Dosing & Uses
Dosage Forms & Strengths
lyophilized powder for reconstitution
- 250 IU
- 500 IU
- 1000 IU
- 1500 IU
- 2000 IU
- 3000 IU
Hemophilia B, Bleeding Episodes
Indicated for control and prevention of bleeding episodes and perioperative management
Initial dose
- Initial dose = body weight (kg) x desired factor IX increase (% or IU/dL) x 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) x desired factor IX increase (% or IU/dL) x 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) x desired factor IX increase (% or IU/dL) x 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) x desired factor IX increase (% or IU/dL) x 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 hr; treatment duration at least 1 day until healing achieved
- Moderate: Circulating factor IX level required = 25-50 IU/dL; dosing interval 12-24 hr; treatment duration 2-7 days until bleeding stops and healing achieved
- Major: Circulating factor IX level required = 50-100 IU/dL; dosing interval 12-24 hr; treatment duration 7-10 days until bleeding stops and healing achieved
Control and prevention of bleeding episodes (Alprolix)
- Minor and moderate: Circulating factor IX level required = 30-60 IU/dL; dosing interval 24 hr prn
- Major: Circulating factor IX level required = 80-100 IU/dL; consider repeating dose after 6-10 hr, then q24hr x3 days, then q48hr until healing achieved
Control and prevention of bleeding episodes (Ixinity)
- Minor: Circulating factor IX level required = 30-60 IU/dL; dosing interval 24 hr prn; 1-3 days until healing achieved
- Moderate: Circulating factor IX level required = 40-80 IU/dL; dosing interval 24 hr prn; 2-7 days until healing achieved
- Major: Circulating factor IX level required = 60-100 IU/dL; dosing interval 12-24 hr prn; 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 give 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 hr; treatment duration at least 1 day until healing achieved
- Major: Circulating factor IX level required = 80-100 IU/dL; dosing interval 8-24 hr; treatment duration 7-10 days until bleeding stops and healing achieved
Perioperative management (BeneFIX)
- Minor: Circulating factor IX level required = 20-30 IU/dL; dosing interval 12-24 hr; treatment duration at least 1 day until healing achieved
- Moderate: Circulating factor IX level required = 25-50 IU/dL; dosing interval 12-24 hr; treatment duration 2-7 days until bleeding stops and healing achieved
- Major: Circulating factor IX level required = 50-100 IU/dL; dosing interval 12-24 hr; treatment duration 7-10 days until bleeding stops and healing 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 hr until bleeding stopped and healing achieved
- Major: Circulating factor IX level required = 60-100 IU/dL (initial level); consider repeating dose after 6-10 hr, then q24hr x3 days, may then reduce dose and extend dosing interval to q48hr (or longer) until 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 hr; treatment duration 1-5 days depending on type of procedure
- Major, pre-op: Circulating factor IX level required = 60-80 IU/dL
-
Major, post-op
- Dosing interval 8-24 hr
- 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 give if needed
- Major: 80 IU/kg IV as a single preoperative dose
Hemophilia B, Routine Prophylaxis
Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
Alprolix
- Initial: 50 IU/kg IV once weekly OR 100 IU/kg q10days
- Adjust dose based on individual response
Ixinity
- ≥12 years: 40-70 IU/kg IV 2x/week
- Adjust dose based on age, bleeding pattern, and physical activity
Rixubis
- 40-60 IU/kg IV bolus 2x/week; not to exceed infusion rate of 10 mL/min
- Adjust dose based on age, bleeding pattern, and physical activity
Dosing Considerations
Rixubis: 1 IU/kg is expected to increase circulating level of Factor IX by 0.9 IU/dL of plasma
BeneFIX (adults): 1 IU/kg is expected to increase circulating level of Factor IX by 0.8 IU/dL (range 0.4-1.2 IU/dL)
Alprolix: 1 IU/kg is expected to increase circulating level of Factor IX by 1% (IU/dL)
Rebinyn: Conjugated to a 40-kDa polyethylene glycol molecule, which slows down its removal from the blood circulation; each vial is labeled with the actual Factor IX potency in IU
Dosage Forms & Strengths
lyophilized powder for reconstitution
- 250 IU
- 500 IU
- 1000 IU
- 1500 IU
- 2000 IU
- 3000 IU
Hemophilia B, Bleeding Control
BeneFIX: Approved for children <15 yr; indicated for control and prevention of bleeding episodes and perioperative management
Ixinity: Approved for children ≥12 yr; indicated for control and prevention of bleeding episodes and perioperative management
Alprolix, Rixubix: Approved for children; indicated for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent/reduce frequency of bleeding episodes
Initial dose
- Initial dose = body weight (kg) x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/dL per IU/kg)
Incremental recovery in previously treated patients (BeneFIX)
- For incremental recovery of 0.7 IU/dL, the dose is calculated as follows:
- Dose (IU) = body weight (kg) x desired factor IX increase (% or IU/dL) x1.4 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) x desired factor IX increase (% or IU/dL) x 1.02 dL/kg
Control and prevention of bleeding episodes (BeneFIX)
- Minor: Circulating factor IX level required = 20-30 IU/dL; dosing interval 12-24 hr; treatment duration at least 1 day until healing achieved
- Moderate: Circulating factor IX level required = 25-50 IU/dL; dosing interval 12-24 hr; treatment duration 2-7 days until bleeding stops and healing achieved
- Major: Circulating factor IX level required = 50-100 IU/dL; dosing interval 12-24 hr; treatment duration 7-10 days until bleeding stops and healing achieved
Control and prevention of bleeding episodes (Alprolix)
- Minor and moderate: Circulating factor IX level required = 30-60 IU/dL; dosing interval 24 hr prn
- Major: Circulating factor IX level required = 80-100 IU/dL; consider repeating dose after 6-10 hr, then q24hr x3 days, then q48hr until healing achieved
Control and prevention of bleeding episodes (Ribuxis)
- Minor: Circulating factor IX level required = 20-30 IU/dL; dosing interval 12-24 hr prn; at least 1 day until healing achieved
- Moderate: Circulating factor IX level required = 25-50 IU/dL; dosing interval 12-24 hr prn; at least 2-7 days until healing achieved
- Major: Circulating factor IX level required = 50-100 IU/dL; dosing interval 12-24 hr prn; at least 7-10 days until healing achieved
Control and prevention of bleeding episodes (Ixinity)
- Minor: Circulating factor IX level required = 30-60 IU/dL; dosing interval 24 hr prn; 1-3 days until healing achieved
- Moderate: Circulating factor IX level required = 40-80 IU/dL; dosing interval 24 hr prn; 2-7 days until healing achieved
- Major: Circulating factor IX level required = 60-100 IU/dL; dosing interval 12-24 hr prn; 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 give if needed
- Major: 80 IU/kg IV; additional doses of 40 IU/kg can be given
Perioperative management (BeneFIX)
- Minor: Circulating factor IX level required = 20-30 IU/dL; dosing interval 12-24 hr; treatment duration at least 1 day until healing achieved
- Moderate: Circulating factor IX level required = 25-50 IU/dL; dosing interval 12-24 hr; treatment duration 2-7 days until bleeding stops and healing achieved
- Major: Circulating factor IX level required = 50-100 IU/dL; dosing interval 12-24 hr; treatment duration 7-10 days until bleeding stops and healing 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 hr until bleeding stopped and healing achieved
- Major: Circulating factor IX level required = 60-100 IU/dL (initial level); consider repeating dose after 6-10 hr, then q24hr x3 days, may then reduce dose and extend dosing interval to q48hr (or longer) until bleeding stopped and healing achieved
Perioperative management (Rixubis)
- Minor: Circulating factor IX level required = 30-60 IU/dL; dosing interval 24 hr; at least 1 day until healing achieved
- Major: Circulating factor IX level required = 80-100 IU/dL; dosing interval 8-24 hr; at least 7-10 days until 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 hr; treatment duration 1-5 days depending on type of procedure
- Major, pre-op: Circulating factor IX level required = 60-80 IU/dL
-
Major, post-op
- Dosing interval 8-24 hr
- 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 give if needed
- Major: 80 IU/kg IV as a single preoperative dose
Hemophilia B, Routine Prophylaxis
Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
Alprolix
- Initial: 50 IU/kg IV once weekly OR 100 IU/kg q10days
- Adjust dose based on individual response
Rixubis
- <12 years: 60-80 IU/kg IV 2x/week
- ≥12 years: 40-60 IU/kg IV 2x/week
- Maximum infusion rate is 10 mL/min
- Adjust dose based age, bleeding pattern, and physical activity
Dosing Considerations
BeneFIX (children <15 years): 1 IU/kg is expected to increase circulating level of Factor IX by 0.7 IU/dL (range 0.2-2.1 IU/dL)
Alprolix: 1 IU/kg is expected to increase circulating level of Factor IX by 1% (IU/dL)
Alprolix (<12 years): May have higher Factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery; therefore, higher dose/kg or more frequent dosing may be needed
Rixubis (<12 years): 1 IU/kg is expected to increase circulating level of Factor IX by 0.7 IU/dL
Rixubis (≥12 years): 1 IU/kg is expected to increase circulating level of Factor IX by 0.9 IU/dL
Rebinyn: Conjugated to a 40-kDa polyethylene glycol molecule, which slows down its removal from the blood circulation; each vial is labeled with the actual Factor IX potency in IU
Adverse Effects
>10% (BeneFIX)
Headache (10.8%)
1-10% (BeneFIX)
Dizziness (7.7%)
Injection site reaction (7.7%)
Injection site pain (6.2%)
Nausea (6.2%)
Rash (6.2%)
Taste perversion (4.6%)
Hives (3.1%)
Flushing (3.1%)
Fever (3.1%)
Factor IX inhibition (1.5%)
Blurred vision (1.5%)
Vomiting (1.5%)
Cellulitis at IV site (1.5%)
Phlebitis at IV site (1.5%)
Shaking (1.5%)
Drowsiness (1.5%)
Renal infarct (1.5%)
Dry cough (1.5%)
Hypoxia (1.5%)
Chest tightness (1.5%)
1-10% (Rixubis)
Factor IX or furin antibodies (7.7%)
Dysgeusia (1.1%)
Pain in extremity (1.1%)
Positive furin antibody test (1.1%)
1-10% (Alprolix)
Headache (1.7%)
Oral paresthesia (1.7%)
<1% (Alprolix)
Dizziness
Dysgeusia
Breath odor
Fatigue
Infusion site pain
Palpitations
Obstructive uropathy
Hypotension
Warnings
Contraindications
Hypersensitivity to product or its excipients including hamster protein
Disseminated intravascular coagulation (DIC)
Signs of fibrinolysis
Cautions
Hypersensitivity reactions including anaphylaxis reported, particularly with initial exposure in previously untreated patients 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 & Lactation
Pregnancy Category: C
Lactation: Unknown if distributed in human breast milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Temporarily replaces missing clotting factor IX which corrects and/or prevents bleeding
Absorption
Rixubis
- Peak plasma concentration: 66.2-72.7 IU/dL
- AUC: 1207-1305 IU•hr/dL
BeneFIX
- Peak plasma concentration: 54.5 IU/dL
- AUC: 548-940 IU•hr/dL
Alprolix
- Peak plasma concentration: 46 IU/dL
- 1619 IU•hr/dL
Rebinyn
- Peak plasma concentration: 65.5-97.9 IU/d
- AUC: 9072-9280 IU·hr/dL
Distribution
Rixubis
- Vd: 201.9-178.6 mL/kg
Alprolix
- Vd: 327 mL/kg
Rebinyn
- Vd: 60.5-64.8 mL/kg
Elimination
Rixubis
- Half-life: 25.4-26.7 hr
- Clearance: 6-6.4 mL/kg/hr
BeneFIX
- Half-life: 18.1-22.4 hr (adults); 19.8 hr (children 2-12 years); 21.1 hr (children 12-15 years)
- Clearance: ~8.5 mL/kg/hr
Alprolix
- Half-life: 86.52 hr
- Clearance: 3.3 mL/kg/hr
Rebinyn
- Half-life: 103.1-114.9 hr
- Clearance: 0.4 mL/hr/kg
Administration
IV Preparation
BeneFIX, Alprolix, Rebinyn: Use the adapter and supplied diluent syringe to reconstitute each vial (see package instructions)
Rixubis: Use the Baxject II device and sterile water for injection provided in each kit to reconstitute each vial (see package instructions)
IV Administration
Safety and efficacy of administration by continuous infusion has not been established
BeneFIX: Administer IV over several minutes
Alprolix, Ixinity, Rixubis: Administer by IV bolus at rate not to exceed 10 mL/min
Rebinyn: Administer IV over 1-4 minutes
Storage
Unopened vials
- Refrigerate at 2-8°C (35-46°F) in original carton for up to 18 months; do not freeze, OR
- May store at room temperature, not to exceed 30°C (86°F) for up to 6 months within the 18 month time period (mark carton on date removed from refrigerator)
- Once stored at room temperature, do not return product to refrigerator
Reconstituted vials
- Use within 3 hr following reconstitution
- Do not refrigerate after reconstitution
- Discard partially used vials
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Rixubis intravenous - | 250 unit vial |  | |
| Rixubis intravenous - | 1,000 unit vial |  | |
| Rixubis intravenous - | 3,000 unit vial |  | |
| Rixubis intravenous - | 2,000 unit vial |  | |
| Rixubis intravenous - | 500 unit vial |  | |
| BeneFIX intravenous - | 2,000 unit vial |  | |
| BeneFIX intravenous - | 250 unit vial |  | |
| BeneFIX intravenous - | 1,000 unit vial |  | |
| BeneFIX intravenous - | 500 unit vial |  | |
| BeneFIX intravenous - | 3,000 unit vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
coagulation factor IX (recomb) intravenous
FACTOR IX, RECOMBINANT - INJECTION
(FACK-ter nine)
COMMON BRAND NAME(S): Alprolix, Benefix, Ixinity
USES: This medication is used to prevent or control bleeding in people with little or no factor IX (due to hemophilia B, Christmas disease). Factor IX is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and stop bleeding. People with little or no factor IX are at risk for bleeding longer after an injury/surgery or bleeding suddenly (often in the joints/muscle) without an obvious cause.This medication should not be used to treat other types of factor deficiencies (such as factors II, VII, VIII, X) or factor problems (such as inhibitor to factor XIII), to reverse the effects of "blood thinners" (such as warfarin), or to treat bleeding from low levels of liver-dependent clotting factors (due to liver problems).
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using factor IX and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein over several minutes as directed by your doctor. Dosage is based on your medical condition (such as the amount and location of bleeding), weight, and response to treatment.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.The medication in the vial and the supplies that come with the medication should be used only once. Do not reuse.For some brands, it is important to limit the amount of blood entering the tubing and to avoid letting any blood enter the syringe. You may need to use a new vial of medication and new set of supplies if this occurs. Consult your pharmacist for details.Tell your doctor if your condition lasts or gets worse.
SIDE EFFECTS: Fever, pain at injection site, chills, headache, flushing, weakness, nausea, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: swelling at injection site, shortness of breath, fast heartbeat, signs of kidney problems (such as change in the amount of urine), swelling of the ankles/feet, pain/redness/swelling of arms or legs, new or increased bleeding/bruising.Get medical help right away if any of these rare but very serious side effects occur: bluish fingers, chest pain, trouble breathing.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using factor IX, tell your doctor or pharmacist if you are allergic to factor IX products; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: other clotting disorders (such as disseminated intravascular coagulation-DIC), recent surgery/procedure, liver disease.Before having surgery, tell your doctor or dentist that you are using this medication.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: drugs that help with clotting (such as aminocaproic acid, tranexamic acid).
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as factor IX activity) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised April 2022. Copyright(c) 2022 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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