Coagulation factor x human
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Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Preparation and Reconstitution Always work on a clean surface and wash your hands before performing the following procedures. To reconstitute, use the diluent (Sterile Water for Injection) and transfer device (Mix2Vial) provided in the COAGADEX carton. To administer, you will also need a syringe and suitable needle (not provided in the COAGADEX carton).
Bring the vials of COAGADEX and the Sterile Water for Injection to room temperature before mixing. The reconstitution is performed as follows: [See table below.] Figure Figure Figure Figure Figure Figure
Administration For intravenous administration only If the dose requires more than one vial of COAGADEX: Reconstitute each vial (steps 1 to 5) using a new Mix2Vial for each vial Draw up all of the solution into a single syringe (steps 6 to 8) Visually inspect the final solution for particulate matter and discoloration prior to administration.
Do not use if particulate matter or discoloration is observed Attach a suitable needle to the syringe Administer by intravenous infusion at a rate of 10 mL/min, but no more than 20 mL/min
| Age | Initial dose | Further management |
|---|---|---|
| Children: Less than 12 years of age | Use a factor of 0.6 to calculate the required dose | Measure post-infusion plasma Factor X levels for each patient before and after surgery to ensure that hemostatic levels are obtained and maintained. Pre-surgery: calculate the dose of COAGADEX to raise plasma Factor X levels to 70-90 IU/dL Post-surgery: Repeat dose as necessary to maintain plasma Factor X levels at a minimum of 50 IU/dL until the patient is no longer at risk of bleeding due to surgery |
| Dose (IU) = body weight (kg) × desired factor X rise† (IU/dL or % of normal) × 0.6 | ||
| Adults and adolescents: 12 years of age or older | Use a factor of 0.5 to calculate the required dose | |
| Dose (IU) = body weight (kg) × desired factor X rise‡ (IU/dL or % of normal) × 0.5 | ||
| Step 1Remove the cap from the vial of COAGADEX and clean the top of the rubber stopper with an alcohol swab (not supplied) and allow to dry prior to opening the Mix2Vial package.Repeat this step with the vial of sterile water.Step 2Peel back the top of the Mix2Vial package. Do not remove the device from the package. | |
| Step 3Place the blue end of the Mix2Vial over the water vial and push straight down until the spike penetrates the rubber stopper and snaps into place.Remove the plastic outer packaging from the Mix2Vial and discard it. Do not touch the exposed end of the device. | |
| Step 4With the COAGADEX vial placed on a flat surface, invert the water vial with the Mix2Vial device still attached.Place the clear end of the Mix2Vial on the product vial and push straight down until the spike penetrates the rubber stopper and snaps into place.The water will automatically transfer into the COAGADEX vial by the vacuum contained within it. Do not use if the water is not pulled into the vial of COAGADEX. | |
| Step 5Gently swirl the COAGADEX vial to make sure that the powder is fully dissolved. Do not shake the vial.The reconstituted solution should be clear or a slightly pearl-like solution. Do not use if particulate matter or discoloration is observed and contact BPL. | |
| Step 6Separate the empty water vial and blue part of the Mix2Vial from the clear part that is attached to the COAGADEX vial by unscrewing counter-clockwise.Step 7Draw air into an empty, sterile syringe (not supplied) by pulling the plunger to the volume of water added.Connect the syringe to the clear part of the Mix2Vial and push the air in the syringe into the vial. | |
| Step 8Immediately invert the COAGADEX vial. The solution will automatically be drawn into the syringe. Draw the remaining solution into the syringe by pulling the plunger back slowly.Disconnect the filled syringe from the device.Use the product immediately after reconstitution. Do not store the reconstituted product. |
Drug interactions
Check coagulation factor x human against a medication listLabel text (1 paragraph)
Drug interaction studies have not been performed. Use with caution in patients who are receiving other plasma products that may contain Factor X (e.g. fresh frozen plasma, prothrombin complex concentrates). Based on the mechanism of action, COAGADEX is likely to be counteracted by direct and indirect Factor Xa inhibitors [ see Clinical Pharmacology (12.1) ].
Contraindications
4 CONTRAINDICATIONS COAGADEX is contraindicated in patients who have had life-threatening hypersensitivity reactions to COAGADEX [ see Description (11) ]. Do not use in patients who have had life-threatening hypersensitivity reactions to COAGADEX ( 4 ).
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for coagulation factor x human. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There is limited data with COAGADEX in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted using COAGADEX. It is not known whether COAGADEX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.