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Prothrombin complex concentrate, 4-factor (Kcentra)

کنسانتره کمپلکس پروترومبین ۴ فاکتوری (PCC)

⚠ Unverified

🩸 Blood And Blood Forming OrgansCoagulation factors II, VII, IX, X

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution 🇮🇷 Not found in Iran list ⛔ 1 contraindications 🇺🇸 FDA approved (BLA) BLA125421 ATC B02BD01

Market / country: 🇺🇸 USA

Kcentra (US)

🧮 Dose calculator

Disease / regimen

Life-threatening bleeding on anticoagulants (reversal) · Regimen source: FDA Kcentra · 2.1, Table 1

Formulation

Age *

Weight (kg) *

Enter age and weight.

🛡️ Safety & information

Contraindications

⛔ Anaphylaxis or severe reaction to any component (heparin, factors, proteins C and S, antithrombin, albumin); DIC; known HIT (contains heparin). FDA Kcentra · 4

Warnings

• Boxed warning: arterial and venous thromboembolism (fatal and non-fatal). Give with vitamin K; repeat dosing not recommended; weight above 100 kg counts as 100 kg. FDA Kcentra · Boxed Warning FDA Kcentra · 2.1
• Human plasma-derived — theoretical risk of transmitting infectious agents. FDA Kcentra · 5.3

Formulations

1000 unit vial (factor IX units; actual potency on carton) — powder for injection 🇺🇸 USA FDA Kcentra · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Kcentra · 8.1
“Risk Summary There are no data with KCENTRA use in pregnancy to inform on drug-associated risk.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Kcentra · 8.2
“Risk Summary There is no information regarding the excretion of KCENTRA 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 Kcentra · 8.4
“The safety and efficacy of KCENTRA in the pediatric population has not been studied.”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Kcentra · 8.5
“Of the total number of subjects (431) with acute major bleeding or with the need for an urgent surgery/invasive procedure treated to reverse VKA anticoagulation in three clinical studies, 66% were 65 years old or greater and 39% were 75 years old or greater.”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)BLA125421
DailyMed (FDA label)FDA Kcentra
MedlinePlus (NIH)❌ None
WHO ATC/DDDB02BD01
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 Kcentra · 3 FDA Kcentra · 2.1, Table 1 FDA Kcentra · 4 FDA Kcentra · Boxed Warning FDA Kcentra · 2.1 FDA Kcentra · 5.3 FDA Kcentra · SPL approval / marketing category FDA Kcentra · 8.1 FDA Kcentra · 8.2 FDA Kcentra · 8.4 FDA Kcentra · 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)✅ Present
Darooyab · search
Clinical review⚠ Unverified

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