Selarsdi ustekinumab-aekn 90 mg/mL Injection, Solution, 1 syringe
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Interleukin-12 Antagonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Ustekinumab injection is used to treat: plaque psoriasis (skin disease in which red, scaly patches form on some areas of the body) psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) Ustekinumab injection is in a class of medications called interleukin antagonists. It works by stopping the act...
Read the full MedlinePlus article ↗- Ustekinumab is approved to treat moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active u...
- What conditions does ustekinumab treat, and is it right for me?
- It depends on your condition. For Crohn's disease and ulcerative colitis, the first dose is given as an IV infusion in a clinical setting. After that, you switch to under-the-skin...
- How is ustekinumab given, and will I need to go to a clinic every time?
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 4QD397987E
An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
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UNII X573657P6P
Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $4,111.76 | $4,111.76 / 1 ml |
| Medicare drug plans payPart D · Q2 2026 | $4,066.02 | $4,066.02 / 1 ml |
| Medicare Part B allowsASP · Q9998 | $10.529 / Q9998 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Selarsdi 90 mg/mL 50090-7769-00 | A-S | 1 ml | — | — | FDA listed | — |
| Ustekinumab-aekn 90 mg/mL 51759-0414-32 | Teva | 1 syringe | — | — | FDA listed | — |
| Selarsdi 90 mg/mLthis 51759-0607-32 | Teva | 1 syringe | — | — | FDA listed | — |
| Ustekinumab-aekn 90 mg/mL 51759-0710-32 | Teva | 1 syringe | — | — | Discontinued | — |
Where does this data come from?
⏳ Availability & biosimilar status
1 biosimilar and 7 interchangeables are FDA-licensed for this reference biologic — see the list below. (Biologics have no small-molecule generics.)
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Apr 16, 2036 |
Is there a biosimilar for SELARSDI 90 MG/ML SYRINGE?
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Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 51759-0607-32 You're viewing this | 1 TRAY in 1 CARTON (51759-607-32) / 1 SYRINGE, GLASS in 1 TRAY / 1 mL in 1 SYRINGE, GLASS | 2025-03-12 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE SELARSDI is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) . ( 1.2 ) moderately to severely active Crohn’s disease (CD).
( 1.3 ) moderately to severely active ulcerative colitis. ( 1.4 ) Pediatric patients 6 years and older with: moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) .
( 1.2 )
1.1Plaque Psoriasis (PsO) SELARSDI™ is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
1.2Psoriatic Arthritis (PsA) SELARSDI is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis.
1.3Crohn’s Disease (CD) SELARSDI is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease.
1.4Ulcerative Colitis SELARSDI is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Adult Patients with Plaque Psoriasis Subcutaneous Recommended Dosage ( 2.1 ) : Weight Range (kilograms) Dosage less than or equal to 100 kg 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks greater than 100 kg 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks Pediatric Patients 6 Years of Age and Older with Plaque Psoriasis Subcutaneous Recommended Dosage ( 2.1 ): Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter.
Weight Range (kilograms) Dose less than 60 kg 0.75 mg/kg 60 kg to 100 kg 45 mg greater than 100 kg 90 mg Psoriatic Arthritis Adult Subcutaneous Recommended Dosage (2.2): The recommended dosage is 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks. For patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg, the recommended dosage is 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks.
Psoriatic Arthritis Pediatric 6 years of Age and Older Subcutaneous Recommended Dosage ( 2.2 ): Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter. Weight Range (kilograms) Dose less than 60 kg 0.75 mg/kg 60 kg or more 45 mg greater than 100 kg with co- existent moderate-to-severe plaque psoriasis 90 mg Crohn’s Disease and Ulcerative Colitis Initial Adult Intravenous Recommended Dose ( 2.3 ): A single intravenous infusion using weight-based dosing: Weight Range (kilograms) Recommended Dose up to 55 kg 260 mg (2 vials) greater than 55 kg to 85 kg 390 mg (3 vials) greater than 85 kg 520 mg (4 vials) Crohn’s Disease and Ulcerative Colitis Maintenance Adult Subcutaneous Recommended Dosage ( 2.3 ): A subcutaneous 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.
2.1Recommended Dosage in Plaque Psoriasis Subcutaneous Adult Dosage Regimen For patients weighing 100 kg or less, the recommended dosage is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks. For patients weighing more than 100 kg, the recommended dosage is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks. In subjects weighing more than 100 kg, 45 mg was also shown to be efficacious.
However, 90 mg resulted in greater efficacy in these subjects [see Clinical Studies ( 14 )]. Subcutaneous Pediatric Dosage Regimen Administer SELARSDI subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter. The recommended dose of SELARSDI for pediatric patients 6 years of age and older with plaque psoriasis based on body weight is shown below (Table 1).
Table 1: Recommended Dose of SELARSDI for Subcutaneous Injection in Pediatric Patients 6 Years of Age and Older With Plaque Psoriasis Body Weight of Patient at the Time of Dosing Recommended Dose less than 60 kg 0.75 mg/kg 60 kg to 100 kg 45 mg more than 100 kg 90 mg For pediatric patients weighing less than 60 kg, the administration volume for the recommended dose (0.75 mg/kg) is shown in Table 2; withdraw the appropriate volume from the vial. Table 2: Injection volumes of SELARSDI 45 mg/0.5 mL Vials for Pediatric Patients 6 Years of Age and Older With Plaque Psoriasis and Pediatric Patients 6 Years of Age and Older With Psoriatic Arthritis* Weighing Less Than 60 kg Body Weight (kg) at the time of dosing Dose (mg) Volume of injection (mL) 15 11.3 0.12 16 12 0.13 17 12.8 0.14 18 13.5 0.15 19 14.3 0.16 20 15 0.17 21 15.8 0.17 22 16.5 0.18 23 17.3 0.19 24 18 0.20 25 18.8 0.21 26 19.5 0.22 27 20.3 0.22 28 21 0.23 29 21.8 0.24 30 22.5 0.25 31 23.3 0.26 32 24 0.27 33 24.8 0.27 34 25.5 0.28 35 26.3 0.29 36 27 0.3 37 27.8 0.31 38 28.5 0.32 39 29.3 0.32 40 30 0.33 41 30.8 0.34 42 31.5 0.35 43 32.3 0.36 44 33 0.37 45 33.8 0.37 46 34…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS SELARSDI (ustekinumab-aekn) injection is a clear and colorless to slightly yellow solution and free of visible particles. Subcutaneous Injection Injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe Injection: 45 mg/0.5 mL solution in a single-dose vial Intravenous Infusion Injection: 130 mg/26 mL (5 mg/mL) solution in a single-dose vial Subcutaneous Injection ( 3 ) Injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe Injection: 45 mg/0.5 mL solution in a single-dose vial Intravenous Infusion ( 3 ) Injection: 130 mg/26 mL (5 mg/mL) solution in a single-dose vial ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS SELARSDI is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in SELARSDI [see Warnings and Precautions ( 5.5 )]. Clinically significant hypersensitivity to ustekinumab products or to any of the excipients in SELARSDI. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Infections: Serious infections have occurred. Avoid starting SELARSDI during any clinically important active infection. If a serious infection or clinically significant infection develops, discontinue SELARSDI until the infection resolves.
( 5.1 ) Theoretical Risk for Particular Infections : Serious infections from mycobacteria, salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances. ( 5.2 ) Tuberculosis (TB): Evaluate patients for TB prior to initiating treatment with SELARSDI.
Initiate treatment of latent TB before administering SELARSDI. ( 5.3 ) Malignancies: Ustekinumab products may increase risk of malignancy. The safety of ustekinumab products in patients with a history of or a known malignancy has not been evaluated.
( 5.4 ) Serious Hypersensitivity Reactions: If a severe or other clinically significant hypersensitivity reaction occurs discontinue SELARSDI immediately and initiate appropriate medical treatment. ( 5.5 ) Posterior Reversible Encephalopathy Syndrome (PRES): If PRES is suspected, treat promptly, and discontinue SELARSDI. ( 5.6 ) Immunizations: Avoid use of live vaccines in patients during treatment with SELARSDI.
( 5.7 ) Noninfectious Pneumonia: Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. If diagnosis is confirmed, discontinue SELARSDI and institute appropriate treatment. ( 5.8 )
5.1Infections Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products [see Adverse Reactions ( 6.1 , 6.3 )]. Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following: Plaque Psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections.
Psoriatic arthritis: cholecystitis. Crohn’s disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis. Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis.
Avoid initiating treatment with SELARSDI in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of SELARSDI in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with SELARSDI and discontinue SELARSDI for serious or clinically significant infections until the infection resolves or is adequately treated.
5.2Theoretical Risk for Vulnerability to Particular Infections Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections.
Consider appropriate diagnostic testing, (e.g., tissue culture, stool culture, as dictated by clinical circumstances).
5.3Pre-treatment Evaluation for Tuberculosis Evaluate patients for tuberculosis infection prior to initiating treatment with SELARSDI. Avoid administering SELARSDI to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering SELARSDI.…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the label: Infections [see Warnings and Precautions ( 5.1 )] Malignancies [see Warnings and Precautions ( 5.4 )] Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions ( 5.6 )] Noninfectious Pneumonia [see Warnings and Precautions ( 5.8) ] Most common adverse reactions are: Psoriasis and Psoriatic Arthritis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
( 6.1 ) Crohn’s Disease, induction (≥3%): vomiting. ( 6.1 ) Crohn’s Disease, maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. ( 6.1 ) Ulcerative colitis, induction (≥3%): nasopharyngitis ( 6.1 ) Ulcerative colitis, maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Subjects with Plaque Psoriasis The safety data reflect exposure to ustekinumab in 3117 adult subjects with plaque psoriasis, including 2414 exposed for at least 6 months, 1855 exposed for at least one year, 1653 exposed for at least two years, 1569 exposed for at least three years, 1482 exposed for at least four years and 838 exposed for at least five years.
Table 5 summarizes the adverse reactions that occurred at a rate of at least 1% with higher rates in the ustekinumab groups during the placebo-controlled period of Ps STUDY 1 and Ps STUDY 2 [see Clinical Studies ( 14 )]. Table 5: Adverse Reactions, Reported by ≥1% of Subjects with Plaque Psoriasis and at Higher Rates in the ustekinumab groups through Week 12 in Ps STUDY 1 and Ps STUDY 2 Ustekinumab Placebo 45 mg 90 mg Subjects treated 665 664 666 Nasopharyngitis 51 (8%) 56 (8%) 49 (7%) Upper respiratory tract infection 30 (5%) 36 (5%) 28 (4%) Headache 23 (3%) 33 (5%) 32 (5%) Fatigue 14 (2%) 18 (3%) 17 (3%) Back pain 8 (1%) 9 (1%) 14 (2%) Dizziness 8 (1%) 8 (1%) 14 (2%) Pharyngolaryngeal pain 7 (1%) 9 (1%) 12 (2%) Pruritus 9 (1%) 10 (2%) 9 (1%) Injection site erythema 3 (<1%) 6 (1%) 13 (2%) Myalgia 4 (1%) 7 (1%) 8 (1%) Depression 3 (<1%) 8 (1%) 4 (1%) Adverse reactions that occurred at rates less than 1% in the controlled period of Ps STUDIES 1 and 2 through week 12 included: cellulitis, herpes zoster, diverticulitis, and certain injection site reactions (pain, swelling, pruritus, induration, hemorrhage, bruising, and irritation).
One case of PRES occurred during clinical trials in adult subjects with plaque psoriasis [see Warnings and Precautions ( 5.6 )]. Infections In the placebo-controlled period of clinical trials of subjects with plaque psoriasis (average follow-up of 12.6 weeks for subjects receiving placebo and 13.4 weeks for ustekinumab-treated subjects), 27% of ustekinumab-treated subjects reported infections (1.39 per patient-years of follow-up) compared with 24% of subjects receiving placebo (1.21 per patient-years of follow-up). Serious infections occurred in 0.3% of ustekinumab-treated subjects (0.01 per patient-years of follow-up) and in 0.4% of subjects receiving placebo (0.02 per patient-years of follow-up) [see Warnings and Precautions ( 5.1 )].
In the controlled and non-controlled portions of clinical trials in subjects with plaque psoriasis (median follow-up of 3.2 years), representing 8998 patient-years of exposure, 72.3% of ustekinumab-treated subjects reported infections (0.87 per patient-years of fol…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Concomitant Therapies In trials in subjects with plaque psoriasis the safety of ustekinumab products in combination with immunosuppressive agents or phototherapy has not been evaluated. In trials in subjects with psoriatic arthritis, concomitant MTX use did not appear to influence the safety or efficacy of ustekinumab. In trials in subjects with Crohn’s disease (CD-1 and CD-2) and ulcerative colitis (UC-1), immunomodulators (6-MP, AZA, MTX) were used concomitantly in approximately 30% of subjects and corticosteroids were used concomitantly in approximately 40% and 50% of Crohn’s disease and ulcerative colitis subjects, respectively.
Use of these concomitant therapies did not appear to influence the overall safety or efficacy of ustekinumab.
7.2CYP450 Substrates The formation of CYP450 enzymes can be suppressed by increased levels of certain cytokines (e.g., IL-1, IL-6, TNFα, IFN) during chronic inflammation. Thus, use of ustekinumab products, antagonists of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of SELARSDI in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect or drug concentration and adjust the individual dosage of the CYP substrate as needed.
See the prescribing information of specific CYP substrates . A CYP-mediated drug interaction effect was not observed in subjects with Crohn’s disease [see Clinical Pharmacology ( 12.3 )] .
7.3Allergen Immunotherapy Ustekinumab products have not been evaluated in patients who have undergone allergy immunotherapy. Ustekinumab products may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/Mother To Baby Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not identified an ustekinumab-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes (see Data). There are risks to the mother and the fetus associated with inflammatory bowel disease (IBD) in pregnancy. In animal reproductive and developmental toxicity studies, no adverse developmental effects were observed in offspring after administration of ustekinumab to pregnant monkeys at exposures greater than 100 times the maximum recommended human dose (MRHD).
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and Embryo/Fetal Risk Published data suggest that the risk of adverse pregnancy outcomes in women with IBD is associated with increased disease activity.
Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, ustekinumab products may be present in infants exposed in utero .
The potential clinical impact of ustekinumab products exposure in infants exposed in utero should be considered. Data Human Data An observational pregnancy registry conducted by (OTIS)/MotherToBaby in the U.S. and Canada (enrollment between 2013 and 2019) assessed the risk of major birth defects, pattern of major and minor anomalies in live-born infants, miscarriage, and adverse infant outcomes in women with ustekinumab exposure. In the registry study, there were 101 participants and 107 pregnancies with exposure to ustekinumab (88 prospective; 19 retrospective).
Most participants had a primary indication of CD (65.4%) or psoriasis (30.8%). The pregnancy registry did not identify a ustekinumab-associated risk of major birth defects, pattern of major or minor anomalies, increased risk of miscarriage or adverse infant outcomes. Methodological limitations of the registry include small sample size, lack of an internal comparison group, a mix of prospective and retrospective reports, and unmeasured confounders.
The conclusions from the pregnancy registry were consistent with the published literature and pharmacovigilance. Animal Data Ustekinumab was tested in two embryo-fetal development toxicity studies in cynomolgus monkeys. No teratogenic or other adverse developmental effects were observed in fetuses from pregnant monkeys that were administered ustekinumab subcutaneously twice weekly or intravenously weekly during the period of organogenesis.
Serum concentrations of ustekinumab in pregnant monkeys were greater than 100 times the serum concentration in patients treated subcutaneously with 90 mg of ustekinumab weekly for 4 weeks. In a combined embryo-fetal development and pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered subcutaneous doses of ustekinumab twice weekly at exposures greater than 100 times the MRHD from the beginning of organogenesis to Day 33 after delivery. Neonatal deaths occurred in the offspring of one monkey administered ustekinumab at 22.5 mg/kg and one monkey dosed at 45 mg/kg.
No ustekinumab-related-effects on functional, morphological, or immunological development were observed in the neonates from birth through six months of age.
8.2Lactation Risk Summary Limited data from published literature suggests that ustekinumab is present in human breast milk. There are no avai…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/Mother To Baby Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not identified an ustekinumab-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes (see Data). There are risks to the mother and the fetus associated with inflammatory bowel disease (IBD) in pregnancy. In animal reproductive and developmental toxicity studies, no adverse developmental effects were observed in offspring after administration of ustekinumab to pregnant monkeys at exposures greater than 100 times the maximum recommended human dose (MRHD).
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and Embryo/Fetal Risk Published data suggest that the risk of adverse pregnancy outcomes in women with IBD is associated with increased disease activity.
Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, ustekinumab products may be present in infants exposed in utero .
The potential clinical impact of ustekinumab products exposure in infants exposed in utero should be considered. Data Human Data An observational pregnancy registry conducted by (OTIS)/MotherToBaby in the U.S. and Canada (enrollment between 2013 and 2019) assessed the risk of major birth defects, pattern of major and minor anomalies in live-born infants, miscarriage, and adverse infant outcomes in women with ustekinumab exposure. In the registry study, there were 101 participants and 107 pregnancies with exposure to ustekinumab (88 prospective; 19 retrospective).
Most participants had a primary indication of CD (65.4%) or psoriasis (30.8%). The pregnancy registry did not identify a ustekinumab-associated risk of major birth defects, pattern of major or minor anomalies, increased risk of miscarriage or adverse infant outcomes. Methodological limitations of the registry include small sample size, lack of an internal comparison group, a mix of prospective and retrospective reports, and unmeasured confounders.
The conclusions from the pregnancy registry were consistent with the published literature and pharmacovigilance. Animal Data Ustekinumab was tested in two embryo-fetal development toxicity studies in cynomolgus monkeys. No teratogenic or other adverse developmental effects were observed in fetuses from pregnant monkeys that were administered ustekinumab subcutaneously twice weekly or intravenously weekly during the period of organogenesis.
Serum concentrations of ustekinumab in pregnant monkeys were greater than 100 times the serum concentration in patients treated subcutaneously with 90 mg of ustekinumab weekly for 4 weeks. In a combined embryo-fetal development and pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered subcutaneous doses of ustekinumab twice weekly at exposures greater than 100 times the MRHD from the beginning of organogenesis to Day 33 after delivery. Neonatal deaths occurred in the offspring of one monkey administered ustekinumab at 22.5 mg/kg and one monkey dosed at 45 mg/kg.
No ustekinumab-related-effects on functional, morphological, or immunological development were observed in the neonates from birth through six months of age.
🧒 Pediatric Use ▾
8.4Pediatric Use Plaque Psoriasis The safety and effectiveness of SELARSDI have been established for the treatment of moderate to severe plaque psoriasis in pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. Use of SELARSDI in pediatric patients 12 to less than 17 years of age is supported by evidence from a multicenter, randomized, 60 week trial (Ps STUDY 3) of ustekinumab that included a 12 week, double-blind, placebo-controlled, parallel group portion, in 110 pediatric subjects 12 years of age and older [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.2 )].
Use of SELARSDI in pediatric patients 6 to 11 years of age is supported by evidence from an open-label, single-arm, efficacy, safety, and pharmacokinetics trial (Ps STUDY 4) of ustekinumab in 44 subjects [see Adverse Reactions ( 6.1 ), Pharmacokinetics ( 12.3 )]. The safety and effectiveness of SELARSDI have not been established in pediatric patients less than 6 years of age with plaque psoriasis. Psoriatic Arthritis The safety and effectiveness of SELARSDI have been established for treatment of psoriatic arthritis in pediatric patients 6 years of age and older.
Use of SELARSDI in these age groups is supported by evidence from adequate and well controlled trials of ustekinumab in adult subjects with psoriasis and PsA, pharmacokinetic data from adult subjects with psoriasis, adult subjects with PsA and pediatric subjects with psoriasis, and safety data of ustekinumab from two clinical trials in 44 pediatric subjects 6 to 11 years old with psoriasis and 110 pediatric subjects 12 years of age and older with psoriasis. The observed pre-dose (trough) concentrations are generally comparable between adult subjects with psoriasis, adult subjects with PsA and pediatric subjects with psoriasis, and the PK exposure is expected to be comparable between adult and pediatric subjects with PsA [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14.1 , 14.2, 14.3 )] .
The safety and effectiveness of SELARSDI have not been established in pediatric patients less than 6 years old with psoriatic arthritis. Crohn’s Disease and Ulcerative Colitis The safety and effectiveness of SELARSDI have not been established in pediatric patients with Crohn’s disease or ulcerative colitis.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 6709 subjects exposed to ustekinumab, a total of 340 were 65 years of age or older (183 subjects with plaque psoriasis, 65 subjects with psoriatic arthritis, 58 subjects with Crohn’s disease, and 34 subjects with ulcerative colitis), and 40 subjects were 75 years of age or older. Clinical trials of ustekinumab did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.
🆘 Overdosage ▾
10 OVERDOSAGE Single doses up to 6 mg/kg intravenously have been administered in clinical trials without dose-limiting toxicity. In case of overdosage, monitor the patient for any signs or symptoms of adverse reactions or effects and institute appropriate symptomatic treatment immediately. Consider contacting the Poison Help line (1-800- 222-1222) or a medical toxicologist for additional overdose management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Ustekinumab products are human IgG1κ monoclonal antibodies that bind with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. In in vitro models, ustekinumab products were 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-12Rβ1.
The cytokines IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn’s disease and ulcerative colitis. In animal models of colitis, genetic absence or antibody blockade of the p40 subunit of IL-12 and IL-23, the target of ustekinumab products, was shown to be protective.
12.2Pharmacodynamics Plaque Psoriasis In a small exploratory trial, a decrease was observed in the expression of mRNA of its molecular targets IL-12 and IL-23 in lesional skin biopsies measured at baseline and up to two weeks post-treatment in subjects with plaque psoriasis. Ulcerative Colitis In both trial UC-1 (induction) and trial UC-2 (maintenance), a positive relationship was observed between exposure and rates of clinical remission, clinical response, and endoscopic improvement. The response rate approached a plateau at the ustekinumab exposures associated with the recommended dosing regimen for maintenance treatment [see Clinical Studies ( 14.5 )] .
12.3Pharmacokinetics Absorption In adult subjects with plaque psoriasis, the median time to reach the maximum serum concentration (T max ) was 13.5 days and 7 days, respectively, after a single subcutaneous administration of 45 mg (N=22) and 90 mg (N=24) of ustekinumab. In healthy subjects (N=30), the median T max value (8.5 days) following a single subcutaneous administration of 90 mg of ustekinumab was comparable to that observed in subjects with plaque psoriasis. Following multiple subcutaneous doses of ustekinumab in adult subjects with plaque psoriasis, steady-state serum concentrations of ustekinumab were achieved by Week 28.
The mean (±SD) steady-state trough serum ustekinumab concentrations were 0.69 ± 0.69 mcg/mL for subjects less than or equal to 100 kg receiving a 45 mg dose and 0.74 ± 0.78 mcg/mL for subjects greater than 100 kg receiving a 90 mg dose. There was no apparent accumulation in serum ustekinumab concentration over time when given subcutaneously every 12 weeks. Following the recommended intravenous induction dose, mean ±SD peak serum ustekinumab concentration was 125.2 ± 33.6 mcg/mL in subjects with Crohn’s disease, and 129.1 ± 27.6 mcg/mL in subjects with ulcerative colitis.
Starting at Week 8, the recommended subcutaneous maintenance dosing of 90 mg ustekinumab was administered every 8 weeks. Steady state ustekinumab concentration was achieved by the start of the second maintenance dose. There was no apparent accumulation in ustekinumab concentration over time when given subcutaneously every 8 weeks.
Mean ±SD steady-state trough concentration was 2.5 ± 2.1 mcg/mL in subjects with Crohn’s disease, and 3.3 ± 2.3 mcg/mL in subjects with ulcerative colitis for 90 mg ustekinumab administered every 8 weeks. Distribution Population pharmacokinetic analyses showed that the volume of distribution of ustekinumab in the central compartment was
2.7L (95% CI: 2.69, 2.78) in subjects with Crohn’s disease and
3.0L (95% CI: 2.96, 3.07) in subjects with ulcerative colitis. The total volume of distribution at steady-state was
4.6 L in subjects with Crohn’s disease and
4.4L in subjects with ulcerative colitis. Elimination The mean (±SD) half-life ranged from 14.9 ± 4.6 to 45.6 ± 80.2 days across all trials in subjects with plaque psoriasis following subcutaneous administration. Population pharmacokinetic analyses showed tha…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Ustekinumab products are human IgG1κ monoclonal antibodies that bind with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. In in vitro models, ustekinumab products were 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-12Rβ1.
The cytokines IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn’s disease and ulcerative colitis. In animal models of colitis, genetic absence or antibody blockade of the p40 subunit of IL-12 and IL-23, the target of ustekinumab products, was shown to be protective.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING SELARSDI (ustekinumab-aekn) injection, is a sterile, preservative-free, clear and colorless to slightly yellow solution and free of visible particles for subcutaneous use. It is supplied as individually packaged, single-dose prefilled syringes or single-dose vials. For Subcutaneous Use Single-dose Prefilled Syringes 45 mg/0.5 mL NDC 51759- 505 -32 90 mg/mL NDC 51759- 607 -32 Each prefilled syringe is equipped with a 29-gauge fixed 1/2 inch needle equipped with a passive safety device and a needle cover.
Not made with natural rubber latex. Single-dose Vial 45 mg/0.5 mL NDC 51759- 505 -13 For Intravenous Infusion Single-dose Vial 130 mg/26 mL (5 mg/mL) NDC 51759- 708 -13 Storage and Stability Store SELARSDI vials and prefilled syringes refrigerated between 36°F to 46°F (2°C to 8°C). Store SELARSDI vials upright.
Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.
If needed, individual prefilled syringes may be stored at room temperature up to 86°F (30°C) for a maximum single period of up to 30 days in the original carton to protect from light. Record the date when the prefilled syringe is first removed from the refrigerator on the carton in the space provided. Once a syringe has been stored at room temperature, do not return to the refrigerator.
Discard the syringe if not used within 30 days at room temperature storage. Do not use SELARSDI after the expiration date on the carton or on the prefilled syringe. If needed, SELARSDI 130 mg vials may be stored at room temperature up to 86°F (30°C) for a maximum single period of up to 7 days, in the original carton to protect from light.
Once a vial has been stored at room temperature, do not return to the refrigerator. Discard the vial if not used within 7 days at room temperature storage. Do not use SELARSDI after the expiration date on the carton or on the vial.
📋 Description ▾
11 DESCRIPTION Ustekinumab-aekn, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aekn is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses.
Ustekinumab-aekn is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. SELARSDI (ustekinumab-aekn) injection is a sterile, preservative-free, clear and colorless to slightly yellow solution free of visible particles with pH of 5.7 to 6.3. SELARSDI for Subcutaneous Use Available as 45 mg of ustekinumab-aekn in 0.5 mL and 90 mg of ustekinumab-aekn in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29-gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-aekn in 0.5 mL in a single-dose borosilicate Type I glass vial with a rubber stopper.
Not made with natural rubber latex. Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-aekn, histidine (0.122 mg), L-histidine monohydrochloride monohydrate (0.507 mg), polysorbate 80 (0.02 mg), sucrose (38 mg) and water for injection (q.s). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-aekn, histidine (0.243 mg), L-histidine monohydrochloride monohydrate (1.013 mg), polysorbate 80 (0.04 mg), sucrose (76 mg) and water for injection (q.s).
SELARSDI for Intravenous Infusion Available as 130 mg of ustekinumab-aekn in 26 mL, supplied as a single-dose borosilicate type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 26 mL vial delivers 130 mg ustekinumab-aekn, edetate disodium (0.47 mg), histidine (20.02 mg), L- histidine monohydrochloride monohydrate (27.04 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), sucrose (2,210 mg), and water for injection (q.s).
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Infections Inform patients that SELARSDI may lower the ability of their immune system to fight infections and to contact their healthcare provider immediately if they develop any signs or symptoms of infection [see Warnings and Precautions ( 5.1 )]. Malignancies Inform patients of the risk of developing malignancies while receiving SELARSDI [see Warnings and Precautions ( 5.4) ].
Serious Hypersensitivity and Reactions Inform patients that serious hypersensitivity reactions have been reported with intravenous and subcutaneous administration of ustekinumab products. Instruct patients to discontinue SELARSDI and seek immediate medical attention if they experience any signs or symptoms of hypersensitivity reactions [see Warnings and Precautions (5.5)]. Posterior Reversible Encephalopathy Syndrome (PRES) Inform patients to immediately contact their healthcare provider if they experience signs and symptoms of PRES (which may include headache, seizures, confusion, or visual disturbances) [see Warnings and Precautions ( 5.6 )].
Immunizations Inform patients that SELARSDI can interfere with the usual response to immunizations and that they should avoid live vaccines [see Warnings and Precautions ( 5.7 )]. Administration Instruct patients to follow sharps disposal recommendations, as described in the Instructions for Use. Brands listed are the trademarks of their respective owners.
Manufactured By: Alvotech USA Inc. Leesburg, VA 20175 U.S. License No.
2225 Product of Iceland Marketed By: Teva Pharmaceuticals Parsippany, NJ 07054
💬 Medication Guide ▾
MEDICATION GUIDE SELARSDI™ (seh-LARS-dee) (ustekinumab-aekn) injection, for subcutaneous or intravenous use What is the most important information I should know about SELARSDI? SELARSDI is a medicine that affects your immune system. SELARSDI can increase your risk of having serious side effects, including: Serious infections.
SELARSDI may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have serious infections during treatment with ustekinumab products, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection.
Your healthcare provider should check you for TB before starting SELARSDI. If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with SELARSDI and during treatment with SELARSDI. Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with SELARSDI.
You should not start SELARSDI if you have any kind of infection unless your healthcare provider says it is okay. Before starting SELARSDI, tell your healthcare provider if you: think you have an infection or have symptoms of an infection such as: fever, sweat, or chills muscle aches cough shortness of breath blood in phlegm weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal feel very tired are being treated for an infection or have any open cuts. get a lot of infections or have infections that keep coming back. have TB, or have been in close contact with someone with TB.
After starting SELARSDI, call your healthcare provider right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. SELARSDI can make you more likely to get infections or make an infection that you have worse.
People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections. These infections can spread throughout the body and cause death. People who take SELARSDI may also be more likely to get these infections.
Cancers. SELARSDI may decrease the activity of your immune system and increase your risk for certain types of cancers. Tell your healthcare provider if you have ever had any type of cancer.
Some people who are receiving ustekinumab products and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with SELARSDI, tell your healthcare provider if you develop any new skin growths. What is SELARSDI?
SELARSDI is a prescription medicine used to treat: adults and children 6 years of age and older with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). adults and children 6 years of age and older with active psoriatic arthritis. adults with moderately to severely active Crohn’s disease. adults with moderately to severely active ulcerative colitis. It is not known if SELARSDI is safe and effective in children with Crohn’s disease or ulcerative colitis or in children less than 6 years of age with plaque psoriasis or psoriatic arthritis.
Who should not use SELARSDI? Do not use SELARSDI if you are allergic to ustekinumab products or any of the ingredients in SELARSDI. See the end of this Medication Guide for a complete list of ingredients in SELARSDI.
Before you use or receive SELARSDI, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section “ What is the most important information I should know about SELARSDI?” ever had an allergic…