Alprolix 250unit Inj, 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Coagulation Factor
Pharmacologic Class
Recombinant Factor IX, Fc Fusion Protein
Pregnancy Category
Not available
FDA Approved
Mar 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Alprolix is a medicine used to treat and prevent bleeding in people with hemophilia B. Hemophilia B is a bleeding disorder where the body doesn't make enough of a protein called Factor IX, which is needed for blood to clot. Alprolix replaces this missing protein, and because it's designed to last longer in the body, it can be given less often than some other Factor IX medicines.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an intravenous injection. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparing the Medication
This medication requires mixing before use. Follow the mixing instructions provided by your doctor. If the medication has been stored in the refrigerator, allow it to reach room temperature before mixing. Do not heat the medication, and avoid shaking the vial. Use the mixed medication within 3 hours of preparation. After mixing, do not refrigerate the medication, and protect it from direct sunlight.
Inspecting the Medication
Before using the medication, inspect the solution for any signs of cloudiness, leakage, or particles. Do not use the medication if the solution has changed color or exhibits any of these signs.
Disposing of Needles and Supplies
Dispose of used needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it. If you miss a dose, contact your doctor for guidance on what to do next.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an intravenous injection. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparing the Medication
This medication requires mixing before use. Follow the mixing instructions provided by your doctor. If the medication has been stored in the refrigerator, allow it to reach room temperature before mixing. Do not heat the medication, and avoid shaking the vial. Use the mixed medication within 3 hours of preparation. After mixing, do not refrigerate the medication, and protect it from direct sunlight.
Inspecting the Medication
Before using the medication, inspect the solution for any signs of cloudiness, leakage, or particles. Do not use the medication if the solution has changed color or exhibits any of these signs.
Disposing of Needles and Supplies
Dispose of used needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it. If you miss a dose, contact your doctor for guidance on what to do next.
Lifestyle & Tips
- Always carry your medication and supplies with you.
- Wear or carry identification (e.g., medical alert bracelet) stating you have hemophilia B.
- Avoid activities that carry a high risk of injury or bleeding.
- Discuss all medications, including over-the-counter drugs, supplements, and herbal remedies, with your doctor, as some can increase bleeding risk (e.g., aspirin, NSAIDs).
- Maintain good dental hygiene to prevent gum bleeding.
- Follow your doctor's instructions for regular infusions, even if you feel well, to prevent bleeding episodes.
Available Forms & Alternatives
Available Strengths:
- Alprolix 500unit Inj 1 Vial
- Alprolix 1000 Unit Inj 1 Vial
- Alprolix 2000 Unit Inj 1 Vial
- Alprolix 3000unit Inj 1 Vial
- Alprolix 4000unit Inj 1 Vial
- Alprolix 250unit Inj 1 Vial
- Alprolix 4000unit Inj 1 Vial
- Alprolix 250unit Inj, 1 Vial
- Alprolix 500unit Inj 1 Vial
- Alprolix 1000unit Inj 1 Vial
- Alprolix 2000unit Inj 1 Vial
- Alprolix 3000unit Inj 1 Vial
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on Factor IX activity levels, type of bleeding, and patient's clinical condition. For routine prophylaxis: 50 IU/kg once weekly or 100 IU/kg once every 10-14 days. For on-demand treatment: 20-50 IU/kg for minor/moderate bleeding, 75-100 IU/kg for major bleeding.
Dose Range:
20 - 100 mg
Condition-Specific Dosing:
prophylaxis:
50 IU/kg once weekly or 100 IU/kg once every 10-14 days
on_demand_minor_moderate_bleeding:
20-50 IU/kg
on_demand_major_bleeding:
75-100 IU/kg
perioperative_management:
Initial dose 75-100 IU/kg pre-surgery, then adjust based on Factor IX activity and clinical need.
Pediatric Dosing
Neonatal:
Not established (safety and efficacy in neonates have not been established).
Infant:
Dosing is individualized based on Factor IX activity levels and clinical response, similar to adults. Prophylaxis: 50 IU/kg once weekly or 100 IU/kg once every 10-14 days. On-demand: 20-100 IU/kg depending on severity.
Child:
Dosing is individualized based on Factor IX activity levels and clinical response, similar to adults. Prophylaxis: 50 IU/kg once weekly or 100 IU/kg once every 10-14 days. On-demand: 20-100 IU/kg depending on severity.
Adolescent:
Dosing is individualized based on Factor IX activity levels and clinical response, similar to adults. Prophylaxis: 50 IU/kg once weekly or 100 IU/kg once every 10-14 days. On-demand: 20-100 IU/kg depending on severity.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Dialysis:
No specific dose adjustment recommended. Factor IX is a large protein and not significantly cleared by dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Eftrenonacog alfa is a recombinant coagulation Factor IX (rFIXFc) with an Fc fusion protein. It temporarily replaces the missing coagulation Factor IX that is needed for effective hemostasis. Factor IX is a vitamin K-dependent coagulation factor that is synthesized in the liver. It is activated by Factor XIa in the intrinsic pathway and by Factor VIIa/tissue factor in the extrinsic pathway. Activated Factor IX (FIXa), in conjunction with Factor VIIIa, calcium, and phospholipid, converts Factor X to Factor Xa. Factor Xa then converts prothrombin (Factor II) to thrombin (Factor IIa), which in turn converts fibrinogen to fibrin, leading to clot formation. The Fc fusion protein extends the half-life of Factor IX by utilizing the native Fc salvage pathway, which recycles IgG molecules and prolongs their circulation in the body.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (intravenous administration)
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Approximately 100-120 mL/kg
ProteinBinding:
Not applicable (functions as a protein itself)
CnssPenetration:
Limited
Elimination:
HalfLife:
Terminal half-life: Approximately 82.1 hours (range 60.2 to 109.9 hours) in adults and adolescents; approximately 62.2 hours (range 47.7 to 77.9 hours) in children 1-11 years.
Clearance:
Approximately 1.3 mL/hr/kg (adults/adolescents); approximately 1.8 mL/hr/kg (children 1-11 years).
ExcretionRoute:
Primarily via protein catabolism, not renal or hepatic excretion of intact protein.
Unchanged:
Not applicable (protein catabolism)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Within minutes of administration (peak Factor IX activity)
DurationOfAction:
Extended due to Fc fusion, allowing for less frequent dosing (up to 7-14 days for prophylaxis).
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Abnormal sensations, such as:
+ Burning
+ Numbness
+ Tingling
Gastrointestinal issues, including:
+ Upset stomach
+ Vomiting
Dizziness or fainting
Restlessness
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
Confusion
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, changes in skin color, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Headache
Numbness or tingling in the mouth
Redness of the skin at the injection site
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Abnormal sensations, such as:
+ Burning
+ Numbness
+ Tingling
Gastrointestinal issues, including:
+ Upset stomach
+ Vomiting
Dizziness or fainting
Restlessness
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
Confusion
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, changes in skin color, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Headache
Numbness or tingling in the mouth
Redness of the skin at the injection site
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of an allergic reaction: hives, rash, itching, swelling of the face, lips, tongue, or throat, dizziness, chest tightness, difficulty breathing.
- Signs of a blood clot: pain, swelling, warmth, or redness in an arm or leg; shortness of breath, chest pain, or coughing up blood.
- Signs of bleeding that is not controlled by treatment.
- Any new or unusual bleeding or bruising.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
This drug has been associated with an increased risk of blood clots. If you have a history of blood clots, be sure to discuss this with your doctor. Regular monitoring of your blood work and other laboratory tests, as directed by your doctor, is crucial.
If you find that the usual dose of this medication is not effective, contact your doctor immediately to discuss alternative options. Before traveling, consult with your doctor to ensure you have an adequate supply of this medication for the duration of your trip.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor, as they relate to both you and your baby.
This drug has been associated with an increased risk of blood clots. If you have a history of blood clots, be sure to discuss this with your doctor. Regular monitoring of your blood work and other laboratory tests, as directed by your doctor, is crucial.
If you find that the usual dose of this medication is not effective, contact your doctor immediately to discuss alternative options. Before traveling, consult with your doctor to ensure you have an adequate supply of this medication for the duration of your trip.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor, as they relate to both you and your baby.
Overdose Information
Overdose Symptoms:
- Risk of thrombotic events (blood clots) due to excessively high Factor IX levels.
- Disseminated intravascular coagulation (DIC) in rare, extreme cases.
What to Do:
In case of suspected overdose, seek immediate medical attention. Management is supportive and may include monitoring for signs of thrombosis and Factor IX activity levels. Call 1-800-222-1222 (Poison Control) or emergency services.
Drug Interactions
Monitoring
Baseline Monitoring
Factor IX activity levels
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to first administration.
Factor IX inhibitor (neutralizing antibody) screen
Rationale: To detect pre-existing inhibitors which could render treatment ineffective.
Timing: Prior to first administration.
Routine Monitoring
Factor IX activity levels
Frequency: Periodically, especially when initiating prophylaxis, changing dose, or managing bleeding episodes.
Target: Target levels vary based on clinical situation (e.g., >1% for prophylaxis, higher for bleeding/surgery).
Action Threshold: If levels are not within expected range or bleeding occurs, adjust dose or investigate for inhibitors.
Factor IX inhibitor (neutralizing antibody) screen
Frequency: Regularly (e.g., every 3-6 months) or if expected Factor IX activity levels are not attained, or if bleeding is not controlled with expected doses.
Target: Negative
Action Threshold: Positive inhibitor titer requires consultation with a hemophilia treatment center and consideration of alternative treatments.
Signs and symptoms of allergic reactions
Frequency: During and after infusion.
Target: Absence of symptoms
Action Threshold: Stop infusion immediately if symptoms occur and provide supportive care.
Signs and symptoms of thrombosis
Frequency: Periodically, especially in patients with risk factors for thrombosis.
Target: Absence of symptoms
Action Threshold: Investigate immediately if symptoms occur.
Symptom Monitoring
- Bleeding episodes (frequency, severity, location)
- Signs of allergic reaction (hives, rash, itching, swelling, dizziness, chest tightness, difficulty breathing)
- Signs of thrombosis (pain, swelling, warmth, redness in a limb; shortness of breath, chest pain)
- Headache
- Fever
- Arthralgia
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Alprolix in pregnant women. Animal reproduction studies have not been conducted. Use during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus. Factor IX levels may increase during pregnancy, potentially altering dosing needs.
Trimester-Specific Risks:
First Trimester:
Risk unknown; use only if clearly needed.
Second Trimester:
Risk unknown; use only if clearly needed.
Third Trimester:
Risk unknown; use only if clearly needed. Monitor Factor IX levels as they may increase.
Lactation
It is not known whether Alprolix is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Alprolix and any potential adverse effects on the breastfed infant from Alprolix or from the underlying maternal condition. Consider the risk of Factor IX transfer to the infant.
Infant Risk:
Not available; potential risk unknown.
Pediatric Use
Alprolix is approved for use in pediatric patients with hemophilia B. Dosing is individualized based on Factor IX activity levels and clinical response. Children (especially those under 12 years) may have a faster Factor IX clearance and require higher or more frequent dosing compared to adults to achieve target levels, though Alprolix's extended half-life helps mitigate this.
Geriatric Use
Clinical studies of Alprolix did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Alprolix offers an extended half-life compared to conventional Factor IX products, allowing for less frequent prophylactic infusions (e.g., once weekly or every 10-14 days).
- Individualize dosing based on patient's Factor IX levels, clinical response, and bleeding phenotype. Peak and trough levels should be monitored, especially when initiating prophylaxis or adjusting dose.
- Patients should be monitored for the development of Factor IX inhibitors, particularly in the first 50 exposure days, as this can lead to lack of efficacy.
- While the risk is low, patients should be educated on the signs and symptoms of allergic reactions and thromboembolic events.
- Reconstitution should be done carefully with the provided diluent and administered via intravenous infusion. Do not shake the vial.
Alternative Therapies
- Other recombinant Factor IX products (e.g., BeneFIX, Rixubis, Idelvion, Rebinyn)
- Plasma-derived Factor IX concentrates (e.g., AlphaNine SD, Mononine)
- Gene therapy for hemophilia B (e.g., Hemgenix)
Cost & Coverage
Average Cost:
Highly variable, typically thousands of dollars per vial depending on strength and quantity. per vial
Insurance Coverage:
Specialty drug, typically covered under medical or pharmacy benefit with high tier co-pays or co-insurance. Requires prior authorization.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.