WEZLANA 130 mg/26mL
ustekinumab-auub · INJECTION, SOLUTION · Nuvaila Limited
WEZLANA is a injection, solution containing ustekinumab-auub at 130 mg/26mL, taken intravenous. Manufactured by Nuvaila Limited.
Key Facts
- Brand Name
- WEZLANA
- Generic Name
- ustekinumab-auub
- NDC Code (Product)
84612-066- Manufacturer
- Nuvaila Limited
- Strength
- 130 mg/26mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761331
- Drug Class
- Interleukin-12 Antagonist [EPC]; Interleukin-23 Antagonist [EPC]
- Marketing Start
- 01/01/2025
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 WEZLANA 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 adult and pediatric patients 6 years of age and older. ( 1.2 ) Moderately to severely active Crohn's disease in adult patients. ( 1.3 ) Moderately to severely active ulcerative colitis in adult patients . ( 1.4 ) 1.1 Plaque Psoriasis (PsO) WEZLANA 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) WEZLANA 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) WEZLANA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease. 1.4 Ulcerative Colitis (UC) WEZLANA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
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 admi…
Contraindications
4 CONTRAINDICATIONS WEZLANA is contraindicated in patients with clinically significant hypersensitivity to any ustekinumab product or to any of the excipients in WEZLANA [see Warnings and Precautions (5.5) ]. Clinically significant hypersensitivity to ustekinumab products or to any of the excipients in WEZLANA. ( 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 WEZLANA 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 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 Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Tria…
Frequently Asked Questions
What is WEZLANA used for?
WEZLANA contains ustekinumab-auub. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is WEZLANA a controlled substance?
WEZLANA is not classified as a controlled substance by the DEA.
What is the generic name for WEZLANA?
The generic name for WEZLANA is ustekinumab-auub. There are no other listed brand versions of ustekinumab-auub.
What is the NDC code for WEZLANA 130 mg/26mL?
The NDC (National Drug Code) for WEZLANA 130 mg/26mL is 84612-066, listed by Nuvaila Limited.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)