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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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.
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NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
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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 quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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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.