Recombinate Inj, 1vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic agent
Pharmacologic Class
Coagulation factor; Factor VIII (recombinant)
Pregnancy 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 genetic condition where your blood doesn't clot properly because you don't have enough of a protein called Factor VIII. Recombinate replaces this missing protein, helping your blood to clot normally 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; 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 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. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, 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 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; 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 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. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, 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 to determine the best course of action.
Lifestyle & Tips
- Always carry your medication and supplies, especially when traveling.
- Follow your doctor's instructions for dosing and frequency, including prophylactic treatment.
- Learn how to self-infuse if recommended by your healthcare provider.
- Avoid activities that carry a high risk of injury or bleeding.
- Wear a medical alert bracelet or carry an identification card stating you have hemophilia.
- Maintain good dental hygiene and inform your dentist about your condition.
- Avoid aspirin and NSAIDs (e.g., ibuprofen, naproxen) as they can increase bleeding risk; consult your doctor for pain relief alternatives.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on patient's Factor VIII level, type of bleeding, and body weight. General formula: Dose (Units) = Body Weight (kg) x Desired Factor VIII Increase (%) x 0.5 (Units/kg per % increase). For on-demand treatment of bleeding episodes, target Factor VIII levels vary (e.g., 20-40% for minor, 30-60% for moderate, 80-100% for severe/surgery). For prophylaxis, typically 25-50 IU/kg 2-3 times per week.
Dose Range:
20 - 100 mg
Condition-Specific Dosing:
minor_bleeding:
20-40 IU/kg to achieve 40-80% Factor VIII activity, repeat every 12-24 hours as needed.
moderate_bleeding:
30-60 IU/kg to achieve 60-120% Factor VIII activity, repeat every 12-24 hours as needed.
severe_bleeding_or_surgery:
40-50 IU/kg to achieve 80-100% Factor VIII activity, then maintain at 30-60% for 10-14 days post-surgery. Initial dose may be higher to achieve 100%.
Pediatric Dosing
Neonatal:
Not established, but used in neonates with hemophilia A. Dosing is individualized based on weight and factor levels, similar to older children.
Infant:
Dosing is individualized based on weight and factor levels, similar to adults. Prophylaxis often initiated early.
Child:
Dosing is individualized based on weight and factor levels, similar to adults. Prophylaxis often initiated early, e.g., 25-50 IU/kg 2-3 times per week.
Adolescent:
Dosing is individualized based on weight and factor levels, similar to adults.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
No specific adjustment needed, as Factor VIII is a large protein 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 temporarily replaces the deficient coagulation Factor VIII in patients with hemophilia A. Factor VIII is an essential cofactor for Factor IXa in the activation of Factor X to Factor Xa in the intrinsic coagulation pathway. By providing exogenous Factor VIII, it enables the formation of a stable fibrin clot, thereby controlling or preventing bleeding episodes.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable (immediate effect with IV administration)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.04-0.08 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:
Typically 8-18 hours (mean ~12 hours), but can vary significantly between individuals.
Clearance:
Approximately 2-6 mL/hr/kg
ExcretionRoute:
Metabolized and eliminated via protein degradation pathways; no specific excretion route like renal or biliary.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Within minutes of administration
DurationOfAction:
Dependent on half-life, typically 8-24 hours, requiring repeat dosing for sustained effect. Clinical duration is related to the maintenance of hemostatic Factor VIII levels.
Confidence:
High
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention 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 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
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 for advice:
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 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
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 for advice:
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:
- Increased frequency or severity of bleeding episodes despite treatment.
- Bleeding that is difficult to stop or recurs quickly after treatment.
- Signs of allergic reaction: hives, rash, itching, swelling of the face/lips/tongue/throat, difficulty breathing, chest tightness, dizziness, fainting.
- Signs of infusion site reactions: pain, redness, swelling at the injection site.
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.
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 your 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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
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 your 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 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 to last throughout 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.
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 to last throughout 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 unlikely to cause severe acute toxicity due to the nature of the protein, very high levels of Factor VIII could theoretically increase the risk of thrombosis (blood clots), though this is rare in hemophilia patients.
- Symptoms of thrombosis could include chest pain, shortness of breath, pain/swelling in a limb, sudden weakness or numbness.
What to Do:
If overdose is suspected, contact your healthcare provider or emergency services immediately. Management is supportive and may involve monitoring for thrombotic events. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity level
Rationale: To determine baseline deficiency and guide initial dosing.
Timing: Prior to first administration and periodically.
Inhibitor (antibody) screen and titer
Rationale: To detect the presence of neutralizing antibodies to Factor VIII, which can render treatment ineffective. High titers require alternative treatments.
Timing: Prior to first administration, periodically (e.g., annually or every 6-12 months), and if treatment efficacy decreases or bleeding becomes difficult to control.
Complete Blood Count (CBC)
Rationale: To assess overall hematological status and monitor for potential bleeding complications.
Timing: Periodically, especially during active bleeding episodes.
Routine Monitoring
Factor VIII activity level
Frequency: Before and after initial dose, then as clinically indicated to ensure target levels are achieved and maintained. For prophylaxis, periodically to confirm trough levels.
Target: Varies by indication (e.g., 20-40% for minor bleeding, 80-100% for severe bleeding/surgery).
Action Threshold: If levels are below target, adjust dose or frequency. If levels are unexpectedly low, investigate for inhibitor development.
Clinical response (cessation of bleeding)
Frequency: Continuously during active bleeding episodes.
Target: Resolution of bleeding symptoms.
Action Threshold: If bleeding persists or recurs, re-evaluate Factor VIII levels, consider inhibitor testing, and adjust treatment.
Signs of hypersensitivity/allergic reaction
Frequency: During and immediately after infusion.
Target: Absence of rash, urticaria, pruritus, facial swelling, dyspnea, chest tightness, hypotension.
Action Threshold: Stop infusion immediately, provide supportive care (antihistamines, corticosteroids, epinephrine).
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, muscle pain, bruising, prolonged bleeding from cuts, nosebleeds, blood in urine/stools)
- Signs of allergic reaction (e.g., rash, hives, itching, facial swelling, difficulty breathing, chest tightness, dizziness)
- Signs of inhibitor development (e.g., increased frequency or severity of bleeding, poor response to Factor VIII treatment)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies of Recombinate in pregnant women. Animal reproduction studies have not been conducted. It should be given to a pregnant woman only if clearly needed. Hemophilia A in women is rare, but carriers may have lower Factor VIII levels and require treatment during pregnancy and delivery to prevent bleeding complications.
Trimester-Specific Risks:
First Trimester:
No specific data, but generally avoided unless essential.
Second Trimester:
No specific data, but generally avoided unless essential.
Third Trimester:
May be used to manage bleeding risk during labor and delivery if Factor VIII levels are low.
Lactation
It is not known whether Recombinate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Recombinate is administered to a nursing mother. The decision to breastfeed should consider the potential benefits of breastfeeding for the infant and the potential benefits of therapy for the mother.
Infant Risk:
Not available, but unlikely to be harmful due to the large protein nature and oral degradation.
Pediatric Use
Recombinate is approved for use in pediatric patients with hemophilia A. Dosing is individualized based on weight, Factor VIII levels, and clinical need. Prophylaxis is often initiated early in life to prevent joint damage. Inhibitor development is a significant concern, particularly in previously untreated patients (PUPs).
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 solely on age.
Clinical Information
Clinical Pearls
- Recombinate is a lyophilized powder that must be reconstituted with sterile water for injection immediately before use. Do not shake vigorously.
- Administer intravenously over several minutes (typically 5-10 minutes). The rate of administration should be determined by the patient's comfort.
- Monitor for inhibitor development, especially in previously untreated patients (PUPs) and during the first 50 exposure days. Inhibitors can make treatment ineffective.
- Patients should be educated on recognizing signs of bleeding and hypersensitivity reactions.
- Store refrigerated (2-8°C or 36-46°F). Do not freeze. Can be stored at room temperature (up to 25°C or 77°F) for a limited period (check specific product insert for duration, typically up to 3 months).
- This product is derived from Chinese Hamster Ovary (CHO) cells and is highly purified, reducing the risk of viral transmission compared to plasma-derived products.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Kogenate FS, Xyntha, Eloctate, Adynovate, Jivi)
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Bypassing agents for patients with inhibitors (e.g., activated prothrombin complex concentrate (aPCC) like FEIBA, recombinant Factor VIIa (rFVIIa) like NovoSeven RT)
- Non-factor replacement therapies (e.g., Emicizumab (Hemlibra) for prophylaxis in patients with or without inhibitors)
- Desmopressin (DDAVP) for mild hemophilia A (increases endogenous Factor VIII release, not for severe hemophilia A)
Cost & Coverage
Average Cost:
Highly variable, typically thousands to tens of thousands of dollars per vial depending on strength (IU). per vial
Insurance Coverage:
Specialty Tier (often requires prior authorization and is covered under medical benefit for hemophilia patients)
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.