guselkumab

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 ILs antagonizes their effects, inhibiting the release of proinflammatory cytokines and chemokines.

Therapeutic effects:

Decrease in area and severity of psoriatic lesions.
Decreased pain and swelling with decreased rate of joint destruction in psoriatic arthritis.
Induction of clinical remission of ulcerative colitis.

Pharmacokinetics ⬆ ⬇

Absorption: 49% absorbed following SUBQ administration.

Distribution: Well distributed to tissues.

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

Half-Life: 15–18 days

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	5.5 days	8 wk

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Active, untreated infection.

Use Cautiously in:

History of tuberculosis (TB) (possibility of reactivation);
OB: Safety not established in pregnancy;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children.

Exercise Extreme Caution in:

Chronic infection or history of recurrent infection.

Adv. Reactions/Side Effects ⬆ ⬇

GI: ↑liver enzymes, diarrhea

Local: injection site reactions

MS: arthralgia

Neuro: headache

Misc: infection, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

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 ⬆ ⬇

Plaque Psoriasis and Psoriatic Arthritis

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

Ulcerative Colitis

IV SC (Adults ): Induction: 200 mg IV infusion initially; then 200 mg IV infusion 4 wk later (Wk 4); then 200 mg IV infusion 4 wk later (Wk 8); then continue with maintenance dosing. Maintenance: 100 mg SUBQ 8 wk after last induction IV dose; then 100 mg SUBQ every 8 wk OR 200 mg SUBQ 4 wk after last induction IV dose; then 200 mg SUBQ every 4 wk.

Availability ⬆ ⬇

Solution for SUBQ injection (prefilled syringes, prefilled pens, and patient-controlled injectors): 100 mg/mL
Solution for IV injection: 10 mg/mL

Assessment ⬆ ⬇

Assess affected area(s) prior to and periodically during therapy.
Assess patient for latent TB with a tuberculin skin test prior to initiation of therapy. Treatment of latent TB 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 TB, prior to injection. Monitor new infections closely; most common are upper respiratory tract infections, bronchitis, and urinary tract infections.
Monitor for signs and symptoms of hypersensitivity reactions (rash; hives; dyspnea; swelling of lips, tongue, or throat) during therapy.

Lab Test Considerations:

May ↑ liver enzymes.

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 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.

IV Administration:

Intermittent Infusion: Induction for ulcerative colitis:Diluent: Guselkumab is a clear and colorless to light yellow solution that may contain small translucent particles. Withdraw and then discard 20 mL of 0.9% NaCl from a 250 mL infusion bag, which is equal to the volume of guselkumab to be added. Withdraw 20 mL of guselkumab from the vial and add it to the 250 mL IV infusion bag of 0.9% NaCl. Gently mix the diluted solution. Discard the vial with any remaining solution. Do not administer solutions that are discolored or contain particulate matter. Diluted solution is stable for 10 hr at room temperature. Do not freeze. 0.8 mg/mL..
Rate: Administer diluted solution over ≥1 hr using only an infusion set with an in-line, sterile, nonpyrogenic, low-protein-binding filter (pore size 0.2 micrometer). Infusion should be completed within 10 hr after the dilution in the infusion bag.
Y-Site Incompatibility: Do not administer other drugs through same IV line.

Patient/Family Teaching ⬆ ⬇

Explain the purpose and side effects of guselkumab to patient. Do not stop receiving drug without consulting health care professional. If an appointment is missed, contact health care professional as soon as possible to reschedule. Instruct patient on correct technique for self-injection, care, and disposal of equipment. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. 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.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Inform patient of pregnancy registry that monitors pregnancy outcomes in women exposed to guselkumab during pregnancy. Encourage patients to enroll by calling 1-877-311-8972.

Evaluation/Desired Outcomes ⬆ ⬇

Decrease in extent and severity of psoriatic lesions.
Decreased pain and swelling with decreased rate of joint destruction in psoriatic arthritis.
Induction of clinical remission of ulcerative colitis.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

57894- Janssen Biotech, Inc.
- 57894-640- Tremfya
  - 57894-640-01- 1 SYRINGE in 1 CARTON (57894-640-01) > 1 mL in 1 SYRINGE

57894- Janssen Biotech, Inc.
- 57894-640- Tremfya
  - 57894-640-04- 1 SYRINGE in 1 CARTON (57894-640-04) > 1 mL in 1 SYRINGE

57894- Janssen Biotech, Inc.
- 57894-640- Tremfya
  - 57894-640-11- 1 SYRINGE in 1 CARTON (57894-640-11) > 1 mL in 1 SYRINGE

57894- Janssen Biotech, Inc.
- 57894-640- Tremfya
  - 57894-640-99- 1 SYRINGE in 1 CARTON (57894-640-99) > 1 mL in 1 SYRINGE

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇