Takhzyro (lanadelumab-flyo)

No dosing information is available for this tab.

Lanadelumab-flyo is administered by subcutaneous injection. The drug is intended for self-administration or administration by a healthcare provider orcaregiver after appropriate training. Adult and pediatric patients>=12 years of age may self-administer lanadelumab-flyo. A healthcare provider or caregiver should administer lanadelumab-flyo to pediatric patients 2 to <12 years of age.

Lanadelumab-flyo is commercially available as a ready-to-use solution in a single-dose vial or prefilled syringe. Additional reconstitution or dilution prior to administration is not required. The vials and prefilled syringes should be stored at 2-8degreesC in the original carton to protect the drug from light; do not freeze or shake the vials or syringes. Prior to administration, inspect the solution for particulate matter or discoloration. The solution should be clear to slightly opalescent and colorless to slightly yellow; discard the drug if the solution is discolored or contains particulates. Avoid vigorous agitation of the vials and syringes.

No dosing information is available for this tab.

No formal drug interaction studies with lanadelumab-flyo have been performed to date.

Use of rescue medications, such as plasma-derived and recombinant complement 1 (C1)-esterase inhibitor (human), icatibant, or ecallantide, for breakthrough hereditary angioedema attacks had no effect on clearance and volume of distribution of lanadelumab. In addition, the manufacturer states that concomitant use of analgesic, antibacterial, antihistamine, anti-inflammatory, or antirheumatic drugs had no effect on clearance and volume of distribution of lanadelumab.

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 effects reported in >=10% of patients receiving lanadelumab-flyo in clinical studies include injection site reactions (e.g., pain, erythema, bruising), upper respiratory tract infection, headache, rash, myalgia, dizziness, and diarrhea.

Less Frequent

• Abnormal hepatic function tests
• Hypersensitivity drug reaction

More Frequent

• Diarrhea
• Dizziness
• Headache disorder
• Myalgia
• Skin rash
• Upper respiratory infection

No enhanced messaging available.

Safety and efficacy of lanadelumab-flyo have not been established in pediatric patients <2 years of age. Among the 125 patients included in the initialpivotal clinical trial of lanadelumab, 10 patients were 12 to <18 years of age; subgroup analysis in such patients indicated that safety and efficacy were consistent with overall study results. An additional 13 pediatric patients aged 12 to <18 years were enrolled in the open-label extension study.

Use of landelumab-flyo in patients 2 to <12 years of age was supported by extrapolation of efficacy datafrom the initial pivotal clinical trial, withadditional pharmacokinetic analyses showing similar drug exposures between adults (>18 years of age) and pediatric patients (2to <12 years of age), and safety and pharmacodynamic data from an open-label, multicenter study in pediatric patientswith HAE aged 2 to <12 years that enrolled 21 patients. The pharmacodynamic responseobserved in this trial for pediatric patients 2 to <12 years of age was similar to that seen in adult and pediatric patients >=12years of age.

An increase in lanadelumab AUC of about 37% has been reported in pediatric patients 12 to <18 years of age compared with adults; this difference is thought to be due to lower body weight and is not considered clinically important. Lanadelumab treatment is not expected to impact growth.

Data are not available regarding the use of lanadelumab in pregnant women. Monoclonal antibodies are transported across the placenta during the third trimester of pregnancy; therefore, the potential for effects of lanadelumab on the fetus is expected to be greater during the third trimester.

In animal studies, no effects on maintenance of pregnancy, parturition, or on embryofetal development, survival, growth, or postnatal development were observed in cynomolgus monkeys administered lanadelumab subcutaneously once weekly from the period of organogenesis through parturition at dose exposures up to 33 times those achieved with the maximum recommended human dose. Lanadelumab has been shown to cross the placenta in monkeys.

It is not known whether lanadelumab is distributed into human milk, affects milk production, or affects breast-fed infants. The drug has been detected in milk in monkeys. Because lanadelumab is a large protein molecule, the amount distributed into breast milk is expected to be very low; in addition, any amount present in breast milk is likely to be destroyed in the infant's GI tract, resulting in minimal absorption.

Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for lanadelumab and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Of the 125 patients with HAE who were studied in the pivotal clinical trial of lanadelumab, 4% were >=65 years of age. Although no overall differences in safety or efficacy were observed between these patients and younger adults, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.