Factor IX, Recombinant

Factor IX, Recombinant is a prescription medication used to control and prevent bleeding episodes in adults with hemophilia B, for perioperative management, and for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in people with hemophilia B.

•  Factor IX, Recombinant is available under the following different brand names: Rixubis, BeneFIX, Alprolix, Ixinity, Rebinyn, nonacog beta pegol

Common side effects of  Factor IX, Recombinant include:

• fever
• injection site reactions (pain, redness, or swelling)
• chills
• headache
• flushing (warmth, redness, or tingly feeling under your skin)
• weakness
• nausea
• vomiting
• dizziness

Serious side effects of  Factor IX, Recombinant include:

• swelling at the injection site
• shortness of breath
• fast heartbeat
• signs of kidney problems (such as a change in the amount of urine)
• swelling of the ankles/feet, pain/redness/swelling of arms or legs
• new or increased bleeding/bruising
• bluish fingers
• chest pain
• trouble breathing

Rare side effects of  Factor IX, Recombinant include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Lyophilized powder for reconstitution

• 250 IU
• 500 IU
• 1000 IU
• 1500 IU
• 2000 IU
• 3000 IU

Hemophilia B, bleeding episodes

Adult and pediatric dosage

• Initial dose
  • Initial dose = body weight (kg) × desired factor IX increase (% or IU/dL) × reciprocal of observed recovery (IU/dL per IU/kg)
• Incremental recovery in previously treated patients (Rixubis)
  • For incremental recovery of 0.9 IU/dL, the dose is calculated as follows:
  • Dose (IU) = body weight (kg) × desired factor IX increase (% or IU/dL) × 1.1 dL/kg
• Incremental recovery in previously treated patients (BeneFIX)
  • For incremental recovery of 0.8 IU/dL, the dose is calculated as follows:
  • Dose (IU) = body weight (kg) × desired factor IX increase (% or IU/dL) ×1.3 dL/kg
• Incremental recovery in previously treated patients (Ixinity)
  • For incremental recovery of 0.98 IU/dL, the dose is calculated as follows:
  • Dose (IU) = body weight (kg) × desired factor IX increase (% or IU/dL) × 1.02 dL/kg
• Control and prevention of bleeding episodes (Rixubis, BeneFIX)
  • Minor: Circulating factor IX level required = 20-30 IU/dL; dosing interval 12-24 hours; treatment duration at least 1 day until healing is achieved
  • Moderate: Circulating factor IX level required = 25-50 IU/dL; dosing interval 12-24 hours; treatment duration 2-7 days until bleeding stops and healing is achieved
  • Major: Circulating factor IX level required = 50-100 IU/dL; dosing interval 12-24 hours; treatment duration 7-10 days until bleeding stops and healing is achieved
• Control and prevention of bleeding episodes (Alprolix)
  • Minor and moderate: Circulating factor IX level required = 30-60 IU/dL; dosing interval 24 hours as needed
  • Major: Circulating factor IX level required = 80-100 IU/dL; consider repeating dose after 6-10 hours, then every 24 hours ×3 days, then every 48 hours until healing is achieved
• Control and prevention of bleeding episodes (Ixinity)
  • Minor: Circulating factor IX level required = 30-60 IU/dL; dosing interval 24 hours as needed; 1-3 days until healing achieved
  • Moderate: Circulating factor IX level required = 40-80 IU/dL; dosing interval 24 hours as needed; 2-7 days until healing achieved
  • Major: Circulating factor IX level required = 60-100 IU/dL; dosing interval 12-24 hours as needed; 2-14 days until healing achieved
• Control and prevention of bleeding episodes (Rebinyn; nonacog beta pegol)
  • Minor and moderate: 40 IU/kg IV as a single dose is typically sufficient; additional doses can be given if needed
  • Major: 80 IU/kg IV; additional doses of 40 IU/kg can be given
• Perioperative management (Rixubis)
  • Minor (eg, tooth extraction): Circulating factor IX level required = 30-60 IU/dL; dosing interval 24 hours; treatment duration at least 1 day until healing achieved
  • Major: Circulating factor IX level required = 80-100 IU/dL; dosing interval 8-24 hours; treatment duration 7-10 days until bleeding stops and healing is achieved
• Perioperative management (BeneFIX)
  • Minor: Circulating factor IX level required = 20-30 IU/dL; dosing interval 12-24 hours; treatment duration at least 1 day until healing is achieved
  • Moderate: Circulating factor IX level required = 25-50 IU/dL; dosing interval 12-24 hours; treatment duration 2-7 days until bleeding stops and healing is achieved
  • Major: Circulating factor IX level required = 50-100 IU/dL; dosing interval 12-24 hours; treatment duration 7-10 days until bleeding stops and healing is achieved
• Perioperative management (Alprolix)
  • Minor and moderate: Circulating factor IX level required = 50-80 IU/dL; a single infusion may be sufficient, may repeat as needed after 24-48 hours until bleeding stops, and healing is achieved
  • Major: Circulating factor IX level required = 60-100 IU/dL (initial level); consider repeating dose after 6-10 hours, then every 24 hours ×3 days, may then reduce the dose and extend the dosing interval to every 48 hours (or longer) until the bleeding stopped and healing achieved
• Perioperative management (Ixinity)
  • Minor, pre-op: Circulating factor IX level required = 50-80 IU/dL
  • Minor, post-op: Circulating factor IX level required = 30-80 IU/dL; dosing interval 24 hours; treatment duration 1-5 days depending on the type of procedure
  • Major, pre-op: Circulating factor IX level required = 60-80 IU/dL
• Major, post-op
• Dosing interval 8-24 hours
  • Days 1-3: Circulating factor IX level required = 40-60 IU/dL
  • Days 4-6: Circulating factor IX level required = 30-50 IU/dL
  • Days 7-14: Circulating factor IX level required = 20-40 IU/dL
• Perioperative management (Rebinyn)
  • Minor: 40 IU/kg IV as a single preoperative dose is typically sufficient; additional doses can be given if needed
  • Major: 80 IU/kg IV as a single preoperative dose

Hemophilia B, Routine Prophylaxis

Adult dosage

• Alprolix
  • Initial: 50 IU/kg IV once weekly OR 100 IU/kg every 10 days
  • Adjust dose based on individual response
• Ixinity
  • Children aged 12 years and older: 40-70 IU/kg IV 2× per week
  • Adjust the dose based on age, bleeding pattern, and physical activity
• Rixubis
  • 40-60 IU/kg IV bolus 2× per week; not to exceed infusion rate of 10 mL/min
  • Adjust the dose based on age, bleeding pattern, and physical activity
• Rebinyn
  • 40 IU/kg IV every week
  • Adjust the dose based on age, bleeding pattern, and physical activity

Pediatric dosage

Alprolix

• Initial: 50 IU/kg IV once weekly OR 100 IU/kg every 10 days
• Adjust dose based on individual response
• Ixinity
  • Children aged younger than 12 years: 40-70 IU/kg IV 2× per week
  • Adjust the dose based on age, bleeding pattern, and physical activity
• Rixubis
  • Children aged younger than 12 years: 60-80 IU/kg IV 2× per week
  • Children aged 12 years and older: 40-60 IU/kg IV 2× per week
  • The maximum infusion rate is 10 mL/min
  • Adjust dose-based age, bleeding pattern, and physical activity
• Rebinyn
  • 40 IU/kg IV every week
  • Adjust the dose based on age, bleeding pattern, and physical activity
• Dosage Considerations – Should be Given as Follows:
  • See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

•  Factor IX, Recombinant has no noted severe interactions with any other drugs.
•  Factor IX, Recombinant has no noted serious interactions with any other drugs.
•  Factor IX, Recombinant has no noted moderate interactions with any other drugs.
•  Factor IX, Recombinant has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to the product or its excipients including hamster protein
• Disseminated intravascular coagulation (DIC)
• Signs of fibrinolysis

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using  Factor IX, Recombinant?”

Long-Term Effects

• See “What Are Side Effects Associated with Using  Factor IX, Recombinant?”

Cautions

• Hypersensitivity reactions including anaphylaxis reported, particularly with initial exposure in previously untreated patients to factor IX inhibitors may develop
• Nephrotic syndrome reported
• Thromboembolic complications may occur (eg, PE, venous or arterial thrombosis); monitor for thrombotic and consumptive coagulopathy, especially in patients with liver disease, signs of fibrinolysis, peri- and post-operatively, or at risk for thrombotic events or DIC
• Monitor factor IX activity plasma levels by the one-stage clotting assay to confirm factor IX levels achieved and maintained

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy
• Lactation
  • Unknown if distributed in human breast milk