Evolocumab
اوولوکومب
❤️ Cardiovascular SystemPCSK9 inhibitor
Market / country: 🇺🇸 USA
Repatha (US)
🧮 Dose calculator
Hyperlipidemia / heterozygous familial hypercholesterolemia · Regimen source: FDA Repatha · 2.1
🛡️ Safety & information
Contraindications
- ⛔ History of serious hypersensitivity to the drug (including angioedema). FDA Repatha · 4
Formulations
- 140 mg/mL pen, autoinjector or syringe — injection 🇺🇸 USA FDA Repatha · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Repatha · 8.1
“Risk Summary Available data from clinical trials and postmarketing reports on REPATHA use in pregnant women are insufficient to evaluate for 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 Repatha · 8.2
“Risk Summary There is no information regarding the presence of evolocumab 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 Repatha · 8.4
“The safety and effectiveness of REPATHA in combination with diet and other LDL-C-lowering therapies for the treatment of HoFH have been established in pediatric patients aged 10 years and older.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Repatha · 8.5
“In controlled trials, 7656 (41%) patients treated with REPATHA were ≥ 65 years old and 1500 (8%) were ≥ 75 years old.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA125522
- DailyMed (FDA label)FDA Repatha
- MedlinePlus (NIH)Evolocumab Injection
- WHO ATC/DDDC10AX13
- Darooyab (Iran)Evolocumab
🇮🇷 Registered in Iran Darooyab · G-5367/Evolocumab
Dosage forms with Iranian generic codes, per Darooyab.
- 50701 · EVOLOCUMAB INJECTION PARENTERAL 140 mg/1mL · فرآورده تزریقی اوولوکومب ۱۴۰ میلیگرم / ۱ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Repatha · 3FDA Repatha · 2.1FDA Repatha · 4FDA Repatha · SPL approval / marketing categoryFDA Repatha · 8.1FDA Repatha · 8.2FDA Repatha · 8.4FDA Repatha · 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-5367/Evolocumab
- Clinical review⚠ Unverified