ustekinumab (Rx)

Brand and Other Names:Stelara
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution for SC

  • 45mg/0.5mL (prefilled syringe or single-dose vial)
  • 90mg/mL (prefilled syringe)

injectable solution for IV infusion

  • 130mg/26mL (5mg/mL) single-dose vial
more...

Plaque Psoriasis

Indicated for the treatment of adults and adolescents aged ≥12 years with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy

≤100 kg: 45 mg SC at Weeks 0 and 4, then q12weeks thereafter

>100 kg: 90 mg SC at Weeks 0 and 4, then q12weeks thereafter

Psoriatic Arthritis

Indicated for adults with active psoriatic arthritis alone or in combination with methotrexate

45 mg SC at Weeks 0 and 4, then q12weeks thereafter

For patients >100 kg with co-existent moderate-to-severe plaque psoriasis, increase dose to 90 mg SC at Weeks 0 and 4, then q12weeks thereafter

Crohn Disease

Indication

  • Indicated for adults with moderately to severely active Crohn disease who have
    • Failed or were intolerant to immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker OR
    • Failed or were intolerant to treatment with ≥1 TNF blockers

Initial weight-based IV dose

  • Single IV dose infused over 1 hr (also see maintenance dose below)
  • ≤55 kg: 260 mg IV
  • >55 kg to 85 kg: 390 mg IV
  • >85 kg: 520 mg IV

Maintenance dose

  • Begin 90 mg SC 8 weeks after the initial IV infusion, then q8wk thereafter

Dosage Modifications

Renal or hepatic impairment: Safety and efficacy not established

Orphan Designations

Primary biliary cirrhosis

Patients with type I DM with residual beta-cell function

Sponsor

  • Janssen Biotech, Inc; 200 Great Valley Parkway; Malvern, PA 19355-1307

Dosage Forms & Strengths

injectable solution for SC

  • 45mg/0.5mL (prefilled syringe or single-dose vial)
  • 90mg/mL (prefilled syringe)
more...

Plaque Psoriasis

Indicated for treatment of adolescents aged ≥12 years with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy

<12 years: Safety and efficacy not established

≥12 years

  • <60 kg: 0.75 mg/kg SC at Weeks 0 and 4, then q12weeks thereafter
  • 60-100 kg: 45 mg SC at at Weeks 0 and 4, then q12weeks thereafter
  • >100 kg: 90 mg SC at Weeks 0 and 4, then q12weeks thereafter
  • See also Administration

Orphan Designations

Pediatric ulcerative colitis

Pediatric systemic lupus erythematosus (SLE)

Sponsor

  • Janssen Biotech, Inc; 1400 McKean Road, Spring House, Pennsylvania 19477
Next:

Interactions

Interaction Checker

and ustekinumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            >10%

            Upper respiratory infection

            1-10%

            Nasopharyngitis

            Back pain

            Cellulitis

            Depression

            Diarrhea

            Fatigue

            Headache

            Injection site erythema

            Myalgia

            Fatigue

            Nasal congestion

            Urticaria

            Rash

            Pruritus

            Antibody formation

            <1% (selected)

            Severe infection

            Malignancy

            Reversible posterior leukoencephalopathy syndrome

            Postmarketing Reports

            Immune system disorders: Serious hypersensitivity reactions (including anaphylaxis and angioedema), other hypersensitivity reactions (including rash and urticaria)

            Skin reactions: Pustular psoriasis, erythrodermic psoriasis

            Previous
            Next:

            Warnings

            Contraindications

            Hypersensitivity

            Active serious infection

            Concomitant live vaccines

            Cautions

            Use caution in patients genetically deficient in IL-12/IL-23

            Reversible posterior leukoencephalopathy syndrome (RPLS) reported (1 case); if RPLS is suspected, administer appropriate therapy and discontinue treatment

            Provide age-appropriate immunization prior to initiating therapy

            Hypersensitivity reactions reported, including anaphylaxis and angioedema

            Infections

            • Do not administer treatment to patients with active tuberculosis infection; initiate treatment of latent tuberculosis (TB) prior to administering ustekinumab; closely monitor for signs and symptoms of active tuberculosis during and after treatment
            • May increase risk of infections and reactivation of latent infections; serious bacterial, fungal, and viral infections observed with treatment; evaluate for TB infection before initiating drug
            • Other serious infections requiring hospitalization reported include diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, and UTIs
            • In patients with Crohn’s disease, serious or other clinically significant infections included anal abscess, gastroenteritis, ophthalmic herpes, pneumonia, and listeria meningitis
            • Treatment should not be initiated in patients with any clinically important active infection until infection resolves or is adequately treated; consider risks and benefits of treatment prior to initiating therapy in patients with a chronic infection or a history of recurrent infection
            • Instruct patients to seek medical advice if signs or symptoms suggestive of infection occur and consider discontinuing therapy for serious or clinically significant infections until infection resolves or is adequately treated

            Malignancies

            • Increased risk of malignancy
            • Reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients with pre-existing risk factors for developing nonmelanoma skin cancer; monitor all patients for nonmelanoma skin cancer

            Drug interactions overview

            • Formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation; ustekinumab (IL-12 and IL-23 antagonist) may normalize the formation of CYP450 enzyme; monitor therapeutic effects (eg, warfarin) or concentration (eg, cyclosporine) with concomitant CYP450 substrates use (especially narrow therapeutic index drugs)
            • Psoriasis studies the safety of ustekinumab in combination with immunosuppressive agents or phototherapy has not been evaluated; in psoriatic arthritis studies, concomitant methotrexate use did not appear to influence the safety or efficacy
            • May decrease the protective effect of allergen immunotherapy
            • Avoid use of live vaccines with ustekinumab
            • BCG vaccines should not be given during treatment or for one year prior to initiating treatment or one year following discontinuation of treatment; use caution when administering live vaccines to household contacts of patients receiving treatment due to the potential risk for shedding from the household contact and transmission to patient
            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy

            Pregnancy registry (1-877-311-8972) available that monitors pregnancy outcomes in women exposed to ustekinumab during pregnancy

            Limited data on ustekinumab use in pregnant women to inform a drug associated risk

            In animal reproductive and developmental toxicity studies, no adverse developmental effects were observed after administration of ustekinumab to pregnant monkeys at exposures greater than 100 times the human exposure at the maximum recommended human subcutaneous dose (MRHD)

            Lactation

            Data are not available on the presence of ustekinumab in human milk, effects on the breastfed infant, or effects on milk production

            Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ustekinumab and any potential adverse effects on the breastfed child from ustekinumab or from the underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Human IgG1қ monoclonal antibody binds to the p40 protein subunit used by IL-12 and IL-23 cytokines; IL-12 and IL-23 are involved in inflammatory and immune responses (eg, natural killer cell activation, CD4+ T-cell differentiation, and activation)

            Absorption

            Bioavailability: 57% (SC)

            Peak plasma time: 13.5 days (45 mg-dose); 7 days (90 mg-dose)

            Distribution

            Vd (steady-state): 4.62 L

            Metabolism

            Ustekinumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG

            Excretion

            Half-life: 14.9 – 45.6 days (SC, psoriasis patients); 19 days (Crohn disease patients)

            Clearance: 0.19 L/day

            Previous
            Next:

            Administration

            SC Preparation

            Visually inspect for particulate matter and discoloration

            Solution should appear clear, colorless to light yellow and may contain a few small translucent or white particles

            Do not use if it is discolored or cloudy, or if other particulate matter is present

            Does not contain preservatives; therefore, discard any unused product remaining in the vial and/or syringe

            SC Administration

            See full prescribing information for how to use prefilled syringe injector

            Each injection should be administered at a different anatomic location (eg, upper arms, gluteal regions, thighs, or any quadrant of abdomen) than the previous injection

            Do not inject into areas where the skin is tender, bruised, erythematous, or indurated

            When using the single-dose vial, a 27-gauge, 0.5-inch needle is recommended

            IV Preparation

            Must be diluted, prepared and infused by a healthcare professional using aseptic technique

            Calculate dose and the number of ustekinumab vials needed based on patient weight (see Adult Dosing)

            Each 26 mL vial contains 130 mg of ustekinumab

            Withdraw, and then discard a volume of the 0.9% NaCl from the 250 mL infusion bag equal to the volume ustekinumab to be added (discard 26 mL NaCl for each vial of needed, for 2 vials- discard 52 mL, for 3 vials- discard 78 mL, 4 vials- discard 104 mL)

            Withdraw 26 mL from each vial needed and add it to the 250 mL infusion bag

            The final volume in the infusion bag should be 250 mL

            Gently mix

            Visually inspect the diluted solution before infusion

            Do not use if visibly opaque particles, discoloration or foreign particles are observed

            IV Administration

            Infuse the diluted solution over a period of at least 1 hr

            Once diluted, the infusion solution may be stored for up to 4 hr prior to infusion

            Use only an infusion set with an in-line, sterile, nonpyrogenic, low protein-binding filter (pore size 0.2 micrometer)

            Do not infuse concomitantly in the same IV line with other agents

            Does not contain preservatives

            Each vial is for single use only

            Discard any remaining solution

            Storage

            Vials and prefilled syringes must be refrigerated at 2-8°C (36-46°F)

            Store vials upright

            Keep the product in the original carton to protect from light until the time of use

            Do not freeze

            Do not shake

            Diluted IV solution

            • If necessary, the diluted infusion solution may be stored for up to 4 hr at room temperature up to 25°C (77°F)
            • Do not freeze
            • Discard any unused portion of the infusion solution
            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous