Alprolix 3000unit Inj 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Coagulation Factor IX, Recombinant, 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 bleeding disorder where the body doesn't make enough of a protein called Factor IX, which is needed for blood clotting. Alprolix works by replacing this missing Factor IX, helping your blood clot properly. It's given as an 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 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
- Maintain regular physical activity as advised by your doctor, avoiding activities that pose a high risk of injury.
- Wear medical alert identification (e.g., bracelet, necklace) indicating you have hemophilia B.
- Keep a detailed record of all infusions, including date, time, dose, and reason for infusion.
- Follow your healthcare provider's instructions for home infusion techniques and storage of the medication.
- Avoid aspirin and NSAIDs (non-steroidal anti-inflammatory drugs) unless specifically approved by your doctor, as they can increase bleeding risk.
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 and clinical response. For routine prophylaxis: 50 units/kg once weekly or 100 units/kg once every 10 days. For on-demand treatment and perioperative management: Dose based on desired Factor IX activity level and patient weight.
Condition-Specific Dosing:
Routine Prophylaxis:
50 units/kg once weekly or 100 units/kg once every 10 days
On-demand Treatment (Minor Bleeds):
Target Factor IX activity 20-40% of normal. Dose (units) = Body Weight (kg) x Desired Factor IX Increase (%) x 0.8 units/kg per % increase.
On-demand Treatment (Major Bleeds/Surgery):
Target Factor IX activity 60-100% of normal. Dose (units) = Body Weight (kg) x Desired Factor IX Increase (%) x 0.8 units/kg per % increase. Repeat as needed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (safety and efficacy in children <1 year of age have not been established)
Child:
Dosing is similar to adults, individualized based on Factor IX activity levels and clinical response. For routine prophylaxis (≥1 year): 50 units/kg once weekly or 100 units/kg once every 10 days.
Adolescent:
Dosing is similar to adults, individualized based on Factor IX activity levels and clinical response. For routine prophylaxis: 50 units/kg once weekly or 100 units/kg once every 10 days.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended
Dialysis:
No specific considerations; Factor IX is a large protein not removed by dialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended
Pharmacology
Mechanism of Action
Factor IX (Recombinant), Fc Fusion Protein, is a recombinant coagulation Factor IX molecule that replaces the deficient Factor IX in patients with hemophilia B. 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 pathway) or Factor VIIa/tissue factor (in the extrinsic pathway) to Factor IXa. 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, facilitating clot formation. The Fc fusion protein extends the half-life of Factor IX by utilizing the neonatal Fc receptor (FcRn) recycling pathway, which normally salvages IgG from lysosomal degradation.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable (IV administration, peak activity is at end of infusion)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 100-120 mL/kg (similar to endogenous Factor IX)
ProteinBinding:
Not applicable (Factor IX is a protein itself, not typically protein-bound in the conventional sense)
CnssPenetration:
Limited (large protein molecule)
Elimination:
HalfLife:
Approximately 82.1 hours (range 52.1 to 128.1 hours) in adults, significantly longer than conventional Factor IX products (18-24 hours).
Clearance:
Approximately 1.3 mL/hr/kg
ExcretionRoute:
Metabolized and excreted as amino acids and small peptides; no specific excretion route for the intact protein.
Unchanged:
Not applicable (metabolized)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
At the end of infusion
DurationOfAction:
Extended, due to prolonged half-life, allowing for less frequent dosing (up to 10-14 days for prophylaxis in some patients).
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
Difficulty 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
+ Difficulty 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 contact your doctor or seek medical help if you notice any of the following:
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 about side effects, consult 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
Difficulty 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
+ Difficulty 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 contact your doctor or seek medical help if you notice any of the following:
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 about side effects, consult 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, blood in urine or stools, joint pain or swelling, severe headache, sudden weakness or numbness.
- Signs of allergic reaction: rash, hives, itching, facial swelling, difficulty breathing, wheezing, dizziness, chest tightness. Seek immediate medical attention if these occur.
- Signs of inhibitor development: increased frequency of bleeding episodes, bleeding that doesn't respond 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 drug may interact with other prescription or over-the-counter (OTC) medications, natural products, or vitamins, which could affect its safety and efficacy.
A complete list of all your current medications, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 drug may interact with other prescription or over-the-counter (OTC) medications, natural products, or vitamins, which could affect its safety and efficacy.
A complete list of all your current medications, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 your usual dose is not providing the expected effect, 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 are breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor, as they will help you weigh the advantages and disadvantages for 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 your usual dose is not providing the expected effect, 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 are breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor, as they will help you weigh the advantages and disadvantages for both you and your baby.
Overdose Information
Overdose Symptoms:
- While overdose is unlikely to cause acute toxicity due to the nature of the protein, very high levels of Factor IX could theoretically increase the risk of thrombotic events (blood clots).
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services immediately. Management is supportive. For severe reactions or suspected thrombosis, call 911 or your local emergency number. For general overdose information, call a poison control center at 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Baseline Factor IX activity level
Rationale: To establish the patient's baseline and guide initial dosing.
Timing: Prior to initiation of therapy
Inhibitor (neutralizing antibody) screen
Rationale: To detect pre-existing inhibitors, which can render treatment ineffective.
Timing: Prior to initiation of therapy
Routine Monitoring
Factor IX activity levels
Frequency: Regularly, especially when initiating therapy, changing dose, or in response to bleeding episodes. At least annually for prophylaxis.
Target: Individualized based on clinical need (e.g., >1% for prophylaxis, 20-40% for minor bleeds, 60-100% for major bleeds/surgery).
Action Threshold: If levels are not within desired range or if bleeding occurs despite adequate dosing, adjust dose or investigate for inhibitors.
Inhibitor (neutralizing antibody) screen
Frequency: Regularly, especially in the first 50 exposure days or if bleeding is not controlled with expected Factor IX levels.
Target: Negative
Action Threshold: If positive, consider alternative Factor IX products or immune tolerance induction.
Signs and symptoms of allergic reactions
Frequency: During and after each infusion
Target: Absence of symptoms
Action Threshold: If symptoms occur, stop infusion immediately and treat appropriately.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from cuts, nosebleeds, blood in urine/stools, severe headache)
- Signs of allergic reaction (e.g., rash, hives, itching, facial swelling, shortness of breath, wheezing, dizziness, chest tightness)
- Signs of thrombotic events (e.g., pain, swelling, warmth, redness in a limb; sudden chest pain, shortness of breath, coughing up blood; sudden vision changes, severe headache, weakness on one side of the body)
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. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential risk to fetus cannot be ruled out; use only if clearly needed.
Second Trimester:
Potential risk to fetus cannot be ruled out; use only if clearly needed.
Third Trimester:
Potential risk to fetus cannot be ruled out; use only if clearly needed.
Lactation
L3 (Moderately Safe). It is not known whether Alprolix is excreted in human milk. However, Factor IX is a large protein molecule, and absorption of intact protein by the infant is unlikely. 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 risk of adverse effects to the infant due to the large molecular weight of Factor IX, making transfer into milk and oral absorption by the infant unlikely.
Pediatric Use
Safety and efficacy have been established in children aged 1 year and older. Dosing is weight-based and individualized, similar to adults. Data in children younger than 1 year are not established.
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 the patient's Factor IX activity levels, clinical response, and pharmacokinetic parameters (if available).
- Monitor for the development of Factor IX inhibitors, especially in the first 50 exposure days or if bleeding control is suboptimal.
- Patients should be educated on the signs of allergic reactions and inhibitor development.
- Ensure proper storage (refrigerated, but can be stored at room temperature for a limited time) and reconstitution techniques.
Alternative Therapies
- Other recombinant Factor IX products (e.g., BeneFIX, Rixubis, Idelvion, Rebinyn)
- Plasma-derived Factor IX products (e.g., AlphaNine SD, Mononine)
- Gene therapy for hemophilia B (e.g., Hemgenix)
- Bypassing agents (e.g., FEIBA, NovoSeven RT) for patients with inhibitors.
Cost & Coverage
Average Cost:
Extremely high (e.g., thousands to tens of thousands of USD per vial depending on unit strength) 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 this 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.