Enjaymo (sutimlimab-jome)

No dosing information is available for this tab.

Administer by IV infusion only. Sutimlimab may be administered as a diluted or undiluted preparation.

Store unopened sutimlimab-jome vials in the refrigerator at 2-8degreesC in the original carton; protect from light. Do not freeze or shake.

Prior to use, remove the drug from the refrigerator and do not shake to minimize foaming. Inspect vials and parenteral drug product visually for particulate matter and discoloration prior to administration. Sutimlimab is a clear to slightly opalescent and colorless to slightly yellow solution.

If using a diluted preparation, withdraw the calculated volume from the appropriate number of vials based on the recommended dosage and dilute the calculated volume with 0.9% sodium chloride injection to a total volume of 500 mL (see Table 1).

If using an undiluted preparation, withdraw the calculated volume from the appropriate number of vials based on the recommended dosage and add to an empty infusion bag (see Table 2).

If the infusion solution is not used immediately, store under refrigeration at 2-8degreesC. Once removed from refrigeration, allow the infusion solution to adjust to room temperature (20-25degreesC) 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, but should not exceed a temperature of 40degreesC.

Administer sutimlimab infusion solution only through a 0.2 micron in-line filter with a polyethersulfone (PES) membrane. Prime the infusion catheter and/or 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.

Table 1. Infusion Reference Table for Sutimlimab-jome Diluted in 0.9% Sodium Chloride

Body Dose Number of Drug Volume of Total Maximum Weight Drug Volume NaCl Volume Infusion Range Vials Diluent Rate Needed 39 to <70 6500 mg 6 130 mL 370 mL 500 mL 250 kg mL/hour 70 to <75 6500 mg 6 130 mL 370 mL 500 mL 500 kg 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.

Table 2. Infusion Reference Table for Sutimlimab-jome Undiluted

Body Weight Dose Number of Drug Drug Volume Maximum Range Vials Needed Infusion Rate >=39 to <75 kg 6500 mg 6 130 mL 130 mL/hour >=75 kg 7500 mg 7 150 mL 150 mL/hour

No dosing information is available for this tab.

No formal drug-drug interaction studies have been conducted with sutimlimab.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Igg Antibodies And Derivatives/Efgartigimod-Alfa

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)

Igg Antibodies And Derivatives/Nipocalimab-Aahu

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Igg Antibodies And Derivatives/Rozanolixizumab-Noli

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)

DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)

*Known hypersensitivity to sutimlimab or any of the inactive ingredients.

There are no contraindication contraindications for this drug.

• Severe infection

• Systemic lupus erythematosus

Most common adverse reactions in the CADENZA study (incidence >=18%) included rhinitis, headache, hypertension, acrocyanosis, and Raynaud's phenomenon. Most common adverse reactions in the CARDINAL study (incidence >=25%) included urinary tract infection, respiratory tract infection, bacterial infection, dizziness, fatigue, peripheral edema, arthralgia, cough, hypertension, and nausea.

Less Frequent

• Cyanosis
• Hypertension
• Infection

Rare or Very Rare

• Dyspnea
• Hypersensitivity drug reaction

More Frequent

• Arthralgia
• Arthritis
• Cough
• Diarrhea
• Dyspepsia
• Peripheral edema
• Upper respiratory infection

Less Frequent

• Acute abdominal pain
• Dizziness
• Fatigue
• Fever
• Gastroenteritis
• Headache disorder
• Nausea
• Urinary tract infection

No enhanced messaging available.

Safety and effectiveness in pediatric patients have not been established.

There are no available data on sutimlimab use in pregnant patients 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 may be transmitted from the mother to the developing fetus. Animal studies in monkeys at doses 2-3 times the maximum recommended human dose did not indicate adverse effects on pregnancy or offspring development.

No effects on reproductive and developmental parameters were observed in maternal animals and offspring, respectively.

There are no data on the presence of sutimlimab in human milk, effects on the breastfed child, or the effects on milk production. Maternal IgG is known to be present in human milk. The effects of local GI exposure and limited systemic exposure in the breastfed child to sutimlimab are unknown. No conclusions can be drawn regarding whether or not sutimlimab is safe for use during breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for sutimlimab and any potential adverse effects on the breastfed child from sutimlimab or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Of the 66 patients with cold agglutinin disease in clinical studies of sutimlimab, 65% were 65 years of age and over including 27% who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients; however, greater sensitivity of some older individuals cannot be ruled out.