UZPRUVO^®▼ 45 mg & 90 mg Solution for Injection in Pre-filled Syringe.
UZPRUVO^®▼ 130 mg Concentrate for Solution for Infusion.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Composition: Uzpruvo 45 mg: Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL. Uzpruvo 90 mg: Each pre-filled syringe contains 90 mg ustekinumab in 1 mL. Uzpruvo 130 mg: Each vial contains 130 mg ustekinumab in 26 mL (5 mg/mL). Excipients include histidine, polysorbate 80, sucrose, and water for injections. The pre-filled syringe components are latex-free. Pharmaceutical Form: 45 mg and 90 mg: Subcutaneous injection (pre-filled glass syringe). 130 mg: Intravenous infusion (glass vial). Mechanism of Action: Ustekinumab is a fully human IgG1κ monoclonal antibody that targets the p40 subunit shared by interleukin (IL)-12 and IL-23. Indications: Uzpruvo 45 and 90 mg is indicated for the treatment of plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis (PsA) and Crohn's disease. Uzpruvo 130 mg is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. Dosage: Uzpruvo is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of conditions for which Uzpruvo is indicated. Refer to Summary of Product Characteristics for information on dosing and administration. Method of administration: 45 and 90 mg: Subcutaneous injection; 130 mg: Intravenous use. Contraindications: Hypersensitivity to the active substance or any excipients. Clinically important, active infections (e.g., active TB). Warnings and Precautions: Record product name and batch number of the administered product for traceability. Ustekinumab may increase the risk of infections and reactivate latent infections. Patients must be monitored for signs of infection before and during treatment. Tuberculosis screening required prior to treatment. Delay initiation in patients with active infection. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. Uzpruvo may increase the risk of malignancy. All patients, particularly those >60 years of age, or with a history of prolonged immunosuppressant therapy or PUVA, should be monitored for skin cancer. Caution when transitioning from or co-administering with other immunosuppressants. Serious hypersensitivity reactions (including anaphylaxis, allergic alveolitis, eosinophilic pneumonia) have been reported. Regularly assess cardiovascular risk factors. Avoid live vaccines during and up to 15 weeks after treatment (e.g. BCG). In infants exposed in utero, defer live vaccines for 12 months after birth or until ustekinumab infant serum levels are undetectable. It is not known whether ustekinumab may affect allergy immunotherapy. In patients with psoriasis, exfoliative dermatitis has been reported following ustekinumab treatment. Monitor patients with psoriasis for symptoms of erythrodermic psoriasis or exfoliative dermatitis. Discontinue Uzpruvo if a drug reaction is suspected. Cases of lupus-related conditions have been reported in patients treated with Ustekinumab. Use caution in the elderly due to higher baseline infection risk. Uzpruvo contains polysorbates that may cause allergic reactions. Interactions: Live vaccines should not be given concurrently with Uzpruvo. The pharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6-mercaptopurine, azathioprine and oral corticosteroids in patients with PsA, Crohn's disease or ulcerative colitis, or prior exposure to anti-TNFα agents, in patients with PsA or Crohn's disease or by prior exposure to biologics in patients with ulcerative colitis. In psoriasis studies, the safety and efficacy of ustekinumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated. In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of ustekinumab. In Crohn's disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did not appear to influence the safety or efficacy of Ustekinumab. Fertility, Pregnancy, and Lactation: Women of childbearing potential should use effective contraception during treatment and for at least 15 weeks after the last dose. Data from >450 pregnancies indicate no increased risk of congenital malformations. Ustekinumab crosses the placenta and has been detected in infant serum. Infants may be at increased risk of infection. Live vaccines should be avoided for 12 months post-birth unless ustekinumab levels are undetectable. Ustekinumab is present in breast milk in low concentrations. Risk to breastfed infants is low, but breastfeeding decisions should balance risks and benefits. Effects on fertility have not been evaluated in humans. Driving and Machinery Use: Uzpruvo has no or negligible influence on the ability to drive and use machines. Undesirable Effects: Upper respiratory infections, nasopharyngitis, sinusitis, dizziness, headache, oropharyngeal pain, diarrhoea, nausea, vomiting, pruritus, back pain, myalgia, arthralgia, fatigue, injection site erythema and pain. Refer to SmPC for full adverse reaction list. Adverse Event Reporting: Adverse reactions should be reported via HPRA Pharmacovigilance, website: www.hpra.ie. Pack Sizes: 45 mg and 90 mg: 1 pre-filled syringe. 130 mg: 1 vial. A copy of the Summary of Product Characteristics is available upon request or go to www.clonmelhealthcare.ie. MA Holder: STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany. EU/1/23/1784/001, 004, 005. Medicinal product subject to restricted medical prescription. Date of Last Revision: August 2025.

Date Prepared: August 2025. 0825/ADV/UZP/191H