Vyepti (eptinezumab-jjmr)

No dosing information is available for this tab.

Eptinezumab-jjmr is administered only by IV infusion. The drug should not be administered by rapid IV injection (e.g., IV push or bolus).

Eptinezumab-jjmr is commercially available as an injection concentrate containing 100 mg/mL in single-dose vials that must be diluted prior to IV infusion.

Single-dose vials of eptinezumab injection concentrate should be stored at 2-8degreesC and in the original carton to protect the drug from light until time of use. The vials should not be frozen or shaken.

Eptinezumab should not be mixed with or administered through the same IV infusion set with other drugs. Diluted solutions of the drug should be administered through a separate IV line using a 0.2- or 0.22-mcm inline or add-on sterile filter. After the infusion is complete, the IV line should be flushed with 20 mL of 0.9% sodium chloride injection.

No dosing information is available for this tab.

The risk of clinically important drug interactions with eptinezumab appears to be minimal. Eptinezumab is not metabolized by cytochrome P-450 (CYP) enzymes. In addition, eptinezumab, a monoclonal antibody, is unlikely to affect drug-metabolizing enzymes or drug transport systems. Therefore, pharmacokinetic interactions with drugs affecting or metabolized by CYP enzymes or substrates of various drug transport systems 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)

*Serious hypersensitivity to eptinezumab or to any excipients in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• Constipation
• Gastrointestinal hypomotility
• Hypertension
• Raynaud's phenomenon

Adverse reactions reported in >=2% of patients receiving eptinezumab-jjmr for preventive treatment of migraine in clinical studies and >=2% more frequently than with placebo include nasopharyngitis and hypersensitivity reactions.

Less Frequent

• Hypersensitivity drug reaction

Rare or Very Rare

• Anaphylaxis
• Angioedema

More Frequent

• Pharyngitis

Less Frequent

• Flushing
• Skin rash

Rare or Very Rare

• Constipation
• Fatigue
• Hypertension
• Raynaud's phenomenon
• Urticaria

No enhanced messaging available.

The manufacturer states that the safety and efficacy of eptinezumab have not been established in pediatric patients.

Pending further clinical experience with the use of anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies in pediatric patients, the Pediatric and Adolescent Headache special interest group of the American Headache Society (AHS) recommends that anti-CGRP monoclonal antibodies should be considered mainly for use in postpubertal adolescents+ with relatively frequent migraines (i.e., 8 or more headache days per month) who have moderate to severe disability associated with migraine (e.g., PedMIDAS score of 30 or more) and in whom at least 2 preventive therapies (including pharmacologic and nonpharmacologic therapies and dietary supplements) have failed. For younger pediatric patients+ with severe chronic migraine that is refractory to multiple preventive therapies, these experts recommend that anti-CGRP monoclonal antibodies be considered only in carefully selected patients with close monitoring (e.g., pubertal status, bone health, linear growth, weight, body mass index (BMI), infectious complications).

There are no adequate data on the developmental risk associated with the use of eptinezumab in pregnant women. In animal studies, no adverse developmental effects were observed following IV administration of eptinezumab throughout the period of organogenesis in rabbits and rats or throughout pregnancy and lactation in rats at systemic exposures greater than those expected clinically.

The estimated rate of major birth defects and miscarriage among deliveries to women with migraine (2.2-2.9 and 17%, respectively) are similar to rates reported in women without migraine. Clinicians should be aware that published data suggest that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.

It is not known whether eptinezumab is distributed into human milk. The effects of the drug on breast-fed infants or on milk production also are unknown. The manufacturer states that the developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for eptinezumab and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

Clinical trials of eptinezumab did not include sufficient numbers of patients >=65 years of age to determine whether they respond differently than younger adults.