Stelara

Ustekinumab

Soln for inj (SC) Moderate to severe plaque psoriasis in adults who failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, MTX, or PUVA. Moderate to severe plaque psoriasis in childn & adolescents ≥6 yr who are inadequately controlled by or are intolerant to other systemic therapies or phototherapies. As monotherapy or in combination w/ MTX for active psoriatic arthritis (PsA) in adults when response to previous non-biological DMARD has been inadequate. Soln for inj (SC) & conc for soln for infusion (IV) Moderately to severely active Crohn's disease in adults who have had an inadequate response w/, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. Moderately to severely active ulcerative colitis in adults who have had an inadequate response w/, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.

Soln for inj Plaque psoriasis & PsA Initially 45 mg SC, followed by a 45-mg dose 4 wk later, & then every 12 wk thereafter. Patient weighing >100 kg Initially 90 mg SC, followed by a 90-mg dose 4 wk later, & then every 12 wk thereafter. Paed plaque psoriasis Administer at wk 0 & 4, then every 12 wk thereafter. Childn ≥6 yr weighing >100 kg 90 mg, ≥60 to ≤100 kg 45 mg, <60 kg 0.75 mg/kg. Crohn's disease & ulcerative colitis Administer 1st dose as IV w/ conc for soln for infusion. Administer 1st SC dose of 90 mg at wk 8 after the IV dose, then every 12 wk. Patients who have not shown adequate response at 8 wk after the 1st SC dose may receive a 2nd SC dose at this time. Patients who lose response on dosing every 12 wk may increase dosing frequency to every 8 wk. Patients may subsequently be dosed every 8 or 12 wk according to clinical judgment. Conc for soln for infusion Crohn's disease & ulcerative colitis Initial single IV dosing based on body wt, administered over at least 1 hr. Patient weighing >85 kg 520 mg, >55 to ≤85 kg 390 mg, ≤55 kg 260 mg.

Hypersensitivity. Clinically important, active infection (eg, active TB).

Avoid areas of skin that show psoriasis as SC inj sites. Risk of infusion-related reactions during IV use. Discontinue treatment in case of anaphylactic or other serious hypersensitivity reaction; allergic alveolitis, eosinophilic pneumonia, & non-infectious organising pneumonia. Potential to increase risk of infections & reactivate latent infections. Caution in patients w/ chronic infection or history of recurrent infection. Evaluate patient for TB infection prior to treatment initiation. Consider anti-TB therapy in patients w/ history of latent or active TB. Potential to increase risk of malignancy. Caution in patients w/ history of malignancy or those who develop malignancy while on treatment. Monitor patients for appearance of non-melanoma skin cancer. Do not give live viral or bacterial vaccines concurrently. W/hold treatment for at least 15 wk after the last dose before vaccination w/ live vaccines, & resume treatment at least 2 wk after vaccination. Exercise caution when considering concomitant immunosuppressive therapy or when transitioning from other immunosuppressive biologics. Has not been evaluated in patients who have undergone allergy immunotherapy. Discontinue if erythrodermic psoriasis or exfoliative dermatitis occurs in patients w/ psoriasis. Latex sensitivity (pre-filled syringe only). Has not been studied in patients w/ renal & hepatic impairment. Women of childbearing potential should use effective contraception during & for at least 15 wk after treatment. Avoid use in pregnancy. Discontinue breastfeeding during & up to 15 wk after treatment, or discontinue treatment during breastfeeding. Safety & efficacy have not been established in childn <6 yr w/ psoriasis & childn <18 yr w/ psoriatic arthritis, Crohn's disease or ulcerative colitis. Elderly ≥65 yr.

URTI, nasopharyngitis, sinusitis; dizziness, headache; oropharyngeal pain; diarrhoea, nausea, vomiting; pruritus; back pain, myalgia, arthralgia; fatigue, inj site erythema &/or pain.

Do not give concurrently w/ live vaccines. Safety & efficacy in combination w/ immunosuppressants, including biologics, or phototherapy have not been evaluated in psoriasis studies.

Immunosuppressants

L04AC05 - ustekinumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.

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