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Risankizumab

ریسانکیزوماب

⚠ Unverified

🎗️ Antineoplastic And Immunomodulating AgentsAnti-IL-23 antibody

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution 🇮🇷 Not found in Iran list ⛔ 1 contraindications 🇺🇸 FDA approved (BLA) BLA761105 ATC L04AC18

Market / country: 🇺🇸 USA

Skyrizi (US)

🧮 Dose calculator

Disease / regimen

Psoriasis and steroid-responsive dermatoses · Regimen source: FDA Skyrizi · 2.3 FDA Skyrizi · 2.4

Formulation

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Enter age (weight is optional for this regimen).

🛡️ Safety & information

Contraindications

⛔ History of serious hypersensitivity to risankizumab. FDA Skyrizi · 4

Warnings

• Hypersensitivity; infections; tuberculosis (screen first); no live vaccines. FDA Skyrizi · 5

Formulations

150 mg/mL pen or syringe — injection 🇺🇸 USA FDA Skyrizi · 3
55 mg/0.37 mL syringe — injection 🇺🇸 USA FDA Skyrizi · 3
600 mg/10 mL vial for IV infusion — injection 🇺🇸 USA FDA Skyrizi · 3
180 mg/1.2 mL syringe or on-body cartridge — injection 🇺🇸 USA FDA Skyrizi · 3
360 mg/2.4 mL on-body cartridge — injection 🇺🇸 USA FDA Skyrizi · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Skyrizi · 8.1
“Risk Summary Available pharmacovigilance and clinical trial data with risankizumab use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Skyrizi · 8.2
“Risk Summary There are no data on the presence of risankizumab-rzaa in human milk, the effects on the breastfed infant, or the effects on milk production.”
👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Skyrizi · 8.4
“Moderate-to-Severe Plaque Psoriasis The safety and effectiveness of SKYRIZI for the treatment of moderate-to-severe plaque psoriasis have been established in pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy.”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Skyrizi · 8.5
“Of the 6,862 subjects exposed to SKYRIZI, a total of 664 were 65 years and older (243 subjects with plaque psoriasis, 246 subjects with psoriatic arthritis, 72 subjects with Crohn’s disease and 103 subjects with ulcerative colitis), and 71 subjects were 75 years and older.”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)BLA761105
DailyMed (FDA label)FDA Skyrizi
MedlinePlus (NIH)Risankizumab-rzaa Injection
WHO ATC/DDDL04AC18
Darooyab (Iran)❌ None

🇮🇷 Not found in Iran list Darooyab · search

Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Skyrizi · 3 FDA Skyrizi · 2.3 FDA Skyrizi · 2.4 FDA Skyrizi · 2.6 FDA Skyrizi · 2 FDA Skyrizi · 2.7 FDA Skyrizi · 4 FDA Skyrizi · 5 FDA Skyrizi · SPL approval / marketing category FDA Skyrizi · 8.1 FDA Skyrizi · 8.2 FDA Skyrizi · 8.4 FDA Skyrizi · 8.5
UK SmPC (eMC / MHRA)❌ Not present
Published guideline❌ Not present
Licensed reference (medical school)❌ Not present
Iranian leaflet (IFDA)❌ Not present
Pharmacy website (secondary, unreliable)✅ Present
Darooyab · search
Clinical review⚠ Unverified