Medically reviewed by Drugs.com. Last updated on Jun 21, 2020.
(gue sel KOO mab)
- CNTO 1959
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.
- Antipsoriatic Agent
- Interleukin-23 Inhibitor
- Monoclonal Antibody
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.
Vd: 13.5 L
Degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Time to Peak
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.
Serious hypersensitivity to guselkumab or any component of the formulation.
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).
Refer to adult dosing.
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.
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.
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.
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
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%)
Nervous system: Migraine
<1%, postmarketing, and/or case reports: Anaphylaxis, hypersensitivity reaction, severe hypersensitivity reaction, skin rash
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.
• 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.
Tuberculosis screening (prior to initiating and periodically during therapy); signs and symptoms of infection, including tuberculosis (during and after treatment).
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).
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
• 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:
• 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
• 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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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More about guselkumab
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- En Español
- 19 Reviews
- Drug class: interleukin inhibitors
Other brands: Tremfya