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.
| 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 |
| 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 |
Contraindications
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) ] . ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for sutimlimab. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary 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 (see Data ) .
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.
Data Animal data Pregnant monkeys were administered sutimlimab-jome at doses of 60 and 180 mg/kg/dose via 30-minute intravenous infusion once-weekly from gestation Day 20 to parturition (approximately 21 doses) resulting in exposures 2 to 3 times the human exposures at the maximum recommended doses, based on area under the curve (AUC). Sutimlimab-jome was detectable in infants born to pregnant females exposed to 180 mg/kg/week. No effects on reproductive and developmental parameters were observed in maternal animals and offspring, respectively.
Breastfeeding (LactMed)
No information is available on the clinical use of sutimlimab during breastfeeding. Because sutimlimab is a large protein molecule with a molecular weight of 147,000 Da the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Until more data become available, sutimlimab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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