check with [5%:20% Decrease by 5 units per kg One trough level of >25% Decrease by 5 units per kg The potency expressed in units is determined using the Berichrom activity assay, referenced to the current International Standard for Blood Coagulation Factor XIII, Plasma. Therefore, a unit herein is equivalent to an International Unit. Preparation and Reconstitution For intravenous use only. Reconstitute, using aseptic techniques, prior to use. Do not use Corifact beyond the expiration date on the vial label and carton. Perform a visual inspection of the reconstituted solution. It should be colorless to slightly yellowish, slightly opalescent, and free from visible particles. Administer Corifact using aseptic techniques to maintain product sterility. Corifact is for single use only. Contains no preservatives. The product must be used within 4 hours after reconstitution. Do not refrigerate or freeze the reconstituted solution. Discard partially used vials. The procedures below are provided as general guidelines for the preparation and reconstitution of Corifact. Reconstitute Corifact at room temperature as follows: 1. Ensure that the Corifact vial and diluent vial are at room temperature. Prepare and administer using aseptic techniques. 2. Place the Corifact vial, diluent vial, and Mix2Vial transfer set on a flat surface. 3. Remove Corifact and diluent vial flip caps and treat the stoppers with the alcohol swab provided, and allow to dry prior to opening the Mix2Vial transfer set package. 4. Open the Mix2Vial transfer set package by peeling away the lid (Fig. 1). Leave the Mix2Vial transfer set in the clear package. Fig. 1 5. Place the diluent vial on a flat surface and hold the vial tightly. Grip the Mix2Vial transfer set together with the clear package and push the plastic spike at the blue end of the Mix2Vial transfer set firmly through the center of the stopper of the diluent vial (Fig. 2). Fig. 2 6. Carefully remove the clear package from the Mix2Vial transfer set. Make sure that you pull up only the clear package, not the Mix2Vial transfer set (Fig. 3). Fig. 3 7. With the Corifact vial placed firmly on a flat surface, invert the diluent vial with the Mix2Vial transfer set attached and push the plastic spike of the transparent adapter firmly through the center of the stopper of the Corifact vial (Fig. 4). The diluent will automatically transfer into the Corifact vial. Fig. 4 8. With the diluent and Corifact vial still attached to the Mix2Vial transfer set, gently swirl the Corifact vial to ensure that the Corifact is fully dissolved (Fig. 5). Do not shake the vial. Fig. 5 9. With one hand, grasp the Corifact side of the Mix2Vial transfer set and with the other hand grasp the blue diluent-side of the Mix2Vial transfer set, and unscrew the set into two pieces. (Fig. 6). Fig. 6 10. Draw air into an empty, sterile syringe. While the Corifact vial is upright, screw the syringe to the Mix2Vial transfer set. Inject air into the Corifact vial. While keeping the syringe plunger pressed, invert the system upside down and draw the concentrate into the syringe by pulling the plunger back slowly. (Fig. 7). Fig. 7 11. Now that the concentrate has been transferred into the syringe, firmly grasp the barrel of the syringe (keeping the plunger facing down) and unscrew the syringe from the Mix2Vial transfer set (Fig. 8). Attach the syringe to a suitable intravenous (IV) administration set. Fig. 8 12. After reconstitution, administration should begin promptly or within 4 hours. 13. If the same patient is to receive more than one vial, you may pool the contents of multiple vials. Use a separate unused Mix2Vial transfer set for each product vial. 14. Corifact is for single use only. Contains no preservatives. The product must be used within 4 hours after reconstitution. Do not refrigerate or freeze the reconstituted solution. Discard partially used vials. Administration Do not mix Corifact with other medicinal products, and administer Corifact through a separate infusion line. Use aseptic techniques when administering Corifact. Administer Corifact after it has been brought to room temperature. It should be administered by slow intravenous injection at a rate not exceeding 4 mL per minute. Record the batch number of the product in the patient's medical records every time Corifact is administered to the patient. Dosage Forms and Strengths Corifact is available as a single-use vial containing 1000-1600 units of FXIII as a lyophilized concentrate. A 20 mL vial of Sterile Water for Injection, USP, is provided for reconstitution. The actual units of potency of FXIII are stated on each Corifact vial label and carton. Contraindications Corifact is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products or to any components in Corifact ( see Description [11] ). Warnings and Precautions Hypersensitivity Hypersensitivity reactions (including allergy, rash, pruritus, and erythema) have been observed with Corifact. If signs or symptoms of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, hypotension) occur, immediately discontinue administration ( see Patient Counseling Information [17] ) and institute appropriate treatment. Immunogenicity Development of inhibitory antibodies against FXIII has been detected in patients receiving Corifact. Monitor patients for possible development of inhibitory antibodies. Presence of inhibitory antibodies may manifest as an inadequate response to treatment. If expected plasma FXIII activity levels are not attained, or if breakthrough bleeding occurs while receiving prophylaxis, an assay that measures FXIII inhibitory antibody concentrations should be performed. One case of inhibitory antibodies against FXIII has been reported in the clinical studies (see Clinical Trials Experience [6.1] ). Cases of inhibitory antibodies against FXIII in patients with congenital FXIII deficiency have also been reported in postmarketing surveillance. Thromboembolic Risk Thromboembolic complications have been reported in postmarketing surveillance ( see Postmarketing Experience [6.2] ). Benefits and risks should be carefully assessed in pregnant women because of their hypercoagulable state and potential for increased risk of thromboembolic events. Transmission of Infectious Agents Corifact is made from human plasma. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. There is also the possibility that unknown infectious agents may be present in such products. The risk that such products could transmit viruses has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and removing certain viruses during manufacture ( see Description [11] ). Despite these measures, such products may still potentially transmit disease. Consider appropriate vaccination (against hepatitis A and B virus) for patients in regular/repeated receipt of Corifact. All infections thought by a physician to have been possibly transmitted by this product should be reported by the physician or other healthcare provider to the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Monitoring Laboratory Tests Monitoring of patient's trough FXIII activity level ( see Dosing Schedule [2.2] ) is recommended during treatment with Corifact. If breakthrough bleeding occurs, or if expected peak plasma FXIII activity levels are not attained ( see Pharmacokinetics [12.3] ), an investigation to determine the presence of FXIII inhibitory antibodies should be performed. Adverse Reactions The most common adverse reactions reported in clinical trials in greater than one subject (frequency >1%) following Corifact treatment are hypersensitivity reactions (including allergy, rash, pruritus, and erythema), chills/rise in temperature, arthralgia, headache, elevated thrombin-antithrombin levels, and an increase in hepatic enzymes. Adverse reactions are those adverse events (AEs) considered to be "at least possibly related" to the infusion of Corifact. Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Twelve clinical studies were conducted and included 187 unique subjects, 90 subjects were]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Manufacturer CSL Behring Drug Class Miscellaneous coagulation modifiers Related Drugs miscellaneous coagulation modifiers pentoxifylline , Trental , tranexamic acid , Lysteda , Amicar , BeneFix Factor XIII Deficiency factor XIII , More... Corifact Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } keep at bay
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