Alprolix 2000 Unit Inj 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Recombinant Coagulation 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 genetic bleeding disorder where the body does not make enough of a protein called Factor IX, which is needed for blood clotting. Alprolix replaces this missing protein, helping the blood to clot properly and reduce bleeding episodes. It is given by injection into a vein.
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.
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. The mixed solution should be used within 3 hours. After mixing, do not refrigerate the solution, and protect it from direct sunlight.
Inspecting the Solution
Before administering the medication, inspect the solution for any signs of cloudiness, leakage, or particles. 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
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
Store this medication in the refrigerator, but do not freeze it.
Missed Dose
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 provide guidance 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. The mixed solution should be used within 3 hours. After mixing, do not refrigerate the solution, and protect it from direct sunlight.
Inspecting the Solution
Before administering the medication, inspect the solution for any signs of cloudiness, leakage, or particles. 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
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
Store this medication in the refrigerator, but do not freeze it.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Avoid activities that may increase the risk of bleeding or injury.
- Maintain good dental hygiene to prevent gum bleeding.
- Inform all healthcare providers (including dentists) about your hemophilia B and Alprolix use.
- Carry identification indicating your hemophilia B status.
- Follow your prescribed dosing schedule carefully to maintain protective Factor IX levels.
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 IU/kg once weekly or 100 IU/kg every 10 days. On-demand: 50 IU/kg for major bleeding, 25-40 IU/kg for minor/moderate bleeding.
Dose Range:
25 - 100 mg
Condition-Specific Dosing:
prophylaxis:
50 IU/kg once weekly or 100 IU/kg every 10 days
on_demand_major_bleeding:
50 IU/kg
on_demand_minor_moderate_bleeding:
25-40 IU/kg
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing based on weight and Factor IX activity, similar to older children/adults.
Child:
Dosing based on weight and Factor IX activity, similar to adults (e.g., 50 IU/kg once weekly for prophylaxis).
Adolescent:
Dosing based on weight and Factor IX activity, similar to adults.
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 recommendations; monitor Factor IX activity and clinical response.
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 Fc fusion protein. It replaces the deficient Factor IX, which is an essential component of the intrinsic coagulation pathway. Factor IX, 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 the formation of a stable clot. The Fc fusion protein extends the half-life of Factor IX by utilizing the neonatal Fc receptor (FcRn) recycling pathway, which normally salvages immunoglobulins from lysosomal degradation.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Not applicable (IV administration, peak activity immediately after infusion)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately 100-120 mL/kg
ProteinBinding:
Not extensively protein bound in the typical sense; circulates as a proenzyme.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 82 hours (adults), 66 hours (adolescents), 62 hours (children 6-11 years), 55 hours (children <6 years)
Clearance:
Approximately 1.0-1.4 mL/hr/kg
ExcretionRoute:
Proteolytic degradation products are excreted via renal and fecal routes
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon infusion)
PeakEffect:
Immediately after infusion
DurationOfAction:
Extended (due to prolonged half-life, allowing for less frequent dosing, e.g., once weekly or every 10 days)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. 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. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, 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, some people may experience severe and potentially life-threatening side effects while taking this medication. 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. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, 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 bleeding: unusual bruising, prolonged bleeding from minor cuts, nosebleeds, gum bleeding, blood in urine or stool, severe headache, joint pain/swelling.
- Signs of allergic reaction: rash, hives, itching, chest tightness, wheezing, difficulty breathing, swelling of face/lips/tongue/throat, dizziness, fainting.
- Signs of inhibitor development: increased bleeding episodes despite regular treatment, or a decrease in the effectiveness of Alprolix.
- Signs of blood clots (thrombosis): pain, swelling, warmth, or redness in an arm or leg; sudden chest pain; shortness of breath; sudden vision changes; slurred speech.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about any allergies you have, including:
Allergies to this medication or any of its components
Allergies to other medications, foods, or substances
The specific symptoms you experienced as a result of the allergy
Additionally, this medication may interact with other medications or health conditions. To ensure safe use, please disclose the following information to your doctor and pharmacist:
All prescription and over-the-counter medications you are currently taking
Any natural products or vitamins you are using
Any existing health problems or conditions
It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions. Do not start, stop, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about any allergies you have, including:
Allergies to this medication or any of its components
Allergies to other medications, foods, or substances
The specific symptoms you experienced as a result of the allergy
Additionally, this medication may interact with other medications or health conditions. To ensure safe use, please disclose the following information to your doctor and pharmacist:
All prescription and over-the-counter medications you are currently taking
Any natural products or vitamins you are using
Any existing health problems or conditions
It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions. Do not start, stop, or modify 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 and discuss the potential risks. Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your condition.
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 breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision about treatment.
This drug may increase the risk of blood clots. If you have a history of blood clots, notify your doctor promptly and discuss the potential risks. Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your condition.
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 breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision about treatment.
Overdose Information
Overdose Symptoms:
- Risk of thrombotic events (blood clots) due to excessively high Factor IX levels.
- Disseminated intravascular coagulation (DIC) in rare cases.
What to Do:
Seek immediate medical attention. Discontinue Alprolix. Management is supportive and may include anticoagulant therapy if thrombosis occurs. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Factor IX activity levels
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy
Bleeding history and severity
Rationale: To assess disease severity and guide treatment strategy.
Timing: Prior to initiation of therapy
Routine Monitoring
Factor IX activity levels
Frequency: Periodically, especially when adjusting dose, prior to surgery, or in cases of inadequate clinical response.
Target: Target levels vary based on clinical situation (e.g., 30-60% for minor bleeding, >80% for major surgery).
Action Threshold: If levels are not within target range or if bleeding is not controlled, adjust dose or frequency.
Signs and symptoms of inhibitor development
Frequency: Regularly, especially in the first 50 exposure days or if bleeding control is inadequate.
Target: Not applicable
Action Threshold: If bleeding is not controlled or if there is an unexpected decrease in Factor IX activity, test for inhibitors (Bethesda assay).
Signs and symptoms of allergic or hypersensitivity reactions
Frequency: During and after infusion.
Target: Not applicable
Action Threshold: Discontinue infusion immediately if severe reaction occurs; manage symptoms.
Signs and symptoms of thrombosis
Frequency: Periodically, especially in patients with risk factors.
Target: Not applicable
Action Threshold: Investigate immediately if thrombosis is suspected.
Symptom Monitoring
- Uncontrolled bleeding
- New or worsening joint pain/swelling
- Headache
- Rash
- Hives
- Itching
- Chest tightness
- Wheezing
- Difficulty breathing
- Swelling of face, lips, tongue, or throat
- Dizziness
- Fainting
- Unusual bruising
- Blood in urine or stool
- Nosebleeds
- Gum bleeding
- Pain, swelling, or redness in a limb (signs of thrombosis)
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 benefits outweigh the potential risks. Hemophilia B is rare in women, but pregnant women with hemophilia B may be at increased risk of bleeding complications during pregnancy and delivery.
Trimester-Specific Risks:
First Trimester:
Risk unknown; Factor IX is a natural protein, but data on recombinant Fc fusion protein in early pregnancy is limited.
Second Trimester:
Risk unknown.
Third Trimester:
Risk unknown; consider potential for increased bleeding during delivery in affected women.
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. Factor IX is a large protein, making transfer into breast milk less likely.
Infant Risk:
Low risk (L3 - No data, but probably compatible)
Pediatric Use
Alprolix is approved for use in pediatric patients with hemophilia B. Dosing is based on body weight and Factor IX activity levels, similar to adults. The extended half-life is observed across pediatric age groups, allowing for less frequent infusions.
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. No specific dose adjustment is recommended for geriatric patients, but monitor for age-related comorbidities and potential for increased thrombotic risk.
Clinical Information
Clinical Pearls
- Alprolix (eftrenonacog alfa) is an extended half-life recombinant Factor IX product, allowing for less frequent intravenous infusions compared to conventional Factor IX products.
- The Fc fusion technology extends the half-life by recycling the molecule via the neonatal Fc receptor (FcRn).
- Dosing is individualized based on the patient's Factor IX activity levels, clinical response, and type of bleeding event or surgical procedure.
- Patients should be monitored for the development of Factor IX inhibitors, especially in the first 50 exposure days, or if bleeding control is inadequate.
- While rare, thrombotic events can occur, particularly in patients with risk factors or very high Factor IX levels. Monitor for signs of thrombosis.
- Patients should be educated on proper home infusion techniques, recognition of bleeding episodes, and signs of allergic reactions.
Alternative Therapies
- Other recombinant Factor IX products (e.g., BeneFIX, Rixubis, Idelvion, Rebinyn)
- Plasma-derived Factor IX products
- Gene therapy for Hemophilia B (e.g., Hemgenix)
- Bypassing agents (e.g., activated prothrombin complex concentrate [aPCC], recombinant Factor VIIa) for patients with inhibitors
Cost & Coverage
Average Cost:
Highly variable, typically several thousand dollars per vial (e.g., $2,000 - $10,000+ per 2000 IU vial depending on contract/provider) per vial
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'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 happened.