Steqeyma

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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. 2.1.
• Recommended 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 STEQEYMA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.
• The recommended dose of STEQEYMA 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 STEQEYMA 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 STEQEYMA 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 Refer to
• Psoriatic Arthritis;
• Subcutaneous Pediatric Dosage Regimen.
• 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 0.2 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 34.5 0.38 47 35.3 0.39 48 36 0.4 49 36.8 0.41 50 37.5 0.42 51 38.3 0.42 52 39 0.43 53 39.8 0.44 54 40.5 0.45 55 41.3 0.46 56 42 0.46 57 42.8 0.47 58 43.5 0.48 59 44.3 0.49 2.2.
• Recommended Dosage in Psoriatic Arthritis Subcutaneous Adult Dosage Regimen The recommended dosage is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
• For patients with co-existent moderate-to-severe plaque psoriasis weighing more than 100 kg, the recommended dosage is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.
• Subcutaneous Pediatric Dosage Regimen Administer STEQEYMA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.
• The recommended dose of STEQEYMA for pediatric patients 6 years of age and older with psoriatic arthritis, based on body weight, is shown below (Table 3).
• Table 3:
• Recommended Dose of STEQEYMA for Subcutaneous Injection in Pediatric Patients 6 years of age and older with Psoriatic Arthritis Body Weight of Patient at the Time of Dosing Recommended Dose less than 60 kg 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. 0.75 mg/kg 60 kg or more 45 mg greater than 100 kg with co-existent moderate-to-severe plaque psoriasis 90 mg 2.3.
• Recommended Dosage in Crohn's Disease and Ulcerative Colitis Intravenous Induction Adult Dosage Regimen A single intravenous infusion dose of STEQEYMA using the weight-based dosage regimen specified in Table 4 [see Instructions for dilution of STEQEYMA 130 mg vial for intravenous infusion (2.5) ] .
• Table 4:
• Initial Intravenous Dosage of STEQEYMA Body Weight of Patient at the time of dosing Dose Number of 130 mg/26 mL (5 mg/mL) STEQEYMA vials 55 kg or less 260 mg 2 more than 55 kg to 85 kg 390 mg 3 more than 85 kg 520 mg 4 Subcutaneous Maintenance Adult Dosage Regimen The recommended maintenance dosage is a subcutaneous 90 mg dose administered 8 weeks after the initial intravenous dose, then every 8 weeks thereafter. 2.4.
• General Considerations for Administration STEQEYMA is intended for use under the guidance and supervision of a healthcare provider.
• STEQEYMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a healthcare provider.
• The appropriate dose should be determined by a healthcare provider using the patient's current weight at the time of dosing.
• In pediatric patients, it is recommended that STEQEYMA be administered by a healthcare provider.
• If a healthcare provider determines that it is appropriate, a patient may self-inject or a caregiver may inject STEQEYMA after proper training in subcutaneous injection technique.
• Instruct patients to follow the directions provided in the Instructions for Use [see Instructions for Use].
• It is recommended that each injection be administered at a different anatomic location (such as upper arms, gluteal regions, thighs, or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, or indurated.
• When using the vial, a 1 mL syringe with a 27 gauge, ½ inch needle is recommended.
• Prior to administration, visually inspect STEQEYMA for particulate matter and discoloration.
• STEQEYMA is a clear to very slightly opalescent and colorless to pale yellow solution.
• Do not use STEQEYMA if it is discolored or cloudy, or if other particulate matter is present.
• STEQEYMA does not contain preservatives; therefore, discard any unused product remaining in the vial and/or syringe.
• After withdrawing STEQEYMA from the single-dose vial for subcutaneous use, administer the dose immediately.
• The vial does not contain preservatives.
• Discard any unused portion of drug remaining in the vial or syringe. 2.5.
• Preparation and Administration of STEQEYMA 130 mg/26 mL (5 mg/mL) Vial for Intravenous Infusion (Crohn's Disease and Ulcerative Colitis) STEQEYMA solution for intravenous infusion must be diluted, prepared, and infused by a healthcare professional using aseptic technique. 1.
• Calculate the dose and the number of STEQEYMA vials needed based on patient weight (Table 4).
• Each 26 mL vial of STEQEYMA contains 130 mg of ustekinumab-stba. 2.
• Withdraw, and then discard a volume of the 0.9% Sodium Chloride Injection, USP from the 250 mL infusion bag equal to the volume of STEQEYMA to be added (discard 26 mL sodium chloride for each vial of STEQEYMA needed, for 2 vials- discard 52 mL, for 3 vials- discard 78 mL, 4 vials- discard 104 mL).
• Alternatively, a 250 mL infusion bag containing 0.45% Sodium Chloride Injection, USP may be used. 3.
• Withdraw 26 mL of STEQEYMA from each vial needed and add it to the 250 mL infusion bag.
• The final volume in the infusion bag should be 250 mL.
• Gently mix. 4.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Do not use if visibly opaque particles, discoloration or foreign particles are observed. 5.
• Infuse the diluted solution over a period of at least one hour.
• Once diluted, the infusion should be completely administered within four hours of the dilution in the infusion bag. 6.
• Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer). 7.
• Do not infuse STEQEYMA concomitantly in the same intravenous line with other agents. 8.
• STEQEYMA does not contain preservatives.
• Each vial is for a one-time use in only one patient.
• Discard any remaining solution.
• Dispose any unused medicinal product in accordance with local requirements.
• Storage If necessary, the diluted infusion solution may be kept at room temperature up to 30°C (86°F) for up to 3 hours.
• Storage time at room temperature begins once the diluted solution has been prepared.
• The infusion should be completed within 4 hours after the dilution in the infusion bag (cumulative time after preparation including the storage and the infusion period).
• Do not freeze.
• Discard any unused portion of the infusion solution.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• 8.4.
• Pediatric Use Plaque Psoriasis The safety and effectiveness of STEQEYMA 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 STEQEYMA 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 STEQEYMA 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 STEQEYMA have not been established in pediatric patients less than 6 years of age with plaque psoriasis.
• Psoriatic Arthritis The safety and effectiveness of STEQEYMA have been established for treatment of psoriatic arthritis in pediatric patients 6 years of age and older.
• Use of STEQEYMA 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 STEQEYMA 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 STEQEYMA have not been established in pediatric patients with Crohn's disease or ulcerative colitis.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• 8.5.
• Geriatric 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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 CELLTRION USA, Inc. at 1-800-560-9414 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1.
• Clinical 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-year 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 follow-up).
• Serious infections were reported in 2.8% of subjects (0.01 per patient-years of follow-up).
• Malignancies 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), 1.7% of ustekinumab-treated subjects reported malignancies excluding non-melanoma skin cancers (0.60 per hundred patient-years of follow-up).
• Non-melanoma skin cancer was reported in 1.5% of ustekinumab-treated subjects (0.52 per hundred patient-years of follow-up) [see Warnings and Precautions (5.4) ] .
• The most frequently observed malignancies other than non-melanoma skin cancer during the clinical trials were:
• prostate, melanoma, colorectal and breast.
• Malignancies other than non-melanoma skin cancer in ustekinumab-treated subjects during the controlled and uncontrolled portions of trials were similar in type and number to what would be expected in the general U.S. population according to the SEER database (adjusted for age, gender and race). 1 Pediatric Subjects with Plaque Psoriasis The safety of ustekinumab was assessed in two trials of pediatric subjects with moderate to severe plaque psoriasis.
• Ps STUDY 3 evaluated safety for up to 60 weeks in 110 pediatric subjects 12 to 17 years old.
• Ps STUDY 4 evaluated safety for up to 56 weeks in 44 pediatric subjects 6 to 11 years old.
• The safety profile in pediatric subjects was similar to the safety profile from trials in
• adults with plaque psoriasis.
• Psoriatic Arthritis The safety of ustekinumab was assessed in 927 subjects in two randomized, double-blind, placebo- controlled trials in
• adults with active psoriatic arthritis (PsA).
• The overall safety profile of ustekinumab in subjects with PsA was consistent with the safety profile seen in clinical trials in adult subjects with plaque psoriasis.
• A higher incidence of arthralgia, nausea, and dental infections was observed in ustekinumab-treated subjects when compared with placebo-treated subjects (3% vs. 1% for arthralgia and 3% vs. 1% for nausea; 1% vs. 0.6% for dental infections) in the placebo-controlled portions of the PsA clinical trials.
• Crohn's Disease The safety of ustekinumab was assessed in 1407 subjects with moderately to severely active Crohn's disease (Crohn's Disease Activity Index [CDAI] greater than or equal to 220 and less than or equal to 450) in three randomized, double-blind, placebo-controlled, parallel-group, multicenter trials.
• These 1407 subjects included 40 subjects who received a prior investigational intravenous ustekinumab formulation but were not included in the efficacy analyses.
• In trials CD-1 and CD-2 there were 470 subjects who received ustekinumab 6 mg/kg as a weight-based single intravenous induction dose and 466 who received placebo [see Dosage and Administration (2.3) ] .
• Subjects who were responders in either trial CD-1 or CD-2 were randomized to receive a subcutaneous maintenance regimen of either 90 mg ustekinumab every 8 weeks, or placebo for 44 weeks in trial CD-3.
• Subjects in these 3 trials may have received other concomitant therapies including aminosalicylates, immunomodulatory agents [azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate (MTX)], oral corticosteroids (prednisone or budesonide), and/or antibiotics for their Crohn's disease [see Clinical Studies (14.4) ] .
• The overall safety profile of ustekinumab was consistent with the safety profile seen in the clinical trials in adult subjects with plaque psoriasis and psoriatic arthritis.
• Common adverse reactions in trials CD-1 and CD-2 and in trial CD-3 are listed in Tables 6 and 7, respectively.
• Table 6:
• Common Adverse Reactions Through Week 8 in Trials CD-1 and CD-2 occurring in ≥3% of Ustekinumab-Treated Subjects and Higher Than Subjects Receiving Placebo Placebo N=466 Ustekinumab 6 mg/kg single intravenous induction dose N=470 Vomiting 3% 4% Other less common adverse reactions reported in subjects in trials CD-1 and CD-2 included asthenia (1% vs 0.4%), acne (1% vs 0.4%), and pruritus (2% vs 0.4%).
• Table 7:
• Common Adverse Reactions Through Week 44 in Trial CD-3 occurring in ≥3% of Ustekinumab-Treated Subjects and Higher Than Subjects Receiving Placebo Placebo N=133 Ustekinumab 90 mg subcutaneous maintenance dose every 8 weeks N=131 Nasopharyngitis 8% 11% Injection site erythema 0 5% Vulvovaginal candidiasis/mycotic infection 1% 5% Bronchitis 3% 5% Pruritus 2% 4% Urinary tract infection 2% 4% Sinusitis 2% 3% Infections In subjects with Crohn's disease, serious or other clinically significant infections included anal abscess, gastroenteritis, and pneumonia.
• In addition, listeria meningitis and ophthalmic herpes zoster were reported in one subject each [see Warnings and Precautions (5.1) ] .
• Malignancies With up to one year of treatment in the Crohn's disease clinical trials, 0.2% of ustekinumab-treated subjects (0.36 events per hundred patient-years) and 0.2% of placebo-treated subjects (0.58 events per hundred patient-years) developed non-melanoma skin cancer.
• Malignancies other than non-melanoma skin cancers occurred in 0.2% of ustekinumab-treated subjects (0.27 events per hundred patient-years) and in none of the placebo-treated subjects.
• Hypersensitivity Reactions Including Anaphylaxis In CD trials, two subjects reported hypersensitivity reactions following ustekinumab administration.
• One subject experienced signs and symptoms consistent with anaphylaxis (tightness of the throat, shortness of breath, and flushing) after a single subcutaneous administration (0.1% of subjects receiving subcutaneous ustekinumab).
• In addition, one subject experienced signs and symptoms consistent with or related to a hypersensitivity reaction (chest discomfort, flushing, urticaria, and increased body temperature) after the initial intravenous ustekinumab dose (0.08% of subjects receiving intravenous ustekinumab).
• These subjects were treated with oral antihistamines or corticosteroids and in both cases symptoms resolved within an hour [see Warnings and Precautions (5.5) ] .
• Ulcerative Colitis The safety of ustekinumab was evaluated in two randomized, double-blind, placebo-controlled clinical trials (UC-1 [IV induction] and UC-2 [SC maintenance]) in 960 adult subjects with moderately to severely active ulcerative colitis [see Clinical Studies (14.5) ] .
• The overall safety profile of ustekinumab in subjects with ulcerative colitis was consistent with the safety profile seen across all approved indications.
• Adverse reactions reported in at least 3% of ustekinumab-treated subjects and at a higher rate than placebo were:
• Induction (UC-1):
• nasopharyngitis (7% vs 4%).
• Maintenance (UC-2):
• nasopharyngitis (24% vs 20%), headache (10% vs 4%), abdominal pain (7% vs 3%), influenza (6% vs 5%), fever (5% vs. 4%), diarrhea (4% vs 1%), sinusitis (4% vs 1%), fatigue (4% vs 2%), and nausea (3% vs 2%).
• Infections In subjects with ulcerative colitis, serious or other clinically significant infections included gastroenteritis and pneumonia.
• In addition, listeriosis and ophthalmic herpes zoster were reported in one subject each [see Warnings and Precautions (5.1) ] .
• Malignancies With up to one year of treatment in the ulcerative colitis clinical trials, 0.4% of ustekinumab- treated subjects (0.48 events per hundred patient-years) and 0.0% of subjects receiving placebo (0.00 events per hundred patient-years) developed non-melanoma skin cancer.
• Malignancies other than non-melanoma skin cancers occurred in 0.5% of ustekinumab-treated subjects (0.64 events per hundred patient-years) and 0.2% of subjects receiving placebo (0.40 events per hundred patient- years). 6.2.
• Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay.
• Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of ustekinumab or of other ustekinumab products.
• Approximately 6 to 12.4% of subjects treated with ustekinumab in clinical trials in subjects with plaque psoriasis and psoriatic arthritis developed antibodies to ustekinumab, which were generally low-titer.
• In clinical trials in subjects with plaque psoriasis, antibodies to ustekinumab were associated with reduced or undetectable serum ustekinumab concentrations and reduced efficacy.
• In trials in subjects with plaque psoriasis, the majority of subjects who were positive for antibodies to ustekinumab had neutralizing antibodies.
• In clinical trials in subjects with Crohn's disease and ulcerative colitis, 2.9% and 4.6% of subjects, respectively, developed antibodies to ustekinumab when treated with ustekinumab for approximately one year.
• No apparent association between the development of antibodies to ustekinumab and the development of injection site reactions was seen. 6.3.
• Postmarketing Experience The following adverse reactions have been reported during post-approval use of ustekinumab products.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to ustekinumab product exposure.
• Immune system disorders:
• Hypersensitivity reactions (e.g., anaphylaxis, angioedema, dyspnea, rash, urticaria), including a fatal case that presented with chest tightness and dyspnea during infusion of the first dose.
• Infections and infestations:
• Lower respiratory tract infection (including opportunistic fungal infections and tuberculosis).
• Neurological disorders: Posterior Reversible Encephalopathy Syndrome (PRES) .
• Respiratory, thoracic and mediastinal disorders:
• Interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia .
• Skin reactions :
• Pustular psoriasis, erythrodermic psoriasis, hypersensitivity vasculitis.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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 STEQEYMA 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 STEQEYMA [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 STEQEYMA 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 STEQEYMA 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.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• 3.
• DOSAGE FORMS AND STRENGTHS STEQEYMA (ustekinumab-stba) is a clear to very slightly opalescent and colorless to pale yellow solution.
• 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 ) 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

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.
• HOW SUPPLIED/STORAGE AND HANDLING STEQEYMA (ustekinumab-stba) injection is a sterile, preservative-free, clear to very slightly opalescent, and colorless to pale yellow solution.
• It is supplied as individually packaged, single-dose prefilled syringes or single-dose vials.
• For Subcutaneous Use Prefilled Syringes 45 mg/0.5 mL (NDC 72606-027-01) 90 mg/mL (NDC 72606-028-01) Each prefilled syringe is equipped with a 27-gauge fixed ½ inch needle, a needle safety guard, and a needle cover that is not made with natural rubber latex.
• Single-dose Vial 45 mg/0.5 mL (NDC 72606-060-01) For Intravenous Infusion Single-dose Vial 130 mg/26 mL (5 mg/mL) (NDC 72606-029-01) Storage and Stability Store STEQEYMA vials and prefilled syringes refrigerated between 2ºC to 8ºC (36ºF to 46ºF).
• Store STEQEYMA vials upright.
• Keep the product in the original carton to protect from light until the time of use.
• Do not freeze.
• Do not shake.
• Prefilled Syringes If needed, individual pre-filled syringes may be stored at room temperature up to 25°C (77°F) for a maximum single period of up to 31 days in the original carton to protect from light.
• Record the date when the pre-filled syringe is first removed from the refrigerator on the carton in the space provided.
• At any time before the end of this period at room temperature, a pre-filled syringe can be returned to the refrigerator once up to the original expiration date.
• Discard the pre-filled syringe if not used within 31 days at room temperature storage.
• Do not use STEQEYMA after the expiration date on the carton or on the prefilled syringe.
• Single-dose Vial If needed, individual vials may be stored at room temperature up to 30°C (86°F) for a maximum single period of up to 15 days in the original carton to protect from light.
• Record the date when the vial is first removed from the refrigerator on the carton in the space provided.
• Once a vial has been stored at room temperature, do not return to the refrigerator.
• Discard the vial if not used within 15 days at room temperature storage.
• Do not use STEQEYMA after the expiration date on the carton or on the vial.

Quoted from the official label, section “How Supplied”.

How to store it

• and Stability Store STEQEYMA vials and prefilled syringes refrigerated between 2ºC to 8ºC (36ºF to 46ºF).
• Store STEQEYMA vials upright.
• Keep the product in the original carton to protect from light until the time of use.
• Do not freeze.
• Do not shake.
• Prefilled Syringes If needed, individual pre-filled syringes may be stored at room temperature up to 25°C (77°F) for a maximum single period of up to 31 days in the original carton to protect from light.
• Record the date when the pre-filled syringe is first removed from the refrigerator on the carton in the space provided.
• At any time before the end of this period at room temperature, a pre-filled syringe can be returned to the refrigerator once up to the original expiration date.
• Discard the pre-filled syringe if not used within 31 days at room temperature storage.
• Do not use STEQEYMA after the expiration date on the carton or on the prefilled syringe.
• Single-dose Vial If needed, individual vials may be stored at room temperature up to 30°C (86°F) for a maximum single period of up to 15 days in the original carton to protect from light.
• Record the date when the vial is first removed from the refrigerator on the carton in the space provided.
• Once a vial has been stored at room temperature, do not return to the refrigerator.
• Discard the vial if not used within 15 days at room temperature storage.
• Do not use STEQEYMA after the expiration date on the carton or on the vial.

Quoted from the official label, section “Storage and Handling”.

What is in it

• 11.
• DESCRIPTION Ustekinumab-stba, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist.
• Using DNA recombinant technology, ustekinumab-stba is produced in a Chinese Hamster Ovary (CHO) cell line.
• The manufacturing process contains steps for the clearance of viruses.
• Ustekinumab-stba is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons.
• STEQEYMA (ustekinumab-stba) injection is a sterile, preservative-free, clear to very slightly opalescent, and colorless to pale yellow solution with pH of 5.7.
• STEQEYMA for Subcutaneous Use Available as 45 mg of ustekinumab-stba in 0.5 mL and 90 mg of ustekinumab-stba in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab-stba in 0.5 mL in a single-dose vial with a rubber stopper.
• The syringe is fitted with a needle safety guard and a needle cover.
• Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-stba, histidine (0.18 mg), L-histidine monohydrochloride monohydrate (0.46 mg), polysorbate 80 (0.02 mg), sucrose (38 mg), and Water for Injection.
• Each 1 mL prefilled syringe delivers 90 mg ustekinumab-stba, histidine (0.36 mg), L-histidine monohydrochloride monohydrate (0.91 mg), polysorbate 80 (0.04 mg), sucrose (76 mg), and Water for Injection.
• STEQEYMA for Intravenous Infusion Available as 130 mg of ustekinumab-stba in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper.
• Each 26 mL vial delivers 130 mg ustekinumab-stba, edetate disodium (0.47 mg), histidine (9.36 mg), L-histidine monohydrochloride monohydrate (23.66 mg), methionine (10.56 mg), polysorbate 80 (10.37 mg), sucrose (1,976 mg), and Water for Injection.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Ustekinumab-Stba