ustekinumab

REMS

Moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy.
Active psoriatic arthritis (as monotherapy or with methotrexate).
Moderately to severely active Crohn's disease.
Moderately to severely active ulcerative colitis.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Active untreated infection.

Use Cautiously in:

History of known malignancy or tuberculosis (TB) (possibility of reactivation);
>60 yr, history of prolonged immunosuppressant therapy, or history of PUVA treatment (↑ risk of skin cancer);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children <18 yr (Crohn's disease) or <6 yr (psoriasis or psoriatic arthritis).

Exercise Extreme Caution in:

Chronic infection or history of recurrent infection.

Adv. Reactions/Side Effects ⬆ ⬇

Local: erythema

Neuro: fatigue, headache, POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME

Resp: eosinophilic pneumonia, interstitial pneumonia, RESPIRATORY FAILURE

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), INFECTION, MALIGNANCY

Interactions ⬆ ⬇

Drug-drug:

May ↓ antibody response to and ↑ risk of adverse reactions from live vaccines.
May ↓ desired antibody response to non-live vaccines.
May affect the activity of CYP450 drug-metabolizing enzymes; when treatment is started during concurrent CYP450 substrates, especially those with a narrow therapeutic indices, including warfarin and cyclosporine; appropriate monitoring and dose adjustment should be carried out.

Availability ⬆ ⬇

Solution for intravenous injection: 5 mg/mL
Solution for SUBQ injection: 45 mg/0.45 mL (vials and prefilled syringes); 90 mg/1 mL (prefilled syringes)

Route/Dosage ⬆ ⬇

Plaque Psoriasis

SC (Adults and Children ≥6 yr and >100 kg): 90 mg initially and 4 wk later, then 90 mg every 12 wk.
SC (Adults ≤100 kg): 45 mg initially and 4 wk later, then 45 mg every 12 wk.
SC (Children ≥6 yr and 60–100 kg): 45 mg initially and 4 wk later, then 45 mg every 12 wk.
SC (Children ≥6 yr and <60 kg): 0.75 mg/kg initially and 4 wk later, then 0.75 mg/kg every 12 wk.

Psoriatic Arthritis

SC (Adults ): 45 mg initially and 4 wk later, then 45 mg every 12 wk.
SC (Adults and Children ≥6 yr and >100 kg and with coexistent moderate to severe plaque psoriasis): 90 mg initially and 4 wk later, then 90 mg every 12 wk.
SC (Children ≥6 yr and ≥60 kg): 45 mg initially and 4 wk later, then 45 mg every 12 wk.
SC (Children ≥6 yr and <60 kg): 0.75 mg/kg initially and 4 wk later, then 0.75 mg/kg every 12 wk.

Crohn's Disease and Ulcerative Colitis

IV SC (Adults >85 kg): 520 mg IV infusion, then 90 mg SUBQ 8 wk later and then 90 mg every 8 wk.
IV SC (Adults 56–85 kg): 390 mg IV infusion, then 90 mg SUBQ 8 wk later and then 90 mg every 8 wk.
IV SC (Adults ≤55 kg): 260 mg IV infusion, then 90 mg SUBQ 8 wk later and then 90 mg every 8 wk.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds to the p40 protein subunit used by both the interleukin (IL) 12 and IL-23 cytokines. These cytokines that are involved in inflammatory and immune responses, including natural killer cell activation and CD4+ T-cell differentiation and activation. Binding to interleukins antagonizes their effects, disrupting IL-12 and IL-23 mediated signaling and cytokine cascades.

Therapeutic effects:

Decrease in area and severity of psoriatic lesions.
Decreased progression of psoriatic arthritis.
Reduced signs and symptoms and maintenance of clinical remission of Crohn's disease and ulcerative colitis.

Classifications ⬆ ⬇

Therapeutic Classification: antipsoriatics

Pharmacologic Classification: interleukin antagonists, monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following SUBQ administration. IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

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

Half-Life: Psoriasis: 15–46 days; Crohn's disease: 19 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
45 mg SUBQ	unknown	13.5 days	12 wk
90 mg SUBQ	unknown	7 days	12 wk
IV	unknown	unknown	unknown

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.
Inform patient that ustekinumab may lower ability to fight and increase risk for infections. Advise patient to notify health care professional immediately if signs of anaphylaxis or infection (fever, sweats, chills, muscle aches, cough, shortness of breath, blood in phlegm, weight loss, warm, red, or painful sores, diarrhea or stomach pain, burning or urination or urinary frequency, tiredness) occur.
Inform patient that ustekinumab may increase for cancer. Advise patient to obtain preventative screening.
Advise patient to notify health care professional if signs of reversible posterior encephalopathy syndrome (headache, seizures, confusion, visual problems) 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 females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

57894- Janssen Biotech, Inc.
- 57894-054- Stelara
  - 57894-054-16- 1 VIAL, SINGLE-USE in 1 BOX (57894-054-16) > 26 mL in 1 VIAL, SINGLE-USE

57894- Janssen Biotech, Inc.
- 57894-054- Stelara
  - 57894-054-27- 1 VIAL, SINGLE-USE in 1 BOX (57894-054-27) > 26 mL in 1 VIAL, SINGLE-USE

57894- Janssen Biotech, Inc.
- 57894-060- STELARA
  - 57894-060-02- 1 VIAL, SINGLE-USE in 1 CARTON (57894-060-02) > .5 mL in 1 VIAL, SINGLE-USE

57894- Janssen Biotech, Inc.
- 57894-060- STELARA
  - 57894-060-03- 1 SYRINGE in 1 CARTON (57894-060-03) > .5 mL in 1 SYRINGE

57894- Janssen Biotech, Inc.
- 57894-060- STELARA
  - 57894-060-04- 1 SYRINGE in 1 CARTON (57894-060-04) > .5 mL in 1 SYRINGE

57894- Janssen Biotech, Inc.
- 57894-061- STELARA
  - 57894-061-03- 1 SYRINGE in 1 CARTON (57894-061-03) > 1 mL in 1 SYRINGE

57894- Janssen Biotech, Inc.
- 57894-061- STELARA
  - 57894-061-04- 1 SYRINGE in 1 CARTON (57894-061-04) > 1 mL in 1 SYRINGE

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Indications ⬇