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Molecule

Coagulation factor ix

Available on requestBiologicCold chain
Presentations
5
Brands
5
Manufacturers
5
Available from stock
0

Coagulation factor ix is a prescription medicine. It is available as kits for intravenous use. MedsAcross supplies Coagulation factor ix for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

US FDA first approval
Not recorded
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous
Dosage forms
Kit
Biologic
Yes

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

RIXUBIS ® (Coagulation Factor IX [Recombinant]) is an antihemophilic factor indicated in adults and children with hemophilia B for: On-demand treatment and control of bleeding episodes Perioperative management of bleeding Routine prophylaxis to reduce the frequency of bleeding episodes. RIXUBIS is not indicated for induction of immune tolerance in patients with hemophilia B.

Source: US FDA prescribing information

How it works

Patients with hemophilia B are deficient in coagulation factor IX, which is required for effective hemostasis. Treatment with RIXUBIS temporarily replaces the missing coagulation factor IX.

Source: US FDA prescribing information

Dosing overview

For intravenous use after reconstitution only. Each vial of RIXUBIS has the recombinant Factor IX (rFIX) potency in international units stated on the vial. Initiate treatment under the supervision of a physician experienced in the treatment of hemophilia. Dosage and duration of treatment with RIXUBIS depend on the severity of factor IX deficiency, the location and extent of bleeding, the patient's clinical condition, age, and pharmacokinetic parameters of factor IX, such as incremental recovery and half-life. Dosing of RIXUBIS may differ from that of plasma-derived factor IX products. Subjects at the low end of the observed factor IX recovery range may require dose adjustment of RIXUBIS. Monitor patients using a factor IX activity assay to ensure that the desired factor IX activity plasma level has been attained.

Source: US FDA prescribing information

Contraindications

RIXUBIS is contraindicated in patients who have: Known hypersensitivity to RIXUBIS or its excipients including hamster protein Disseminated Intravascular Coagulation (DIC) Signs of fibrinolysis Do not use in patients with: Known hypersensitivity to RIXUBIS or its excipients including hamster protein. Disseminated intravascular coagulation (DIC). Signs of fibrinolysis.

Source: US FDA prescribing information

Warnings and precautions

Hypersensitivity reactions, including anaphylaxis, may occur. Should symptoms occur, discontinue RIXUBIS and administer appropriate treatment. Patients may also develop hypersensitivity to hamster (CHO) protein, which is present in trace amounts in the product. Development of neutralizing antibodies (inhibitors) to RIXUBIS may occur. If expected factor IX activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor IX inhibitor concentration. Nephrotic syndrome has been reported following immune tolerance induction with factor IX products in hemophilia B patients with factor IX inhibitors. The use of factor IX-containing products has been associated with the development of thromboembolic complications.

Source: US FDA prescribing information

Side effects

Common adverse reactions observed in >1% of subjects in clinical studies were dysgeusia, pain in extremity, and positive furin antibody test. Common adverse reactions observed in >1% of subjects in clinical trials were: dysgeusia, pain in extremity, and positive test for furin antibody.

Source: US FDA prescribing information

Storage

Store at refrigerated temperature [2°C to 8°C (36°F to 46°F)] or room temperature [not to exceed 30°C (86°F)] for up to 36 months. Do not freeze.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

5 presentations of Coagulation factor ix, sorted by availability.

MedicineManufacturerRegisterAvailability
AlphaNine SD kitIntravenous Cold chainGrifolsUS FDAAvailable on request
Alprolix kit Cold chainBioverativ TherapeuticsUS FDAAvailable on request
BeneFIX kit Cold chainWyeth BioPharmaUS FDAAvailable on request
Rixubis kit Cold chainTakeda PharmaceuticalsUS FDAAvailable on request
Ixinity kit Cold chainMedexus PharmaUS FDAAvailable on request

Brands by market

5 brand names across 1 markets.

Brand names by country

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDANot recorded—
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Coagulation factor ix available for export from India?

Yes, on request. MedsAcross lists 5 presentations of Coagulation factor ix and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Coagulation factor ix have?

The catalogue lists 5 brand names for Coagulation factor ix, including AlphaNine SD, Alprolix, BeneFIX, Ixinity, Rixubis.

Does Coagulation factor ix need cold chain shipping?

At least one listed presentation of Coagulation factor ix must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

References

  1. RIXUBIS prescribing information (Takeda Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 12 May 2026

Request Coagulation factor ix for export supply

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