Inmazeb (NATIONAL STOCKPILE) (atoltivimab-maftivimab-odesivimab-ebgn)

No dosing information is available for this tab.

Atoltivimab, maftivimab, and odesivimab-ebgn is administered via IV infusion. It is available as a concentrate for injection that must be diluted prior to administration. It is supplied in single-dose vials containing either 16.67 or 33.33 mg of each antibody per mL. The solution should be clear to slightly opalescent and colorless to pale yellow in appearance; discard the vial if the solution is cloudy, discolored, or contains extraneous particulate matter.

Prior to dilution, store vials in the original carton at 2-8oC. Protect from light; do not freeze or shake.

Administer the diluted solution through an IV line containing a sterile, in-line or add-on 0.2 micron filter. Do not mix other medications with atoltivimab, maftivimab, and odesivimab-ebgn solution.

No dosing information is available for this tab.

No formal drug interaction studies have been performed.

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.

There are no severe contraindications for this drug.

• No disease contraindications

The most common adverse reactions with atoltivimab, maftivimab, and odesivimab (incidence >=20%) are pyrexia, chills, tachycardia, tachypnea, and vomiting.

More Frequent

• Chills
• Fever
• Tachycardia
• Tachypnea
• Vomiting

Less Frequent

• Diarrhea
• Hypoxia
• Increased alanine transaminase
• Increased aspartate transaminase

Rare or Very Rare

• Hypersensitivity drug reaction
• Hypotension

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

The safety and effectiveness of atoltivimab, maftivimab, and odesivimab-ebgn for the treatment of Zaire ebolavirus infection has been established in pediatric patients from birth to <18 years of age. Use in this patient population is supported by data from a multicenter, open-label, randomized controlled trial that included 39 pediatric patients, including neonates born to a mother positive for Zaire ebolavirus infection. The 28-day mortality and safety in adult and pediatric patients were similar. An additional 38 pediatric patients from birth to <18 years of age have been treated with atoltivimab, maftivimab, and odesivimab-ebgn in an expanded access program.

Available data from the PALM trial and an expanded access program in which pregnant women with Zaire ebolavirusinfection were treated with atoltivimab, maftivimab, and odesivimab-ebgn demonstrate the high rate of maternal and fetal/neonatal morbidity associated with underlying maternal Zaire ebolavirus infection. However, these data are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal/fetal outcome. Animal reproduction studies have not been conducted. Human monoclonal antibodies, such as atoltivimab, maftivimab, and odesivimab-ebgn, are transported across the placenta; therefore, the drug has the potential to be transferred from the mother to the developing fetus.

Maternal, fetal, and neonatal outcomes are poor among pregnant women infected with Zaire ebolavirus. The majority of such pregnancies resulted in maternal death with miscarriage, stillbirth, or neonatal death. Zaire ebolavirus infection is life-threatening for both the mother and fetus, and treatment should not be withheld due to pregnancy.

The Centers for Disease Control and Prevention recommends that patients with confirmed Zaire ebolavirus not breast-feed their infants to reduce the risk of postnatal transmission.

There are no data regarding the presence of atoltivimab, maftivimab, and odesivimab-ebgn in human milk, effects on the breast-fed infant, or on milk production. Maternal immunoglobulin G (IgG) is known to be present in human milk. The effects of local GI exposure and limited systemic exposure in the breast-fed infant to atoltivimab, maftivimab, and odesivimab-ebgn is unknown.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Clinical studies of atoltivimab, maftivimab, and odesivimab-ebgn did not include a sufficient number of patients >=65 years of age to determine whether they respond differently from younger patients. Of the 154 patients treated with atoltivimab, maftivimab, and odesivimab-ebgn in a clinical trial, 5 patients were >=65 years of age. The limited clinical experience has not identified differences in responses between elderly and younger patients.