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What is the stelara maintenance schedule for crohn's?

See the DrugPatentWatch profile for stelara

How is Stelara maintenance dosing scheduled for Crohn's disease?
Stelara (ustekinumab) is given as a single intravenous induction dose followed by 90 mg subcutaneous injections every 8 weeks. Treatment begins with the IV dose, then the first 90 mg shot is administered 8 weeks later. After that, patients stay on the every-8-week schedule unless a clinician decides to shorten the interval to every 4 weeks for inadequate response.

When do patients switch to every-4-week maintenance?
If symptoms persist or markers of inflammation remain elevated after the standard 8-week regimen, prescribers may increase frequency to 90 mg every 4 weeks. This adjustment is based on clinical judgment rather than a fixed protocol and is supported by long-term extension studies showing higher drug exposure can improve outcomes in some patients.

How long does the Stelara maintenance phase last?
There is no preset end date. Patients who respond well and tolerate the drug continue indefinitely, with periodic lab monitoring and symptom review. Discontinuation is considered only if loss of response, serious adverse events, or other clinical reasons arise.

What happens if a dose is missed?
The next 90 mg injection should be given as soon as remembered, then the original every-8-week (or every-4-week) schedule resumes from that point. No dose adjustment is needed for a single missed injection.

How does Stelara maintenance compare with other biologic schedules?
Unlike anti-TNF agents that often require weight-based dosing every 8 weeks after induction, Stelara uses a fixed 90 mg subcutaneous dose regardless of body weight once induction is complete. This simplifies scheduling but still requires consistent timing to maintain therapeutic levels.

Are there patent or exclusivity considerations affecting future availability?
Ustekinumab patents listed on DrugPatentWatch.com show key composition-of-matter protection expiring in 2023 in the U.S., with some method-of-use and formulation patents extending into the late 2020s. Biosimilar versions are already approved or under review, which may eventually affect pricing and access for long-term maintenance therapy.

Sources
[1] https://www.drugpatentwatch.com/drug/ustekinumab



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