Alprolix 500unit Inj 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic agent; Coagulation factor
Pharmacologic Class
Recombinant coagulation factor IX, Fc fusion protein
Pregnancy Category
Category C
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 condition where your blood doesn't clot properly because you're missing a special protein called Factor IX. Alprolix replaces this missing protein, helping your blood clot normally. Because it's designed to stay in your body longer, you might not need to take it as often as some other hemophilia 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 instruct you on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Administration
Before use, this medication must be mixed according to the 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 administering the medication, inspect the solution for any signs of cloudiness, leakage, or particulate matter. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution has changed color.
Disposal 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 to determine the best course of action.
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 instruct you on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Administration
Before use, this medication must be mixed according to the 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 administering the medication, inspect the solution for any signs of cloudiness, leakage, or particulate matter. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution has changed color.
Disposal 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 to determine the best course of action.
Lifestyle & Tips
- Follow your prescribed dosing schedule carefully.
- Learn how to self-infuse if recommended by your healthcare provider.
- Keep a log of your infusions and any bleeding episodes.
- Avoid activities that put you at high risk for injury or bleeding.
- Inform your dentist and other healthcare providers that you have hemophilia B and are on Factor IX replacement therapy.
- Wear a medical alert tag or bracelet.
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:
Prophylaxis: 50 units/kg once weekly, or 100 units/kg every 10 days. On-demand: Dose depends on severity of bleed and target Factor IX activity (e.g., 75 units/kg for major bleeds).
Dose Range:
50 - 100 mg
Condition-Specific Dosing:
prophylaxis:
50 units/kg once weekly or 100 units/kg every 10 days; adjust to 100 units/kg once weekly if needed.
on_demand_minor_bleed:
25-50 units/kg to achieve 25-50% Factor IX activity.
on_demand_major_bleed:
75 units/kg to achieve 75-100% Factor IX activity, repeat as needed.
perioperative_minor:
50 units/kg pre-op to achieve 50% Factor IX activity.
perioperative_major:
75 units/kg pre-op to achieve 75-100% Factor IX activity.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing is weight-based, similar to older children and adults. Efficacy and safety established in pediatric patients.
Child:
Dosing is weight-based, similar to adults (e.g., 50 units/kg once weekly for prophylaxis).
Adolescent:
Dosing is weight-based, similar to adults (e.g., 50 units/kg once weekly for prophylaxis).
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 considerations; Factor IX is a 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
Alprolix is a recombinant Factor IX Fc fusion protein. Factor IX is a vitamin K-dependent coagulation factor that, in the presence of calcium, phospholipids, and Factor VIIIa, converts Factor X to Factor Xa. Factor Xa then converts prothrombin to thrombin, leading to fibrin formation and clot stabilization. The Fc region of IgG1 extends the half-life by binding to the neonatal Fc receptor (FcRn), which recycles IgG back into circulation, thereby prolonging the presence of Factor IX in the bloodstream.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Not applicable (IV infusion, peak activity at end of infusion)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 100-120 mL/kg
ProteinBinding:
Not extensively protein bound in the typical sense; it is a protein itself.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 82 hours (adults), 62 hours (adolescents), 60 hours (children)
Clearance:
Approximately 1.4 mL/hr/kg (adults)
ExcretionRoute:
Metabolites primarily eliminated via renal excretion.
Unchanged:
Not applicable (protein catabolism)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of infusion)
PeakEffect:
At the end of infusion
DurationOfAction:
Extended, allowing for less frequent dosing (e.g., once weekly or every 10-14 days) due to prolonged half-life.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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, color changes, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Headache
Numbness or tingling in the mouth
Redness of the skin at the injection site
Reporting Side Effects
This is not an exhaustive list of possible 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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, color changes, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Headache
Numbness or tingling in the mouth
Redness of the skin at the injection site
Reporting Side Effects
This is not an exhaustive list of possible 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 allergic reaction: rash, hives, itching, facial swelling, difficulty breathing, chest tightness, wheezing, dizziness, fainting.
- Signs of bleeding that is not controlled by treatment.
- Signs of inhibitor development: increased bleeding, lack of response to usual doses of Alprolix.
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 as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage 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 as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage 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 may increase the risk of blood clots. If you have a history of blood clots, notify your doctor promptly. Discuss your individual situation with your doctor to assess the potential risks and benefits.
Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your condition while taking this medication.
If you find that the usual dose is not effective, contact your doctor immediately to discuss possible alternatives.
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 breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
This drug may increase the risk of blood clots. If you have a history of blood clots, notify your doctor promptly. Discuss your individual situation with your doctor to assess the potential risks and benefits.
Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your condition while taking this medication.
If you find that the usual dose is not effective, contact your doctor immediately to discuss possible alternatives.
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 breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Excessive Factor IX levels could theoretically increase the risk of thrombosis (blood clots), though this is rare with therapeutic use.
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services immediately. For general poison control, call 1-800-222-1222.
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 screen (Bethesda assay)
Rationale: To detect pre-existing inhibitors which can affect treatment efficacy.
Timing: Prior to first administration.
Routine Monitoring
Factor IX activity levels
Frequency: Periodically, especially for dose adjustments, before surgery, or if clinical response is inadequate.
Target: Depends on clinical situation (e.g., 25-50% for minor bleeds, 75-100% for major bleeds/surgery).
Action Threshold: If levels are not within target range, adjust dose or frequency; if unexpectedly low, consider inhibitor development.
Factor IX inhibitor screen (Bethesda assay)
Frequency: If expected Factor IX activity levels are not attained, or if bleeding is not controlled with expected doses.
Target: <0.6 Bethesda Units (BU)/mL
Action Threshold: >0.6 BU/mL indicates inhibitor presence, requiring alternative treatment strategies.
Signs and symptoms of allergic reactions
Frequency: During and after infusion.
Target: Absence of symptoms
Action Threshold: Presence of rash, hives, itching, facial swelling, dyspnea, chest tightness, or anaphylaxis requires immediate discontinuation and supportive care.
Symptom Monitoring
- Increased bleeding episodes
- Lack of response to treatment
- Hives
- Rash
- Itching
- Facial swelling
- Dyspnea
- Chest tightness
- Wheezing
- Dizziness
- Fainting
Special Patient Groups
Pregnancy
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects based on animal data; human data lacking.
Second Trimester:
Potential for adverse effects based on animal data; human data lacking.
Third Trimester:
Potential for adverse effects based on animal data; human data lacking.
Lactation
Lactation Risk L3 (Moderately safe). It is unknown whether Alprolix is excreted in human milk. Consider the developmental and health benefits of breastfeeding 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.
Infant Risk:
Low to moderate risk. Large protein molecules like Factor IX are generally not expected to pass into breast milk in significant amounts or be absorbed intact by the infant. Monitor for any unusual symptoms in the infant.
Pediatric Use
Efficacy and safety have been established in pediatric patients. Dosing is weight-based and similar to adults. Pharmacokinetic parameters may vary slightly in younger children, but dose adjustments are typically based on clinical response and Factor IX activity levels.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No specific dose adjustment is recommended based on age, but caution should be exercised in elderly patients due to potential comorbidities and increased risk of cardiovascular events in this population.
Clinical Information
Clinical Pearls
- Alprolix offers an extended half-life compared to conventional Factor IX products, allowing for less frequent intravenous infusions, which can significantly improve patient adherence and quality of life.
- Patients should be monitored for the development of Factor IX inhibitors, especially if they experience a lack of response to treatment or increased bleeding episodes.
- While rare, allergic-type hypersensitivity reactions, including anaphylaxis, can occur. Patients should be educated on the signs and symptoms and what to do if they occur.
- The dose and frequency of Alprolix should be individualized based on the patient's Factor IX levels, clinical response, and pharmacokinetic parameters (if determined).
- This product is for intravenous administration only. Ensure proper aseptic technique during preparation and administration to prevent infection.
Alternative Therapies
- Other recombinant Factor IX products (e.g., BeneFIX, Idelvion, Rebinyn, Hemlibra (emicizumab) for hemophilia A with inhibitors, though not a direct Factor IX replacement)
- Plasma-derived Factor IX products (e.g., AlphaNine SD, Mononine)
- Gene therapy for hemophilia B (e.g., Hemgenix)
Cost & Coverage
Average Cost:
Highly variable, typically ranges from hundreds of thousands to over a million USD annually depending on patient weight and dosing regimen. per year
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high co-pays or co-insurance)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.