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Brexpiprazole

برکس‌پیپرازول

⚠ Unverified

🧠 Nervous SystemAtypical antipsychotic

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Dangerous / avoid 👴 Older adults:Dangerous / avoid 🇮🇷 Not found in Iran list ⛔ 1 contraindications 🇺🇸 FDA approved (NDA) NDA205422 ATC N05AX16

Market / country: 🇺🇸 USA

Rexulti (US)

🧮 Dose calculator

Disease / regimen

Schizophrenia · Regimen source: FDA Rexulti · 2.3

Formulation

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🛡️ Safety & information

Contraindications

⛔ Hypersensitivity to brexpiprazole. FDA Rexulti · 4

Warnings

• Boxed warning: increased mortality in elderly patients with dementia-related psychosis; suicidal thoughts in children and young adults. FDA Rexulti · Boxed Warning

Renal adjustment

• eGFR < 60: CrCl <60: max 2 mg (MDD, agitation) or 3 mg (schizophrenia). FDA Rexulti · 2.6

Formulations

0.5 mg tablet — tablet 🇺🇸 USA FDA Rexulti · 3
1 mg tablet — tablet 🇺🇸 USA FDA Rexulti · 3
2 mg tablet — tablet 🇺🇸 USA FDA Rexulti · 3
3 mg tablet — tablet 🇺🇸 USA FDA Rexulti · 3
4 mg tablet — tablet 🇺🇸 USA FDA Rexulti · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Rexulti · 8.1
“Risk Summary Adequate and well-controlled studies have not been conducted with REXULTI in pregnant women to inform drug-associated risks.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Rexulti · 8.2
“Risk Summary Lactation studies have not been conducted to assess the presence of brexpiprazole in human milk, the effects of brexpiprazole on the breastfed infant, or the effects of brexpiprazole on milk production.”
👶 ChildrenDangerous / avoid
Boxed warning in the label about children. FDA Rexulti · Boxed Warning
“( 5.1 ) Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients.”
👴 Older adultsDangerous / avoid
Label: serious warning or avoid in older adults. FDA Rexulti · Boxed Warning
“WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning.”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)NDA205422
DailyMed (FDA label)FDA Rexulti
MedlinePlus (NIH)Brexpiprazole
WHO ATC/DDDN05AX16
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 Rexulti · 3 FDA Rexulti · 2.3 FDA Rexulti · 2.2 FDA Rexulti · 2.4 FDA Rexulti · 4 FDA Rexulti · Boxed Warning FDA Rexulti · 2.6 FDA Rexulti · SPL approval / marketing category FDA Rexulti · 8.1 FDA Rexulti · 8.2
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