STELARA 45 mg/.5mL
ustekinumab · INJECTION, SOLUTION · Janssen Biotech, Inc.
STELARA is a injection, solution containing ustekinumab at 45 mg/.5mL, taken subcutaneous. Manufactured by Janssen Biotech, Inc..
Key Facts
- Brand Name
- STELARA
- Generic Name
- ustekinumab
- NDC Code (Product)
57894-060- Manufacturer
- Janssen Biotech, Inc.
- Strength
- 45 mg/.5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA125261
- Drug Class
- Interleukin-12 Antagonist [EPC]; Interleukin-23 Antagonist [EPC]
- Marketing Start
- 09/25/2009
Recall History
Kroger Specialty Pharmacy, Inc.
Lack of Processing Controls.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. ( 1.1 ) Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. ( 1.2 ) Moderately to severely active Crohn's disease in adult and pediatric patients 2 years of age and older. ( 1.3 ) Moderately to severely active ulcerative colitis in adult patients. ( 1.4 ) 1.1 Plaque Psoriasis (PsO) STELARA 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. 1.2 Psoriatic Arthritis (PsA) STELARA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis. 1.3 Crohn's Disease (CD) STELARA is indicated for the treatment of adults and pediatric patients 2 years of age and older with moderately to severely active Crohn's disease. 1.4 Ulcerative Colitis (UC) STELARA is indicated for the treatment of adult patients with moder…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adult Patients with Plaque Psoriasis Subcutaneous Recommended Dosage ( 2.1 ) : Weight Range (kilograms) Recommended 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) Recommended 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 ad…
Contraindications
4 CONTRAINDICATIONS STELARA is contraindicated in patients with clinically significant hypersensitivity to any ustekinumab product or to any of the excipients in STELARA [see Warnings and Precautions (5.5) ]. Clinically significant hypersensitivity to any ustekinumab product or to any of the excipients in STELARA. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Concomitant Therapies In trials in subjects with plaque psoriasis the safety of STELARA 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 STELARA. 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 STELARA. 7.2 CYP450 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 STELARA, an antagonist of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of STELARA in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider m…
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 in Adults induction (≥3%): vomiting. ( 6.1 ) maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. ( 6.1 ) Ulcerative Colitis in Adults induction (≥3%): nasopharyngitis. ( 6.1 ) maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clin…
Frequently Asked Questions
What is STELARA used for?
STELARA contains ustekinumab. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is STELARA a controlled substance?
STELARA is not classified as a controlled substance by the DEA.
What is the generic name for STELARA?
The generic name for STELARA is ustekinumab. There are 10 other brand versions of ustekinumab.
What is the NDC code for STELARA 45 mg/.5mL?
The NDC (National Drug Code) for STELARA 45 mg/.5mL is 57894-060, listed by Janssen Biotech, Inc..