Recombinate 401-800 Inj,1vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Coagulation Factor, Recombinant
Pregnancy Category
C
FDA Approved
Feb 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Recombinate is a medicine used to treat and prevent bleeding in people with hemophilia A, a genetic bleeding disorder. It works by replacing a missing clotting protein (Factor VIII) in the blood, which helps the blood to clot properly and stop bleeding.
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 you are using this medication at home, store unopened containers at room temperature or in the refrigerator. Avoid freezing 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 you are using this medication at home, store unopened containers at room temperature or in the refrigerator. Avoid freezing the medication.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Avoid activities that carry a high risk of injury or bleeding (e.g., contact sports) unless approved by your doctor.
- Avoid medications that can increase bleeding risk, such as aspirin, ibuprofen, naproxen, or other NSAIDs, unless specifically instructed by your doctor.
- Maintain good dental hygiene to prevent gum bleeding.
- Always carry your medication and identification indicating you have hemophilia.
- Learn proper self-administration techniques if you are infusing at home.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on Factor VIII levels, type and severity of bleeding, and patient weight. For on-demand treatment, typical doses range from 20-60 IU/kg for minor to moderate bleeds, and 50-100 IU/kg for severe bleeds or surgery. For prophylaxis, typical doses are 25-40 IU/kg 2-3 times per week.
Dose Range:
20 - 100 mg
Condition-Specific Dosing:
minor_bleed:
20-40 IU/kg IV, repeat every 12-24 hours as needed to achieve 40-60% Factor VIII activity.
moderate_bleed:
30-60 IU/kg IV, repeat every 12-24 hours as needed to achieve 60-80% Factor VIII activity.
severe_bleed_or_surgery:
50-100 IU/kg IV, repeat every 8-24 hours as needed to achieve 80-120% Factor VIII activity.
prophylaxis:
25-40 IU/kg IV 2-3 times per week.
Pediatric Dosing
Neonatal:
Not established (use in neonates with hemophilia A is based on clinical judgment and Factor VIII levels, similar to older children, but with careful monitoring).
Infant:
Dosing is weight-based, similar to older children and adults. Typically 25-50 IU/kg for on-demand treatment or prophylaxis.
Child:
Dosing is weight-based, similar to adults. Typically 25-50 IU/kg for on-demand treatment or prophylaxis.
Adolescent:
Dosing is weight-based, similar to adults. Typically 25-50 IU/kg for on-demand treatment or prophylaxis.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
No specific adjustment needed; Factor VIII is a large protein and not significantly cleared by dialysis.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Pharmacology
Mechanism of Action
Antihemophilic Factor (Recombinant) is a glycoprotein that replaces the deficient endogenous coagulation Factor VIII in patients with hemophilia A. Factor VIII functions as a cofactor for activated Factor IX (Factor IXa) in the intrinsic pathway of coagulation, accelerating the conversion of Factor X to activated Factor X (Factor Xa). Factor Xa, in turn, converts prothrombin to thrombin, which then converts fibrinogen to fibrin, forming a stable clot.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (within minutes of IV infusion)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.05 L/kg (similar to plasma volume)
ProteinBinding:
Highly bound to von Willebrand factor (vWF)
CnssPenetration:
Limited
Elimination:
HalfLife:
12.4 Âą 3.6 hours (mean Âą SD in adults)
Clearance:
3.1 Âą 0.9 mL/hr/kg
ExcretionRoute:
Metabolic degradation (catabolism)
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of infusion)
PeakEffect:
Within minutes of infusion
DurationOfAction:
Dependent on half-life and target Factor VIII level, typically 8-24 hours for therapeutic effect.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help 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
A burning, numbness, or tingling feeling that is not normal
A change in the color of your mouth to blue
Chest pain or pressure, or a fast heartbeat
Dizziness or fainting
Feeling cold
Fever or chills
Flushing
Pale skin
Restlessness
Shortness of breath
Upset stomach or vomiting
Feeling very tired or weak
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Irritation at the injection site
* Headache
Note: This is not an exhaustive list of all 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help 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
A burning, numbness, or tingling feeling that is not normal
A change in the color of your mouth to blue
Chest pain or pressure, or a fast heartbeat
Dizziness or fainting
Feeling cold
Fever or chills
Flushing
Pale skin
Restlessness
Shortness of breath
Upset stomach or vomiting
Feeling very tired or weak
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Irritation at the injection site
* Headache
Note: This is not an exhaustive list of all 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: new or worsening joint pain/swelling, muscle pain, unusual bruising, prolonged bleeding from cuts, nosebleeds, blood in urine or stool, severe headache, vision changes.
- Signs of allergic reaction: hives, rash, itching, swelling of the face/lips/tongue/throat, difficulty breathing, chest tightness, dizziness, feeling faint.
- Signs of inhibitor development: your usual dose of Recombinate doesn't stop bleeding as effectively as before, or you experience more frequent or severe bleeding episodes.
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 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.
Any other medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or health conditions.
Any existing health problems you have, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to review all your medications and health conditions with your doctor and pharmacist. Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
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 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.
Any other medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or health conditions.
Any existing health problems you have, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to review all your medications and health conditions with your doctor and pharmacist. Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
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 or bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. This could be an indication that your current dosage 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 or bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. This could be an indication that your current dosage 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 overdose is rare and not typically associated with acute toxicity, very high Factor VIII levels could theoretically increase the risk of thrombotic events (blood clots).
- Symptoms of thrombosis could include chest pain, shortness of breath, pain/swelling in a limb, sudden severe headache, vision changes.
What to Do:
In case of suspected overdose or unusual symptoms, seek immediate medical attention. Contact your doctor or emergency services. For general poison control, call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity levels
Rationale: To determine baseline deficiency and guide initial dosing.
Timing: Prior to initiation of therapy.
Inhibitor (neutralizing antibody) screen (Bethesda assay)
Rationale: To detect pre-existing inhibitors that would render treatment ineffective.
Timing: Prior to initiation of therapy, especially in previously untreated patients (PUPs) or those with a history of inhibitor development.
Routine Monitoring
Factor VIII activity levels
Frequency: During acute bleeding episodes or surgical procedures: frequently (e.g., daily or every 8-24 hours) to ensure adequate hemostasis. For prophylaxis: periodically to confirm trough levels.
Target: Varies by clinical situation (e.g., 40-60% for minor bleeds, 80-120% for severe bleeds/surgery).
Action Threshold: If levels are below target, increase dose or frequency; if levels are higher than needed, consider dose reduction.
Inhibitor (neutralizing antibody) screen (Bethesda assay)
Frequency: Regularly (e.g., annually) in all patients, and whenever there is a lack of expected clinical response to Factor VIII replacement therapy or an unexpected bleeding episode.
Target: <0.6 Bethesda Units (BU)/mL (negative)
Action Threshold: If inhibitor levels are âĨ0.6 BU/mL, consider alternative treatments (e.g., bypassing agents) and consult a hemophilia treatment center.
Signs of allergic reaction
Frequency: During and immediately after infusion.
Target: Absence of symptoms
Action Threshold: If symptoms occur, stop infusion immediately and manage symptoms (e.g., antihistamines, epinephrine).
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, muscle pain, bruising, prolonged bleeding from cuts, nosebleeds, blood in urine/stool, headache, vision changes)
- Signs of allergic reaction (e.g., hives, rash, itching, facial swelling, difficulty breathing, chest tightness, dizziness, faintness)
- Signs of inhibitor development (e.g., increased frequency or severity of bleeding, lack of response to usual Factor VIII doses)
Special Patient Groups
Pregnancy
Recombinate is Pregnancy Category C. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus. Hemophilia A in pregnant women is rare, but Factor VIII levels may need to be monitored and managed, especially around delivery.
Trimester-Specific Risks:
First Trimester:
No specific data suggesting increased risk during the first trimester. Risk is generally low as Factor VIII is a large protein.
Second Trimester:
No specific data suggesting increased risk.
Third Trimester:
Factor VIII levels may rise naturally in the third trimester, but supplementation may still be required, particularly for delivery, to prevent hemorrhage. Close monitoring of Factor VIII levels is crucial.
Lactation
It is not known whether Recombinate is excreted in human milk. However, Factor VIII is a large protein and is unlikely to be transferred into breast milk in clinically significant amounts. Use with caution and only if clinically indicated. The benefits of breastfeeding should be weighed against the potential risks.
Infant Risk:
Low risk to the infant due to the large molecular weight of Factor VIII, making significant transfer into breast milk unlikely.
Pediatric Use
Dosing is weight-based. Children, especially previously untreated patients (PUPs), have a higher risk of developing Factor VIII inhibitors. Close monitoring for inhibitor development is crucial. Otherwise, the safety and efficacy profile is similar to adults.
Geriatric Use
No specific dose adjustments are typically required based on age alone. Dosing should be individualized based on Factor VIII levels and clinical response. Elderly patients may have co-morbidities that require careful consideration, but Factor VIII pharmacokinetics are generally similar to younger adults.
Clinical Information
Clinical Pearls
- Recombinate is a recombinant Factor VIII product, meaning it is not derived from human plasma, reducing the theoretical risk of transmitting blood-borne pathogens.
- The most significant complication of Factor VIII replacement therapy is the development of neutralizing antibodies (inhibitors), which can render the treatment ineffective. Patients should be regularly monitored for inhibitor development.
- Dosing is highly individualized; regular monitoring of Factor VIII activity levels is essential to ensure adequate hemostasis and prevent over- or under-dosing.
- Patients and caregivers should be educated on the signs of bleeding, allergic reactions, and inhibitor development, and when to seek immediate medical attention.
- Prophylactic treatment with Factor VIII is the standard of care for severe hemophilia A to prevent bleeding episodes and joint damage.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Nuwiq, Xyntha, Adynovate, Afstyla, Esperoct)
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Bypassing agents for patients with inhibitors (e.g., FEIBA, NovoSeven RT)
- Non-factor replacement therapies (e.g., Emicizumab [Hemlibra] for prophylaxis in patients with or without inhibitors)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand dollars per vial (e.g., $1,000 - $5,000+ per 500 IU vial) per vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by major medical and government programs due to medical necessity)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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 medical attention. When seeking help, be prepared to provide details about what was taken, the amount, and the time it occurred.