Gohibic (Eua) (vilobelimab)

No dosing information is available for this tab.

Vilobelimab is administered by IV infusion. Do not administer vilobelimab with other medications in the same IV line.

Store unopened vials of vilobelimab under refrigeration (2-8degreesC) in the original carton. Protect from light and do not freeze or shake.

No dosing information is available for this tab.

No drug interaction studies have been conducted with vilobelimab to date.

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.

• Severe infection

There are no moderate contraindications for this drug.

Adverse effects reported in >=3% of patients include pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal infection, bronchopulmonary aspergillosis, increased hepatic enzymes, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum, respiratory tract infection, supraventricular tachycardia, constipation, and rash.

More Frequent

• Pneumonia
• Pulmonary thromboembolism
• Sepsis

Less Frequent

• Abnormal hepatic function tests
• Deep venous thrombosis
• Herpes simplex infection
• Hypertension
• Hypoxia
• Infection
• Pneumothorax
• Pulmonary aspergillosis
• Supraventricular tachycardia
• Thrombocytopenic disorder

More Frequent

• Delirium

Less Frequent

• Constipation
• Skin rash
• Upper respiratory infection
• Urinary tract infection

No enhanced messaging available.

The FDA EUA does not permit the use of vilobelimab for the treatment of COVID-19 in hospitalized pediatric patients when initiated within 48 hours of receiving invasive mechanical ventilation or ECMO.

Data are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The estimated background risk of major birth defects and miscarriage related to COVID-19 is also unknown. Monoclonal antibodies, such as vilobelimab, cross the placenta to a greater degree during the third trimester of pregnancy; therefore, potential fetal effects are more likely to occur during this trimester. In a study involving cynomolgus monkeys, vilobelimab placental transport occurred; however, there was no evidence of fetal harm following IV administration throughout pregnancy at doses 2.5 times the maximum recommended human dose.

It is not known whether vilobelimab is distributed into human or animal milk or has effects on the breast-fed infant or on milk production. Maternal immunoglobulin G (IgG) is known to be present in human milk.

The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for vilobelimab and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.

The manufacturer does not make specific dosage recommendations for geriatric patients.

In clinical studies evaluating the use of vilobelimab for patients receiving invasive mechanical ventilation or ECMO, 53 (30%) were >65 years of age. No overall differences in safety or effectiveness were observed between geriatric patients and younger adults.