Alprolix 1000 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
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 genetic bleeding disorder where the body doesn't make enough of a protein called Factor IX, which is essential for blood clotting. Alprolix provides your body with the Factor IX it needs, but it's specially designed to stay in your body longer than other Factor IX medicines, meaning you might need fewer injections.
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 of preparation. After mixing, do not refrigerate the solution. Protect it from direct sunlight.
Inspecting the Solution
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
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 of preparation. After mixing, do not refrigerate the solution. Protect it from direct sunlight.
Inspecting the Solution
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
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
- Always carry identification stating you have hemophilia B.
- Avoid activities that carry a high risk of injury or bleeding.
- Avoid medications that interfere with blood clotting, such as aspirin and NSAIDs (e.g., ibuprofen, naproxen), unless specifically approved by your doctor.
- Maintain good dental hygiene to prevent gum bleeding.
- Regularly consult with your hemophilia treatment center for comprehensive care.
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 every 10 days. For on-demand treatment of bleeding episodes: 50 IU/kg.
Condition-Specific Dosing:
routine_prophylaxis:
50 IU/kg once weekly or 100 IU/kg every 10 days
on_demand_bleeding:
50 IU/kg for minor/moderate bleeding, higher doses may be needed for severe bleeding or surgery (e.g., 75-100 IU/kg)
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing is weight-based and individualized, similar to adults. Prophylaxis: 50 IU/kg once weekly or 100 IU/kg every 10 days. On-demand: 50 IU/kg.
Child:
Dosing is weight-based and individualized, similar to adults. Prophylaxis: 50 IU/kg once weekly or 100 IU/kg every 10 days. On-demand: 50 IU/kg.
Adolescent:
Dosing is weight-based and individualized, similar to adults. Prophylaxis: 50 IU/kg once weekly or 100 IU/kg every 10 days. On-demand: 50 IU/kg.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, monitor Factor IX activity.
Moderate:
No specific dose adjustment recommended, monitor Factor IX activity.
Severe:
No specific dose adjustment recommended, monitor Factor IX activity.
Dialysis:
No specific dose adjustment recommended, monitor Factor IX activity. Not significantly removed by dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, monitor Factor IX activity.
Moderate:
No specific dose adjustment recommended, monitor Factor IX activity.
Severe:
No specific dose adjustment recommended, monitor Factor IX activity.
Pharmacology
Mechanism of Action
Factor IX (recombinant, Fc fusion protein) is a recombinant coagulation Factor IX molecule that is fused to the Fc domain of human immunoglobulin G1 (IgG1). It temporarily replaces the missing coagulation Factor IX that is needed for effective hemostasis. Factor IX is a vitamin K-dependent single-chain glycoprotein that is synthesized in the liver and circulates in an inactive form. It is activated by Factor XIa in the intrinsic coagulation pathway and by Factor VIIa/tissue factor in the extrinsic pathway. Activated Factor IX (Factor IXa), 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 extends the half-life of Factor IX by utilizing the neonatal Fc receptor (FcRn) pathway, which recycles IgG molecules, thereby reducing the frequency of infusions.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Achieved immediately after intravenous infusion
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Approximately 0.8-1.0 dL/kg (similar to plasma volume)
ProteinBinding:
Minimal
CnssPenetration:
Limited
Elimination:
HalfLife:
Terminal half-life: Approximately 82-102 hours (significantly extended compared to conventional Factor IX products)
Clearance:
Approximately 2.8-3.7 mL/hr/kg
ExcretionRoute:
Primarily via proteolytic degradation; small amounts may be renally excreted.
Unchanged:
Not applicable (protein catabolism)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of infusion)
PeakEffect:
Within minutes of infusion completion
DurationOfAction:
Extended, up to 7-10 days for prophylaxis due to prolonged half-life
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 notice 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, 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. 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 for advice:
Headache
Numbness or tingling in the mouth
Redness of the skin at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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 notice 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, 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. 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 for advice:
Headache
Numbness or tingling in the mouth
Redness of the skin at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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 cuts, nosebleeds, blood in urine or stool, joint pain or swelling, severe headaches, vision changes, sudden weakness or numbness.
- Signs of allergic reaction: rash, hives, itching, facial swelling, difficulty breathing, wheezing, dizziness, fainting, chest tightness.
- Signs of inhibitor development: increased frequency or severity of bleeding episodes despite adequate dosing, or failure to achieve expected Factor IX levels after infusion.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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, and discuss the potential risks and benefits. Regular blood tests and other laboratory evaluations, as directed by your doctor, are crucial to monitor your condition.
If you find that the usual dose is not effective, immediately contact your doctor. 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. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
This drug may increase the risk of blood clots. If you have a history of blood clots, notify your doctor, and discuss the potential risks and benefits. Regular blood tests and other laboratory evaluations, as directed by your doctor, are crucial to monitor your condition.
If you find that the usual dose is not effective, immediately contact your doctor. 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. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- While rare, very high doses could theoretically increase the risk of thrombotic events (blood clots). Symptoms might include pain, swelling, warmth, or redness in an arm or leg; sudden chest pain, shortness of breath, or vision changes.
What to Do:
In case of suspected overdose or severe adverse reaction, seek immediate medical attention. Call 911 or your local emergency number. For general overdose information, call a poison control center (e.g., 1-800-222-1222 in the US).
Drug Interactions
Monitoring
Baseline Monitoring
Baseline Factor IX activity levels
Rationale: To establish a baseline for individualized dosing and to confirm Factor IX deficiency.
Timing: Prior to initiation of therapy
Inhibitor (neutralizing antibody) screen
Rationale: To detect pre-existing Factor IX inhibitors, which can render treatment ineffective.
Timing: Prior to initiation of therapy
Bleeding history and severity
Rationale: To guide initial dosing and treatment strategy.
Timing: Prior to initiation of therapy
Routine Monitoring
Factor IX activity levels
Frequency: Periodically, especially when initiating therapy, changing dose, or in response to bleeding episodes/surgery. For prophylaxis, monitor trough levels.
Target: Target levels vary based on clinical situation (e.g., >1% for prophylaxis, higher for bleeding/surgery).
Action Threshold: Subtherapeutic levels may indicate need for dose adjustment or inhibitor development.
Clinical signs and symptoms of bleeding
Frequency: Continuously by patient/caregiver, regularly by healthcare provider.
Target: Absence of bleeding episodes.
Action Threshold: Recurrent bleeding may indicate inadequate dosing or inhibitor development.
Inhibitor (neutralizing antibody) screen
Frequency: Regularly (e.g., every 3-6 months, or if treatment efficacy decreases, or if bleeding is not controlled).
Target: Negative for inhibitors.
Action Threshold: Positive inhibitor titer requires alternative treatment strategies.
Signs of allergic reaction/anaphylaxis
Frequency: During and immediately after infusion.
Target: Absence of symptoms.
Action Threshold: Stop infusion immediately and treat symptoms.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, muscle pain, bruising, nosebleeds, blood in urine/stool, prolonged bleeding from cuts)
- Signs of allergic reaction (e.g., rash, hives, itching, facial swelling, shortness of breath, chest tightness, dizziness, fainting)
- Signs of thrombotic events (e.g., pain, swelling, warmth, redness in a limb; sudden chest pain, shortness of breath, vision changes)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies of Alprolix in pregnant women. Animal reproduction studies have not been conducted. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Hemophilia B is rare in women, but management of bleeding during pregnancy and delivery is critical.
Trimester-Specific Risks:
First Trimester:
Limited data; use only if clearly needed.
Second Trimester:
Limited data; use only if clearly needed.
Third Trimester:
Limited data; use only if clearly needed. Consider Factor IX levels for delivery planning.
Lactation
L3 (Moderately Safe). It is not known whether Factor IX (recombinant, Fc fusion protein) 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 large molecular weight of the protein, making transfer into milk less likely.
Infant Risk:
Low to unknown. Potential for oral absorption by the infant is minimal due to protein degradation in the infant's GI tract.
Pediatric Use
Alprolix is approved for use in pediatric patients with hemophilia B, including neonates, infants, children, and adolescents. Dosing is weight-based and individualized, similar to adults. Clinical studies included pediatric patients as young as 1 year of age. Safety and efficacy in neonates (<1 month) have not been fully established, but it is used in this population under expert guidance.
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. No specific dose adjustments are typically required based on age alone, but monitor for age-related comorbidities.
Clinical Information
Clinical Pearls
- Alprolix offers an extended half-life compared to conventional Factor IX products, allowing for less frequent intravenous infusions (e.g., once weekly or every 10-14 days for prophylaxis).
- Dosing is highly individualized based on the patient's Factor IX levels, bleeding history, and clinical response. Regular monitoring of Factor IX activity is crucial.
- Patients should be educated on proper infusion technique if self-administering, and on recognizing signs of bleeding, allergic reactions, and inhibitor development.
- The development of Factor IX inhibitors (neutralizing antibodies) is a serious complication that can render the treatment ineffective. Patients should be monitored for this.
- Alprolix is for intravenous use only. Do not administer subcutaneously or intramuscularly.
- Ensure proper storage (refrigerated, but can be stored at room temperature for a limited time as per package insert).
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] or recombinant Factor VIIa [rFVIIa]) for patients with inhibitors.
Cost & Coverage
Average Cost:
Extremely high (e.g., tens of thousands to hundreds of thousands of dollars annually depending on dosing) per 1000 IU vial (price varies significantly by strength and vendor)
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high deductibles/copays)
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's a good idea 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.