ustekinumab (Rx)

Brand and Other Names:Stelara
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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

Plaque Psoriasis

Indicated for moderate to severe plaque psoriasis in patients 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

Indicated for adults with moderately to severely active Crohn disease

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 SC dose

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

Ulcerative Colitis

Indicated for adults with moderately to severely active ulcerative colitis

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 SC 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)

Plaque Psoriasis

Indicated for treatment of children aged ≥6 years with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy

<6 years: Safety and efficacy not established

≥6 years

  • <60 kg: 0.75 mg/kg SC at Weeks 0 and 4, then q12weeks thereafter
  • 60-100 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 active psoriatic arthritis in children aged ≥6 years

<6 years: Safety and efficacy not established

≥6 years

  • <60 kg: 0.75 mg/kg SC at Weeks 0 and 4, then q12weeks thereafter
  • >60 kg: 45 mg SC at Weeks 0 and 4, then q12weeks thereafter
  • >100 kg with coexisting moderate-to-severe plaque psoriasis: 90 mg SC at Weeks 0 and 4, then q12weeks thereafter

Orphan Designations

Pediatric ulcerative colitis

Pediatric systemic lupus erythematosus (SLE)

Sponsor

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

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            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

            Respiratory, thoracic and mediastinal disorders: Lower respiratory tract infection; interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia

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            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); cases reported in postmarketing experience in patients with psoriasis, psoriatic arthritis, and Crohn’s disease; 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, mycobacterial, and viral infections observed with treatment; evaluate for TB infection before initiating drug
            • Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported; if diagnosis is confirmed, discontinue therapy and institute appropriate treatment
            • Other serious infections requiring hospitalization reported include diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, and UTIs
            • Do not initiate in patients with any clinically important active infection until infection resolves or is adequately treated; consider risks and benefits of treatment before 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
            • Infections observed by disease treated
              • Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical studies included the following
              • Psoriasis: Diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections
              • Psoriatic arthritis: Cholecystitis
              • Crohn disease: Anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis
              • Ulcerative colitis: Gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis

            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
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            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.

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            Pharmacology

            Mechanism of Action

            Human IgG1κ 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); 19 days (Crohn disease)

            Clearance: 0.19 L/day

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            Administration

            SC Preparation

            Visually inspect for particulate matter and discoloration; solution is clear, colorless to light yellow and may contain a few small translucent or white particles

            Do not use if solution discolored or cloudy, or if other particulate matter 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

            For children and adolescents, injection should be administered by a healthcare provider; if determine appropriate, a patient may self-inject or a caregiver may inject dose after proper training in SC injection technique

            Administer 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 discard volume from the 250-mL infusion bag of 0.45% and 0.9% NaCl equal to the calculated drug volume (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; final volume in the infusion bag should be 250 mL; gently mix

            Visually inspect diluted solution before infusion; do not use if visibly opaque particles, discoloration or foreign particles are observed

            IV Administration

            Infuse over at least 1 hr

            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

            Unopened vials

            • Refrigerate at 2-8ºC (36-46ºF); do not freeze
            • Protect from light

            Prefilled syringes

            • Refrigerate at 2-8ºC (36-46ºF); do not freeze
            • Once removed from refrigerator, may store at room temperature (up to 30ºC [86ºF]) for up to 30 days
            • Store vials upright; protect from light until the time of use
            • Do not shake

            Diluted IV solution

            • If necessary, diluted solution may be stored for up to 7 hr at room temperature up to 25ºC (77ºF); do not freeze
            • Complete infusion within 8 hr after dilution (cumulative time after preparation including the storage and the infusion period)
            • Discard any unused portion of the infusion solution
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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Stelara subcutaneous
            -
            45 mg/0.5 mL vial
            Stelara subcutaneous
            -
            90 mg/mL solution
            Stelara subcutaneous
            -
            45 mg/0.5 mL solution
            Stelara intravenous
            -
            130 mg/26 mL vial

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            ustekinumab subcutaneous

            USTEKINUMAB - INJECTION

            (US-te-KIN-ue-mab)

            COMMON BRAND NAME(S): Stelara

            USES: Ustekinumab is used to treat plaque psoriasis, a certain type of arthritis (psoriatic arthritis), or certain bowel conditions (Crohn's disease, ulcerative colitis). It works by blocking certain natural proteins in your body (interleukin-12 and interleukin-23) that cause inflammation (swelling) in these conditions. Ustekinumab does not cure these diseases, but helps to lessen symptoms of the disease. It can help to decrease the amount of plaques in plaque psoriasis, decrease the number of swollen/painful joints in psoriatic arthritis, and decrease symptoms such as abdominal pain/cramping and diarrhea in Crohn's disease and ulcerative colitis.

            HOW TO USE: Read the Medication Guide and the Instructions for Use provided by your pharmacist before you start using ustekinumab and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Before starting this drug, you should take a tuberculosis (TB) skin test to check for a type of tuberculosis that may not be causing any symptoms (latent TB). If you are diagnosed with TB, to prevent a serious TB infection you must first be treated for it before you start ustekinumab.For the treatment of psoriasis or psoriatic arthritis, this medication is given by injection under your skin as directed by your doctor. You will receive one dose, followed by a second dose 4 weeks later. Then this medication is given every 3 months.For the treatment of Crohn's disease or ulcerative colitis, the first dose of this medication is given by injection into a vein by a health care professional. The medication is then given by injection under your skin every 8 weeks as directed by your doctor.The dosage is based on your weight, medical condition, and response to treatment.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Do not shake the solution. The solution is normally colorless to light yellow. It may contain a few small white particles of protein. Before using, check this product visually for other particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. Do not reuse syringes.When given under the skin, this medication should be injected in either the upper arms, buttock, thighs, or abdomen. It is important to change the location of the injection site with each dose to avoid problem areas under the skin. Choose a different injection site with each dose. Do not inject into skin that is irritated, sore, or infected.Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder.Tell your doctor if your condition does not improve or if it worsens.

            SIDE EFFECTS: Bruising, itching, pain, redness, swelling, or hardening of the skin at the injection site may occur. Injection site reactions usually go away after 1 or 2 days. Headache, back pain, or sinus/throat pain may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: cough that doesn't go away, shortness of breath.This medication can affect your immune system. It can lower your body's ability to fight an infection. You may be more likely to get serious infections, such as lung infections, bone/joint infections, skin infections, sinus infections, or bowel/gallbladder infections. It may also be harder to fight an infection you already have. Tell your doctor right away if you develop any signs of an infection, such as nausea/vomiting that doesn't stop, worsening redness/swelling/tenderness at the injection site after 2 days, fever/chills, cold/flu symptoms, painful/frequent urination, unusual vaginal discharge/burning/itching/odor, or severe stomach pain. (See also Precautions section.)Ustekinumab may cause a rare (sometimes fatal) condition called PRES (posterior reversible encephalopathy syndrome). Get medical help right away if you develop headache that doesn't go away, seizures, sudden vision changes, mental/mood changes (such as confusion).There is a rare risk of developing cancer (including skin cancer) due to this medication. Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you develop symptoms such as unusual lumps/growths, unusual skin changes (including a sore that does not heal or a change in the size/shape/color of a mole), swollen glands, unexplained weight loss.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before using ustekinumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the needle cover on the prefilled syringe), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent/returning infection (including hepatitis and tuberculosis), cancer.Ustekinumab can make you more likely to get infections or may worsen any current infections. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Avoid receiving BCG vaccines for one year after completing treatment with ustekinumab. Also avoid contact with people who have infections that may spread to others (such as chickenpox, flu).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This drug may pass into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.Lab and/or medical tests (such as skin exams) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

            MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

            STORAGE: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised December 2022. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

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

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            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.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.