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Guselkumab

Class: Skin and Mucous Membrane Agents, Miscellaneous
Molecular Formula: C6402H9864N1676O1994S42
CAS Number: 1350289-85-8
Brands: Tremfya

Introduction

Guselkumab, a recombinant human IgG1 lambda monoclonal antibody, binds specifically to and inhibits the biologic activity of interleukin-23 (IL-23), a proinflammatory cytokine.1

Uses for Guselkumab

Guselkumab has the following uses:

Guselkumab is an interleukin-23 blocker indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.1

Guselkumab Dosage and Administration

General

Guselkumab is available in the following dosage form(s) and strength(s):

Injection: 100 mg/mL in a single-dose prefilled syringe.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.1

Cautions for Guselkumab

Contraindications

None.1

Warnings/Precautions

Infections

Guselkumab may increase the risk of infection. In clinical trials, infections occurred in 23% of subjects in the guselkumab group versus 21% of subjects in the placebo group through 16 weeks of treatment. Upper respiratory tract infections, gastroenteritis, tinea infections, and herpes simplex infections occurred more frequently in the guselkumab group than in the placebo group. The rate of serious infections for the guselkumab group and the placebo group was ≤0.2%. Treatment with guselkumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.1

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing guselkumab. Instruct patients to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection or is not responding to standard therapy, monitor the patient closely and discontinue guselkumab until the infection resolves.1

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with guselkumab. Initiate treatment of latent TB prior to administering guselkumab. In clinical studies, 105 subjects with latent TB who were concurrently treated with guselkumab and appropriate TB prophylaxis did not develop active TB (during the mean follow-up of 43 weeks). Monitor patients for signs and symptoms of active TB during and after guselkumab treatment. Consider anti-TB therapy prior to initiating guselkumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Do not administer guselkumab to patients with active TB infection.1

Immunizations

Prior to initiating therapy with guselkumab, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with guselkumab. No data are available on the response to live or inactive vaccines.1

Specific Populations

Pregnancy

Risk Summary: There are no available data on guselkumab 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. In a combined embryofetal development and pre- and post-natal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of guselkumab during organogenesis through parturition at doses up to 30 times the maximum recommended human dose (MRHD). Neonatal deaths were observed at 6–30 times the MRHD. The clinical significance of these nonclinical findings is unknown.1

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.1

Animal Data: In a combined embryofetal development and pre- and post-natal development study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of guselkumab up to 50 mg/kg (30 times the MRHD based on a mg/kg comparison) from the beginning of organogenesis to parturition. Neonatal deaths occurred in the offspring of one control monkey, three monkeys administered guselkumab at 10 mg/kg/week (6 times the MRHD based on a mg/kg comparison), and three monkeys administered guselkumab at 50 mg/kg/week (30 times the MRHD based on a mg/kg comparison). The clinical significance of these findings is unknown. No guselkumab-related effects on functional or immunological development were observed in the infants from birth through 6 months of age.1

Lactation

There are no data on the presence of guselkumab in human milk, the effects on the breastfed infant, or the effects on milk production. Guselkumab was not detected in the milk of lactating cynomolgus monkeys. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for guselkumab and any potential adverse effects on the breastfed infant from guselkumab or from the underlying maternal condition.1

Pediatric Use

The safety and efficacy of guselkumab in pediatric patients (less than 18 years of age) have not been established.1

Geriatric Use

Of the 1748 subjects with plaque psoriasis exposed to guselkumab, a total of 93 subjects were 65 years or older, and 4 subjects were 75 years or older. No overall differences in safety or effectiveness were observed between older and younger subjects who received guselkumab. However, the number of subjects aged 65 years and older was not sufficient to determine whether they respond differently from younger subjects.1

Common Adverse Effects

Most common (≥1%) adverse reactions associated with guselkumab include upper respiratory infections, headache, injection site reactions, arthralgia, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.1

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Avoid use of live vaccines in patients treated with guselkumab.1

Actions

Mechanism Of Action

Guselkumab is a human monoclonal IgG1λ antibody that selectively binds to the p19 subunit of interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Guselkumab inhibits the release of proinflammatory cytokines and chemokines.1

Advice to Patients

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) before starting guselkumab therapy, and each time the prescription is renewed, as there may be new information they need to know.1

Infections

Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any symptoms of an infection.1

Instruction on Injection Technique

Instruct the patient or caregivers to perform the first self-injection under the supervision and guidance of a qualified healthcare professional for proper training in subcutaneous injection technique. Instruct patients who are self-administering to inject the full dose of guselkumab.1

Instruct patients or caregivers in the technique of proper needle and syringe disposal. Needles and syringes should be disposed of in a puncture-resistant container. Advise patients and caregivers not to reuse needles or syringes.1

Remind patients if they forget to take their dose of guselkumab to inject their dose as soon as they remember. They should then take their next dose at the appropriate scheduled time.1

Additional Information

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Guselkumab

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection

100 mg/1 mL

Tremfya

Janssen Biotech Inc.

AHFS Drug Information. © Copyright 2018, Selected Revisions July 31, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. Janssen Biotech, Inc.. Tremfya (Guselkumab) SUBCUTANEOUS prescribing information. 2017 Jul.

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