Romosozumab
رموزوزومب
🦴 Musculo-Skeletal SystemSclerostin inhibitor
Market / country: 🇺🇸 USA
Evenity (US)
🧮 Dose calculator
Osteoporosis / calcium and vitamin D deficiency · Regimen source: FDA Evenity · 2.2
- • One dose per MONTH (not daily) = two 105 mg syringes one after the other by a healthcare provider; 12 months. Adequate calcium and vitamin D. FDA Evenity · 2.1FDA Evenity · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypocalcaemia (correct before starting); systemic hypersensitivity to romosozumab. FDA Evenity · 4
Warnings
- • Boxed warning: possible increase in MI, stroke and cardiovascular death — do not start within a year of MI or stroke. FDA Evenity · Boxed Warning
Formulations
- 105 mg/1.17 mL syringe (dose = 2 syringes) — injection 🇺🇸 USA FDA Evenity · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Evenity · 8.1
“Risk Summary EVENITY is not indicated for use in women of reproductive potential.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Evenity · 8.2
“Risk Summary EVENITY is not indicated for use in women of reproductive potential.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Evenity · 8.4
“Safety and effectiveness of EVENITY have not been established in pediatric patients.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Evenity · 8.5
“Of the 6544 postmenopausal women with osteoporosis in the clinical studies of EVENITY, 5234 (80%) were age 65 years and over and 2390 (37%) were age 75 years and over.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA761062
- DailyMed (FDA label)FDA Evenity
- MedlinePlus (NIH)Romosozumab-aqqg Injection
- WHO ATC/DDDM05BX06
- 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)✅ PresentFDA Evenity · 3FDA Evenity · 2.2FDA Evenity · 2.1FDA Evenity · 4FDA Evenity · Boxed WarningFDA Evenity · SPL approval / marketing categoryFDA Evenity · 8.1FDA Evenity · 8.2FDA Evenity · 8.4FDA Evenity · 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 · search
- Clinical review⚠ Unverified