Guselkumab

🧮 Dose calculator

Psoriasis and steroid-responsive dermatoses · Regimen source: FDA Tremfya · 2.2

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👥 Special populations

• 🤰 PregnancyUse with caution

  Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Tremfya · 8.1

  “Risk Summary Available data from literature, post-marketing reports, and ongoing pregnancy registry with TREMFYA 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 Tremfya · 8.2

  “Risk Summary There are no data on the presence of guselkumab 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 Tremfya · 8.4

  “Plaque Psoriasis The safety and effectiveness of TREMFYA 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 [see Adverse Reactions (6.1) and Clinical Studies (14.1) ] .”

• 👴 Older adultsUse with caution

  Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Tremfya · 8.5

  “Of the 6418 subjects with plaque psoriasis, psoriatic arthritis, ulcerative colitis, or Crohn's disease exposed to TREMFYA, a total of 489 subjects were 65 years or older, and 55 subjects were 75 years or older.”

• ⚥ Females & males of reproductive potentialNo data

  The source for this drug has no section for this group.