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Guselkumab

Medically reviewed by Drugs.com. Last updated on Jun 21, 2020.

Pronunciation

(gue sel KOO mab)

Index Terms

  • CNTO 1959

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Pen-injector, Subcutaneous [preservative free]:

Tremfya: 100 mg/mL (1 mL) [contains polysorbate 80]

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Tremfya: 100 mg/mL (1 mL) [contains polysorbate 80]

Brand Names: U.S.

  • Tremfya

Pharmacologic Category

  • Antipsoriatic Agent
  • Interleukin-23 Inhibitor
  • Monoclonal Antibody

Pharmacology

Human IgG1 monoclonal antibody selectively binds with IL-23, thereby reducing serum levels of IL-17A, IL-17F, and IL-22. Guselkumab inhibits the release of proinflammatory cytokines and chemokines.

Distribution

Vd: 13.5 L

Metabolism

Degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.

Time to Peak

5.5 days

Half-Life Elimination

15 to 18 days

Use: Labeled Indications

Plaque psoriasis: Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Psoriatic arthritis: Treatment of active psoriatic arthritis in adults.

Contraindications

Serious hypersensitivity to guselkumab or any component of the formulation.

Dosing: Adult

Plaque psoriasis: SubQ: 100 mg at weeks 0, 4, and then every 8 weeks thereafter.

Psoriatic arthritis: SubQ: 100 mg at weeks 0, 4, and then every 8 weeks thereafter; may administer alone or in combination with conventional disease-modifying antirheumatic drugs (eg, methotrexate).

Dosing: Geriatric

Refer to adult dosing.

Reconstitution

Allow prefilled syringe to reach room temperature (~30 minutes) in original carton before injecting. Do not warm in any other way. Intact solution should be colorless to light yellow; solution may develop a few fine, translucent particles. Discard unused portion of prefilled syringe.

Administration

SubQ: Administer SubQ into front of thighs, lower abdomen (except for 2 inches around navel), or back of upper arms; do not inject into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.

Storage

Store at 2°C to 8°C (36°F to 46°F) in the original carton; do not freeze. Protect from light. Do not shake.

Drug Interactions

Baricitinib: Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. Consider therapy modification

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Belimumab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Avoid combination

Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Management: Consider avoiding Echinacea in patients receiving therapeutic immunosuppressants. If coadministered, monitor for reduced efficacy of the immunosuppressant during concomitant use. Consider therapy modification

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Inebilizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

InFLIXimab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Avoid combination

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Management: Avoid use of immunosuppressants (including systemic corticosteroids) prior to initiation of nivolumab. Use of immunosuppressants after administration of nivolumab (eg, for immune-related toxicity) is unlikely to affect nivolumab efficacy. Consider therapy modification

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Ozanimod: Immunosuppressants may enhance the immunosuppressive effect of Ozanimod. Monitor therapy

Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Management: Consider avoiding concomitant use of roflumilast and immunosuppressants as recommended by the Canadian product monograph. Inhaled or short-term corticosteroids are unlikely to be problematic. Consider therapy modification

Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. Consider therapy modification

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification

Upadacitinib: Immunosuppressants may enhance the immunosuppressive effect of Upadacitinib. Management: Concomitant use of upadacitinib with potent immunosuppressants is not recommended. Drugs listed as exceptions to this monograph are discussed in separate drug interaction monographs. Avoid combination

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Vaccines (Live): Guselkumab may enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Adverse Reactions

>10%:

Infection: Infection (23%)

Respiratory: Upper respiratory tract infection (14%)

1% to 10%:

Dermatologic: Tinea (1%)

Gastrointestinal: Diarrhea (2%), gastroenteritis (1%)

Hepatic: Increased liver enzymes (3%)

Immunologic: Antibody development (6% to 9%; neutralizing antibodies: 6% to 7%; efficacy of guselkumab may be affected)

Infection: Herpes simplex infection (1%)

Local: Injection site reaction (5%)

Nervous system: Headache (5%)

Neuromuscular & skeletal: Arthralgia (3%)

<1%:

Dermatologic: Urticaria

Infection: Candidiasis

Nervous system: Migraine

<1%, postmarketing, and/or case reports: Anaphylaxis, hypersensitivity reaction, severe hypersensitivity reaction, skin rash

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur; may require hospitalization. Discontinue use and initiate appropriate therapy if serious hypersensitivity reactions occur.

• Infections: Guselkumab may increase the risk of infections; upper respiratory tract infections, gastroenteritis, tinea infections, and herpes simplex infections have occurred more frequently. Consider the risks versus benefits prior to treatment initiation in patients with a history of chronic or recurrent infection; treatment should not be initiated in patients with clinically important active infections until it is resolved or treated. Monitor for infections; patients should seek medical attention for signs/symptoms of a clinically important infection (acute or chronic). If a serious infection develops or is unresponsive to appropriate therapy for the infection, monitor closely and discontinue guselkumab until the infection resolves.

• Tuberculosis: Patients should be evaluated for tuberculosis (TB) infection prior to initiating therapy. Do not administer to patients with an active TB infection. Treatment for latent TB should be administered prior to administering guselkumab. Consider anti-TB therapy prior to treatment initiation in patients with a history of latent or active TB in whom an adequate course of TB treatment cannot be confirmed. Monitor closely for signs/symptoms of active TB during and after guselkumab treatment.

Other warnings/precautions:

• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently; there are no data available concerning secondary transmission of infection by live vaccines in patients receiving therapy.

Monitoring Parameters

Tuberculosis screening (prior to initiating and periodically during therapy); signs and symptoms of infection, including tuberculosis (during and after treatment).

Pregnancy Considerations

Guselkumab is a humanized monoclonal antibody (IgG1). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).

Agents other than guselkumab are currently recommended for the treatment of psoriasis in pregnancy (Menter 2019; Yeung 2020).

Data collection to monitor pregnancy and infant outcomes following exposure to guselkumab is ongoing. Patients exposed to guselkumab during pregnancy are encouraged to enroll themselves in the pregnancy registry (1-877-311-8972).

Patient Education

What is this drug used for?

• It is used to treat plaque psoriasis.

• It is used to treat psoriatic arthritis.

• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Common cold symptoms

• Headache

• Injection site irritation

• Joint pain

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Infection

• Red, painful, or itchy skin that is hot to touch

• Shortness of breath

• Coughing with or without phlegm or blood

• Weight loss

• Passing urine more often

• Diarrhea

• Stomach pain

• Sweating a lot

• Muscle pain

• Dizziness or passing out

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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