Steqeyma

Adults w/ moderately to severely active Crohn's disease who had inadequate response w/, lost response to, or were intolerant to either conventional therapy or TNFα antagonist or have medical contraindications to such therapies. 45 mg & 90 mg: Moderate to severe plaque psoriasis in adults who failed to respond to, or have contraindication to, or are intolerant to other systemic therapies including ciclosporin, MTX or PUVA. Moderate to severe plaque psoriasis in childn & adolescent ≥6 yr who are inadequately controlled by, or intolerant to, other systemic therapies or phototherapies. As monotherapy or in combination w/ MTX for active psoriatic arthritis in adults when response to previous non-biological DMARD therapy has been inadequate.

45 mg & 90 mg SC Plaque psoriasis, psoriatic arthritis Initially 45 mg, followed by 45 mg dose after 4 wk, then every 12 wk thereafter. Patient weighing >100 kg Initially 90 mg, followed by 90 mg dose after 4 wk, then every 12 wk thereafter. Paed plaque psoriasis Ped patient ≥6 yr weighing >100 kg 90 mg administered at wk 0 & 4, then every 12 wk thereafter, ≥60 to ≤100 kg 45 mg at wk 0 & 4 then every 12 wk thereafter. Crohn's disease 1st 90 mg SC dose to be administered 8 wk after IV dose, then every 12 wk thereafter. Patient who have not shown adequate response at 8 wk after 1st SC dose May give 2nd SC dose. Patient who lose response on dosing every 12 wk May increase dosing frequency to every 8 wk. 130 mg IV Crohn's disease Administer as single IV infusion over at least 1 hr. Recommended initial IV dose: Patient weighing >85 kg 520 mg (as 4 vials), >55 to ≤85 kg 390 mg (as 3 vials), ≤55 kg 260 mg (as 2 vials). 1st SC dose to be given at wk 8 following IV dose.

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

Anaphylaxis & angioedema; allergic alveolitis, eosinophilic pneumonia & non-infectious organising pneumonia. Discontinue treatment if anaphylactic or other serious hypersensitivity reaction occurs; diagnosis of resp hypersensitivity reaction is confirmed; drug reaction eg, erythrodermic psoriasis or exfoliative dermatitis is suspected; diagnosis of lupus-related condition is confirmed. Not to be given in patients w/ active TB. May increase risk of infections & reactivate latent infections; malignancy. Opportunistic infections including reactivation of TB, other opportunistic bacterial (atypical mycobacterial infection, listeria meningitis, pneumonia legionella & nocardiosis), fungal, viral (encephalitis caused by herpes simplex 2) & parasitic (ocular toxoplasmosis) infections. CV events including MI & CVA. Exfoliative dermatitis; erythrodermic psoriasis. Cutaneous lupus erythematosus & lupus-like syndrome. Patients w/ chronic infection or history of recurrent infection; w/ history of malignancy or those who develop malignancy while continuing treatment; who have undergone allergy immunotherapy. Evaluate patients for TB infection; initiate treatment for latent TB prior to treatment initiation. Consider anti-TB therapy prior to treatment initiation in patients w/ history of latent or active TB in whom adequate course of treatment cannot be confirmed. Closely monitor patient who develops serious infection & not to administer treatment until infection resolves; patients receiving treatment for signs & symptoms of active TB during & after treatment. Monitor patients w/ medical history of prolonged immunosuppressant therapy, those w/ history of PUVA treatment, or >60 yr for appearance of skin cancer. Regularly assess risk factors for CV disease during treatment. Not to be given concurrently w/ live viral or bacterial vaccines (eg, BCG). Withhold treatment for at least 15 wk after last dose before live viral or bacterial vaccination, & can be resumed at least 2 wk after vaccination. Concomitant use w/ immunosuppressants including biologics or phototherapy; transitioning from other immunosuppressive biologics. Women of childbearing potential should use effective methods of contraception during treatment & for at least 15 wk after treatment. Avoid use in pregnancy. Not recommended to administer live vaccines (eg, BCG) in infants exposed in utero for 12 mth following birth or until infant serum levels of ustekinumab are undetectable. Consider discontinuation of therapy, or breastfeeding during & up to 15 wk after treatment. Childn <6 yr w/ psoriasis; <18 yr w/ psoriatic arthritis or Crohn's disease. Higher incidence of infections in the elderly. 45 mg & 90 mg: Consider discontinuation in patients showing no response up to 28 wk of treatment; 16 wk after IV induction dose or 16 wk after switching to 8-wkly maintenance dose. Avoid psoriatic areas of skin as inj site. 130 mg: Serious infusion-related reactions including anaphylactic reactions. Discontinue treatment if serious or life-threatening reaction is observed. Patients on restricted Na diet.

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

Concomitant use w/ live vaccines (eg, BCG).

Immunosuppressants

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

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