Ebanga (National Stockpile) (ansuvimab-zykl)

No dosing information is available for this tab.

Ansuvimab-zykl is administered as an IV infusion over 60 minutes through a central line or peripheral catheter; do not administer as an IV push or bolus.

An IV line containing a 1.2 micron in-line filter should be used to administer ansuvimab-zykl. If a syringe pump is used to administer the drug, flush the infusion line with 2-5 mL of diluent, not to exceed the total infusion volume, after administration to ensure delivery of the full dose. If an infusion bag is used to administer the drug, flush the infusion line with 25 mL of diluent following administration to ensure delivery of the full dose.

Ansuvimab-zykl is available as a lyophilized powder that must be reconstituted and further diluted before IV administration.

Store ansuvimab-zykl vials at 2-8oC in the original carton to protect from light. Do not freeze or shake.

Do not mix with or administer as an infusion with other medicinal products.

No dosing information is available for this tab.

No dosing information is available for this tab.

No formal drug interaction studies have been conducted with ansuvimab-zykl.

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.

• Lactation

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most common adverse reactions occurring in >=5% of patients receiving ansuvimab-zykl were pyrexia, tachycardia, diarrhea, vomiting, hypotension, tachypnea, and chills.

More Frequent

• Hypotension

Less Frequent

• Hypoxia

Rare or Very Rare

• Hypersensitivity drug reaction

More Frequent

• Chills
• Diarrhea
• Fever
• Tachycardia
• Tachypnea
• Vomiting

No enhanced messaging available.

Safety and efficacy of ansuvimab-zykl for the treatment of Zaire ebolavirus infection have been established in pediatric patients from birth to <18 years of age. Use of ansuvimab-zykl for Zaire ebolavirus infection is supported by evidence from the PALM trial, which included 54 pediatric patients ranging in age from birth to <18 years. In the trial, the outcome of 28-day mortality was similar between adult and pediatric patients receiving ansuvimab-zykl. Safety was also similar between age groups. An additional 78 pediatric patients from birth to <18 years of age have also received ansuvimab-zykl for Zaire ebolavirus infection in an expanded-access program.

Since Zaire ebolavirus infection is life-threatening to both the mother and the fetus, do not withhold treatment during pregnancy. Data in pregnant women infected with Zaire ebolavirus receiving ansuvimab-zykl in the PALM study indicate high rates of maternal and fetal/neonatal morbidity from Zaire ebolavirus, which is consistent with prior published literature. The available data are not adequate to evaluate for a drug-associated risk of major birth defects, miscarriage, or maternal/fetal harm with ansuvimab-zykl use during pregnancy.

No animal reproductive data are available to evaluate the safety of ansuvimab-zykl use during pregnancy. Because other monoclonal antibodies are transported across the placenta, there is potential for fetal exposure to ansuvimab-zykl if administered during pregnancy.

Fetal, neonatal, and maternal outcomes are poor in women infected with Zaire ebolavirus during pregnancy. Most cases result in maternal death with miscarriage, stillbirth, or death of the neonate.

To reduce the risk of postnatal transmission, the Centers for Disease Control and Prevention (CDC) recommends that women with confirmed Zaire ebolavirus infection avoid breastfeeding.

No data are available on the presence of ansuvimab-zykl in milk. The effects of ansuvimab-zykl on the breast-fed infant or on milk production are not known. Maternal immunoglobulin G (IgG) is present in the milk of lactating women.

The manufacturer makes no specific dosage recommendations for geriatric patients.

An insufficient number of patients >=65 years of age were included in clinical trials of ansuvimab-zykl to determine whether the safety profile differs in geriatric patients compared to younger adults. Of the patients who received ansuvimab-zykl in the PALM trial, only 6 patients (3%) were >=65 years of age. Based on this limited clinical experience, no overall differences in response were observed between geriatric patients and younger adults.