Recombinate 801-1240 Inj,1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Coagulation Factor, Recombinant Factor VIII
Pregnancy Category
Category C
FDA Approved
Dec 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Recombinate is a medicine that replaces a missing protein in your blood called Factor VIII. This protein is essential for your blood to clot properly. People with hemophilia A don't have enough Factor VIII, which causes them to bleed easily and for longer periods. By giving you Recombinate, we can help your blood clot and prevent or stop bleeding episodes.
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.
If the medication has been stored in the refrigerator, allow it to reach room temperature before mixing. Do not heat the medication. Mixing is required before use, and you should follow the instructions provided by your doctor. Avoid shaking the medication, and do not use it if the solution appears cloudy, is leaking, or contains particles. The medication should be colorless to faintly yellow; if the color changes, do not use it. After mixing, the medication should not be refrigerated.
Use the mixed medication within 3 hours of preparation. Discard any unused portion of the opened vial after use. Dispose of needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items, and follow local regulations for disposing of the box when it is full. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
If using this medication at home, store unopened containers at room temperature or in the refrigerator. Do not freeze the medication.
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 instruct you on the proper technique. Before and after handling the medication, wash your hands thoroughly.
If the medication has been stored in the refrigerator, allow it to reach room temperature before mixing. Do not heat the medication. Mixing is required before use, and you should follow the instructions provided by your doctor. Avoid shaking the medication, and do not use it if the solution appears cloudy, is leaking, or contains particles. The medication should be colorless to faintly yellow; if the color changes, do not use it. After mixing, the medication should not be refrigerated.
Use the mixed medication within 3 hours of preparation. Discard any unused portion of the opened vial after use. Dispose of needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items, and follow local regulations for disposing of the box when it is full. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
If using this medication at home, store unopened containers at room temperature or in the refrigerator. Do not freeze the medication.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Always carry medical identification (e.g., bracelet, card) stating you have hemophilia A and are on Factor VIII replacement therapy.
- Avoid activities that carry a high risk of injury or bleeding (e.g., contact sports) unless approved by your doctor.
- Maintain good dental hygiene and inform your dentist about your hemophilia.
- Avoid medications that can increase bleeding risk, such as aspirin or NSAIDs (e.g., ibuprofen, naproxen), unless specifically instructed by your doctor.
- Learn how to self-administer the medication if appropriate, and always follow sterile technique.
- Store the medication as directed (refrigerated or at room temperature, depending on specific product instructions) and do not use expired vials.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on Factor VIII deficiency, severity of bleeding, and patient weight. For on-demand treatment of bleeding episodes: 10-50 IU/kg. For prophylaxis: 25-50 IU/kg 2-3 times per week.
Dose Range:
10 - 50 mg
Condition-Specific Dosing:
hemophiliaA_onDemand:
10-50 IU/kg, depending on severity of bleeding (e.g., 10-20 IU/kg for minor, 20-40 IU/kg for moderate, 30-50 IU/kg for major). Repeat as needed.
hemophiliaA_prophylaxis:
25-50 IU/kg 2-3 times per week.
Pediatric Dosing
Neonatal:
Individualized, weight-based (IU/kg), similar to adult dosing principles. Not established for routine use in neonates without specific indication.
Infant:
Individualized, weight-based (IU/kg), similar to adult dosing principles.
Child:
Individualized, weight-based (IU/kg), similar to adult dosing principles.
Adolescent:
Individualized, weight-based (IU/kg), similar to adult dosing principles.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally required.
Moderate:
No specific dose adjustment generally required.
Severe:
No specific dose adjustment generally required; however, monitor closely due to potential for altered protein metabolism.
Dialysis:
Not applicable; Factor VIII is a large protein and not removed by dialysis. No specific dose adjustment required.
Hepatic Impairment:
Mild:
No specific dose adjustment generally required.
Moderate:
No specific dose adjustment generally required.
Severe:
No specific dose adjustment generally required; however, monitor closely due to potential for altered protein metabolism and overall patient status.
Pharmacology
Mechanism of Action
Antihemophilic Factor (Recombinant) is a glycoprotein that temporarily replaces the deficient coagulation Factor VIII in patients with hemophilia A. It acts as an essential cofactor for activated Factor IX (FIXa) in the intrinsic pathway of blood coagulation, forming a complex that activates Factor X (FX) to Factor Xa (FXa). FXa then converts prothrombin to thrombin, which in turn converts fibrinogen to fibrin, leading to the formation of a stable clot.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediately after intravenous infusion (peak activity at end of infusion)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately 0.05-0.08 L/kg (similar to plasma volume)
ProteinBinding:
Binds to von Willebrand factor (vWF) in plasma, which stabilizes Factor VIII and prolongs its half-life.
CnssPenetration:
Limited
Elimination:
HalfLife:
10-19 hours (mean terminal half-life)
Clearance:
Approximately 2.5-5.0 mL/hr/kg
ExcretionRoute:
Not excreted; degraded endogenously.
Unchanged:
Not applicable (protein is degraded)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of intravenous infusion)
PeakEffect:
Immediate (at end of infusion)
DurationOfAction:
Varies based on dose and patient's half-life, typically 8-24 hours for significant activity, but clinical effect can last longer depending on target factor level and bleeding severity.
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
Abnormal sensations, such as burning, numbness, or tingling
Discoloration of the mouth, turning blue
Chest pain or pressure, or a rapid heartbeat
Dizziness or fainting
Feeling cold
Fever or chills
Flushing
Pale skin
Restlessness
Shortness of breath
Upset stomach or vomiting
Feeling extremely tired or weak
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 that bother you or persist, contact your doctor:
Irritation at the injection site
* Headache
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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, 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
Abnormal sensations, such as burning, numbness, or tingling
Discoloration of the mouth, turning blue
Chest pain or pressure, or a rapid heartbeat
Dizziness or fainting
Feeling cold
Fever or chills
Flushing
Pale skin
Restlessness
Shortness of breath
Upset stomach or vomiting
Feeling extremely tired or weak
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 that bother you or persist, contact your doctor:
Irritation at the injection site
* Headache
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 cuts, nosebleeds, blood in urine or stool, severe headache, vision changes, joint pain or swelling, abdominal pain.
- Signs of allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, dizziness, lightheadedness, chest tightness, difficulty breathing, wheezing.
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, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have an allergy to cows, hamsters, or mice, as this may be relevant to your treatment.
Potential interactions with other medications or health conditions. To ensure safe treatment, disclose all of your current medications, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any existing health problems, as these may affect the safety and efficacy of this medication.
Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug. This will help ensure your safety and the effectiveness of your treatment.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have an allergy to cows, hamsters, or mice, as this may be relevant to your treatment.
Potential interactions with other medications or health conditions. To ensure safe treatment, disclose all of your current medications, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any existing health problems, as these may affect the safety and efficacy of this medication.
Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug. This will help ensure your safety and the effectiveness of your treatment.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Regular blood tests and other laboratory assessments should be conducted as directed by your doctor to monitor your condition.
If you experience unexplained bruising, bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. These symptoms may indicate that your current dose is not effective.
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, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Regular blood tests and other laboratory assessments should be conducted as directed by your doctor to monitor your condition.
If you experience unexplained bruising, bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. These symptoms may indicate that your current dose is not effective.
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, notify 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 an overdose is unlikely to cause severe adverse effects due to the nature of the protein, very high levels could theoretically increase the risk of thrombotic events (blood clots).
- Symptoms of thrombosis could include pain, swelling, warmth, or redness in a limb; sudden chest pain; shortness of breath; sudden severe headache; sudden vision changes.
What to Do:
In case of suspected overdose, contact your doctor or emergency services immediately. Management is supportive and may involve monitoring for signs of thrombosis. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity levels
Rationale: To confirm diagnosis of Hemophilia A, determine baseline deficiency, and guide initial dosing calculations.
Timing: Prior to initiation of therapy
Inhibitor (antibody) screen (Bethesda assay)
Rationale: To detect pre-existing Factor VIII inhibitors (neutralizing antibodies) which would render treatment ineffective and require alternative therapies.
Timing: Prior to initiation of therapy
Routine Monitoring
Factor VIII activity levels
Frequency: During acute bleeding episodes or surgery: daily or more frequently as clinically indicated. For prophylaxis: periodically to ensure trough levels are adequate.
Target: Varies based on clinical goal (e.g., >30% for minor bleeding, >80-100% for major surgery/bleeding).
Action Threshold: Levels below target may require increased dose or frequency; persistently low levels despite adequate dosing may indicate inhibitor development.
Inhibitor (antibody) screen (Bethesda assay)
Frequency: Regularly, especially in previously untreated patients (PUPs) or those with poor response to treatment (e.g., every 3-6 months for first few years, then annually or as clinically indicated).
Target: Negative (<0.6 Bethesda Units/mL)
Action Threshold: Presence of inhibitors (>0.6 BU/mL) requires consultation with a hemophilia treatment center and consideration of bypassing agents or immune tolerance induction.
Clinical response (e.g., cessation of bleeding, absence of new bleeding)
Frequency: Continuously during treatment.
Target: Resolution of bleeding symptoms.
Action Threshold: Persistent or recurrent bleeding despite adequate Factor VIII levels may indicate inhibitor development or other complications.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from cuts, nosebleeds, blood in urine/stool, severe headache, vision changes, abdominal pain)
- Signs of allergic or hypersensitivity reactions (e.g., hives, rash, itching, facial swelling, dizziness, lightheadedness, chest tightness, difficulty breathing, wheezing)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Hemophilia in women is rare, but management during pregnancy and delivery is critical due to bleeding risks.
Trimester-Specific Risks:
First Trimester:
Limited data; theoretical risk is low as Factor VIII is a large protein and unlikely to cross the placenta significantly.
Second Trimester:
Limited data; continued monitoring of Factor VIII levels may be necessary.
Third Trimester:
Critical for management of labor and delivery to prevent maternal and neonatal hemorrhage. Dosing should be individualized to maintain adequate Factor VIII levels.
Lactation
L3 (Moderately safe). It is unknown whether Antihemophilic Factor (Recombinant) is excreted in human milk. Caution should be exercised when administering to a nursing mother. The benefits of breastfeeding should be weighed against the potential risks.
Infant Risk:
Low risk. Factor VIII is a large protein and is unlikely to be absorbed intact by the infant if present in breast milk. No adverse effects have been reported in breastfed infants.
Pediatric Use
Recombinate is widely used and effective in pediatric patients with hemophilia A, including infants and children. Dosing is weight-based and individualized. Close monitoring for inhibitor development is crucial, especially in previously untreated patients (PUPs).
Geriatric Use
No specific dose adjustments are required based on age alone. However, geriatric patients may have age-related comorbidities (e.g., cardiovascular disease, renal/hepatic impairment) that warrant careful monitoring and consideration of overall health status.
Clinical Information
Clinical Pearls
- Dosing is highly individualized based on the patient's Factor VIII deficiency, weight, and the type/severity of bleeding or surgical procedure. Always calculate dose based on current Factor VIII levels and desired increase.
- Regular monitoring of Factor VIII activity levels is essential to ensure therapeutic efficacy and prevent under- or over-dosing.
- Patients should be educated on the signs and symptoms of bleeding and allergic reactions, and how to self-administer the product if appropriate.
- The development of Factor VIII inhibitors (antibodies) is a significant complication in hemophilia A treatment. Patients should be regularly screened for inhibitors, especially if they show a poor response to treatment.
- Patients should carry medical alert identification indicating their hemophilia A status and Factor VIII deficiency.
- Proper storage and reconstitution techniques are critical for maintaining product potency and sterility.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Nuwiq, Xyntha, Adynovate, Afstyla, Altuviiio)
- Plasma-derived Factor VIII concentrates
- Bypassing agents (for patients with inhibitors): Activated Prothrombin Complex Concentrate (aPCC, e.g., FEIBA), Recombinant Factor VIIa (e.g., NovoSeven RT)
- Non-factor replacement therapies (for prophylaxis in patients with or without inhibitors): Emicizumab (Hemlibra)
- Desmopressin (DDAVP) for mild Hemophilia A (not effective for severe Hemophilia A or in patients with Factor VIII inhibitors)
Cost & Coverage
Average Cost:
Very expensive (price varies significantly by IU and vial size, typically thousands of dollars per vial) per vial (IU)
Insurance Coverage:
Specialty tier, often requires prior authorization and is typically covered by major medical insurance plans due to medical necessity for hemophilia A.
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 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 details about the medication taken, the amount, and the time it occurred.