Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 100mg/mL (single-dose prefilled syringe)
- 100mg/mL (single-dose One-Press patient-controlled syringe)
Plaque Psoriasis
Indicated for moderate-to-severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy
100 mg SC at Week 0, Week 4, and q8Weeks thereafter
<18 years: Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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
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
Serious hypersensitivity reactions reported with postmarket use
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
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
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
Patient Handout
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
