Coagulation Factor IX (Recombinant)

What is Coagulation Factor IX (Recombinant)?

• Coagulation Factor IX (Recombinant) (Rixubis) (Coagulation Factor IX [Recombinant]) is an antihemophilic factor used for the treatment of hemophilia B.

What are the uses of this medicine?

This medicine is used 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.

limitation of use:

• Rixubis is not indicated for induction of immune tolerance in patients with Hemophilia B.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Known hypersensitivity to Rixubis or its excipients including hamster protein
• Disseminated Intravascular Coagulation (DIC)
• Signs of fibrinolysis

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Rixubis.

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013.

How should this medicine be used?

Recommended Dosage: On-demand treatment and control of bleeding episodes and perioperative management of bleeding:

• One international unit of Rixubis per kg of body weight increases the circulating activity of factor IX by 0.7 international units/dL for patients <12 years of age and 0.9 international units/dL for patients ≥12 years of age.

Initial Dose:

• Required international units = body weight (kg) × desired factor IX increase (% of normal or IU/dL) × reciprocal of observed recovery (IU/kg per IU/dL).
• The maintenance dose depends on the type of bleed or surgery, the intensity of the hemostatic challenge, and number of days until adequate wound healing is achieved.

Routine prophylaxis:

• Patients <12 years of age: 60 to 80 international units per kg twice weekly.
• Patients ≥12 years of age: 40 to 60 international units per kg twice weekly.

Administration

• The safety and efficacy of Rixubis administration by continuous infusion has not been established.
• Inspect parenteral drug products for particulate matter and discoloration prior to administration. The solution should be clear and colorless in appearance. Do not use Rixubis if you notice any particulates or turbidity in the solution and notify Baxalta.
• Perform product administration and handling of the administration set and needles with caution. Percutaneous puncture with a needle contaminated with blood can transmit infectious viruses including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs. Place needles in a sharps container after single-use.
• Administer Rixubis at room temperature and within 3 hours of reconstitution. Discard any unused product.
• Use a plastic syringe with this product.
• Remove the blue cap from the BAXJECT II device. Connect the syringe to the BAXJECT II device by screwing it clockwise until the syringe is secured . Do not over tighten.
• Do not inject air.
• Turn the system upside down (factor concentrate vial now on top). Draw the factor concentrate into the syringe by pulling the plunger back slowly.
• Disconnect the syringe by unscrewing it counterclockwise; attach a suitable needle to the syringe and inject intravenously by bolus infusion. If a patient is to receive more than one vial of Rixubis, the contents of multiple vials may be drawn into the same syringe.
• Maximum infusion rate of 10 mL/min.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a lyophilized powder in single-dose vials containing nominally 250, 500, 1000, 2000 or 3000 international units.

This medicine is available in fallowing brand namesː

• Rixubis

What side effects can this medication cause?

The most common side effects of this medicine include:

• dysgeusia
• pain in extremity
• positive test for furin antibody

What special precautions should I follow?

• 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.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no data with Rixubis use in pregnant women to inform a drug-associated risk.
• Rixubis can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Can this medicine be used in children?

• Safety, efficacy and pharmacokinetics of Rixubis have been evaluated in 23 previously treated pediatric patients.
• A 22% lower recovery has been observed in pediatric patients (<12 years, n=23). Clearance (based on per kg body weight) was 30% (6-12 years) and 59% (<6 years) higher in children than adults.
• Dose adjustment is needed.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• COAGULATION FACTOR IX RECOMBINANT HUMAN

Inactive ingredients:

• HISTIDINE
• SODIUM CHLORIDE
• CALCIUM CHLORIDE
• MANNITOL
• SUCROSE
• POLYSORBATE 80

Who manufactures and distributes this medicine?

• Packager: BAXALTA US INC.

What should I know about storage and disposal of this medication?

• 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.
• Do not use beyond the expiration date printed on the carton or vial.

• Dailymed label info on Coagulation Factor IX (Recombinant)
• FDA Coagulation Factor IX (Recombinant)