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Generic Name
Ustekinumab
Brand Names
Otulfi, Pyzchiva, Selarsdi, Starjemza, Stelara, Steqeyma, Ustekinumab-AAUZ, Ustekinumab-aekn, Ustekinumab-TTWE, Wezlana, Yesintek
FDA approval date: September 25, 2009
Classification: Interleukin-12 Antagonist
Form: Injection, Solution
What is Otulfi (Ustekinumab)?
OTULFI is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
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Brand Information
Otulfi (ustekinumab-aauz)
1DOSAGE FORMS AND STRENGTHS
OTULFI (ustekinumab-aauz) is a clear to slightly opalescent and colorless to slightly brown-yellow solution.
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
2CONTRAINDICATIONS
OTULFI is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in OTULFI
3ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the label:
- Infections
- Malignancies
- Serious Hypersensitivity Reactions
- Posterior Reversible Encephalopathy Syndrome (PRES)
- Noninfectious Pneumonia
3.1Clinical 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.
3.2Immunogenicity
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.
3.3Postmarketing 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.
4OVERDOSAGE
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.
5DESCRIPTION
Ustekinumab-aauz, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aauz is produced in a Chinese hamster ovary (CHO) cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aauz is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons.
OTULFI (ustekinumab-aauz) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to slightly brown-yellow solution with pH of 5.7- 6.3.
6REFERENCES
- Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Incidence - SEER 6.6.2 Regs Research Data, Nov 2009 Sub (1973- 2007) - Linked To County Attributes - Total U.S., 1969-2007 Counties, National Cancer Institute, DCCPS, Surveillance Research Program, Surveillance Systems Branch, released April 2010, based on the November 2009 submission.
7HOW SUPPLIED/STORAGE AND HANDLING
OTULFI (ustekinumab-aauz) injection is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly brown-yellow solution. It is supplied as individually packaged, single-dose prefilled syringes or single-dose vials.
8PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
9Principal Display Panel – 45 mg Carton Label
NDC 65219-824-01
RX only
Otulfi
ustekinumab-aauz
Injection
Injection
For subcutaneous use
1 Single-dose prefilled syringe. Discard unused portion.
Carton contains:
1 Single-dose prefilled syringe
1 Prescribing Information
1 Medication Guide
Manufactured by:
Fresenius Kabi USA, LLC
Lake Zurich, Illionis 60047
U.S. Licence No. 2146
10Principal Display Panel – 45 mg Syringe Label
Single dose prefilled syringe
Discard unused portion
Otulfi
ustekinumab-aauz
Injection
Injection
45 mg/0.5 mL
For subcutaneous use
Mfg by: Fresenius Kabi USA, LLC
U.S. License No. 2146
NDC 65219-824-01
Rx only
Store at 36 °F to 46 °F
11Principal Display Panel – 90 mg Carton Label
NDC 65219-826-26
RX only
Otulfi
ustekinumab-aauz
Injection
Injection
For subcutaneous use
1 Single-dose prefilled syringe. Discard unused portion.
Carton contains:
1 Single-dose prefilled syringe
1 Prescribing Information
1 Medication Guide
Manufactured by:
Fresenius Kabi USA, LLC
Lake Zurich, Illionis 60047
U.S. Licence No. 2146
12Principal Display Panel – 90 mg syringe Label
Single dose prefilled syringe
Discard unused portion
Otulfi
ustekinumab-aauz
Injection
Injection
90 mg/mL
For subcutaneous use
Mfg by: Fresenius Kabi USA, LLC
U.S. License No. 2146
NDC 65219-826-26
Rx only
Store at 36 °F to 46 °F
13Principal Display Panel – 130 mg Carton Label
NDC 65219-828-05
Rx only
Otulfi
ustekinumab-aauz
Injection
Injection
130 mg/26 mL
(5 mg/mL)
(5 mg/mL)
For Intravenous Infusion Only
Must be diluted
ATTENTION: Dispense
the enclosed Medication
Guide to each patient.
the enclosed Medication
Guide to each patient.
Carton contains:
1 Single-dose vial
1 Prescribing Information
1 Medication Guide
1 Single-dose vial.
Discard unused portion.
14Principal Display Panel – 130 mg Vial Label
NDC 65219-828-05
Rx only
Otulfi
ustekinumab-aauz
Injection
Injection
130 mg/26 mL
(5 mg/mL)
(5 mg/mL)
For Intravenous Infusion Only
Must be diluted
Single-dose vial.
Discard unused portion.
Dosage: See Precribing
Information
Store in a refrigerator at
36 °F (2 °C to 8 °C)
In original carton to
Protect from light
Manufactured by:
Fresenius Kabi USA, LLC
Lake Zurich,
Illinois 60047
US License No. 2146
Product of Netherlands
15Principal Display Panel – 45 mg Carton Label
NDC 65219-822-05
Rx only
Otulfi
ustekinumab-aauz
Injection
Injection
45 mg/0.5 mL
For Subcutaneous use
1 Single-dose vial.
Discard unused portion.
Manufactured by:
Fresenius Kabi USA, LLC
Lake Zurich,
Illinois 60047
U.S. License No. 2146
16Principal Display Panel – 45 mg Vial Label
NDC 65219-822-05 Rx only
Otulfi
ustekinumab-aauz
45 mg/0.5 mL
For Subcutaneous use
Single-dose vial.
Discard unused portion.
Manufactured by:
Fresenius Kabi USA, LLC
Lake Zurich,
Illinois 60047
U.S. License No. 2146
