Coagulation factor ix recombinant glycopegylated
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From MedlinePlus, U.S. National Library of Medicine
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
Prepare this dose
Your numbers for coagulation factor ix recombinant glycopegylated. Take vial strength, diluent, and limits from the label below.
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Reconstitution
Always wash hands and ensure that the area is clean before performing the reconstitution procedures.
Use aseptic technique during the reconstitution procedures.
If the patient uses more than one vial of REBINYN per infusion, reconstitute each vial according to the following instructions. Overview of REBINYN Package The instructions below serve as a general guideline for reconstitution of REBINYN. For full instructions, refer to the FDA-approved patient information and Instructions for Use.
Reconstitution 1. Bring the REBINYN vial and the pre-filled diluent syringe to room temperature. 2. Remove the plastic cap from the REBINYN vial. 3. Wipe the rubber stopper on the vial with a sterile alcohol swab and allow it to dry prior to use. 4. Remove the protective paper from the vial adapter. Do not remove the vial adapter from the protective cap. 5.
Place the vial on a flat and solid surface. While holding the protective cap, place the vial adapter over the REBINYN vial and press down firmly on the protective cap until the vial adapter spike penetrates the rubber stopper. 6. Remove the protective cap from the vial adapter. 7. Grasp the plunger rod as shown in the diagram.
Attach the plunger rod to the syringe by holding the plunger rod by the wide top end. Turn the plunger rod clockwise into the rubber plunger inside the pre-filled diluent syringe until resistance is felt. 8. Break off the syringe cap from the pre-filled diluent syringe by snapping the perforation of the cap. 9. Connect the pre-filled diluent syringe to the vial adapter by turning it clockwise until it is secured. 10.
Push the plunger rod to slowly inject all the diluent into the vial. 11. Without removing the syringe, gently swirl the REBINYN vial until all of the powder is dissolved. 12. Administer the REBINYN solution immediately [see Administration]. If not used immediately after reconstitution, store the solution in the vial with the vial adapter and the syringe attached, at room temperature ≤ 86°F (30°C).
Do not store for longer than 4 hours. Overview of REBINYN Package Fig. A Fig. B Fig. C Fig. D Fig. E Fig. F FIg. G Fig. H Fig. I Fig. J
Administration For intravenous infusion only.
Accidental needle stick with a needle contaminated with blood can transmit infectious viruses including HIV (AIDS) and hepatitis. If a needle stick occurs, obtain immediate medical attention. Place needles in a sharps container after single use.
Inspect the reconstituted REBINYN solution visually prior to administration [ see Description ]. The solution should be clear and have no particles. Do not use if particulate matter or discoloration is observed.
Do not administer REBINYN in the same tubing or container with other medicinal products. 1. Invert the REBINYN vial and slowly draw the solution into the syringe. 2. Detach the syringe from the vial adapter by turning the syringe counterclockwise. 3. Attach the syringe to the luer end of an infusion needle set. 4. Infuse the reconstituted REBINYN intravenously slowly over 1 to 4 minutes. 5.
After infusion, safely dispose of the syringe with the infusion set, the vial with the vial adapter, any unused REBINYN, and other waste materials. Caution: The pre-filled diluent syringe is made of glass with an internal tip diameter of 0.037 inches, and is compatible with a standard Luer-lock connector. Some needleless connectors for intravenous catheters are incompatible with the glass diluent syringes (for example, certain connectors with an internal spike, such as Clave ® /MicroClave ® , InVision-Plus ® , InVision-Plus CS ® , Invision-Plus Junior ® , Bionector ® ), and their use can damage the connector and affect administration.
To administer REBINYN through incompatible needleless connectors, withdraw the reconstituted product into a standard 10 mL sterile Luer-lock plastic syringe. If you encounter any problems with attaching the pre-filled histidine-diluent syringe to any Luer‐lock compatible device, please contact Novo Nordisk at 303-4448. Fig.
Drug interactions
Check interactions
Add the patient's other drugs. Matches come from both FDA labels: by name, drug class, and enzyme or transporter pathway.
- Coagulation factor ix recombinant glycopegylated
Contraindications
4 CONTRAINDICATIONS REBINYN is contraindicated in patients who have known hypersensitivity to REBINYN or its components (including hamster proteins) [ see Warnings and Precautions ( 5.1 ) and Description ( 11 ) ] Do not use in patients who have known hypersensitivity to REBINYN or its components, including hamster proteins ( 4 ).
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for coagulation factor ix recombinant glycopegylated. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no data with REBINYN use in pregnant women to determine whether there is a drug-associated risk. Animal reproduction studies have not been conducted with REBINYN. It is unknown whether REBINYN can cause fetal harm when administered to a pregnant woman or can affect fertility. In the U.S. general population, the estimated background risk of major birth defect 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.