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Skyrizi喜開悅

Skyrizi

risankizumab

Manufacturer:

AbbVie

Distributor:

The Glory Medicina
/
DKSH
Concise Prescribing Info
Contents
Risankizumab
Indications/Uses
150 mg: Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Alone or in combination w/ MTX for the treatment of active psoriatic arthritis in adults who have had inadequate response or who have been intolerant to ≥1 DMARDs. 360 mg/600 mg: Treatment of moderately to severely active Crohn's disease in adults who have had inadequate response to, lost response to, or were intolerant to conventional therapy or biologic therapy.
Dosage/Direction for Use
Plaque psoriasis/Psoriatic arthritis 150 mg SC inj at wk 0 & 4, & every 12 wk thereafter. Crohn's disease 600 mg IV infusion over at least 1 hr at wk 0, 4, & 8, followed by 360 mg SC inj at wk 12, & every 8 wk thereafter.
Contraindications
Hypersensitivity. Clinically important active infections (eg, active TB).
Special Precautions
Immediately discontinue administration if a serious hypersensitivity reaction occurs. Increased risk of infection. Caution in patients w/ chronic infection, history of recurrent infection, or known risk factors for infection. Do not initiate risankizumab treatment in patients w/ any clinically important active infection until it resolves or is adequately treated. Evaluate for TB infection prior to initiating risankizumab treatment. Monitor for signs & symptoms of active TB in patients on risankizumab treatment. Consider anti-TB therapy prior to initiating risankizumab in patients w/ history of latent or active TB in whom adequate course of treatment cannot be confirmed. Consider completion of all appropriate immunisations prior to initiating risankizumab therapy. Patients who have received live vaccination (viral or bacterial) should wait at least 4 wk prior to starting risankizumab treatment. Patients on risankizumab treatment should not receive live vaccines during treatment & for at least 21 wk after treatment. Women of childbearing potential should use effective contraception during treatment & for at least 21 wk after treatment. Preferable to avoid use during pregnancy. A decision should be made whether to discontinue/abstain from risankizumab therapy during breast-feeding. Limited information in elderly ≥65 yr. 150 mg: Should not be injected into areas where skin is tender, bruised, erythematous, indurated, or affected by psoriasis. Safety & efficacy in childn & adolescents 5-18 yr have not been established. No relevant use in childn <6 yr for the indication of moderate to severe plaque psoriasis or in childn <5 yr for the indication of psoriatic arthritis. 360 mg: Should not be injected into areas where skin is tender, bruised, erythematous, indurated or damaged. 360 mg/600 mg: Contains polysorbate 20, which may cause allergic reactions. Safety & efficacy in childn ≤17 yr have not yet been established for the treatment of Crohn's disease.
Adverse Reactions
Upper resp infections. Tinea infections; headache; pruritus, rash; fatigue, inj site reactions. 360 mg/600 mg: Eczema.
Drug Interactions
Safety & efficacy have not been evaluated in combination w/ immunosuppressants, including biologics. 150 mg: Safety & efficacy have not been evaluated in combination w/ phototherapy.
MIMS Class
Immunosuppressants / Psoriasis, Seborrhea & Ichthyosis Preparations
ATC Classification
L04AC18 - risankizumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Skyrizi conc for soln for infusion (vial) 600 mg/10 mL
Packing/Price
1's
Form
Skyrizi soln for inj (cartridge) 360 mg/2.4 mL
Packing/Price
1's
Form
Skyrizi soln for inj (pre-filled pen) 150 mg/1 mL
Packing/Price
1's
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