Skip to Content

Guselkumab

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 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.

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Canadian labeling (not in the US labeling): 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.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

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

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

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. Consider therapy modification

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. 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. Consider therapy modification

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy

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

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy

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): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination

Adverse Reactions

>10%:

Infection: Infection (23%)

Respiratory: Upper respiratory tract infection (14%)

1% to 10%:

Central nervous system: Headache (5%)

Dermatologic: Tinea (1%)

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

Hepatic: Increased liver enzymes (3%)

Immunologic: Antibody development (6%; neutralizing antibodies: 2%; efficacy of guselkumab was affected)

Infection: Herpes simplex infection (1%)

Local: Injection site reaction (5%)

Neuromuscular & skeletal: Arthralgia (3%)

<1%, postmarketing, and/or case reports: Candidiasis, migraine, urticaria

Warnings/Precautions

Concerns related to adverse effects:

• 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 monoclonal IgG antibody. Human IgG is known to cross the placenta; therefore, exposure to the fetus may occur if administered to pregnant women.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience common cold symptoms, headache, injection site irritation, or joint pain. Have patient report immediately to prescriber signs of infection; red, painful, or itchy skin that is hot to touch; shortness of breath; coughing up blood; severe cough; weight loss; polyuria; diarrhea; abdominal pain; sweating a lot; or muscle pain (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

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

Hide