guselkumab

General

Pronunciation:
gue-sel-koo-mab


Trade Name(s)

  • Tremfya

Ther. Class.
antipsoriatics

Pharm. Class.
interleukin antagonists
monoclonal antibodies

Indications

Moderate-to-severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy.

Action

Binds to the p19 protein subunit of the interleukin (IL)-23 cytokine to prevent its interaction with the IL-23 receptor. This cytokine is normally involved in inflammatory and immune responses. Binding to interleukins antagonizes their effects, inhibiting the release of proinflammatory cytokines and chemokines.

Therapeutic Effect(s):

Decrease in area and severity of psoriatic lesions.

Pharmacokinetics

Absorption: 49% absorbed following subcutaneous administration.

Distribution: Well distributed to tissues.

Metabolism and Excretion: Broken down by catabolic processes into peptides and amino acids.

Half-life: 15–18 days

TIME/ACTION PROFILE (plasma concentrations)

ROUTEONSETPEAKDURATION
Subcutunknown5.5 days8 wk

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity;
  • Active, untreated infection.

Use Cautiously in:

  • History of tuberculosis (possibility of reactivation);
  • OB:  Use only if potential maternal benefit justifies potential fetal risk;
  • Lactation: Safety not established;
  • Pedi:   Safety and effectiveness not established.

Exercise Extreme Caution in:

Chronic infection or history of recurrent infection.

Adverse Reactions/Side Effects

CNS: headache

GI: diarrhea, ↑ liver enzymes

Local: injection site reactions

MS: arthralgia

Misc: HYPERSENSITIVITY REACTIONS, infection

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

  • May ↓ antibody response to and ↑ risk of adverse reactions from  live vaccines ; avoid use during therapy.
  • May affect the activity of CYP450 drug-metabolizing enzymes; appropriate monitoring and dose adjustment should be carried out when treatment is started in patients receiving concurrent treatment with CYP450 substrate, especially those with a narrow therapeutic index, including  warfarin  and  cyclosporine.

Route/Dosage

SC (Adults): 100 mg initially and 4 wk later, then 100 mg every 8 wk.

Availability

Solution for injection (prefilled syringes and patient-controlled injectors): 100 mg/mL

Assessment

  • Assess affected area(s) prior to and periodically during therapy.
  • Assess patient for latent tuberculosis with a tuberculin skin test prior to initiation of therapy. Treatment of latent tuberculosis should be started before therapy with guselkumab.
  • Assess for signs of infection (fever, dyspnea, flu-like symptoms, frequent or painful urination, redness or swelling at the site of a wound), including tuberculosis, prior to injection. Monitor new infections closely; most common are upper respiratory tract infections, bronchitis, and urinary tract infections.

Lab Test Considerations:

May cause ↑ liver enzymes.

Potential Diagnoses

Implementation

  • Update immunizations to current prior to initiating therapy. Patients on guselkumab may receive concurrent vaccinations, except for live vaccines.
  • SC Allow syringe and solution to reach room temperature, for 30 min before injecting. Solution is clear and colorless to light yellow solution and may contain small translucent particles; do not administer solutions that are cloudy, discolored or contain large particles. Store solution in refrigerator in original carton to protect from light; do not shake or freeze. Inject full amount (1 mL) of  One Press injector  in front of thigh, abdomen, or upper arm. Avoid areas that are tender, bruised, red, hard, thick, scaly, or affected by psoriasis.

Patient/Family Teaching

  • Instruct patient on correct technique for self-injection, care and disposal of equipment. Review  Medication Guide  with patient before starting therapy and with each injection.
  • Advise patient to notify health care professional if signs and symptoms of infection (fever, chills, sore throat, painful urination) occur.
  • Instruct patient to avoid receiving live vaccines during therapy.
  • Advise patient to notify health care professional immediately if signs and symptoms of hypersensitivity reaction (feel faint; swelling of face, eyelids, lips, mouth, tongue or throat; trouble breathing; throat tightness; chest tightness; skin rash; hives) occur.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
  • Instruct patient to notify health care professional of medication regimen prior to treatment or surgery.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected, or if breast feeding.

Evaluation/Desired Outcomes

Decrease in extent and severity of psoriatic lesions.

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