Tremfya One-Press (guselkumab)

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Guselkumab is administered by subcutaneous injection or IV infusion, dependent upon indication for use.

If a subcutaneous dose is missed, the missed dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.

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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)

*Known serious hypersensitivity to guselkumab or any ingredient in the formulation.

• Active tuberculosis

• Acute hepatic failure
• Hepatic cirrhosis
• Inactive tuberculosis
• Infection

There are no moderate contraindications for this drug.

The most common adverse effects reported in >=1% of patients receiving guselkumab for plaque psoriasis and psoriatic arthritis in clinical studies include upper respiratory tract infection, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

The most common adverse effects reported in >=3% of patients receiving guselkumab for ulcerative colitis in clinical studies include injection site reactions, arthralgia, upper respiratory tract infections, headache, gastroenteritis, fatigue, pyrexia, and rash.

The most common adverse effects reported in >=3% of patients receiving guselkumab for Crohn's disease in clinical studies include respiratory tract infections, abdominal pain, injection site reactions, headache, fatigue, arthralgia, diarrhea, and gastroenteritis.

More Frequent

• Infection

Less Frequent

• Abnormal hepatic function tests

Rare or Very Rare

• Anaphylaxis
• Hypersensitivity drug reaction
• Neutropenic disorder

More Frequent

• Acute abdominal pain
• Injection site sequelae
• Upper respiratory infection

Less Frequent

• Arthralgia
• Bronchitis
• Dermatophytosis
• Diarrhea
• Fatigue
• Fever
• Gastroenteritis
• Headache disorder
• Herpes simplex infection
• Tinea cruris
• Tinea manuum
• Tinea pedis

Rare or Very Rare

• Skin rash

No enhanced messaging available.

Safety and efficacy of guselkumab have been established in pediatric patients >=6 years of age who weigh >=40 kg with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy or those with active psoriatic arthritis. The use of guselkumab in this age group for these indications is supported by evidence from clinical trials in adults, pharmacokinetic data from adults and pediatric patients, and safety data from a clinical trial involving 120 pediatric patients 6 to 17 years of age with plaque psoriasis.

Safety and efficacy of guselkumab in pediatric patients <18 years of age with ulcerative colitis or Crohn's disease have not been established.

Clinical data from the biomedical literature, postmarketing reports, and an ongoing pregnancy registry are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes with guselkumab administration during pregnancy. Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses; therefore, it is expected that guselkumab may be present in infants exposed in utero. A study in cynomolgus monkeys revealed no evidence of adverse developmental effects after subcutaneous guselkumab administration during organogenesis through parturition; however, neonatal deaths in monkeys were observed at dose exposures 4 to 18 times the exposure in humans. No guselkumab-related effects on functional or immunologic development were observed in the offspring from birth through 6 months of age.

A pregnancy registry has been established to monitor fetal outcomes of pregnant women exposed to guselkumab; patients or clinicians may contact the registry at 1-877-311-8972 or by visiting https://mothertobaby.org/ongoing-study/tremfya-guselkumab/.

It is not known whether guselkumab is distributed into human milk, affects milk production, or affects the breast-fed infant. Endogenous maternal IgG and monoclonal antibodies are transferred into human milk; the effects of local GI exposure and the extent of systemic exposure in the breastfed infant to guselkumab are unknown. Consider the benefits of breast-feeding and the importance of guselkumab to the woman along with potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.

Dosage adjustment is not necessary in geriatric patients.

Of the 5723 patients with plaque psoriasis, psoriatic arthritis, ulcerative colitis, or Crohn's disease who received guselkumab in clinical trials, 313 patients were >=65 years of age, and 32 patients were >=75 years of age. The clinical trials for each indication did not include sufficient numbers of patients >=65 years of age to determine whether geriatric patients respond differently than younger adults. Age was not associated with any clinically meaningful differences in the pharmacokinetics of guselkumab.