Exdensur (depemokimab-ulaa)

No dosing information is available for this tab.

Administer depemokimab-ulaa subcutaneously by a healthcare provider.

Prior to administration, remove the prefilled syringe from the refrigerator and allow it to warm to room temperature for 30 minutes. Do not warm the product in any other way. Do not remove the needle cap until ready for injection. Do not use the syringe if it has been left out of the carton for >8 hours or if it has been dropped, damaged, or the security seal on the carton is broken.

Inspect the injection solution visually for particulate matter and discoloration prior to administration. The solution should be colorless to yellow to brown, clear to opalescent in color. Do not use if the product exhibits discoloration, cloudiness, or particulate matter. Air bubble may be present. Do not expel the air bubble prior to administration. Do not shake the device.

Administer subcutaneous innjections of depemokimab-ulaa into upper arm, thigh, or abdomen, avoiding the 2 inches (5 centimeters) around the navel. Do not give injections into areas where the skin is tender, bruised, red, or hard.

Prior to use, store depemokimab-ulaa injection refrigerated at 2-8degreesC in the original carton to protect from light. Do not freeze or shake. Avoid exposure to heat. The prefilled syringe can be removed from the refrigerator and kept in the unopened carton, protected from light for up to 7 days at room temperature (up to 30degreesC). Discard the product if it is left out of the refrigerator for >7 days. The prefilled syringe must be administered within 8 hours once removed from the carton. Discard if not administered within 8 hours.

No dosing information is available for this tab.

No drug-drug interaction studies have been conducted with depemokimab-ulaa. Drug interactions via inhibition or induction of cytochrome P-450 (CYP) enzymes or transporters are not expected since depemokimab-ulaa is a monoclonal antibody and is eliminated by non-specific clearance pathways.

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.

• Parasitic infection

There are no moderate contraindications for this drug.

The most common adverse reactions (incidence >=4%) reported with depemokimab-ulaa in clinical studies were upper respiratory tract infection, allergic rhinitis, influenza, arthralgia, and pharyngitis.

There are no severe adverse reactions for this drug.

More Frequent

• Allergic rhinitis
• Arthralgia
• Influenza
• Injection site sequelae
• Pharyngitis
• Upper respiratory infection

No enhanced messaging available.

Pharmacokinetic and pharmacodynamic data have not demonstrated any clinically significant differences in systemic exposure of depemokimab-ulaa and reduction in blood eosinophil counts in pediatric patients 12 years of age and older compared to that observed in adults following administration of the recommended dosage. The safety of depemokimab-ulaa in pediatric patients 12 years of age and older was generally similar to that of the adult population in the SWIFT-1 and SWIFT-2 studies.

The safety and effectiveness of depemokimab-ulaa have not been established in pediatric patients younger than 12 years of age.

Available data from clinical trials with depemokimab-ulaa use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with asthma in pregnancy.

Transport of endogenous IgG antibodies and monoclonal antibodies, such as depemokimab-ulaa, across the placenta increases as pregnancy progresses and peaks during the third trimester. The impact of the drug's triple amino acid substitution (YTE) modification on placental transfer is uncertain; however, the presence of the YTE modification may lead to prolonged and increased exposure of the infant in utero; the potential clinical impact is unknown and should be considered. No treatment-related effects on embryofetal or postnatal development have been shown in animal studies targeting IL-5 signaling pathways.

Pregnant women exposed to depemokimab-ulaa, or their healthcare providers, should report exposure by calling 1-888-825-5249.

There are no data on the presence of depemokimab-ulaa in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Depemokimab-ulaa is a humanized monoclonal antibody (IgG1 kappa), and maternal IgG is present in human milk in small amounts. The effects of local GI exposure and the extent of systemic exposure in the breastfed infant to depemokimab-ulaa are unknown.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for depemokimab-ulaa, 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 501 patients with asthma treated with depemokimab-ulaa, 133 (27%) were 65 years of age and older and 22 (4%) were 75 years of age and older. No overall differences in safety or effectiveness were observed between these patients and younger patients.