Yartemlea (narsoplimab-wuug)

The recommended dosage of narsoplimab-wuug for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adults and pediatric patients 2 years of age and older is as follows:

For patients >=50 kg, the recommended dose is 370 mg given as an IV infusion over 30 minutes once weekly. For patients <50 kg, the recommended dose is 4 mg/kg given as an IV infusion over 30 minutes once weekly.

Increase the dosing frequency to twice weekly if there is inadequate improvement in TA-TMA signs and symptoms.

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

Narsoplimab-wuug is administered as an IV infusion through a polyvinyl chloride (PVC) or PVC-lined infusion line with a 0.2 micron polyethersulfone (PES) in-line filter and a polyurethane catheter. The drug is supplied in single-dose vials as a 185-mg/mL injection concentrate that must be further diluted prior to administration.

Store narsoplimab-wuug vials refrigerated at 2-8degrees in the original carton to protect the drug from light until time of use. Do not freeze or shake.

After the infusion is complete, flush the IV line with a sufficient volume of 5% dextrose injection to ensure full delivery of the dose. Do not co-administer other drugs through the same IV line.

Prior to dilution, remove the narsoplimab-wuug vial from the refrigerator and allow the drug to come to room temperature (18-25degrees) for 30 minutes. The vial must be used to prepare the appropriate dosing solution within 4 hours following removal from refrigerated storage.

If the diluted solution is not used immediately, store the solution at room temperature at 18-25degrees for up to 4 additional hours. Discard unused narsoplimab-wuug solution if not used within 4 hours from the time of dilution to the end of the infusion.

No dosing information is available for this tab.

No drug-drug interaction studies have been performed with narsoplimab. Narsoplimab-wuug is not expected to be an inhibitor or inducer of CYP enzymes or transporters.

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)

*None.

There are no contraindication contraindications for this drug.

• Infection

There are no moderate contraindications for this drug.

The most common adverse reactions (incidence >20%) reported with narsoplimab-wuug were viral infections, sepsis, hemorrhage, diarrhea, vomiting, nausea, neutropenia, pyrexia, fatigue, and hypokalemia.

More Frequent

• Hemorrhage
• Infection
• Neutropenic disorder
• Pneumonia
• Sepsis

Less Frequent

• Acute cognitive impairment
• Acute kidney injury
• Acute myocardial infarction
• Acute respiratory failure
• Alveolar hemorrhage
• Neutropenic sepsis
• Pulmonary edema
• Septic shock

More Frequent

• Acute abdominal pain
• Anemia
• Back pain
• Diarrhea
• Fatigue
• Fever
• Hypokalemia
• Hypotension
• Nausea
• Viral infection
• Vomiting

No enhanced messaging available.

The safety and effectiveness of narsoplimab-wuug for treatment of TA-TMA have been established in pediatric patients 2 years of age and older. Use of narsoplimab-wuug for this indication is supported by evidence from studies in adults and in 6 pediatric patients, and additional safety data from 83 additional pediatric patients 2 years of age and older. The safety and effectiveness of narsoplimab-wuug have not been established in pediatric patients younger than 2 years of age.

The available data on the use of narsoplimab-wuug during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses and peaks during the third trimester. It is expected that narsoplimab-wuug will be present in infants exposed in utero during the third trimester. The potential clinical impact of narsoplimab-wuug exposure on infants exposed in utero should be considered.

There are no data on the presence of narsoplimab-wuug in human milk, the effects on the breastfed child, or the effects on milk production. Narsoplimab-wuug is present in the milk of lactating mice. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Endogenous maternal IgG and monoclonal antibodies are transferred into human milk. The effects of local GI exposure and the extent of systemic exposure in the breastfed child to narsoplimab-wuug are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for narsoplimab-wuug and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendation for geriatric patients.

Of the patients treated with narsoplimab-wuug in the clinical trial and expanded access program for TA-TMA, 21 (8.4%) were 65 years of age and older, while 1 (0.4%) was at least 75 years of age. Clinical studies of narsoplimab-wuug did not include sufficient numbers of patients at least 65 years of age to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients.