Antihemophilic factor VIII (recombinant)
فاکتور ۸ نوترکیب
🩸 Blood And Blood Forming OrgansCoagulation factor
Market / country: 🇺🇸 USA
Advate (US)
🧮 Dose calculator
Haemophilia A · Regimen source: FDA Advate · 2.1
- • Bleeding or surgery: dose (IU) = weight (kg) × desired FVIII rise (%) × 0.5; frequency by bleed type. Or every third day targeting trough ≥1%. FDA Advate · 2.1
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Life-threatening hypersensitivity to mouse or hamster protein or product constituents. FDA Advate · 4
Warnings
- • Hypersensitivity; neutralising antibodies (inhibitors) — test if the expected response is not achieved. FDA Advate · 5
Formulations
- 1000 IU vial (also 250–4000 IU) — powder for injection 🇺🇸 USA FDA Advate · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Advate · 8.1
“Risk Summary There are no data with ADVATE use in pregnant women to inform a drug-associated risk.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Advate · 8.2
“Risk Summary There is no information regarding the presence of ADVATE in human milk, the effect 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 Advate · 8.4
“Pharmacokinetic studies in children have demonstrated higher clearance, a shorter half-life and lower recovery of factor VIII compared to adults [see Clinical Pharmacology (12.3) ] .”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Advate · 8.5
“In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease and other drug therapy.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA125063
- DailyMed (FDA label)FDA Advate
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDB02BD02
- Darooyab (Iran)Factor-VIII
🇮🇷 Registered in Iran Darooyab · G-1397/Factor-VIII
Dosage forms with Iranian generic codes, per Darooyab.
- 13238 · ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT) 250U VIAL · ویال ضدهموفیلی فاکتور VIII (نوترکیب) ۲۵۰ واحد
- 12544 · ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT) 500U VIAL · ویال ضدهموفیلی فاکتور VIII (نوترکیب) ۵۰۰ واحد
- 05728 · ANTIHEMOPHILIC FACTOR VIII 1000U VIAL · ویال ضدهموفیلی فاکتور VIII ۱۰۰۰ واحد
- 00089 · ANTIHEMOPHILIC FACTOR VIII 250U VIAL · ویال ضدهموفیلی فاکتور VIII ۲۵۰ واحد
- 00090 · ANTIHEMOPHILIC FACTOR VIII 500U VIAL · ویال ضدهموفیلی فاکتور VIII ۵۰۰ واحد
- 21779 · ANTIHEMOPHILIC FACTOR VIII500IU VIAL · ویال ضدهموفیلی فاکتور VIII ۵۰۰ واحد بینالمللی
- 52879 · COAGULATION FACTOR VIII (RECOMBINANT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PARENTERAL 500 [iU] · محلول تزریقی انعقادی فاکتور VIII (نوترکیب) ۵۰۰ واحد بینالمللی
- 52878 · COAGULATION FACTOR VIII (RECOMBINANT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PARENTERAL 250 [iU] · محلول تزریقی انعقادی فاکتور VIII (نوترکیب) ۲۵۰ واحد بینالمللی
- 52880 · COAGULATION FACTOR VIII (RECOMBINANT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PARENTERAL 1000 [iU] · محلول تزریقی انعقادی فاکتور VIII (نوترکیب) ۱۰۰۰ واحد بینالمللی
- 52933 · EFMOROCTOCOG ALFA INJECTION, POWDER, FOR SOLUTION PARENTERAL 500 [iU] · پودر برای تهیه محلول تزریقی افموروکتوکوگ آلفا ۵۰۰ واحد بینالمللی
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Advate · 3FDA Advate · 2.1FDA Advate · 4FDA Advate · 5FDA Advate · 8.1FDA Advate · 8.2FDA Advate · 8.4FDA Advate · 8.5FDA Advate · SPL approval / marketing category
- 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-1397/Factor-VIII
- Clinical review⚠ Unverified