Alirocumab
آلیروکومب
❤️ Cardiovascular SystemPCSK9 inhibitor
Market / country: 🇺🇸 USA
Praluent (US)
🧮 Dose calculator
Hyperlipidemia / heterozygous familial hypercholesterolemia · Regimen source: FDA Praluent · 2.1FDA Praluent · 2.2
🛡️ Safety & information
Contraindications
- ⛔ History of serious hypersensitivity to the drug (including angioedema). FDA Praluent · 4
Formulations
- 75 mg/mL or 150 mg/mL pen — injection 🇺🇸 USA FDA Praluent · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Praluent · 8.1
“Risk Summary Available data from clinical trials and postmarketing reports on PRALUENT 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 Praluent · 8.2
“Risk Summary There is no information regarding the presence of alirocumab 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 Praluent · 8.4
“The safety and effectiveness of PRALUENT as an adjunct to diet and other LDL-C-lowering therapies for the treatment of HeFH have been established in pediatric patients aged 8 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 Praluent · 8.5
“In controlled trials, 3663 patients treated with PRALUENT were ≥65 years of age and 734 patients treated with PRALUENT were ≥75 years of age.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA125559
- DailyMed (FDA label)FDA Praluent
- MedlinePlus (NIH)Alirocumab Injection
- WHO ATC/DDDC10AX14
- 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 Praluent · 3FDA Praluent · 2.1FDA Praluent · 2.2FDA Praluent · 4FDA Praluent · SPL approval / marketing categoryFDA Praluent · 8.1FDA Praluent · 8.2FDA Praluent · 8.4FDA Praluent · 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