Dosing & Uses
Dosage Forms & Strengths
injectable solution
-
prefilled syringe, single-dose
- 100mg/mL
-
one-Press patient-controlled injector, single-dose
- 100mg/mL
Plaque Psoriasis
Indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
100 mg SC at Week 0, Week 4, and q8Weeks thereafter
Psoriatic Arthritis
Indicated for active psoriatic arthritis
100 mg SC at Week 0, Week 4, and q8Weeks thereafter
May be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (eg, methotrexate)
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (15)
- adenovirus types 4 and 7 live, oral
guselkumab, adenovirus types 4 and 7 live, oral. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
- BCG vaccine live
guselkumab, BCG vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
- cholera vaccine
guselkumab, cholera vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
- influenza virus vaccine quadrivalent, intranasal
guselkumab, influenza virus vaccine quadrivalent, intranasal. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
- measles (rubeola) vaccine
guselkumab, measles (rubeola) vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
- measles mumps and rubella vaccine, live
guselkumab, measles mumps and rubella vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
- measles, mumps, rubella and varicella vaccine, live
guselkumab, measles, mumps, rubella and varicella vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
- rotavirus oral vaccine, live
guselkumab, rotavirus oral vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
- rubella vaccine
guselkumab, rubella vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
- smallpox (vaccinia) vaccine, live
guselkumab, smallpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
- typhoid polysaccharide vaccine
guselkumab, typhoid polysaccharide vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
- typhoid vaccine live
guselkumab, typhoid vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
- varicella virus vaccine live
guselkumab, varicella virus vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
- yellow fever vaccine
guselkumab, yellow fever vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
- zoster vaccine live
guselkumab, zoster vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
Monitor Closely (31)
- caffeine
guselkumab, caffeine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- carbamazepine
guselkumab, carbamazepine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- cyclosporine
guselkumab, cyclosporine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- dengue vaccine
guselkumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- disopyramide
guselkumab, disopyramide. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- fentanyl
guselkumab, fentanyl. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- fentanyl intranasal
guselkumab, fentanyl intranasal. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- fentanyl transdermal
guselkumab, fentanyl transdermal. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- fentanyl transmucosal
guselkumab, fentanyl transmucosal. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- fosphenytoin
guselkumab, fosphenytoin. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- ifosfamide
ifosfamide, guselkumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor.
- isavuconazonium sulfate
guselkumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- lomustine
lomustine and guselkumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- mechlorethamine
mechlorethamine, guselkumab. immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- midazolam
guselkumab, midazolam. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- ofatumumab SC
ofatumumab SC, guselkumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- oxaliplatin
oxaliplatin and guselkumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Use of oxaliplatin with concomitant immunosuppressants or with impaired immune systems may increased risk for serious infections.
- phenobarbital
guselkumab, phenobarbital. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- phenytoin
guselkumab, phenytoin. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- pimozide
guselkumab, pimozide. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- primidone
guselkumab, primidone. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- quinidine
guselkumab, quinidine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- quinine
guselkumab, quinine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- tacrolimus
guselkumab, tacrolimus. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- theophylline
guselkumab, theophylline. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- thioridazine
guselkumab, thioridazine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- trastuzumab
trastuzumab, guselkumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, guselkumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- valproic acid
guselkumab, valproic acid. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- warfarin
guselkumab, warfarin. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of guselkumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- zoster vaccine recombinant
guselkumab decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.
Minor (0)
Adverse Effects
>10%
Infections (23%)
Upper respiratory tract infections (14.3%)
1-10%
Headache (4.6%)
Injection site reactions (4.5%)
Arthralgia (2.7%)
Elevated liver enzymes (2.6%)
Diarrhea (1.6%)
Gastroenteritis (1.3%)
Tinea infections (1.1%)
Herpes simplex infections (1.1%)
Postmarketing Reports
Immune system disorders: Hypersensitivity, including anaphylaxis
Skin and subcutaneous tissue disorders: Rash
Warnings
Contraindications
History of serious hypersensitivity reaction to guselkumab or to any of the excipients
Cautions
May increase infection risk; consider risks and benefits in patients with a chronic infection or history of recurrent infection; discontinue drug if patient develops serious infection or is not responding to therapy; treatment should not be initiated in patients with any clinically important active infection until infection resolves or is adequately treated
Serious hypersensitivity reactions, including anaphylaxis, reported with postmarket use; some cases required hospitalization; if a serious hypersensitivity reaction occurs, discontinue drug and initiate appropriate therapy
Do not initiate in patients with clinically important active infection until infection resolves or is adequately treated
Screen for tuberculosis (TB) before initiating treatment; initiate treatment for latent TB prior to administering guselkumab; monitor patients for signs and symptoms of active TB during and after treatment
Consider completion of all age-appropriate immunizations before initiating guselkumab; avoid live vaccines
Drug interaction overview
- Avoid use of live vaccines
-
CYP450 substrates
- The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, interleukin [IL]-1, IL-6, IL-10, tumor necrosis factor-alpha, interferon) during chronic inflammation
- Guselkumab may modulate serum levels of some cytokines
- Therefore, upon initiating or discontinuing guselkumab in patients who are receiving concomitant drugs that are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (eg, for warfarin) or drug concentration (eg, for cyclosporine) and consider dosage modification of the CYP450 substrate
Pregnancy
Pregnancy
There is a pregnancy registry that monitors pregnancy outcomes in women exposed to drug during pregnancy; encourage patients to enroll by calling 1-877-311- 8972
No available data on use in pregnant women to inform a drug-associated risk of adverse developmental outcomes
Human IgG antibodies are known to cross the placental barrier; therefore, guselkumab may be transmitted from the mother to the developing fetus
Animal studies
- In a combined embryofetal development and prenatal and postnatal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after SC administration during organogenesis through parturition at doses up to 30 times the maximum recommended human dose (MRHD)
- Neonatal deaths were observed at 6-to 30-times the MRHD
Lactation
Unknown if distributed in human breast milk; maternal IgG is known to be present in human milk
Guselkumab was not detected in the milk of lactating cynomolgus monkeys
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Monoclonal antibody (IgG1-lambda) that inhibits IL-23 by selectively binding to p19 subunit of IL-23; IL-23 is a natural cytokine associated with inflammatory and immune responses; guselkumab inhibits the proinflammatory actions of IL-23, thereby decreasing cytokine and chemokine release
Absorption
Bioavailability: 49%
Peak plasma time (100-mg dose): 5.5 days
Peak plasma concentration: 8.09 mcg/mL
Distribution
Vd: 13.5 L
Metabolism
Exact pathway not characterized; expected to degrade into small peptides and amino acids via catabolic pathways similarly to endogenous IgG
Elimination
Half-life: 15-18 days
Total body clearance: 0.516 L/day
Administration
SC Preparation
Remove from refrigerator; allow syringe to reach room temperature (~30 min) before removing syringe cap
Preservative free; visually inspect syringe for any particulates or discoloration prior to administration
SC Administration
For SC use only; inject full amount (1 mL)
Do not inject areas where skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis
Discard unused drug and syringes in a puncture resistant container
Intended for use under physician supervision and guidance; administer SC by a healthcare professional or patient may self-inject after proper training
If dose was missed, inject as soon as possible, then adjust dosing schedule accordingly
Storage
Store refrigerated at 2-8°C (36-46°F)
Protect from light until use
Do not freeze
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Tremfya subcutaneous - | 100 mg/mL solution |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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