Alprolix 1000unit 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 help your blood clot. It replaces a missing protein called Factor IX in people with Hemophilia B, a bleeding disorder. Because it's designed to stay in your body longer, you might need fewer injections than with 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.
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.
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.
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 your medicine and supplies with you.
- Wear a medical alert tag or bracelet indicating you have Hemophilia B.
- Avoid activities that put you at high risk for injury or bleeding.
- Maintain good dental hygiene to prevent gum bleeding.
- Inform all healthcare providers (including dentists) that you have Hemophilia B and are using Alprolix.
- Learn how to recognize and treat bleeding episodes early.
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: Dose (IU) = Body Weight (kg) x Desired Factor IX Increase (%) x 1.2 IU/kg per % increase.
Dose Range:
50 - 100 mg
Condition-Specific Dosing:
Prophylaxis:
50 IU/kg once weekly or 100 IU/kg every 10 days
On-demand treatment of bleeding episodes:
Target Factor IX activity level depends on severity of bleed (e.g., 20-40% for minor, 60-80% for major). Dose calculated based on desired increase.
Perioperative management:
Target Factor IX activity level depends on type of surgery (e.g., 60-80% for major surgery). Dose calculated based on desired increase.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing similar to adults, based on body weight and target Factor IX activity. Safety and efficacy established in pediatric patients.
Child:
Dosing similar to adults, based on body weight and target Factor IX activity. Safety and efficacy established in pediatric patients.
Adolescent:
Dosing similar to adults, based on body weight and target Factor IX activity. Safety and efficacy established in pediatric patients.
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 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
Factor IX (recombinant), Fc fusion protein, replaces the deficient coagulation Factor IX in patients with Hemophilia B. Factor IX is a vitamin K-dependent glycoprotein that is synthesized in the liver. It is activated by Factor XIa in the intrinsic coagulation 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 to thrombin, 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 neonatal Fc receptor (FcRn) pathway, which recycles IgG antibodies and their Fc fusion partners, preventing lysosomal degradation.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Not applicable (IV administration, immediate peak)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.06-0.08 L/kg (similar to plasma volume)
ProteinBinding:
Not applicable (it is a protein itself)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 82.1 hours (range 60.5-117.7 hours) in adults, significantly extended compared to conventional Factor IX products.
Clearance:
Approximately 0.8-1.0 mL/hr/kg
ExcretionRoute:
Metabolites excreted via renal and biliary routes.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of intravenous infusion)
PeakEffect:
Within minutes of infusion
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, 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 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, 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 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, 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 a bleeding episode: unusual bruising, nosebleeds, bleeding gums, blood in urine or stool, joint pain or swelling, severe headache, prolonged bleeding from cuts.
- Signs of an allergic reaction: hives, rash, itching, facial swelling, difficulty breathing, chest tightness, wheezing, dizziness, fainting.
- Signs of a blood clot (thrombosis): pain, swelling, warmth, or redness in an arm or leg; sudden chest pain, shortness of breath, rapid heart rate, 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 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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust 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 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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust 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.
Be aware that this drug can 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 understand the potential risks and benefits.
Regular monitoring of your blood work and other laboratory tests is crucial while taking this medication. Adhere to the schedule recommended by your doctor for these tests.
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, 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 your care.
Be aware that this drug can 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 understand the potential risks and benefits.
Regular monitoring of your blood work and other laboratory tests is crucial while taking this medication. Adhere to the schedule recommended by your doctor for these tests.
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, 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 your care.
Overdose Information
Overdose Symptoms:
- Increased risk of thrombosis (blood clots)
- Disseminated intravascular coagulation (DIC)
What to Do:
Seek immediate medical attention. Management may include discontinuing Alprolix, supportive care, and treatment of thrombotic events. Call 911 or your local emergency number. 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 initiation of therapy.
Factor IX inhibitor screen (Bethesda assay)
Rationale: To detect pre-existing inhibitors which can render treatment ineffective.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor IX activity levels
Frequency: Periodically, especially during prophylaxis or for on-demand treatment of major bleeds/surgery. Adjust frequency based on clinical need.
Target: Varies based on clinical situation (e.g., >1% for prophylaxis, 20-40% for minor bleeds, 60-80% for major bleeds/surgery).
Action Threshold: If levels are not within target range, adjust dose or frequency. If unexpected low levels, consider inhibitor development.
Factor IX inhibitor screen (Bethesda assay)
Frequency: Regularly (e.g., every 3-6 months) or if there is a lack of clinical response to treatment.
Target: <0.6 Bethesda Units (BU)
Action Threshold: If inhibitor levels are ≥0.6 BU, treatment may be ineffective; consider alternative therapies or immune tolerance induction.
Signs and symptoms of allergic reactions
Frequency: During and immediately after infusion, and routinely thereafter.
Target: Absence of symptoms
Action Threshold: If symptoms occur (e.g., rash, hives, dyspnea, chest tightness), stop infusion immediately and provide supportive care.
Signs and symptoms of thrombosis
Frequency: Routinely, especially in patients with risk factors.
Target: Absence of symptoms
Action Threshold: If symptoms occur (e.g., pain, swelling, redness in limb; chest pain, shortness of breath), investigate promptly.
Symptom Monitoring
- Bleeding episodes (frequency, severity, location)
- Signs of allergic reaction (hives, rash, itching, facial swelling, difficulty breathing, chest tightness, dizziness)
- Signs of thrombosis (pain, swelling, warmth, redness in a limb; sudden chest pain, shortness of breath, rapid heart rate, sudden vision changes, slurred speech)
- Headache
- Fever
- Chills
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 outweighs the potential risk to the fetus. It is not known if Alprolix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
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.
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 infant exposure to Factor IX (Recombinant [Fc Fusion Protein]) through breast milk.
Infant Risk:
Risk unknown; potential for infant exposure is low due to large molecular size, but caution is advised.
Pediatric Use
Alprolix is approved for use in pediatric patients of all ages. Dosing is weight-based and similar to adults. Safety and efficacy have been demonstrated in pediatric clinical trials. No specific dose adjustments are needed beyond weight-based calculations.
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 adjustments are recommended for geriatric patients; dosing should be based on body weight and clinical response.
Clinical Information
Clinical Pearls
- Alprolix offers an extended half-life compared to conventional Factor IX products, allowing for less frequent infusions (e.g., once weekly or every 10-14 days for prophylaxis).
- Patients should be monitored for the development of Factor IX inhibitors, especially early in treatment, as these can lead to a lack of efficacy.
- While rare, thrombotic events can occur with Factor IX products; monitor patients for signs of thrombosis, particularly those with risk factors.
- The Fc fusion technology leverages the body's natural recycling pathway for antibodies, contributing to the prolonged circulation of Factor IX.
- Ensure patients and caregivers are thoroughly trained on proper reconstitution and administration techniques, as well as recognizing and managing bleeding episodes and adverse reactions.
Alternative Therapies
- BeneFIX (Factor IX (Recombinant)) - standard half-life
- Rixubis (Factor IX (Recombinant)) - standard half-life
- Hemgenix (etranacogene dezaparvovec) - Gene therapy for Hemophilia B
- Other Factor IX concentrates (plasma-derived or recombinant, non-extended half-life)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of USD per vial depending on unit strength and quantity. A 1000 IU vial could be in the range of $1,500 - $3,000+. 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.