Ustekinumab-Srlf: uses, dosing, side effects & brands
Ustekinumab-Srlf is an interleukin-12 antagonist sold in the U.S. under one brand, for ulcerative colitis, crohn disease and psoriasis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Interleukin-12 Antagonist
- Treats
- Ulcerative Colitis, Crohn Disease and Psoriasis
- Available as
- Injectable
- Sold as
- Imuldosa
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How ustekinumab-srlf is dosed
From the FDA label for Imuldosa (application BLA761364). Other ustekinumab-srlf products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 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 subcutaneously every 12 weeks. Psoriatic Arthritis Pediatric Patients 6 Years of Age and Older Subcutaneous Recommended Dosage (2.2) : Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter. Weight…
Ustekinumab-Srlf side effects
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 Accord BioPharma Inc. at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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…
Who shouldn’t take ustekinumab-srlf
IMULDOSA is contraindicated in patients with clinically significant hypersensitivity to Ustekinumab products or to any of the excipients in IMULDOSA [ see Warnings and Precautions ( 5.5 ) ]. Clinically significant hypersensitivity to ustekinumab products or to any of the excipients in IMULDOSA
Ustekinumab-Srlf 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 IMULDOSA in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect or drug concentration and adjust the individual dosage of the CYP substrate as needed. See the prescribing information of specific CYP substrates. A CYP-mediated drug interaction effect was not observed in subjects with Crohn’s disease [see Clinical Pharmacology ( 12.3 )] . 7.3 Allergen Immunotherapy Ustekinumab products have not been evaluated in patients who have undergone allergy immunotherapy. Ustekinumab products may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.
Every ustekinumab-srlf product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Imuldosa.
Related calculators
Frequently asked questions
What is ustekinumab-srlf?
Imuldosa (Ustekinumab-Srlf) is an interleukin-12 antagonist used to treat Ulcerative Colitis, Crohn Disease, Psoriasis, Psoriatic Arthritis.
What kind of drug is ustekinumab-srlf?
The FDA classifies ustekinumab-srlf as an interleukin-12 antagonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take ustekinumab-srlf with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ustekinumab-srlf against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does ustekinumab-srlf come in?
Across the brands we track, ustekinumab-srlf is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic ustekinumab-srlf?
We do not currently list a generic-labelled ustekinumab-srlf product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Ustekinumab-Srlf: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ustekinumab-srlf
- MLA
- “Ustekinumab-Srlf: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ustekinumab-srlf.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for ustekinumab-srlf on DailyMed (NIH) ↗.