Recombinate 1800iu Inj, 1vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic agent
Pharmacologic Class
Coagulation factor
Pregnancy Category
Category C
FDA Approved
Dec 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. Hemophilia A is a condition where your blood doesn't clot properly because you're missing a special protein called Factor VIII. Recombinate provides this missing protein, helping your blood to clot 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 provide guidance 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; follow the instructions provided by your doctor. Avoid shaking the medication. Do not use the solution if it appears cloudy, is leaking, or contains particles. The medication should be colorless to faintly yellow; discard it if the color changes. After mixing, do not refrigerate the medication. Use the medication within 3 hours of preparation and discard any unused portion of the opened vial.
Dispose of needles and other sharp objects in a designated 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 and Disposal
If 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 for guidance on the next steps to take.
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.
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; follow the instructions provided by your doctor. Avoid shaking the medication. Do not use the solution if it appears cloudy, is leaking, or contains particles. The medication should be colorless to faintly yellow; discard it if the color changes. After mixing, do not refrigerate the medication. Use the medication within 3 hours of preparation and discard any unused portion of the opened vial.
Dispose of needles and other sharp objects in a designated 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 and Disposal
If 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 for guidance on the next steps to take.
Lifestyle & Tips
- Always carry your medication and supplies, especially when traveling.
- Follow your doctor's instructions for dosing and administration carefully.
- Maintain a regular infusion schedule if on prophylaxis.
- Avoid activities that carry a high risk of injury or bleeding.
- Wear a medical alert bracelet or carry an identification card indicating you have hemophilia A.
- Practice good dental hygiene to prevent gum bleeding.
- Inform all healthcare providers (including dentists) that you have hemophilia A.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on patient weight, desired factor VIII level, and severity/location of hemorrhage or surgical procedure. Dosing is calculated as: Dose (IU) = Body Weight (kg) x Desired Factor VIII Increase (%) x 0.5 (IU/kg per % increase). For on-demand treatment of bleeding, target levels vary (e.g., 20-40% for minor bleeds, 30-60% for moderate, 80-100% for severe/surgery). For prophylaxis, typical doses are 25-50 IU/kg every 2-3 days.
Condition-Specific Dosing:
on_demand_minor_bleed:
20-40 IU/kg to achieve 40-80% FVIII activity, repeat every 12-24 hours as needed.
on_demand_major_bleed:
50 IU/kg to achieve 80-100% FVIII activity, repeat every 8-12 hours as needed.
surgical_prophylaxis:
50 IU/kg pre-op to achieve 80-100% FVIII activity, then maintain levels with subsequent doses.
routine_prophylaxis:
25-50 IU/kg every 2-3 days.
Pediatric Dosing
Neonatal:
Not established (use with caution, consult hematologist).
Infant:
Dosing is weight-based, similar to adults (IU/kg). Prophylaxis often initiated early in life.
Child:
Dosing is weight-based, similar to adults (IU/kg). Prophylaxis often initiated early in life.
Adolescent:
Dosing is weight-based, similar to adults (IU/kg). Prophylaxis often initiated early in life.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
No specific adjustment needed; monitor factor VIII levels as usual.
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 purified glycoprotein that temporarily replaces the missing coagulation factor VIII (FVIII) in patients with hemophilia A. FVIII is an essential cofactor in the intrinsic pathway of blood coagulation, where it binds to activated factor IX (FIXa) and phospholipids, accelerating the activation of factor X (FX) to factor Xa (FXa). FXa then converts prothrombin to thrombin, leading to the formation of a stable fibrin clot.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable (immediate effect after IV infusion)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately 0.04-0.08 L/kg (similar to plasma volume)
ProteinBinding:
Binds to von Willebrand factor (vWF) in plasma, which stabilizes FVIII and prolongs its half-life.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10-19 hours (mean 14.6 hours) in previously treated patients with hemophilia A.
Clearance:
Approximately 2.9-6.6 mL/hr/kg
ExcretionRoute:
Metabolized and eliminated via cellular degradation pathways; not renally or hepatically excreted as intact protein.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of IV infusion)
PeakEffect:
Within minutes of infusion
DurationOfAction:
Dependent on half-life and initial dose; typically 8-24 hours for clinical effect, but factor levels decline over 2-3 days.
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediate medical attention:
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
+ Tingling
Change in mouth color to blue
Chest pain or pressure
Fast 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 symptoms that bother you or do not go away, contact your doctor:
Irritation at the injection site
Headache
This is not an exhaustive list of possible 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 immediate medical attention:
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
+ Tingling
Change in mouth color to blue
Chest pain or pressure
Fast 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 symptoms that bother you or do not go away, contact your doctor:
Irritation at the injection site
Headache
This is not an exhaustive list of possible 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: new or worsening joint pain/swelling, unusual bruising, prolonged bleeding from minor cuts, nosebleeds, blood in urine or stool, severe headaches, vision changes, sudden weakness or numbness.
- Signs of allergic reaction: rash, hives, itching, swelling (especially of the face, lips, tongue, or throat), dizziness, lightheadedness, shortness of breath, chest tightness, wheezing.
- Signs of inhibitor development: if your usual dose of Recombinate doesn't stop bleeding as expected, or if you need more frequent or higher doses to control bleeding.
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 exacerbate existing health problems.
All of your health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all of your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor. Always consult with your doctor and pharmacist to confirm that it is safe to take this medication in conjunction with your other treatments.
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 exacerbate existing health problems.
All of your health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all of your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor. Always consult with your doctor and pharmacist to confirm that it is safe to take this medication in conjunction with your other treatments.
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:
- No specific symptoms of overdose are known for Recombinate. High doses may lead to elevated factor VIII levels, which theoretically could increase the risk of thrombosis, though this is rare in hemophilia A patients.
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services immediately. For general poison control, call 1-800-222-1222. Management is supportive and based on clinical presentation. Monitor for signs of thrombosis.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity level
Rationale: To establish baseline deficiency and guide initial dosing.
Timing: Prior to first administration or when switching products.
Inhibitor (neutralizing antibody) screen
Rationale: To detect the presence of antibodies against factor VIII, which can render treatment ineffective. Important for all patients, especially those with severe hemophilia A.
Timing: Prior to first administration, annually, and whenever there is a lack of expected clinical response or factor VIII activity.
Complete Blood Count (CBC)
Rationale: To assess overall hematologic status, especially in bleeding episodes.
Timing: As clinically indicated.
Routine Monitoring
Factor VIII activity level
Frequency: Before and after initial dose to confirm recovery and half-life; then as needed to guide subsequent dosing, especially for major bleeds or surgery.
Target: Varies based on clinical indication (e.g., 80-100% for major surgery, 40-60% for moderate bleeds).
Action Threshold: If levels are lower than expected, consider inhibitor development or altered pharmacokinetics.
Clinical response (cessation of bleeding)
Frequency: Continuously during treatment of bleeding episodes.
Target: Resolution of bleeding symptoms.
Action Threshold: Persistent or recurrent bleeding despite adequate factor VIII levels may indicate inhibitor development or other complications.
Inhibitor (neutralizing antibody) screen
Frequency: Annually for all patients; more frequently (e.g., every 3-6 months) in young children or after intensive exposure to factor VIII; whenever there is a lack of expected clinical response.
Target: Negative (less than 0.6 Bethesda Units/mL).
Action Threshold: Positive inhibitor titer requires specialized management by a hematologist.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from cuts, blood in urine/stools, nosebleeds, headaches, vision changes)
- Signs of allergic reaction (e.g., rash, hives, itching, swelling, dizziness, shortness of breath, chest tightness)
- Signs of inhibitor development (e.g., lack of response to usual factor VIII doses, increased bleeding frequency or severity)
Special Patient Groups
Pregnancy
Use only if clearly needed. Hemophilia A is rare in females, but if a pregnant woman has hemophilia A or is a carrier with low factor VIII levels, treatment may be necessary to prevent or manage bleeding complications during pregnancy and delivery. Factor VIII does not cross the placenta significantly.
Trimester-Specific Risks:
First Trimester:
No specific risks identified beyond general pregnancy considerations.
Second Trimester:
No specific risks identified beyond general pregnancy considerations.
Third Trimester:
May be used to maintain adequate factor VIII levels to prevent hemorrhage during labor and delivery.
Lactation
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Recombinate and any potential adverse effects on the breastfed infant from Recombinate or from the underlying maternal condition. Factor VIII is a large protein and is unlikely to be excreted into breast milk in significant amounts.
Infant Risk:
Low risk of adverse effects on the breastfed infant.
Pediatric Use
Recombinate is approved for use in pediatric patients with hemophilia A. Dosing is weight-based and individualized. Inhibitor development is more common in previously untreated patients (PUPs) and young children, requiring close monitoring.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Dosing should be individualized based on factor VIII levels and clinical response, similar to younger adults. No specific dose adjustment is generally required based on age alone.
Clinical Information
Clinical Pearls
- Recombinate is a recombinant product, meaning it is not derived from human plasma, reducing the risk of transmitting blood-borne pathogens.
- Always reconstitute the product immediately before use and administer via intravenous infusion.
- Monitor for inhibitor development, especially in previously untreated patients (PUPs) and young children, as this is the most significant complication of factor VIII replacement therapy.
- Patients should be educated on self-administration techniques, signs of bleeding, and signs of allergic reactions.
- Ensure proper storage (refrigerated, but can be stored at room temperature for a limited time as per package insert).
- The 1800 IU vial is a high-dose presentation, often used for severe bleeding episodes or surgical prophylaxis in larger patients.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Adynovate, Jivi, Nuwiq, Xyntha, Hemlibra (emicizumab - a non-factor VIII alternative for prophylaxis))
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate - contain vWF and FVIII)
- 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 dose depending on strength and quantity) per vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by major medical and pharmacy benefit 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 use, 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. If you have any questions or concerns about this 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 seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.