Version May 2024
Factor X deficiency: Dose, dosing frequency, and duration are based on location and severity of bleeding, and the patient's clinical condition. In general, administration of factor X 1 unit/kg will increase circulating factor X levels by ~2 units/dL.
Bleeding episodes: IV:
Prophylaxis: Initial: 25 units/kg twice weekly. Adjust dose to clinical response and factor X trough levels targeting ≥ 5 units/dL; do not exceed a peak of 120 units/dL.
Treatment: 25 units/kg/dose. Repeat every 24 hours until bleeding stops. Alternatively, a patient-specific dose to achieve a desired peak target can be calculated using the following equation. Adjust dose and frequency based on peak and trough factor X levels.
Number of factor X units required = Body weight (kg) × desired factor X increase (units/dL or % of normal) × 0.5.
For example: 50 kg × 30 (units/dL increase) × 0.5 = 750 units factor X.
Maximum daily dose: 60 units/kg/day.
Note: Dosing should be tailored to maintain factor X trough at 10 to 20 units/dL and may consider higher trough of >40 units/dL (Menegatti 2019).
Perioperative management of bleeding: IV:
Pre-surgery, the calculated dose should raise plasma factor X levels to 70 to 90 units/dL (or % of normal) using the following equation:
Number of factor X units required = Body weight (kg) × desired factor X increase (units/dL or % of normal) × 0.5.
For example: 50 kg × 30 (units/dL increase) × 0.5 = 750 units factor X.
Maximum daily dose: 60 units/kg/day.
Post-surgery, the calculated dose should maintain plasma factor X levels at ≥50 units/dL (or % of normal) until patient is no longer at risk of bleeding; Maximum daily dose: 60 units/kg/day.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
(For additional information see "Factor X, concentrate from human plasma: Pediatric drug information")
Factor X deficiency: Dose, dosing frequency, and duration are based on location and severity of bleeding, patient age, and the patient's clinical condition. In general, administration of 1 unit/kg of factor X will increase circulating factor X concentrations by ~1.7 units/dL in children <12 years or by ~2 units/dL in children ≥12 years and adolescents.
Bleeding episodes:
Prophylaxis: Adjust dose to clinical response and factor X trough concentration targeting ≥5 units/dL; do not exceed a peak of 120 units/dL
Children <12 years: IV: Initial: 40 units/kg/dose twice weekly
Children ≥12 years and Adolescents: IV: Initial: 25 units/kg/dose twice weekly
Treatment:
Children <12 years: IV: 30 units/kg/dose. Repeat every 24 hours until bleeding stops.
Children ≥12 years and Adolescents: IV: 25 units/kg/dose. Repeat every 24 hours until bleeding stops.
Perioperative management of bleeding: IV:
Pre-surgery: Formula to calculate dosage required is based on desired increase in factor X concentrations (may be expressed as units/dL or as %). The calculated dose should raise plasma factor X concentrations to a desired target of 70 to 90 units/dL (or % of normal) using the following equation:
Children <12 years:
Dose (units) = Body weight (kg) x desired factor X increase (units/dL or % of normal) x 0.6
For example: 25 kg x 30 (% increase) x 0.6 = 450 units factor X
Maximum daily dose: 60 units/kg/day
The estimated factor X increase may be determined by the following equation:
Estimated increase of factor X (units/dL or % of normal) = [Total dose administered (units) x 1.7] divided by body weight (kg)
For example: [1,400 units x 1.7] divided by 35 kg = 68%
Children ≥12 years and Adolescents:
Dose (units) = Body weight (kg) x desired factor X increase (units/dL or % of normal) x 0.5
For example: 50 kg x 30 (% increase) x 0.5 = 750 units factor X
Maximum daily dose: 60 units/kg/day
The estimated factor X increase may be determined by the following equation:
Estimated increase of factor X (units/dL or % of normal) = [Total dose administered (units) x 2] divided by body weight (kg)
For example: [1,400 units x 2] divided by 70 kg = 40%
Post-surgery: Children and Adolescents: Repeat pre-surgery dose as needed to maintain plasma factor X concentrations at ≥50 units/dL (or % of normal) until patient is no longer at risk of bleeding; maximum daily dose: 60 units/kg/day
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not always defined. Reported adverse reactions are for adolescents and adults.
1% to 10%:
Local: Erythema at injection site, infusion-site pain
Nervous system: Fatigue
Neuromuscular & skeletal: Back pain
Life-threatening hypersensitivity reactions to factor X (human) or any component of the formulation
Concerns related to adverse effects:
• Antibody formation: The development of inhibitory antibodies may occur. Factor X inhibitory antibodies should be measured when bleeding is not controlled and/or factor X levels are suboptimal after apparent adequate dosing.
• Hypersensitivity reactions: Hypersensitivity and anaphylactic reactions may occur with use; discontinue immediately if hypersensitivity reaction develops and initiate appropriate management.
Dosage form specific issues:
• Human plasma: Product of human plasma; may potentially contain infectious agents which 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.
• Human proteins: Contains traces of human proteins other than factor X.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous [preservative free]:
Coagadex: 250 units (1 ea); 500 units (1 ea) [latex free]
No
Solution (reconstituted) (Coagadex Intravenous)
250 unit (per each): $13.07
500 unit (per each): $13.07
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.
IV: For IV administration only. Administer at a rate of 10 to 20 mL/minute within 1 hour of reconstitution.
IV: For IV administration only. Administer at a rate of 10 to 20 mL/minute within 1 hour of reconstitution.
Bleeding episodes and perioperative management of bleeding: Prophylaxis and treatment of bleeding episodes in children and adults with hereditary factor X deficiency and perioperative management of bleeding episodes in children and adults with mild and moderate hereditary factor X deficiency.
Limitations of use: Due to rarity of hereditary factor X deficiency, there are limited data regarding the perioperative management of bleeding with surgery in patients with severe hereditary factor X deficiency (Escobar 2016).
None known.
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.
Anticoagulants (Inhibitors of Factor Xa): May diminish the therapeutic effect of Factor X (Human). Risk C: Monitor therapy
Pregnant patients with factor X deficiency may have an increased risk of bleeding following abortion, antenatal procedures, delivery, and miscarriage; close surveillance is recommended. Clotting factors should be monitored at the first antenatal visit, once or twice during the third trimester, at delivery, and prior to surgical or invasive procedures. Although factor X concentrations may increase during pregnancy, patients with severe deficiency remain at risk for bleeding. In addition, treatment may be needed if concentrations are <0.3 IU/mL at term or prior to procedure. Hemostatic concentrations should be maintained for at least 3 days following procedures or postpartum. When available, factor X concentrate may be used (RCOG [Pavord 2017]).
This product is a plasma-derived, sterile, purified concentrate of human coagulation factor X. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Factor X levels should be measured at baseline and at peak concentration ~30 minutes after infusion to assess target level achievement. The frequency of factor X monitoring depends on indication and clinical response. Factor X inhibitory antibodies should be measured if inadequate clinical response and/or factor X trough levels are suboptimal. Signs/symptoms of hypersensitivity reactions, bleeding and thrombotic events, and infection.
Replaces deficient clotting factor X needed for effective hemostasis. Factor X, an inactive zymogen, can be activated by factor IXa via the intrinsic pathway or by factor IIa via the extrinsic pathway. Factor X is then converted from its inactive form to the active form (factor Xa) by the cleavage of a 52-residue peptide from the heavy chain. Factor Xa associates with factor Va on the phospholipid surface to form the prothrombinase complex, which actives prothrombin to thrombin in the presence of calcium ions. Thrombin then acts upon soluble fibrinogen and factor XIII to generate a cross-linked fibrin clot.
Distribution: Vd: Children ≥12 years, Adolescents, and Adults: 56.3 mL/kg
Half-life elimination: Single dose: Children ≥12 years, Adolescents, and Adults: 30.3 hours
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