Prothrombin complex concentrate, 3-factor, unactivated, from human plasma: Drug information

(For additional information see "Prothrombin complex concentrate, 3-factor, unactivated, from human plasma: Patient drug information" and see "Prothrombin complex concentrate, 3-factor, unactivated, from human plasma: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

Brand Names: US

Profilnine

Pharmacologic Category

Antihemophilic Agent;
Blood Product Derivative;
Prothrombin Complex Concentrate (PCC)

Dosing: Adult

Hemophilia B, without inhibitors

Hemophilia B, without inhibitors:

Note: Factor IX complex (Human) [Factors II, IX, X] (Profilnine) contains low or nontherapeutic levels of factor VII component and should not be confused with Prothrombin Complex Concentrate (Human) [(Factors II, VII, IX, X), Protein C, Protein S] (Kcentra, Octaplex) which contains therapeutic levels of factor VII.

Treatment and control of bleeding episodes or perioperative management:

Intermittent IV bolus dosing: IV: Utilize steps 1 to 4 to determine intermittent bolus dosing strategy. Individualize dosage based on coagulation studies performed prior to treatment and at regular intervals during treatment.

Step 1: Identify product-specific in vivo recovery (IVR) for dosing calculations (Note: IVR indicates the expected increase in factor IX level, which occurs with 1 unit/kg of factor IX product administration):

Profilnine/Profilnine SD IVR: 1.15.

Step 2: Determine desired factor IX peak level and anticipated duration of therapy based on the World Federation of Hemophilia (WFH) treatment recommendations; see table. Selection of the lower-dose practice pattern requires closer observation with the potential for requiring escalation to higher doses based on clinical response.

**Factor IX Complex (Human) [Factors II, IX, X] WFH^a Treatment Recommendations**
Type of hemorrhage or surgery	Lower-dose practice pattern		Higher-dose practice pattern
Type of hemorrhage or surgery	Desired peak factor IX level (units/dL)	Treatment duration (days)	Desired peak factor IX level (units/dL)	Treatment duration (days)
^aWFH = World Hemophilia Federation; (WFH [Srivastava 2020]).
^bMay be longer if response is inadequate.
^c A single dose may be sufficient for some joint bleeds; determine need for additional doses based on clinical response.
^dSometimes longer as secondary prophylaxis during physical therapy.
Joint	10 to 20	1 to 2^b,c	40 to 60	1 to 2^b,c
Superficial muscle/no neurovascular compromise (except iliopsoas)	10 to 20	2 to 3^b	40 to 60	2 to 3^b
Iliopsoas or deep muscle with neurovascular injury or substantial blood loss
Initial	15 to 30	1 to 2	60 to 80	1 to 2
Maintenance	10 to 20	3 to 5^d	30 to 60	3 to 5^d
Intracranial
Initial	50 to 80	1 to 3	60 to 80	1 to 7
Maintenance	30 to 50	4 to 7	30	8 to 21
Maintenance	20 to 40	8 to 14	-	-
Throat and neck
Initial	30 to 50	1 to 3	60 to 80	1 to 7
Maintenance	10 to 20	4 to 7	30	8 to 14
GI
Initial	30 to 50	1 to 3	60 to 80	7 to 14
Maintenance	10 to 20	4 to 7	30
Renal	15 to 30	3 to 5	40	3 to 5
Deep laceration	15 to 30	5 to 7	40	5 to 7
Surgery (major)
Pre-op	50 to 70	-	60 to 80	-
Post-op	30 to 40	1 to 3	40 to 60	1 to 3
	20 to 30	4 to 6	30 to 50	4 to 6
	10 to 20	7 to 14	20 to 40	7 to 14
Surgery (minor)
Pre-op	40 to 80		50 to 80
Post-op	20 to 50	1 to 5	30 to 80	1 to 5

Step 3: Calculate dose using IVR from step 1, desired peak factor IX level from step 2, and the following equation:

Factor IX units required = [(desired peak factor IX level − patient's baseline factor IX level) × body weight (kg)] / IVR

(Note: Factor IX units are in units/dL.)

Example (Profilnine) for 50 kg patient with desired peak factor IX level of 35 units/dL, baseline factor IX level of 5 units/dL, IVR = 1.15:

Factor IX units required = [(35 units/dL − 5 units/dL) × 50 kg)] ⁄ 1.15 = 1,304 units factor IX

Step 4: Determine need for repeat dosing based on manufacturer’s recommended frequency of repeat dosing. Note: Frequency of administration must also take into consideration subsequent factor IX activity measurements and clinical response.

**Factor IX Complex (Human) [Factors II, IX, X] Administration Frequency According to Clinical Scenario**
Product	Bleeding event			Surgery
Product	Minor severity	Moderate severity	Major severity	Minor bleeding risk	Major bleeding risk
Profilnine	Every 16 to 24 hours	Every 16 to 24 hours	Every 16 to 24 hours	Every 16 to 24 hours	Every 16 to 24 hours

Life-threatening hemorrhage associated with warfarin

Life-threatening hemorrhage associated with warfarin (off-label use): IV: Note: Products contain low or nontherapeutic levels of factor VII component; therefore, additional fresh frozen plasma (FFP) or factor VIIa may be considered (Masotti 2011). When immediate INR reversal is required, concomitant use of 1 to 2 units of FFP should be considered to ensure acute INR reversal (Baker 2004; Holland 2009). Coadminister vitamin K (phytonadione) 5 to 10 mg by slow IV infusion (ACCP [Guyatt 2012]); vitamin K may be repeated every 12 hours if INR is persistently elevated. Factor IX complex (human) dosing has not been established in this setting; the following regimens have been used with some success.

The following 2 methods have been suggested, but are not product specific:

Adjusted-dose regimen, weight based (Liumbruno 2009):

INR <2: 20 units/kg

INR 2 to 4: 30 units/kg

INR >4: 50 units/kg

Note: If after administration, INR remains >1.5 consider repeating dose appropriate for INR.

May also determine dose based on presenting INR and estimated functional prothrombin complex (PC) expressed as percentage of normal plasma levels (see table; Masotti 2011):

Units needed to be infused = (target % of functional PC to be reached – current estimated % of functional PC) x kg of body weight

Example:

Patient (weight: 70 kg) presents with INR of 4.5 which corresponds to an estimated % functional PC of 10% (see table). Target INR of 1.4 corresponds to an estimated target % functional PC of 40%.

Units needed to be infused = (40 - 10) x 70 kg = 2,100 units

**Conversion of the INR to Estimated Functional Prothrombin Complex (PC)**
INR Value	Estimated Functional PC
≥5	5%
4 to 4.9	10%
2.6 to 3.2	15%
2.2 to 2.5	20%
1.9 to 2.1	25%
1.7 to 1.8	30%
1.4 to 1.6	40%
1 to 1.3	100%

Intracranial hemorrhage associated with warfarin

Intracranial hemorrhage associated with warfarin (off-label use): IV: Note: Factor IX complex (human) products contain low or nontherapeutic levels of factor VII component (ie, considered a 3-factor PCC). Four-factor PCC is preferred. Administer with vitamin K IV (NCS/SCCM [Frontera 2016]).

Fixed-dose regimen, weight based: INR ≥1.4: 50 units/kg; repeat INR within 15 to 60 minutes and serially every 6 to 8 hours for the next 24 to 48 hours. If INR remains ≥1.4 within the first 24 to 48 hours after initial dose, use FFP (alone) for further correction. For initial reversal, it is suggested to administer factor IX complex (PCC) alone rather than combined with FFP or recombinant factor VIIa (NCS/SCCM [Frontera 2016]).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; monitor factor IX levels. Use with caution due to the risk of thromboembolic complications.

Dosing: Obesity: Adult

There are insufficient data to recommend the best dosing weight to use in patients with obesity. Dose adjustments should ultimately be made based on individual patient response to therapy. Due to the paucity of data, refer to institutional protocols. Refer to adult dosing for indication-specific dosing.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Prothrombin complex concentrate, 3-factor, unactivated, from human plasma: Pediatric drug information")

Note: Bebulin has been discontinued in the US for >1 year.

Hemophilia B

Hemophilia B: Children and Adolescents: IV: Dosage is expressed in units of factor IX activity and must be individualized based on severity of factor IX deficiency, extent and location of bleeding, and clinical status of patient (WHF 2013). When multiple doses are required, administer at 24-hour intervals unless otherwise specified.

Formula for units required to raise blood level %:

Bebulin VH: In general, 1 unit/kg of factor IX will increase the plasma factor IX level by 0.8%.

Number of Factor IX units required = body weight (kg) x desired factor IX increase (as % of normal) x 1.2 units/kg

For example, to increase factor IX level to 25% of normal in a 70 kg patient: Number of factor IX units needed = 70 kg x 25 x 1.2 unit/kg = 2100 units

Profilnine SD: In general, 1 unit/kg of factor IX will increase the plasma factor IX level by 1%:

Number of factor IX units required = bodyweight (kg) x desired factor IX increase (as % of normal) x 1 unit/kg

For example, to increase factor IX level to 25% of normal in a 70 kg patient: Number of factor IX units needed = 70 kg x 25 x 1 unit/kg = 1750 units

As a general rule, the level of factor IX required for treatment of different conditions is listed below:

Hemorrhage:

Minor bleeding (early hemarthrosis, minor epistaxis, gingival bleeding, mild hematuria):

Bebulin VH: Raise factor IX level to 20% of normal [typical initial dose: 25 to 35 units/kg]; generally a single dose is sufficient.

Profilnine SD: Mild to moderate bleeding: Raise factor IX level to 20% to 30% of normal; generally a single dose is sufficient.

Moderate bleeding (severe joint bleeding, early hematoma, major open bleeding, minor trauma, minor hemoptysis, hematemesis, melena, major hematuria):

Bebulin VH: Raise factor IX level to 40% of normal [typical initial dose: 40-55 units/kg]; average duration of treatment is 2 days or until adequate wound healing.

Profilnine SD: Mild to moderate bleeding: Raise factor IX level to 20% to 30% of normal.

Major bleeding (severe hematoma, major trauma, severe hemoptysis, hematemesis, melena):

Bebulin VH: Raise factor IX level to ≥60% of normal [typical initial dose: 60 to 70 units/kg]; average duration of treatment is 2 to 3 days or until adequate wound healing. Do not raise >60% in patients who may be predisposed to thrombosis.

Profilnine SD: Raise factor IX level to 30% to 50% of normal; daily infusions are usually required.

Surgical procedures:

Dental surgery:

Bebulin VH: Raise factor IX level to 40% to 60% of normal on day of surgery [typical dose: 50 to 60 units/kg]. One infusion, administered 1 hour prior to surgery, is generally sufficient for the extraction of one tooth; for the extraction of multiple teeth, replacement therapy may be required for up to 1 week (see dosing guidelines for Minor Surgery).

Profilnine SD: Raise factor IX level to 50% of normal immediately prior to procedure; administer additional doses if bleeding recurs.

Minor surgery:

Bebulin VH: Raise factor IX level to 40% to 60% of normal on day of surgery [typical initial dose: 50 to 60 units/kg]. Decrease factor IX level from 40% of normal to 20% of normal during initial postoperative period (1 to 2 weeks or until adequate wound healing) [typical dose: 55 units/kg decreasing to 25 units/kg]. The preoperative dose should be given 1 hour prior to surgery. The average dosing interval may be every 12 hours initially, then every 24 hours later in the postoperative period.

Profilnine SD: Raise factor IX level to 30% to 50% of normal for at least 1 week following surgery.

Major surgery:

Bebulin VH: Raise factor IX level to ≥60% of normal on day of surgery [typical initial dose: 70 to 95 units/kg]; do not raise >60% in patients who may be predisposed to thrombosis. Decrease factor IX level from 60% of normal to 20% of normal during initial postoperative period (1-2 weeks) [typical dose: 70 units/kg decreasing to 35 units/kg]; further decrease to maintain a factor IX level of 20% of normal during late postoperative period (≥3 weeks) and continuing until adequate wound healing is achieved [typical dose: 35 units/kg decreasing to 25 units/kg]. The preoperative dose should be given 1 hour prior to surgery. The average dosing interval may be every 12 hours initially, then every 24 hours later in the postoperative period.

Profilnine SD: Raise factor IX level to 30% to 50% of normal for at least 1 week following surgery.

Prophylaxis, hemorrhage (long-term management): Bebulin VH: 20 to 30 units/kg/dose once or twice a week may reduce frequency of spontaneous hemorrhage; dosing regimen should be individualized.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; monitor factor IX levels. Use with caution due to the risk of thromboembolic complications.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Cardiovascular: Flushing, thrombosis (sometimes fatal)

Central nervous system: Chills, drowsiness, headache, lethargy, paresthesia

Dermatologic: Skin rash, urticaria

Gastrointestinal: Nausea, vomiting

Hematologic & oncologic: Disseminated intravascular coagulation, heparin-induced thrombocytopenia (with products containing heparin)

Hypersensitivity: Anaphylactic shock

Immunologic: Antibody development (to clotting factor)

Respiratory: Dyspnea

Miscellaneous: Fever

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Antibody formation: The development of factor IX antibodies (or inhibitors) has been reported with factor IX therapy (usually occurs within the first 10 to 20 exposure days); the risk of severe hypersensitivity reactions occurring may be greater in these patients. When clinical response is suboptimal, the patient has reached a specified number of exposure days, or patient is to undergo surgical procedure, screen for inhibitors. Patients with severe hemophilia compared to those with mild or moderate hemophilia are more likely to develop inhibitors (WFH [Srivastava 2013]).

• Hypersensitivity reactions: Hypersensitivity and anaphylactic/anaphylactoid reactions have been reported with use. Delayed reactions (up to 20 days after infusion) in previously untreated patients may also occur. Due to potential for allergic reactions, the initial ~10 to 20 administrations should be performed under appropriate medical supervision. Hypersensitivity reactions may be associated with factor IX inhibitor development; patients experiencing allergic reactions should be evaluated for factor IX inhibitors. If severe hypersensitivity reactions occur, consider the use of alternative hemostatic measures (WFH [Srivastava 2013]).

• Thrombotic events: Thrombotic events (eg, deep vein thrombosis, pulmonary embolism, thrombotic strokes) as well as disseminated intravascular coagulation (DIC) have occurred. Monitor closely for signs or symptoms of intravascular coagulation or thrombosis; risk is higher in patients with congenital or acquired coagulation disorders, and with repeated dosing or high doses. Use with caution when administering to patients with liver disease, history of coronary artery disease, pre- or postoperatively, neonates, or patients at risk of thromboembolic phenomena, disseminated intravascular coagulation or patients with signs of fibrinolysis due to the potential risk of thromboembolic complications. Discontinue infusion immediately if signs or symptoms of thrombosis or embolism occur.

Disease-related concerns:

• Hepatic impairment: Use with extreme caution in patients with hepatic impairment due to the risk of thromboembolic complications.

Dosage form specific issues:

• Human plasma: Product of human plasma; may potentially contain infectious agents that could transmit disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer.

• Latex: Some product packaging may contain natural rubber latex.

Other warnings/precautions:

• Appropriate use: Factor IX Complex (Human) [Factors II, IX, X] (Profilnine) contains low or nontherapeutic levels of factor VII component and should not be confused with Prothrombin complex concentrate (Human) [(Factors II, VII, IX, X), Protein C, Protein S] (Kcentra, Octaplex) which contains therapeutic levels of factor VII. Factor IX Complex (Human) [Factors II, IX, X] (Profilnine) should not be used for the treatment of factor VII deficiency. When treating warfarin-associated hemorrhage (off-label use), administration of additional fresh frozen plasma (FFP) or factor VIIa should be considered.

• Clinical response: Response to factor IX administration may vary. If bleeding is not controlled with the recommended dose, determine plasma level of factor IX and follow with a sufficient dose to achieve satisfactory clinical response. If plasma levels of factor IX fail to increase as expected or bleeding continues, suspect the presence of an inhibitor; test as appropriate.

• Immune tolerance induction: Safety and efficacy have not been established in immune tolerance induction with factor IX products. Nephrotic syndrome has occurred following immune tolerance induction in patients with hemophilia B with factor IX inhibitors receiving factor IX products.

Dosage Forms Considerations

Strengths expressed as an approximate value. Consult individual vial labels for exact potency within each vial.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Profilnine: 500 units (1 ea)

Profilnine: 500 units (1 ea) [contains polysorbate 80]

Profilnine: 1000 units (1 ea)

Profilnine: 1000 units (1 ea) [contains polysorbate 80]

Profilnine: 1500 units (1 ea)

Profilnine: 1500 units (1 ea) [contains polysorbate 80]

Generic Equivalent Available: US

Pricing: US

Solution (reconstituted) (Profilnine Intravenous)

500 unit (Price provided is per AHF Unit): $1.78

1000 unit (Price provided is per AHF Unit): $1.78

1500 unit (Price provided is per AHF Unit): $1.78

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

IV: Solution should be infused at room temperature. Rate should not exceed 10 mL/minute. Vasomotor reactions may result from rapid administration; do not exceed the recommended infusion rates. Slowing the rate of infusion, changing the lot of medication, or administering antihistamines may relieve some adverse reactions.

Administration: Pediatric

Parenteral: IV administration only. Visually inspect for particulate matter and discoloration prior to administration whenever permitted by solution or container. Infuse slowly; rate of administration should be individualized for patient's comfort; rapid IV administration may cause vasomotor reactions; maximum rates of administration: Bebulin VH: 2 mL/minute; Profilnine SD: 10 mL/minute; Note: Slowing the rate of infusion, changing the lot of medication, or administering antihistamines may relieve some adverse reactions.

Use: Labeled Indications

Hemophilia B: Prevention and control of bleeding in patients with factor IX deficiency (hemophilia B or Christmas disease).

Limitations of use: Not indicated for the treatment of other factor deficiencies (eg, factor II, VII, VIII, X), treatment of hemophilia A patients with inhibitors to factor VIII, or treatment of bleeding caused by low levels of liver-dependent coagulation factors.

Use: Off-Label: Adult

Intracranial hemorrhage associated with warfarin; Life-threatening hemorrhage associated with warfarin

Medication Safety Issues

Sound-alike/look-alike issues:

Factor IX Complex may be confused with Factor IX

Safety concern:

Factor IX Complex may be confused with Factor IX

The term “Prothrombin Complex Concentrate” or “PCC” has been used to describe both Factor IX Complex (Human) [Factors II, IX, X] and Prothrombin Complex Concentrate (Human) [(Factors II, VII, IX, X), Protein C, Protein S]. Factor IX Complex (Human) [Factors II, IX, X] (Profilnine) contains low or nontherapeutic levels of factor VII component and should not be confused with Prothrombin Complex Concentrate (Human) [(Factors II, VII, IX, X), Protein C, Protein S] (Kcentra, Octaplex) which contains therapeutic levels of factor VII.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Antifibrinolytic Agents: May enhance the adverse/toxic effect of Factor IX Complex (Human) [(Factors II, IX, X)]. Specifically, the risk for thrombosis may be increased. Risk X: Avoid combination

Pregnancy Considerations

Pregnant patients with inherited coagulation disorders may have an increased bleeding risk following invasive procedures, spontaneous miscarriage, termination of pregnancy, and delivery; close surveillance is recommended. Clotting factors should be monitored at the first antenatal visit, once or twice during the third trimester, prior to surgical or invasive procedures, and at delivery. Although factor IX levels remain stable during pregnancy, factor IX replacement is recommended if concentrations are <50 units/dL and any of the following occur: need for invasive procedures (including delivery), spontaneous miscarriage, insertion and removal of epidural catheters, or active bleeding. Hemostatic factor IX concentrations should be maintained for at least 3 to 5 days following invasive procedures or postpartum. If replacement with a factor IX concentrate is indicated to increase factor IX during pregnancy, a recombinant product is preferred. In addition, the use of factor IX concentrates that also contain factors II, VII, IX, and X (also known as PCCs) are rarely used; pure factor IX concentrations are preferred (NHF 2017; RCOG [Pavord 2017]; WFH [Srivastava 2020]).

Factor II concentrations do not increase during pregnancy. In women with severe factor II deficiency, PCCs may be administered if factor II activity is < 0.2 IU/mL with significant bleeding, during labor, or prior to cesarean delivery. Patients treated with PCCs prior to pregnancy may continue use. Factor X concentrations may increase during pregnancy; however, patients with severe factor X deficiency remain at risk for bleeding. In addition, treatment may be needed if concentrations are <30 units/dL at term or prior to procedure. Hemostatic concentrations should be maintained for at least 3 days following procedures or postpartum. PCCs may be used for severe factor X deficiency in pregnancy (RCOG [Pavord 2017]).

Monitoring Parameters

When used for hemophilia B:

Monitoring assay selection: For plasma-derived FIX products, the World Federation of Hemophilia (WFH) recommends use of a one-stage or chromogenic FIX activity assay calibrated with a plasma standard traceable to a WHO international standard (WFH [Srivastava 2020]).

Monitoring frequency: During treatment of an acute bleeding event or in the perioperative setting using intermittent bolus administration, factor IX levels should be measured at baseline, and as peaks 15 to 30 minutes after infusion to assess target level achievement. The frequency of peak factor IX activity monitoring during active treatment depends on the indication, clinical response, and treatment day. Measurement of FIX trough levels may aid in calculation of subsequent doses (WFH [Srivastava 2020]).

For long-term bleeding prophylaxis, trough factor IX measurements should be obtained to tailor prophylaxis regimens, with the goal of achieving factor IX troughs >3 to 5 units/dL; prophylaxis targets should be tailored to individual level of activity, lifestyle, and pharmacokinetics.

Additional monitoring considerations: Heart rate and BP before and during IV administration, signs of hypersensitivity reactions (which may be an early sign of inhibitor development), hemoglobin/hematocrit, and signs and symptoms of intravascular hemolysis.

Lower than expected factor IX recovery or reduced half-life are early signs of inhibitor formation.

When used for warfarin reversal:

PT, PTT; INR; signs and symptoms of hypersensitivity reactions, DIC, thrombosis, especially in patients with liver disease, surgical patients, and patients with known risk factors predisposing to thrombosis.

Reference Range

Classification of hemophilia; normal is defined as 100% factor IX (WFH [Srivastava 2020]).

Severe: factor level <1% of normal.

Moderate: factor level 1% to 5% of normal.

Mild: factor level 5% to <40% of normal.

Mechanism of Action

Replaces deficient clotting factor including factor X; hemophilia B, or Christmas disease, is an X-linked recessively inherited disorder of blood coagulation characterized by insufficient or abnormal synthesis of the clotting protein factor IX. Factor IX is a vitamin K-dependent coagulation factor which is synthesized in the liver. Factor IX is activated by factor XIa in the intrinsic coagulation pathway. Activated factor IX (IXa), in combination with factor VII:C, activates factor X to Xa, resulting ultimately in the conversion of prothrombin to thrombin and the formation of a fibrin clot. The infusion of exogenous factor IX to replace the deficiency present in hemophilia B temporarily restores hemostasis.

Pharmacokinetics (Adult Data Unless Noted)

Half-life elimination: IX component: ~19 to 25 hours

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(BG) Bulgaria: Prothromplex total;
(CZ) Czech Republic: Prothromplex total;
(DE) Germany: Prothromplex nf;
(ES) Spain: Prothromplex total;
(GR) Greece: Prothromplex total;
(PL) Poland: Prothromplex total;
(PR) Puerto Rico: Profilnine;
(TN) Tunisia: Prothromplex nf

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Prothrombin complex concentrate, 3-factor, unactivated, from human plasma: Drug information