Stelara

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders
  • Colorectal disorders
  • Psoriasis
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Stelara Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Ustekinumab 45mg/0.5mL, 90mg/mL; soln for SC inj; or 130mg/26mL; soln for IV infusion after dilution; preservative-free.

    Pharmacological Class

    Interleukin-12 and interleukin-23 antagonist.

    How Supplied

    Single-dose vial (45mg/0.5mL, 130mg/26mL)—1; single-dose prefilled syringe (45mg/0.5mL, 90mg/mL)—1

    Manufacturer

    Janssen Biotech, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Binds with high affinity and specificity to the p40 protein subunit used by both the interleukin (IL)-12 and IL-23 cytokines. In in vitro models, ustekinumab was shown to disrupt IL-12 and IL-23 mediated signaling and cytokine cascades by disrupting the interaction of these cytokines with a shared cell-surface receptor chain, IL-12 beta-1.

    Stelara Indications

    Indications

    Active psoriatic arthritis.

    Stelara Dosage and Administration

    Adult

    ≥18yrs: initially 45mg SC once, then 4 weeks later, followed by 45mg every 12 weeks. >100kg with co-existent moderate to severe plaque psoriasis: initially 90mg once, then 4 weeks later, followed by 90mg every 12 weeks. Rotate inj site.

    Children

    <6yrs: not established. Give by SC at Weeks 0 and 4, then every 12 weeks thereafter. 6–17yrs (<60kg): 0.75mg/kg; (≥60kg): 45mg; (>100kg with co-existent moderate to severe plaque psoriasis): 90mg.

    Administration

    Administer under supervision of a physician. Rotate injection sites (eg, upper arms, gluteal regions, thighs, or any abdomen quadrant). Do not inject in areas where skin is tender, bruised, erythematous, or indurated. When using the single-use vial, a 27 gauge, 1/2 inch needle is recommended.

    Nursing Considerations

    Administer under supervision of a physician. Rotate injection sites (eg, upper arms, gluteal regions, thighs, or any abdomen quadrant). Do not inject in areas where skin is tender, bruised, erythematous, or indurated. When using the single-use vial, a 27 gauge, 1/2 inch needle is recommended.

    Stelara Contraindications

    Not Applicable

    Stelara Boxed Warnings

    Not Applicable

    Stelara Warnings/Precautions

    Warnings/Precautions

    Use under physician supervision. May increase risk of infections. Active infections: do not initiate. Chronic or history of recurrent infection: consider the risks and benefits. If a serious infection develops, monitor closely and discontinue until resolves. Risk of disseminated infections (eg, mycobacteria, salmonella, BCG vaccines) in IL-12/IL-23 genetically deficient patients. Evaluate for tuberculosis (TB) infection prior to initiating. History of latent or active TB (without confirmed adequate treatment); consider anti-TB therapy prior to initiation. Monitor for signs/symptoms of active TB during and after therapy. Patients with active TB infection: do not initiate. Consider completion of all age appropriate immunizations according to current guidelines before starting therapy. Avoid close contact with live vaccine recipients. History of malignancies. Monitor for appearance of non-melanoma skin cancer. Monitor closely in patients aged >60yrs, history of prolonged immunosuppressant therapy, or prior PUVA treatment. Monitor for reversible posterior leukoencephalopathy syndrome (RPLS); discontinue and treat if suspected. Risk of noninfectious pneumonia; discontinue and treat if confirmed. Latex allergy (syringe). Pregnancy. Nursing mothers.

    Stelara Pharmacokinetics

    Absorption

    Adults with Psoriasis

    • Median time to reach the maximum serum concentration (Tmax): 13.5 days and 7 days, respectively, after a single SC administration of 45 mg and 90 mg.

    • Steady-state serum concentration was reached by Week 28 after multiple SC doses.

    • Mean (±SD) steady-state trough serum concentrations: 0.69 ± 0.69 mcg/mL for patients ≤100 kg receiving a 45 mg dose; 0.74 ± 0.78 mcg/mL for patients >100 kg receiving a 90 mg dose.

    Crohn’s Disease and Ulcerative Colitis

    • Mean ±SD peak serum ustekinumab concentration (following the IV induction dose): 125.2 ± 33.6 mcg/mL in Crohn disease; 129.1 ± 27.6 mcg/mL in ulcerative colitis .

    • Steady-state concentration was achieved by the start of the second maintenance dose.

    • Mean (±SD) steady-state trough serum concentration: 2.5 ± 2.1 mcg/mL in Crohn disease; 3.3 ± 2.3 mcg/mL in ulcerative colitis.

    Distribution

    Volume of distribution:

    • 2.7 L (95% CI: 2.69, 2.78) in Crohn disease;
    • 3.0 L (95% CI: 2.96, 3.07) in ulcerative colitis. 

    Total volume of distribution at steady-state:

    • 4.6 L in Crohn disease;
    • 4.4 L in ulcerative colitis.

    Metabolism

    Catabolic pathways.

    Elimination

    Half-life: 14.9 ± 4.6 to 45.6 ± 80.2 days (all psoriasis); ~19 days (Crohn disease and ulcerative colitis).

    Stelara Interactions

    Interactions

    Concomitant live vaccines: not recommended. Do not give BCG vaccines during or within 1 year of starting or stopping ustekinumab. Non-live vaccines: may get suboptimal response. Concomitant CYP450 substrates with narrow therapeutic index: monitor and adjust dose as needed. Caution with concomitant allergen immunotherapy (esp. for anaphylaxis). Concomitant other immunosuppressants or phototherapy in psoriasis: not established.

    Stelara Adverse Reactions

    Adverse Reactions

    Nasopharyngitis, upper respiratory tract infection, headache, fatigue, vomiting, inj site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, UTI, sinusitis, abdominal pain, influenza, fever, diarrhea, nausea; malignancies, RPLS, hypersensitivity reactions (discontinue if occur).

    Stelara Clinical Trials

    See Literature

    Stelara Note

    Not Applicable

    Stelara Patient Counseling

    See Literature

    Stelara Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Ustekinumab 45mg/0.5mL, 90mg/mL; soln for SC inj; or 130mg/26mL; soln for IV infusion after dilution; preservative-free.

    Pharmacological Class

    Interleukin-12 and interleukin-23 antagonist.

    How Supplied

    Single-dose vial (45mg/0.5mL, 130mg/26mL)—1; single-dose prefilled syringe (45mg/0.5mL, 90mg/mL)—1

    Manufacturer

    Janssen Biotech, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Binds with high affinity and specificity to the p40 protein subunit used by both the interleukin (IL)-12 and IL-23 cytokines. In in vitro models, ustekinumab was shown to disrupt IL-12 and IL-23 mediated signaling and cytokine cascades by disrupting the interaction of these cytokines with a shared cell-surface receptor chain, IL-12 beta-1.

    Stelara Indications

    Indications

    Moderately to severely active Crohn's disease or ulcerative colitis.

    Stelara Dosage and Administration

    Adult

    Induction: give as a single IV infusion over 1hr. ≥18yrs (≤55kg): 260mg; (>55–85kg): 390mg; (>85kg): 520mg. Maintenance: 90mg by SC inj given 8 weeks after initial IV dose, then every 8 weeks thereafter. Rotate inj site.

    Children

    <18yrs: not established.

    Administration

    Administer under supervision of a physician. Rotate injection sites (eg, upper arms, gluteal regions, thighs, or any abdomen quadrant). Do not inject in areas where skin is tender, bruised, erythematous, or indurated. When using the single-use vial, a 27 gauge, 1/2 inch needle is recommended.

    Nursing Considerations

    Administer under supervision of a physician. Rotate injection sites (eg, upper arms, gluteal regions, thighs, or any abdomen quadrant). Do not inject in areas where skin is tender, bruised, erythematous, or indurated. When using the single-use vial, a 27 gauge, 1/2 inch needle is recommended.

    Stelara Contraindications

    Not Applicable

    Stelara Boxed Warnings

    Not Applicable

    Stelara Warnings/Precautions

    Warnings/Precautions

    Use under physician supervision. May increase risk of infections. Active infections: do not initiate. Chronic or history of recurrent infection: consider the risks and benefits. If a serious infection develops, monitor closely and discontinue until resolves. Risk of disseminated infections (eg, mycobacteria, salmonella, BCG vaccines) in IL-12/IL-23 genetically deficient patients. Evaluate for tuberculosis (TB) infection prior to initiating. History of latent or active TB (without confirmed adequate treatment); consider anti-TB therapy prior to initiation. Monitor for signs/symptoms of active TB during and after therapy. Patients with active TB infection: do not initiate. Consider completion of all age appropriate immunizations according to current guidelines before starting therapy. Avoid close contact with live vaccine recipients. History of malignancies. Monitor for appearance of non-melanoma skin cancer. Monitor closely in patients aged >60yrs, history of prolonged immunosuppressant therapy, or prior PUVA treatment. Monitor for reversible posterior leukoencephalopathy syndrome (RPLS); discontinue and treat if suspected. Risk of noninfectious pneumonia; discontinue and treat if confirmed. Latex allergy (syringe). Pregnancy. Nursing mothers.

    Stelara Pharmacokinetics

    Absorption

    Adults with Psoriasis

    • Median time to reach the maximum serum concentration (Tmax): 13.5 days and 7 days, respectively, after a single SC administration of 45 mg and 90 mg.

    • Steady-state serum concentration was reached by Week 28 after multiple SC doses.

    • Mean (±SD) steady-state trough serum concentrations: 0.69 ± 0.69 mcg/mL for patients ≤100 kg receiving a 45 mg dose; 0.74 ± 0.78 mcg/mL for patients >100 kg receiving a 90 mg dose.

    Crohn’s Disease and Ulcerative Colitis

    • Mean ±SD peak serum ustekinumab concentration (following the IV induction dose): 125.2 ± 33.6 mcg/mL in Crohn disease; 129.1 ± 27.6 mcg/mL in ulcerative colitis .

    • Steady-state concentration was achieved by the start of the second maintenance dose.

    • Mean (±SD) steady-state trough serum concentration: 2.5 ± 2.1 mcg/mL in Crohn disease; 3.3 ± 2.3 mcg/mL in ulcerative colitis.

    Distribution

    Volume of distribution:

    • 2.7 L (95% CI: 2.69, 2.78) in Crohn disease;
    • 3.0 L (95% CI: 2.96, 3.07) in ulcerative colitis. 

    Total volume of distribution at steady-state:

    • 4.6 L in Crohn disease;
    • 4.4 L in ulcerative colitis.

    Metabolism

    Catabolic pathways.

    Elimination

    Half-life: 14.9 ± 4.6 to 45.6 ± 80.2 days (all psoriasis); ~19 days (Crohn disease and ulcerative colitis).

    Stelara Interactions

    Interactions

    Concomitant live vaccines: not recommended. Do not give BCG vaccines during or within 1 year of starting or stopping ustekinumab. Non-live vaccines: may get suboptimal response. Concomitant CYP450 substrates with narrow therapeutic index: monitor and adjust dose as needed. Caution with concomitant allergen immunotherapy (esp. for anaphylaxis). Concomitant other immunosuppressants or phototherapy in psoriasis: not established.

    Stelara Adverse Reactions

    Adverse Reactions

    Nasopharyngitis, upper respiratory tract infection, headache, fatigue, vomiting, inj site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, UTI, sinusitis, abdominal pain, influenza, fever, diarrhea, nausea; malignancies, RPLS, hypersensitivity reactions (discontinue if occur).

    Stelara Clinical Trials

    See Literature

    Stelara Note

    Not Applicable

    Stelara Patient Counseling

    See Literature

    Stelara Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Ustekinumab 45mg/0.5mL, 90mg/mL; soln for SC inj; or 130mg/26mL; soln for IV infusion after dilution; preservative-free.

    Pharmacological Class

    Interleukin-12 and interleukin-23 antagonist.

    How Supplied

    Single-dose vial (45mg/0.5mL, 130mg/26mL)—1; single-dose prefilled syringe (45mg/0.5mL, 90mg/mL)—1

    Manufacturer

    Janssen Biotech, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Binds with high affinity and specificity to the p40 protein subunit used by both the interleukin (IL)-12 and IL-23 cytokines. In in vitro models, ustekinumab was shown to disrupt IL-12 and IL-23 mediated signaling and cytokine cascades by disrupting the interaction of these cytokines with a shared cell-surface receptor chain, IL-12 beta-1.

    Stelara Indications

    Indications

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

    Stelara Dosage and Administration

    Adult

    ≥18yrs (≤100kg): initially 45mg SC once, then 4 weeks later, and then once every 12 weeks; (>100kg): initially 90mg once, then 4 weeks later, and then once every 12 weeks. Rotate inj site.

    Children

    <6yrs: not established. Give by SC at Weeks 0 and 4, then every 12 weeks thereafter. 6–17yrs (<60kg): 0.75mg/kg; (60–100kg): 45mg; (>100kg): 90mg.

    Administration

    Administer under supervision of a physician. Rotate injection sites (eg, upper arms, gluteal regions, thighs, or any abdomen quadrant). Do not inject in areas where skin is tender, bruised, erythematous, or indurated. When using the single-use vial, a 27 gauge, 1/2 inch needle is recommended.

    Nursing Considerations

    Administer under supervision of a physician. Rotate injection sites (eg, upper arms, gluteal regions, thighs, or any abdomen quadrant). Do not inject in areas where skin is tender, bruised, erythematous, or indurated. When using the single-use vial, a 27 gauge, 1/2 inch needle is recommended.

    Stelara Contraindications

    Not Applicable

    Stelara Boxed Warnings

    Not Applicable

    Stelara Warnings/Precautions

    Warnings/Precautions

    Use under physician supervision. May increase risk of infections. Active infections: do not initiate. Chronic or history of recurrent infection: consider the risks and benefits. If a serious infection develops, monitor closely and discontinue until resolves. Risk of disseminated infections (eg, mycobacteria, salmonella, BCG vaccines) in IL-12/IL-23 genetically deficient patients. Evaluate for tuberculosis (TB) infection prior to initiating. History of latent or active TB (without confirmed adequate treatment); consider anti-TB therapy prior to initiation. Monitor for signs/symptoms of active TB during and after therapy. Patients with active TB infection: do not initiate. Consider completion of all age appropriate immunizations according to current guidelines before starting therapy. Avoid close contact with live vaccine recipients. History of malignancies. Monitor for appearance of non-melanoma skin cancer. Monitor closely in patients aged >60yrs, history of prolonged immunosuppressant therapy, or prior PUVA treatment. Monitor for reversible posterior leukoencephalopathy syndrome (RPLS); discontinue and treat if suspected. Risk of noninfectious pneumonia; discontinue and treat if confirmed. Latex allergy (syringe). Pregnancy. Nursing mothers.

    Stelara Pharmacokinetics

    Absorption

    Adults with Psoriasis

    • Median time to reach the maximum serum concentration (Tmax): 13.5 days and 7 days, respectively, after a single SC administration of 45 mg and 90 mg.

    • Steady-state serum concentration was reached by Week 28 after multiple SC doses.

    • Mean (±SD) steady-state trough serum concentrations: 0.69 ± 0.69 mcg/mL for patients ≤100 kg receiving a 45 mg dose; 0.74 ± 0.78 mcg/mL for patients >100 kg receiving a 90 mg dose.

    Crohn’s Disease and Ulcerative Colitis

    • Mean ±SD peak serum ustekinumab concentration (following the IV induction dose): 125.2 ± 33.6 mcg/mL in Crohn disease; 129.1 ± 27.6 mcg/mL in ulcerative colitis .

    • Steady-state concentration was achieved by the start of the second maintenance dose.

    • Mean (±SD) steady-state trough serum concentration: 2.5 ± 2.1 mcg/mL in Crohn disease; 3.3 ± 2.3 mcg/mL in ulcerative colitis.

    Distribution

    Volume of distribution:

    • 2.7 L (95% CI: 2.69, 2.78) in Crohn disease;
    • 3.0 L (95% CI: 2.96, 3.07) in ulcerative colitis. 

    Total volume of distribution at steady-state:

    • 4.6 L in Crohn disease;
    • 4.4 L in ulcerative colitis.

    Metabolism

    Catabolic pathways.

    Elimination

    Half-life: 14.9 ± 4.6 to 45.6 ± 80.2 days for psoriasis; ~19 days for Crohn disease and ulcerative colitis.

    Stelara Interactions

    Interactions

    Concomitant live vaccines: not recommended. Do not give BCG vaccines during or within 1 year of starting or stopping ustekinumab. Non-live vaccines: may get suboptimal response. Concomitant CYP450 substrates with narrow therapeutic index: monitor and adjust dose as needed. Caution with concomitant allergen immunotherapy (esp. for anaphylaxis). Concomitant other immunosuppressants or phototherapy in psoriasis: not established.

    Stelara Adverse Reactions

    Adverse Reactions

    Nasopharyngitis, upper respiratory tract infection, headache, fatigue, vomiting, inj site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, UTI, sinusitis, abdominal pain, influenza, fever, diarrhea, nausea; malignancies, RPLS, hypersensitivity reactions (discontinue if occur).

    Stelara Clinical Trials

    See Literature

    Stelara Note

    Not Applicable

    Stelara Patient Counseling

    See Literature

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