Otulfi 45 mg/.5mL
ustekinumab-aauz · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
Otulfi is a injection, solution containing ustekinumab-aauz at 45 mg/.5mL, taken subcutaneous. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Otulfi
- Generic Name
- ustekinumab-aauz
- NDC Code (Product)
65219-822- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 45 mg/.5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761379
- Drug Class
- Interleukin-12 Antagonist [EPC]; Interleukin-23 Antagonist [EPC]
- Marketing Start
- 09/29/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE OTULFI 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 ) 1.1 Plaque Psoriasis (PsO) OTULFI 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) OTULFI 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) OTULFI is indicated for the treatment of adult patients with moderately to severely active Crohn's disease. 1.4 Ulcerative Colitis OTULFI is indicated for the treatment of adult patients wit…
Dosage & 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 subcutaneous…
Contraindications
4 CONTRAINDICATIONS OTULFI is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in OTULFI [see Warnings and Precautions ( 5.5 )]. Clinically significant hypersensitivity to ustekinumab products or to any of the excipients in OTULFI. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Concomitant 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. 7.2 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 ustekinumab products, antagonists of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of OTULFI in patients who are receiving concomitant CYP450 substrates, particularly those with a narr…
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 Fresenius Kabi USA, LLC at 1-800-551-7176, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.…
Frequently Asked Questions
What is Otulfi used for?
Otulfi contains ustekinumab-aauz. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Otulfi a controlled substance?
Otulfi is not classified as a controlled substance by the DEA.
What is the generic name for Otulfi?
The generic name for Otulfi is ustekinumab-aauz. There are 2 other brand versions of ustekinumab-aauz.
What is the NDC code for Otulfi 45 mg/.5mL?
The NDC (National Drug Code) for Otulfi 45 mg/.5mL is 65219-822, listed by Fresenius Kabi USA, LLC.