Apremilast
آپرمیلاست
🎗️ Antineoplastic And Immunomodulating AgentsPDE4 inhibitor
Market / country: 🇺🇸 USA
Otezla (US)
🧮 Dose calculator
Psoriasis and steroid-responsive dermatoses · Regimen source: FDA Otezla · 2.1
- • Days 1–5 titration per label Table 1 (from 10 mg in the morning) to reduce GI effects. Severe renal impairment: 30 mg once daily. FDA Otezla · 2.1FDA Otezla · 2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to apremilast. FDA Otezla · 4
Warnings
- • Severe diarrhoea, nausea and vomiting; depression and suicidal thoughts; weight loss. FDA Otezla · 5
Formulations
- 10 mg tablet — tablet 🇺🇸 USA FDA Otezla · 3
- 20 mg tablet — tablet 🇺🇸 USA FDA Otezla · 3
- 30 mg tablet — tablet 🇺🇸 USA FDA Otezla · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Otezla · 8.1
“Risk Summary Available data with OTEZLA use in pregnant women have not identified a drug-associated risk of major birth defects or adverse maternal or fetal outcomes (see Data ) .”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Otezla · 8.2
“Risk Summary There are no data on the presence of apremilast in human milk, its effects on the breastfed infant, or its effects on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Otezla · 8.4
“OTEZLA Plaque Psoriasis The safety and effectiveness of OTEZLA have been established in pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Otezla · 8.5
“… om severe diarrhea, nausea, or vomiting, monitor geriatric patients closely for such complications [see Warnings and Precautions (5.2) ] .”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA205437
- DailyMed (FDA label)FDA Otezla
- MedlinePlus (NIH)Apremilast
- WHO ATC/DDDL04AA32
- Darooyab (Iran)Apremilast
🇮🇷 Registered in Iran Darooyab · G-5537/Apremilast
Dosage forms with Iranian generic codes, per Darooyab.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Otezla · 3FDA Otezla · 2.1FDA Otezla · 2FDA Otezla · 4FDA Otezla · 5FDA Otezla · SPL approval / marketing categoryFDA Otezla · 8.1FDA Otezla · 8.2FDA Otezla · 8.4FDA Otezla · 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)✅ PresentDarooyab · G-5537/Apremilast
- Clinical review⚠ Unverified