TM Owner Amgen
Wezlana 45mg/0.5mL Injection
Global Shipping : Reliable Global Distribution Network
Express Delivery : Priority Shipping for Every Order
Secure Payments : Trusted Payment Protection System
Disclaimer
Secure Handling
24/7 Worldwide Support
Global Access
Worldwide Access to Health
Cold-Chain Expert
Excellence in Cold-Chain
Trusted Supply
Certified Medical Supply
Indications & Clinical Uses
- Wezlana 45 mg/0.5 mL (ustekinumab-auub) is a biosimilar to Stelara and a human interleukin-12 and -23 antagonist given by injection under the skin from a prefilled syringe or vial; the 130 mg/26 mL vial is given by intravenous infusion, and a 90 mg/mL syringe also exists.
- In the US it is approved for moderate-to-severe plaque psoriasis and active psoriatic arthritis in adults and children aged 6 years and over, and for moderately to severely active Crohn's disease and ulcerative colitis in adults only.
- In plaque psoriasis, adults weighing 100 kg or less receive 45 mg at start, 4 weeks later, then every 12 weeks; above 100 kg the dose is 90 mg on the same schedule.
- Marketed as Wezenla in the EU.
- Do not mix up the 45 mg, 90 mg and 130 mg presentations.
Side Effects
- The most common side effects in psoriasis and psoriatic arthritis (3% or more) are nasopharyngitis, upper respiratory infection, headache and tiredness.
- In Crohn's disease maintenance they include nasopharyngitis, injection-site redness, vulvovaginal yeast infection, bronchitis, itching, urinary tract infection and sinusitis; in ulcerative colitis, nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhoea, sinusitis, tiredness and nausea.
- Serious effects include serious infections, tuberculosis, malignancies, severe hypersensitivity reactions, posterior reversible encephalopathy syndrome (PRES) and noninfectious pneumonia.
- The US label has no boxed warning.
- Report fever, cough, headache with vision changes or confusion, or any allergic reaction straight away.
Precautions & Warnings
- Do not start Wezlana during a clinically important active infection, and have tuberculosis evaluation, with latent TB treated first.
- Ustekinumab products may increase malignancy risk.
- If a severe hypersensitivity reaction occurs, stop Wezlana immediately.
- Monitor for PRES and stop for confirmed noninfectious pneumonia.
- The prefilled syringes are for subcutaneous use only and must never be used for the intravenous dose; the IV formulation is a separate 130 mg/26 mL vial.
- Pregnancy data are limited and insufficient to inform a drug-associated risk; a registry of 107 pregnancies showed no ustekinumab-associated risk of major birth defects.
- Keep refrigerated at 2°C to 8°C in the original carton and do not freeze.
Avoid Interactions
- Medicines and treatments that increase risk: live vaccines should not be given during treatment, and BCG vaccine should not be given during treatment or for one year before or after it.
- The label also discusses allergen immunotherapy, so mention it to your healthcare provider.
- The label says ustekinumab may normalise CYP450 enzyme formation, so patients on CYP450 substrates with a narrow therapeutic index need monitoring.
- Medicines that reduce efficacy: none identified.
- Wezlana can be used together with methotrexate, corticosteroids or other immunomodulators.
- Tell your healthcare provider about all medicines, vaccines and supplements you use, including any planned vaccination.
References
- WEZLANA (ustekinumab-auub) - US Prescribing Information (Nuvaila Limited label, revised 5/2026), DailyMed
- WEZLANA (ustekinumab-auub) - US Prescribing Information (Amgen, revised 12/2024), DailyMed
- WEZLANA (ustekinumab-auub) - FDA-approved label (2023), Drugs@FDA
- Wezenla - EPAR Product Information (SmPC), European Medicines Agency
Frequently Asked Questions
Wezlana (ustekinumab-auub), a biosimilar to Stelara, treats moderate-to-severe plaque psoriasis and active psoriatic arthritis in adults and children aged 6 and over. It also treats moderately to severely active Crohn's disease and ulcerative colitis in adults only. In the EU it is sold as Wezenla.
Wezlana (ustekinumab-auub) is injected under the skin, or given as an infusion from a 130 mg/26 mL vial by a healthcare provider. For adult psoriasis, 45 mg (or 90 mg above 100 kg) is given at start, 4 weeks later, then every 12 weeks. Never use the syringe for IV dosing.
Wezlana (ustekinumab-auub) commonly causes nasopharyngitis, upper respiratory infection, headache and tiredness. Serious risks include infections, tuberculosis, cancers, severe allergic reactions, PRES and noninfectious pneumonia. Stop and seek urgent help for severe allergic reactions. The US label has no boxed warning.
Avoid live vaccines while using Wezlana (ustekinumab-auub), and avoid BCG vaccine during treatment and for one year before or after. Do not start it during a clinically important active infection. Tell your healthcare provider before any vaccine, and about any medicines that have a narrow therapeutic index.
Store Wezlana (ustekinumab-auub) in the refrigerator at 2°C to 8°C in its original carton, and do not freeze it. If needed, it can be kept at room temperature up to 30°C for up to 30 days in a single period, then discarded.
Yes, for some conditions. Wezlana (ustekinumab-auub) is approved for plaque psoriasis and psoriatic arthritis in children aged 6 and over. Crohn's disease and ulcerative colitis are approved in adults only. Tuberculosis screening and avoiding live vaccines apply at any age.
Trusted & Reliable – Your Partner in Global Distribution.
We provide comprehensive lines of pharmaceutical products to support all your healthcare distribution needs.
