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Ixinity

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Overview

What is Ixinity?

IXINITY [coagulation factor IX (recombinant)] is a purified protein that has 415 amino acids. It has an amino acid sequence that is comparable to the Thr148 allelic form of plasma-derived factor IX. Coagulation factor IX (recombinant) is a single-chain glycoprotein with a molecular mass of about 55,000 Dalton that is secreted by a genetically engineered mammalian cell line derived from Chinese hamster ovary (CHO) cells. No human or animal proteins are added during any stage of manufacturing or formulation of IXINITY. The CHO cell line secretes recombinant factor IX into a defined cell culture medium that does not contain hormones. The recombinant factor IX is purified by a chromatography purification process. The process includes three validated steps for virus inactivation and removal, namely, solvent/detergent treatment, a chromatographic step, and nanofiltration. The process also includes a validated step to reduce the presence of CHO proteins in the final drug product.

IXINITY is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units (IU). Each vial contains nominally 250, 500, 1000, 1500, 2000, or 3000 IU of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:



What does Ixinity look like?



What are the available doses of Ixinity?

IXINITY is available as a lyophilized white or almost white powder, in single-use glass vials containing nominally 250, 500, 1000, 1500, 2000, or 3000 international units (IU) per vial

What should I talk to my health care provider before I take Ixinity?

How should I use Ixinity?

IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children ≥ 12 years of age with hemophilia B for:

IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B.

For intravenous use after reconstitution only.


What interacts with Ixinity?

Sorry No Records found


What are the warnings of Ixinity?

Sorry No Records found


What are the precautions of Ixinity?

Sorry No Records found


What are the side effects of Ixinity?

Sorry No records found


What should I look out for while using Ixinity?

IXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [].


What might happen if I take too much Ixinity?

Sorry No Records found


How should I store and handle Ixinity?

Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.IXINITY is supplied as a lyophilized powder in single-use glass vials containing the labeled amount of factor IX activity, expressed in international units (IU). The actual factor IX activity in IU is stated on the label of each vial.Kits include one or two single-use vials (containing nominally 250, 500, 1000, 1500, 2000, or 3000 IU per vial), a 10 mL syringe pre-filled with 5 mL of Sterile Water for Injection with plunger rod attached, vial adapter with filter, and a sterile 20 mL LUER-LOK Administration Syringe. All of the kit components are not made with natural rubber latex.250 IU strength only; store at 2 to 8°C (36 to 46°F).500, 1000, 1500, 2000, and 3000 IU strengths: store at 2 to 25°C (36 to 77°F).Do not freeze.Keep the vial in the carton and protect from light.Infuse reconstituted solution immediately or within 3 hours of storage at room temperature after reconstitution. Do not refrigerate after reconstitution.IXINITY is supplied as a lyophilized powder in single-use glass vials containing the labeled amount of factor IX activity, expressed in international units (IU). The actual factor IX activity in IU is stated on the label of each vial.Kits include one or two single-use vials (containing nominally 250, 500, 1000, 1500, 2000, or 3000 IU per vial), a 10 mL syringe pre-filled with 5 mL of Sterile Water for Injection with plunger rod attached, vial adapter with filter, and a sterile 20 mL LUER-LOK Administration Syringe. All of the kit components are not made with natural rubber latex.250 IU strength only; store at 2 to 8°C (36 to 46°F).500, 1000, 1500, 2000, and 3000 IU strengths: store at 2 to 25°C (36 to 77°F).Do not freeze.Keep the vial in the carton and protect from light.Infuse reconstituted solution immediately or within 3 hours of storage at room temperature after reconstitution. Do not refrigerate after reconstitution.IXINITY is supplied as a lyophilized powder in single-use glass vials containing the labeled amount of factor IX activity, expressed in international units (IU). The actual factor IX activity in IU is stated on the label of each vial.Kits include one or two single-use vials (containing nominally 250, 500, 1000, 1500, 2000, or 3000 IU per vial), a 10 mL syringe pre-filled with 5 mL of Sterile Water for Injection with plunger rod attached, vial adapter with filter, and a sterile 20 mL LUER-LOK Administration Syringe. All of the kit components are not made with natural rubber latex.250 IU strength only; store at 2 to 8°C (36 to 46°F).500, 1000, 1500, 2000, and 3000 IU strengths: store at 2 to 25°C (36 to 77°F).Do not freeze.Keep the vial in the carton and protect from light.Infuse reconstituted solution immediately or within 3 hours of storage at room temperature after reconstitution. Do not refrigerate after reconstitution.IXINITY is supplied as a lyophilized powder in single-use glass vials containing the labeled amount of factor IX activity, expressed in international units (IU). The actual factor IX activity in IU is stated on the label of each vial.Kits include one or two single-use vials (containing nominally 250, 500, 1000, 1500, 2000, or 3000 IU per vial), a 10 mL syringe pre-filled with 5 mL of Sterile Water for Injection with plunger rod attached, vial adapter with filter, and a sterile 20 mL LUER-LOK Administration Syringe. All of the kit components are not made with natural rubber latex.250 IU strength only; store at 2 to 8°C (36 to 46°F).500, 1000, 1500, 2000, and 3000 IU strengths: store at 2 to 25°C (36 to 77°F).Do not freeze.Keep the vial in the carton and protect from light.Infuse reconstituted solution immediately or within 3 hours of storage at room temperature after reconstitution. Do not refrigerate after reconstitution.IXINITY is supplied as a lyophilized powder in single-use glass vials containing the labeled amount of factor IX activity, expressed in international units (IU). The actual factor IX activity in IU is stated on the label of each vial.Kits include one or two single-use vials (containing nominally 250, 500, 1000, 1500, 2000, or 3000 IU per vial), a 10 mL syringe pre-filled with 5 mL of Sterile Water for Injection with plunger rod attached, vial adapter with filter, and a sterile 20 mL LUER-LOK Administration Syringe. All of the kit components are not made with natural rubber latex.250 IU strength only; store at 2 to 8°C (36 to 46°F).500, 1000, 1500, 2000, and 3000 IU strengths: store at 2 to 25°C (36 to 77°F).Do not freeze.Keep the vial in the carton and protect from light.Infuse reconstituted solution immediately or within 3 hours of storage at room temperature after reconstitution. Do not refrigerate after reconstitution.IXINITY is supplied as a lyophilized powder in single-use glass vials containing the labeled amount of factor IX activity, expressed in international units (IU). The actual factor IX activity in IU is stated on the label of each vial.Kits include one or two single-use vials (containing nominally 250, 500, 1000, 1500, 2000, or 3000 IU per vial), a 10 mL syringe pre-filled with 5 mL of Sterile Water for Injection with plunger rod attached, vial adapter with filter, and a sterile 20 mL LUER-LOK Administration Syringe. All of the kit components are not made with natural rubber latex.250 IU strength only; store at 2 to 8°C (36 to 46°F).500, 1000, 1500, 2000, and 3000 IU strengths: store at 2 to 25°C (36 to 77°F).Do not freeze.Keep the vial in the carton and protect from light.Infuse reconstituted solution immediately or within 3 hours of storage at room temperature after reconstitution. Do not refrigerate after reconstitution.IXINITY is supplied as a lyophilized powder in single-use glass vials containing the labeled amount of factor IX activity, expressed in international units (IU). The actual factor IX activity in IU is stated on the label of each vial.Kits include one or two single-use vials (containing nominally 250, 500, 1000, 1500, 2000, or 3000 IU per vial), a 10 mL syringe pre-filled with 5 mL of Sterile Water for Injection with plunger rod attached, vial adapter with filter, and a sterile 20 mL LUER-LOK Administration Syringe. All of the kit components are not made with natural rubber latex.250 IU strength only; store at 2 to 8°C (36 to 46°F).500, 1000, 1500, 2000, and 3000 IU strengths: store at 2 to 25°C (36 to 77°F).Do not freeze.Keep the vial in the carton and protect from light.Infuse reconstituted solution immediately or within 3 hours of storage at room temperature after reconstitution. Do not refrigerate after reconstitution.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Hemophilia B is a sex-linked hereditary disorder of blood coagulation caused by a deficiency in factor IX and results in bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. Treatment with IXINITY replaces factor IX, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.

Non-Clinical Toxicology
IXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [].

The presence of barium sulfate formulations in the GI tract may alter the absorption of therapeutic agents taken concomitantly. In order to minimize any potential change in absorption, the separate administration of barium sulfate from that of other agents should be considered.

Hypersensitivity reactions, including anaphylaxis, may occur with IXINITY, and have been reported with factor IX containing products. Signs of allergic reactions, which can progress to anaphylaxis, include angioedema, chest tightness, hypotension, lethargy, nausea, vomiting, paresthesia, restlessness, wheezing and dyspnea. Immediately discontinue administration and initiate appropriate treatment if allergic or anaphylactic-type reactions occur. In case of severe allergic reactions, consider alternative hemostatic measures.

There are literature reports of allergic reactions occurring in close temporal association with the development of factor IX inhibitors.

IXINITY contains trace amounts of Chinese hamster ovary (CHO) proteins. Patients treated with this product may develop hypersensitivity to CHO proteins.

The most common adverse reaction (> 2%) reported in clinical trials was headache.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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