Skyrizi On-Body (risankizumab-rzaa)

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Risankizumab-rzaa is administered by subcutaneous injection for the treatment of plaque psoriasis and psoriatic arthritis. For the treatment of Crohn disease and ulcerative colitis, the induction dosage is administered by IV infusion and the maintenance dosage is administered by subcutaneous injections.

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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)

*History of serious hypersensitivity reactions to risankizumab or any excipients in the formulation.

• Active tuberculosis

• Inactive tuberculosis
• Severe infection

There are no moderate contraindications for this drug.

Adverse reactions reported in >=1% of patients receiving risankizumab in clinical studies for plaque psoriasis and psoriatic arthritis include upper respiratory infection, headache, fatigue, injection site reaction, and tinea infection.

Adverse reactions reported in >3% of patients receiving risankizumab in clinical studies for induction treatment in Crohn disease include upper respiratory infection, headache, and arthralgia.

Adverse reactions reported in >3% of patients receiving risankizumab in clinical studies for maintenance treatment in Crohn disease include arthralgia, injection site reaction, abdominal pain, anemia, pyrexia, back pain, arthropathy, and urinary tract infection.

Adverse reactions reported in >=3% of patients receiving risankizumab in clinical studies for induction treatment in ulcerative colitis include arthralgia.

Adverse reactions reported in >=3% of patients receiving risankizumab in clinical studies for maintenance treatment in ulcerative colitis include arthralgia, pyrexia, injection site reactions, and rash.

More Frequent

• Infection

Rare or Very Rare

• Anaphylaxis
• Cellulitis
• Herpes zoster
• Hyperbilirubinemia
• Hypersensitivity drug reaction
• Increased alanine transaminase
• Increased alkaline phosphatase
• Osteomyelitis
• Pneumonia
• Sepsis

More Frequent

• Acute abdominal pain
• Anemia
• Arthralgia
• Back pain
• Dermatophytosis
• Fatigue
• Fever
• Headache disorder
• Injection site sequelae
• Upper respiratory infection

Less Frequent

• Hypercholesterolemia
• Skin rash
• Urinary tract infection

Rare or Very Rare

• Allergic rhinitis
• Eczema
• Facial edema
• Folliculitis
• Urticaria

No enhanced messaging available.

Safety and efficacy of risankizumab in pediatric patients <18 years of age have not been established.

Available data regarding use of risankizumab in pregnant women are inadequate for establishing a drug-associated risk of major birth defects, miscarriage , or other adverse maternal or fetal outcomes. Monoclonal antibodies can cross the placenta and may cause immunosuppression in the in utero-exposed infant. Consider the risks and benefits of administering live vaccines to infants exposed to risankizumab in utero. Since the duration of persistence of risankizumab in infant serum after birth is not well established and a specific time frame to delay immunization is unknown, consider delaying administration of live vaccines for a minimum of 5 months after birth due to the half-life of risankizumab.

In an enhanced pre- and post-natal developmental study, pregnant cynomolgus monkeys received risankizumab 5 or 50 mg/kg once weekly during the period of organogenesis up to parturition. Fetal/infant loss was observed at the 50 mg/kg dose, which resulted in approximately 5 times the exposure in humans administered the maximum recommended 1200 mg induction dose and 32 times the exposure to the maximum recommended 360 mg maintenance dose. No malformations and no adverse effects on growth and development, immunologic development, or neurobehavioral development were observed in infant monkeys from birth through 6 months of age. Following delivery, most adult female monkeys and all infant monkeys from the risankizumab-treated groups had measurable serum concentrations of the drug for up to 91 days postpartum. The clinical relevance of these findings is unknown.

A pregnancy exposure registry has been established to monitor outcomes in women who become pregnant while receiving risankizumab-rzaa; patients may be enrolled by calling 877-302-2161or visiting https://glowpregnancyregistry.com.

It is not known whether risankizumab is distributed into human milk, affects milk production, or affects breast-fed infants. Endogenous maternal IgG and monoclonal antibodies are transferred in human milk. Because risankizumab is a large protein molecule, absorption by a breast-fed infant is thought to be unlikely since the drug will probably be destroyed in the infant's GI tract. The effects of local GI and limited systemic exposure in the breast-fed infant are unknown.

Consider the benefits of breast-feeding along with the mother's clinical need for risankizumab 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 6862 patients who received risankizumab-rzaa in clinical trials, 664 were >=65 years of age and 71 were >=75 years of age. Clinical trials of patients for each approved indication did not include sufficient numbers of patients >=65 years of age to determine whether geriatric patients respond differently than younger adults. No clinically meaningful differences in the pharmacokinetics of risankizumab-rzaa were observed based on age.