Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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
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
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.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
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
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.
Patient Handout
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.
Formulary
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Adding plans allows you to:
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