Ilumya (tildrakizumab-asmn)

For the management of moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy, the recommended dosage of tildrakizumab-asmn is 100 mg by subcutaneous injection at weeks 0 and 4, followed by 100 mg every 12 weeks. If a dose is missed, the missed dose should be administered as soon as possible, and dosing should be resumed at the regularly scheduled interval.

Tildrakizumab-asmn is administered by subcutaneous injection. The manufacturer states that the drug should only be administered by a clinician.

Tildrakizumab-asmn is commercially available in single-use prefilled syringes. Prior to administration, the solution should be inspected visually for particulate matter or discoloration, and should be discarded if either is present. The solution should appear as a clear to slightly opalescent, colorless to slightly yellow solution that may contain air bubbles; there is no need to remove the bubbles prior to administration.

Tildrakizumab-asmn prefilled syringes should be stored at 2-8degreesC in the original carton for protection from light until use. The injection should not be frozen or shaken. Alternatively, the prefilled syringes may be stored in the original carton at room temperature (25degreesC) for up to 30 days; syringes that have been stored at room temperature should not be returned to the refrigerator. The drug should not be stored at temperatures exceeding 25degreesC. If previously refrigerated, the prefilled syringe should be allowed to sit at room temperature inside the closed carton for 30 minutes prior to administration. The needle cap should not be removed while the solution is warming to room temperature.

Tildrakizumab-asmn is administered by subcutaneous injection into an accessible area with clear skin, such as the anterior thigh, lower abdomen (except for the 2-inch area around the umbilicus), or upper arm. Injections should not be made into areas where the skin is tender, bruised, red, or indurated. Injections into psoriatic lesions, scars, stretch marks, or blood vessels also should be avoided.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

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)

*Serious hypersensitivity reaction to tildrakizumab or any ingredient in the formulation.

• Active tuberculosis

• Infection

There are no moderate contraindications for this drug.

Adverse effects reported in 1% or more of patients with plaque psoriasis receiving tildrakizumab-asmn include upper respiratory infection, injection site reaction, and diarrhea.

Rare or Very Rare

• Angioedema
• Hypersensitivity drug reaction
• Infection
• Urticaria

More Frequent

• Diarrhea
• Injection site sequelae
• Upper respiratory infection

No enhanced messaging available.

Safety and efficacy of tildrakizumab-asmn in pediatric patients younger than 18 years of age have not been established.

Available data regarding use of tildrakizumab in pregnant women are inadequate for establishing a drug-associated risk of adverse developmental outcomes. Human immunoglobulin G (IgG) is known to cross the placenta; thus, the potential exists for fetal exposure to the drug.

Tildrakizumab crossed the placenta in cynomolgus monkeys. An embryofetal development study in cynomolgus monkeys revealed no evidence of adverse developmental effects; however, when tildrakizumab administration was continued until parturition, a small increase in neonatal deaths was observed at doses of 59 times the maximum recommended human dose; clinical relevance of this finding is unknown.

It is not known whether tildrakizumab is distributed into human milk, affects milk production, or affects breast-fed infants. Very low concentrations of the drug have been detected in breast milk in monkeys, and human IgG is known to be present in breast milk. Because tildrakizumab is a large protein, absorption by a breast-fed infant is thought to be unlikely after the first few weeks postpartum since the drug will probably be destroyed in the infant's GI tract.

The benefits of breast-feeding should be considered along with the mother's clinical need for tildrakizumab and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

Of the 1083 patients with psoriasis who received tildrakizumab-asmn 100 mg in clinical trials, 8% were 65 years of age and older, while 1.6% were 75 years of age and older. Although no overall differences in efficacy or safety between geriatric patients and younger adults were observed, the clinical trials did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger adults.