Evkeeza (evinacumab-dgnb)

No dosing information is available for this tab.

Evinacumab-dgnb is administered by IV infusion over 60 minutes through an IV line containing a sterile, in-line or add-on, 0.2-5 micron filter. The drug is available as a concentrate for injection that must be diluted prior to administration.

In patients with HoFH receiving lipoprotein apheresis, evinacumab may be administered without regard to timing of the procedure.

Store evinacumab concentrate for injection between 2-8degreesC in the original carton to protect from light. Do not freeze or shake.

Evinacumab concentrate for injection is preservative-free. Discard any unused portion left in the single-use vial after preparation.

If a dose of evinacumab is missed, the missed dose should be administered as soon as possible. Adjust the monthly infusion schedule thereafter based on the date of the last dose administered.

Do not mix other medications with evinacumab or administer other medications concomitantly via the same infusion line.

Slow, interrupt, or discontinue the infusion if the patient develops any signs of adverse reactions, including infusion or hypersensitivity reactions.

No dosing information is available for this tab.

No formal drug interaction studies have been performed with evinacumab.

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)

*History of serious hypersensitivity reactions to evinacumab or to any excipients.

There are no contraindication contraindications for this drug.

• Pregnancy

There are no moderate contraindications for this drug.

Adverse reactions reported in >=5% of patients receiving evinacumab-dgnb include nasopharyngitis, influenza-like illness, dizziness, rhinorrhea, fatigue, and nausea.

Infusion reactions occurred in 7% of patients receiving evinacumab, and more frequently with the drug than with placebo. Infusion reactions include infusion site pruritis, pyrexia, muscular weakness, nausea, and nasal congestion.

Less Frequent

• Anaphylaxis
• Hypersensitivity drug reaction

More Frequent

• Dizziness
• Flu-like symptoms
• Nausea
• Pharyngitis
• Rhinorrhea

Less Frequent

• Acute abdominal pain
• Constipation
• Fever
• General weakness
• Injection site sequelae
• Muscle weakness
• Nasal congestion
• Pain in extremities
• Upper respiratory infection

No enhanced messaging available.

Safety and efficacy of evinacumab-dgnb as an adjunct to other LDL-C-lowering therapies for the treatment of HoFH have been established in pediatric patients >=1 year of age. Evidence from adequate and well-controlled studies in adults and additional pharmacokinetic, efficacy, and safety data in pediatric patients >=1 year of age support this use. The safety profile of evinacumab-dgnb in pediatric patients 1-11 years of age was similar to the safety profile in adults and pediatric patients >=12 years of age, with the additional adverse reaction of fatigue in pediatric patients aged 5-11 years of age.

Safety and efficacy of evinacumab have not been established in pediatric patients with HoFH who are <1 year of age.

Animal data indicate that evinacumab-dgnb may cause fetal harm if used during pregnancy. Human data are inadequate to determine the risk of fetal malformations, miscarriage, and adverse outcomes associated with use of evinacumab during pregnancy. Human immune globulin G (IgG) is known to cross the placenta; therefore, evinacumab, a human IgG4 antibody, has the potential to cross the placental barrier and be transmitted to the developing fetus. Animal studies indicate that evinacumab crosses the placental barrier. In animal studies, an increase in fetal malformations was observed when evinacumab was administered during organogenesis.

If a patient becomes pregnant while on evinacumab, providers should call 1-833-385-3392 to report exposure.

It is not known whether evinacumab is distributed into human or animal milk. However, maternal IgG is known to be present in human milk. The effects of the drug on the breastfed infant or on the production of milk are not known. The benefits of breastfeeding should be balanced with the potential for adverse effects from evinacumab exposure to the breastfed infant, along with the mother's clinical need for evinacumab.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Insufficient numbers of patients >=65 years of age were included in clinical studies of evinacumab to determine whether there are differences in response compared to younger patients.