Nemluvio (nemolizumab-ilto)

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Administer nemolizumab-ilto by subcutaneous injection only.

Nemolizumab-ilto is available as a single-dose prefilled pen with a dual chamber containing 30 mg of lyophilized powder in one chamber and water for injection in the other chamber. The drug must be reconstituted prior to administration by activating the pen to mix the contents of the 2 chambers.

No dosing information is available for this tab.

Nemolizumab shows no clinically significant impact on the pharmacokinetics of the following cytochrome P-450 (CYP) substrates: midazolam (a CYP3A4/5 substrate), warfarin (a CYP2C9 substrate), omeprazole (a CYP2C19 substrate), metoprolol (a CYP2D6 substrate), and caffeine (a CYP1A2 substrate).

The manufacturer states that chronic inflammation can alter CYP enzyme formation due to increased cytokine levels (e.g., IL-1, IL-6, IL-10, tumor necrosis factor (TNF) alpha, interferon (IFN)). Nemolizumab may modulate cytokine levels, potentially influencing CYP enzyme activity. When initiating or discontinuing nemolizumab in patients receiving CYP substrates concomitantly, particularly those with a narrow therapeutic index (e.g., warfarin, cyclosporine), monitor drug effects (e.g., for warfarin) or concentrations (e.g., for cyclosporine) and adjust dosages as needed.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Selected Immunosuppressive Agents/Live Vaccines; Live Bcg

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: A variety of disease modifying agents suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(2)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) Patients who receive anti-B cell therapies should not receive live vaccines for at least 6 months after such therapies due to a prolonged duration of immunosuppression. An exception is the Zoster vaccine, which can be given at least 1 month after receipt of anti-B cell therapies.(1) The US manufacturer of abatacept states live vaccines should not be given during or for up to 3 months after discontinuation of abatacept.(2) The US manufacturer of live BCG for intravesicular treatment of bladder cancer states use is contraindicated in immunosuppressed patients.(3) The US manufacturer of daclizumab states live vaccines are not recommended during and for up to 4 months after discontinuation of treatment.(4) The US manufacturer of guselkumab states that live vaccines should be avoided during treatment with guselkumab.(5) The US manufacturer of inebilizumab-cdon states that live vaccines are not recommended during treatment and after discontinuation until B-cell repletion. Administer all live vaccinations at least 4 weeks prior to initiation of inebilizumab-cdon.(6) The US manufacturer of ocrelizumab states that live vaccines are not recommended during treatment and until B-cell repletion occurs after discontinuation of therapy. Administer all live vaccines at least 4 weeks prior to initiation of ocrelizumab.(7) The US manufacturer of ozanimod states that live vaccines should be avoided during and for up to 3 months after discontinuation of ozanimod.(8) The US manufacturer of siponimod states that live vaccines are not recommended during treatment and for up to 4 weeks after discontinuation of treatment.(9) The US manufacturer of ustekinumab states BCG vaccines should not be given in the year prior to, during, or the year after ustekinumab therapy.(10) The US manufacturer of satralizumab-mwge states that live vaccines are not recommended during treatment and should be administered at least four weeks prior to initiation of satralizumab-mwge.(11) The US manufacturer of ublituximab-xiiy states that live vaccines are not recommended during treatment and until B-cell recovery. Live vaccines should be administered at least 4 weeks prior to initiation of ublituximab-xiiy.(12) The US manufacturer of etrasimod states that live vaccines should be avoided during and for 5 weeks after treatment. Live vaccines should be administered at least 4 weeks prior to initiation of etrasimod.(13) The US manufacturer of emapalumab-lzsg states that live vaccines should not be administered to patients receiving emapalumab-lzsg and for at least 4 weeks after the last dose of emapalumab-lzsg. The safety of immunization with live vaccines during or following emapalumab-lzsg therapy has not been studied.(14) The US manufacturer of sibeprenlimab-szsi states live vaccines should not be given within 30 days prior to initiation or during treatment with sibeprenlimab-szsi.(15)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)

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)

*Known hypersensitivity to nemolizumab-ilto or any of the excipients in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

Atopic dermatitis: The most common adverse reactions (incidence >=1%) in patients with atopic dermatitis receiving nemolizumab-ilto in clinical studies were headache (including migraine), arthralgia, urticaria, and myalgia.

Prurigo nodularis: The most common adverse reactions (incidence >=1%) in patients with prurigo nodularis receiving nemolizumab-ilto in clinical studies were headache, atopic dermatitis, eczema, and eczema nummular.

Less Frequent

• Angioedema

More Frequent

• Eczema
• Headache disorder

Less Frequent

• Arthralgia
• Hypersensitivity drug reaction
• Myalgia

Rare or Very Rare

• Herpes zoster
• Injection site sequelae
• Urticaria

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Atopic dermatitis: Clinical trials have demonstrated the safety and efficacy of nemolizumab-ilto, in combination with topical corticosteroids and/or topical calcineurin inhibitors, in pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis inadequately controlled by topical therapies. Evidence from two randomized, double-blind, placebo-controlled trials (ARCADIA 1 and ARCADIA 2) supports these findings. Safety and efficacy between pediatric and adults were similar

Prurigo nodularis: The safety and efficacy of nemolizumab-ilto for the treatment of prurigo nodularis have not been established in pediatric patients.

Data on the use of nemolizumab in pregnant women are insufficient to determine the risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Human IgG antibodies, including nemolizumab, cross the placenta increasingly throughout pregnancy, peaking in the third trimester. In a pre- and postnatal development study in cynomolgus monkeys, subcutaneous administration of nemolizumab-ilto during organogenesis through parturition led to increased early postnatal deaths at doses 36-50 times the maximum recommended human dose; however, the clinical relevance of this finding is unknown.

Because IgG antibodies can cross the placenta and may interfere with an infant's immune response, the risks and benefits of administering live vaccines to infants exposed to nemolizumab in utero should be carefully considered. Although the exact duration of drug persistence in infants is unknown, delaying live vaccines for at least 3 months after birth is recommended based on the half-life of nemolizumab-ilto and general principles of antibody transfer.

There are no data on the presence of nemolizumab in human milk, its effects on breastfed infants, or its impact on milk production. Nemolizumab has been detected in breast milk in monkeys, and maternal IgG and monoclonal antibodies are known to transfer into human milk. The effects of GI exposure and limited systemic exposure to the drug in breastfed infants are unknown. Consider the benefits of breastfeeding, the mother's need for nemolizumab, and any potential risks to the infant from the drug or the maternal condition.

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

Atopic dermatitis:In the clinical trials of patients with atopic dermatitis, 6% of patients in the primary safety population were >=65 years of age and 4.5% of patients in the long-term safety population were >=65 years of age. However, clinical studies did not include a sufficient number of older adults to determine if their response differs from that of younger patients.

Prurigo nodularis: In the OLYMPIA 1 and OLYMPIA 2 trials, 26.8% of patients were >=65 years of age. Long-term safety was evaluated in 26.2% of patients >=65 years of age. However, clinical studies did not include enough older adults to determine if their response differs from that of younger patients.