Pemgarda (Eua) (pemivibart)

If a mild infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care. If signs and symptoms of a clinically significant hypersensitivity reaction, infusion-related reaction, or anaphylaxis occur during administration of pemivibart, immediately discontinue administration and initiate appropriate medications and/or supportive care. Discontinue pemivibart therapy permanently in individuals who experience signs and symptoms of anaphylaxis.

Pemivibart is administered as an IV infusion by a healthcare professional. The drug should only be administered in settings in which appropriate medical support is available to manage hypersensitivity reactions, including anaphylaxis, and with the ability to activate the emergency medical system, as necessary.

Pemivibart requires dilution of the commercially available injection concentrate prior to administration. Remove pemivibart vials from refrigerated storage and allow to equilibrate to room temperature (18-26degreesC) for 10 minutes before preparation. Do not expose vials to direct heat. Do not shake vials. Pemivibart is a clear to slightly opalescent, colorless to yellow solution. Visually inspect the vials for particulate matter and discoloration. Discard the vial if the solution is cloudy, discolored, or if visible particles are observed.

Prior to administration, attach an infusion set including an in-line 0.2 micron filter to the prepared IV bag and prime the infusion set.

Once the infusion is complete, flush line with 0.9% sodium chloride injection. Clinically monitor patients during infusion and observe patients for at least 2 hours after infusion is complete.

Store unopened vials in the refrigerator at 2-8oC in the original carton to protect from light. Do not freeze or shake. Do not use if the seal is broken or missing. After dilution, if immediate administration is not possible, the diluted solution may be stored at room temperature under ambient light for up to 4 hours.

No dosing information is available for this tab.

Drug-drug interaction studies with pemivibart have not been performed. Pemivibart is not renally excreted or metabolized by cytochrome P-450 (CYP) isoenzymes; therefore, interactions with concomitant medications that are renally excreted or that are substrates, inducers, or inhibitors of CYP isoenzymes are unlikely.

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.

Covid-19 Monoclonal Antibodies/Covid-19 Vaccines

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: COVID-19 monoclonal antibodies such as tixagevimab-cilgavimab and pemivibart may prevent the immune system from properly responding to the COVID-19 vaccine.(1-3)

CLINICAL EFFECTS: Administration of a COVID-19 monoclonal antibody such as tixagevimab-cilgavimab and pemivibart, soon after receipt of a COVID-19 vaccine may interfere with vaccine-induced immune responses and impair the efficacy of the vaccine.(1-3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: In individuals who have received a COVID-19 vaccine, a COVID-19 monoclonal antibody (such as tixagevimab-cilgavimab and pemivibart) should be administered at least two weeks after vaccination.(2,3) Patients who previously received a COVID-19 monoclonal antibody may be vaccinated against COVID-19 at any time.(1)

DISCUSSION: There is no data on the safety or efficacy of COVID-19 vaccines in patients who subsequently receive COVID-19 monoclonal antibodies. Given a lack of data, the CDC recommends that tixagevimab-cilgavimab be temporarily deferred for 2 weeks in patients who previously received COVID-19 vaccines.(1)

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)

*Previous severe hypersensitivity reactions, including anaphylaxis, to any component of pemivibart.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

The most common adverse events (incidence >=2%) observed with pemivibart in patients with moderate-to-severe immune compromise include systemic and local infusion-related or hypersensitivity reactions, upper respiratory tract infection, viral infection, influenza-like illness, fatigue, headache, and nausea.

Less Frequent

• Anaphylaxis

More Frequent

• Fatigue
• Flu-like symptoms
• Headache disorder
• Hypersensitivity drug reaction
• Nausea
• Upper respiratory infection
• Viral infection

Less Frequent

• Extravasation injury
• Injection site erythema

No enhanced messaging available.

Pemivibart is not authorized for use in pediatric patients younger than 12 years of age or weighing less than 40 kg. The safety and effectiveness of pemivibart have not been established in pediatric patients. The recommended dosing regimen is expected to result in comparable serum exposures of pemivibart in adolescents 12 years of age and older and weighing at least 40 kg as observed in adults, since adults with similar body weight have been included in the CANOPY study. The pharmacokinetics of pemivibart have not been studied in the pediatric population.

There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes with pemivibart. Pemivibart should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Nonclinical reproductive toxicity studies have not been performed with pemivibart. In tissue cross-reactivity studies using human fetal tissues, no off-target binding was detected for pemivibart. Human immunoglobulin G1 (IgG1) antibodies are known to cross the placental barrier; therefore, pemivibart has the potential to be transferred from the mother to the developing fetus. It is unknown whether the potential transfer of pemivibart provides any treatment benefit or risk to the developing fetus.

There are no available data on the presence of pemivibart in human or animal milk, the effects on the breast-fed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for pemivibart and any potential adverse effects on the breast-fed infant from pemivibart.

The manufacturer states that no dosage adjustment is recommended in geriatric patients.

Of the 623 participants who received pemivibart in the CANOPY trial, 156 (25%) were >=65 years of age and 31 (5%) were >=75 years of age. Based on population pharmacokinetic analyses, there were no clinically meaningful differences of age on the pharmacokinetics of pemivibart.