Factor IX, recombinant/albumin fusion protein (Rx)

Brand and Other Names:Idelvion
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder for reconstitution

  • 250 IU/vial
  • 500 IU/vial
  • 1000 IU/vial
  • 2000 IU/vial
  • 3500 IU/vial

Hemophilia B

Indicated for children and adults with hemophilia B (congenital Factor IX deficiency) for

  • On-demand control and prevention of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes

Dose calculation

  • Dosage and treatment duration depends on the severity of Factor IX deficiency, the location and extent of bleeding, and the patient’s clinical condition, age, and recovery of Factor IX
  • Calculating the required dose is based on the empirical finding that one IU per kg body weight is expected to increase the circulating level of Factor IX by 1.3 IU/dL in patients aged ≥12 yr, and by 1 IU/dL in patients aged <12 yr
  • Required units (IU) = Body weight (kg) x desired Factor IX rise (% of normal or IU/dL) x (reciprocal of recovery [IU/dL per IU/kg]), OR
  • Increase in Factor IX IU/dL (or % of normal) = Dose (IU) x recovery (IU/dL per IU/kg)/body weight (kg)
  • Adjust the dose based on the individual patient’s clinical condition and response

Hemophilia B, Bleeding Episodes

Indicated for on-demand control and prevention of bleeding episodes

Minor or moderate

  • Uncomplicated hemarthrosis, muscle bleeding (except iliopsoas), or oral bleeding
  • Maintain circulating FIX at 30-60 % or IU/dL; may repeat q48-72hr; duration of at least 1day, until bleeding stops and healing is achieved; single dose should be sufficient for majority of these bleeds

Major

  • Life- or limb-threatening hemorrhage; deep muscle bleeding, including iliopsoas, intracranial, and retropharyngeal
  • Maintain circulating Factor IX at 60-100 % or IU/dL; may repeat q48-72hr; duration of 7-14 days, until bleeding stops and healing is achieved; consider weekly maintenance dose

Hemophilia B, Perioperative Management

Indicated for perioperative management of bleeding

Minor

  • Includes uncomplicated tooth extraction
  • Maintain circulating Factor IX at 50-80 % or IU/dL; duration of at least 1day or until healing is achieved; single dose should be sufficient for majority of minor surgeries

Major

  • Includes intracranial, pharyngeal, retropharyngeal, or retroperitoneal
  • Maintain circulating FactorIX at 60-100 % or IU/dL; repeat q48-72hr for first week or until healing achieved; duration of 7-14 days, until bleeding stops and healing is achieved; maintenance dose 1-2 times per week

Hemophilia B, Routine Prophylaxis

Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes

25-40 IU/kg IV q7days

Patients who are well-controlled on the 7-day regimen may be switched to a 14-day interval regimen of 50-75 IU/kg

Adjust dose based on individual response

Dosing Considerations

Limitation of use: Not indicated for immune tolerance induction in patients with hemophilia B

Dosage Forms & Strengths

lyophilized powder for reconstitution

  • 250 IU/vial
  • 500 IU/vial
  • 1000 IU/vial
  • 2000 IU/vial
  • 3500 IU/vial

Hemophilia B

Indicated for children and adults with hemophilia B (congenital Factor IX deficiency) for

  • On-demand control and prevention of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes

Dose calculation

  • Dosage and treatment duration depends on the severity of Factor IX deficiency, the location and extent of bleeding, and the patient’s clinical condition, age, and recovery of Factor IX
  • Calculating the required dose is based on the empirical finding that one IU per kg body weight is expected to increase the circulating level of Factor IX by 1.3 IU/dL in patients aged ≥12 yr, and by 1 IU/dL in patients aged <12 yr
  • Required units (IU) = Body weight (kg) x desired Factor IX rise (% of normal or IU/dL) x (reciprocal of recovery [IU/dL per IU/kg]), OR
  • Increase in Factor IX IU/dL (or % of normal) = Dose (IU) x recovery (IU/dL per IU/kg)/body weight (kg)
  • Adjust the dose based on the individual patient’s clinical condition and response

Hemophilia B, Bleeding Episodes

Indicated for on-demand control and prevention of bleeding episodes

Minor or moderate

  • Uncomplicated hemarthrosis, muscle bleeding (except iliopsoas), or oral bleeding
  • Maintain circulating Factor IX at 30-60 % or IU/dL; may repeat q48-72hr; duration of at least 1day, until bleeding stops and healing is achieved; single dose should be sufficient for majority of these bleeds

Major

  • Life or limb threatening hemorrhage; deep muscle bleeding, including iliopsoas, intracranial, and retropharyngeal
  • Maintain circulating Factor IX at 60-100 % or IU/dL; may repeat q48-72hr; duration of 7-14 days, until bleeding stops and healing is achieved; consider weekly maintenance dose

Hemophilia B, Perioperative Management

Indicated for perioperative management of bleeding

Minor

  • Includes uncomplicated tooth extraction
  • Maintain circulating Factor IX at 50-80 % or IU/dL; duration of at least 1day or until healing is achieved; single dose should be sufficient for majority of minor surgeries

Major

  • Includes intracranial, pharyngeal, retropharyngeal, or retroperitoneal
  • Maintain circulating Factor IX at 60-100 % or IU/dL; repeat q48-72hr for first week or until healing achieved; duration of 7-14 days, until bleeding stops and healing is achieved; maintenance dose 1-2 times per week

Hemophilia B, Routine Prophylaxis

Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes

<12 years: 40-55 IU/kg IV q7days

≥12 years

  • 25-40 IU/kg IV q7days
  • Patients who are well-controlled on the 7-day regimen may be switched to a 14-day interval regimen of 50-75 IU/kg
  • Adjust dose based on individual response

Dosing Considerations

Limitation of use: Not indicated for immune tolerance induction in patients with hemophilia B

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Adverse Effects

1-10%

Headache (1.8%)

<1%

Dizziness

Hypersensitivity

Rash

Eczema

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Warnings

Contraindications

Life-threatening hypersensitivity reactions to the drug or its components, including hamster proteins

Cautions

Hypersensitivity reactions, including anaphylaxis, are possible; if hypersensitivity symptoms occur, immediately discontinue administration and initiate appropriate treatment (see Contraindications)

Formation of neutralizing antibodies to Factor IX may occur

Thromboembolism (eg, pulmonary embolism, venous thrombosis, arterial thrombosis) may occur when using Factor IX-containing products

Nephrotic syndrome reported following attempted immune tolerance induction in hemophilia B patients who develop

Patients with Factor IX inhibitors and a history of allergic reactions

Monitor Factor IX plasma levels and development of inhibitors

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Pregnancy & Lactation

Pregnancy

No data exist regarding use in pregnant women to inform on drug-associated risk

Animal reproduction studies have not been conducted

Should be given to a pregnant woman only if clearly needed

Lactation

Unknown if distributed in human breast milk

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

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.

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Pharmacology

Mechanism of Action

Recombinant protein that temporarily replaces missing coagulation Factor IX needed for effective hemostasis

Comprised of genetically fused recombinant coagulation Factor IX and recombinant albumin; fusion with recombinant albumin extends the half-life of Factor IX

Absorption

Peak plasma concentration: 41.1-82 IU/dL

AUC: 4658-9345 h·IU/dL

Distribution

Vd: 0.86-1.2 dL/kg

Elimination

Half-life: 104-188 hr

Mean residence time: 143-153 hr

Clearance: 0.57-0.84 mL/hr/kg

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Administration

IV Preparation

Each vial contains the recombinant Factor IX potency in international units (IU) that is stated on the carton and vial label

Follow directions within kit by using provided diluent (sterile water for injection) and Mix2Vial provided

IV Administration

For IV use after reconstitution only

Do not mix or administer in the same tubing or container with other medicinal products

Visually inspect the final solution for particulate matter and discoloration; do not use if particulate matter or discoloration observed

Attach the syringe containing the reconstituted solution to a sterile infusion set and administer by IV injection

Adapt the infusion rate to the comfort level of each patient, not exceeding 10 mL/min

Administer at room temperature and within 4 hr of reconstitution

Discard any unused product

Storage

Unreconstituted vial

  • Store in original package to protect from light
  • May store in refrigeratory or at room temperature (2-25°C [36-77°F])
  • Do not freeze
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Images

No images available for this drug.
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Patient Handout

Patient Education
factor IX recombinant, Fc fusion protein 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 therefore 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 (e.g., factors II, VII, VIII, X) or factor problems (e.g., inhibitor to factor XIII), to reverse the effects of "blood thinners" (e.g., 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 persists or worsens.

SIDE EFFECTS: Fever, pain at injection site, chills, headache, flushing, weakness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she 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 (e.g., 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 (e.g., 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 October 2020. Copyright(c) 2021 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.

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.