Andembry Autoinjector (garadacimab-gxii)

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

No formal drug interaction studies with garadacimab-gxii have been performed to date.

Since garadacimab-gxii is a monoclonal antibody, direct drug-drug interactions via inhibition or induction of cytochrome P450 enzymes or transporters are not expected.

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 reactions (>=7%) reported with garadacimab-gxii in clinical trials were nasopharyngitis and abdominal pain.

There are no severe adverse reactions for this drug.

More Frequent

• Injection site sequelae
• Pharyngitis

Less Frequent

• Acute abdominal pain
• Prolonged activated partial thromboplastin time

No enhanced messaging available.

Safety and efficacy of garadacimab-gxii have been established in pediatric patients aged 12 years and older. Among the 64 patients included in the pivotal clinical trial (VANGUARD), 6 pediatric patients were >=12 years of age; subgroup analysis in such patients indicated that safety and efficacy were consistent with overall study results.

Safety and efficacy of garadacimab-gxii have not been established in pediatric patients <12 years of age.

There are no adequate data regarding use of garadacimab-gxii in pregnant women. Monoclonal antibodies are transported across the placenta during the third trimester of pregnancy; therefore, the potential for effects of garadacimab-gxii on the fetus is expected to be greater during the third trimester.

In an animal reproductive study, use of garadacimab-gxii was not associated with fetal harm at doses up to approximately 100 times the exposure achieved at the maximum recommended human dose (MRHD) of 200 mg once monthly. In a pre- and postnatal development study in rabbits, garadacimab-gxii showed no effects on survival, growth, or development of F1 offspring at doses resulting in approximately 76 times that observed at the MRHD.

It is not known whether garadacimab-gxii is distributed into human milk, or if the drug has any effects on the breastfed infant or on milk production. Maternal IgG is known to be present in human milk. The effects of local GI exposure and limited systemic absorption of garadacimab-gxii in breastfed infants are unknown.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for garadacimab-gxii and any potential adverse effects on the breastfed infant from garadacimab-gxii or the underlying maternal condition.

Among the patients with HAE who were studied in the pivotal clinical trial of garadacimab-gxii, 6 (9%) were >=65 years of age. No overall differences in safety or efficacy were observed between these patients and younger adults.