Prescribing Information for: Uzpruvo▼45 mg, 90 mg solution for injection in pre-filled syringe, Uzpruvo▼130 mg concentrate for solution for infusion.
Please refer to the Summary of Product Characteristics before prescribing Uzpruvo.
Presentation: Each pre-filled syringe contains either 45 mg ustekinumab in 0.5 mL or 90 mg ustekinumab in 1 mL. Each vial contains 130 mg ustekinumab in 26 mL (5 mg/mL).
Indications: Uzpruvo 45 mg, 90 mg: Treatment of plaque psoriasis in adults who failed to respond to, have a contraindication to or are intolerant to other systemic therapies. Moderate to severe plaque psoriasis in children from the age of 6 years who are inadequately controlled by, or intolerant to other systemic therapies or phototherapies. Uzpruvo 45 mg, 90 mg: Active psoriatic arthritis (PsA) in adults when response to non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Uzpruvo 45 mg, 90 mg, 130mg: Treatment of moderate to severe Crohn’s disease in adults who have an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFαantagonist or have medical contraindications to such therapies. Uzpruvo 45 mg, 90 mg, 130mg: Treatment of moderate to severe ulcerative colitis in adults who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.
Dosage and administration: Use under the guidance and supervision of physicians experienced in the diagnosis and treatment of the indicated conditions. Plaque psoriasis: Initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter. PsA: Initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter, alternatively, 90 mg may be used in patients with a body weight > 100 kg. Paediatric plaque psoriasis (6 years and older): Dose is based on body weight ≥ 60 kg. See SmPC before prescribing. Uzpruvo should be administered at weeks 0 and 4, then every 12 weeks thereafter. Crohn’s disease and ulcerative colitis (Adults): Treatment should be initiated by intravenous infusion based on body weight. The first subcutaneous administration of 90 mg should take place at week 8 after the intravenous dose. Thereafter, dosing every 12 weeks is recommended. Patients may be dosed every 8 weeks or every 12 weeks according to clinical judgment. Discontinuing treatment may be considered in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose or 16 weeks after switching to the 8-weekly maintenance dose. Immunomodulators and/or corticosteroids may be continued during treatment with Uzpruvo. In responsive patients, corticosteroids may be reduced or discontinued in accordance with standard of care. See SmPC before prescribing. Method of administration: Uzpruvo 130 mg: Intravenous use only, administered over at least 1 hour. Uzpruvo 45 mg, 90 mg: Subcutaneous injection only.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Clinically important, active infection.
Warnings and Precautions: Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections. Opportunistic infections have been reported. Caution should be exercised in patients with chronic infection or history of recurrent infection. Patients should be evaluated for tuberculosis infection before, during and after treatment. Immunosuppressants have the potential to increase the risk of malignancy. The risk may be higher in psoriasis patients previously treated with biologics. All patients, in particular those greater than 60 years, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be monitored for the appearance of non-melanoma skin cancer. Serious hypersensitivity reactions including anaphylaxis and angioedema have occurred. Allergic alveolitis, eosinophilic pneumonia, and non-infectious organising pneumonia have been reported. In patients with psoriasis exposed to ustekinumab cardiovascular events including myocardial infarction and cerebrovascular accident have been observed. Live viral or live bacterial vaccines should not be given concurrently with Uzpruvo. In patients with psoriasis, exfoliative dermatitis has been reported. Patients with plaque psoriasis may develop erythrodermic psoriasis. Lupus-related conditions have been reported. Due to higher incidence of infections in the elderly, use with caution in these patients.
Pregnancy and lactation: Women of childbearing potential should use effective methods of contraception during treatment and for at least 15 weeks after treatment. Pregnancy: Avoid the use of Uzpruvo in pregnancy. Breast-feeding: Ustekinumab is excreted in breast milk, risk to the breastfed infant cannot be excluded.
Undesirable effects: Serious side effects: Cellulitis, herpes zoster, serious hypersensitivity reactions, anaphylaxis, angioedema, organising pneumonia, eosinophilic pneumonia, exfoliative dermatitis, bullous pemphigoid, erythrodermic psoriasis, hypersensitivity vasculitis, myocardial infarction, cerebrovascular accident, lupus-like syndrome, cutaneous lupus erythematosus. Common side effects: Upper respiratory tract infection, nasopharyngitis, sinusitis, dizziness, headache, oropharyngeal pain, diarrhoea, nausea, vomiting, pruritus, back pain, myalgia, arthralgia. For full list of side effects, consult SmPC.
Legal Category: POM
Pack size and price: Solution for injection in pre-filled syringe – 1 x 45 mg (£1,932.30), 1 x 90 mg (£1,932.30). Concentrate for solution for infusion 1 x 130 mg vial (£1,932.30)
MA Number: PLGB 17225/0022, PLGB 17225/0023, PLGB 17225/0025
MA Holder: Genus Pharmaceuticals Holdings Limited (trading as STADA), Linthwaite, Huddersfield, HD7 5QH, UK
Date of preparation: October 2024
Unique ID number: UK-Uzpru-9(2)a(1)
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Thornton and Ross Limited by emailing thorntonross@medinformation.co.uk or by calling 01484 848164.
UK-Uzpru-9(2)a(1)a | October 2024