Kovaltry 3000unit Inj, 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Coagulation Factor VIII
Pregnancy Category
Category C
FDA Approved
Mar 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Kovaltry is a medicine used to treat and prevent bleeding in people with hemophilia A, a genetic bleeding disorder. It works by replacing a missing protein in the blood called Factor VIII, which is essential for blood clotting. It is given as an injection into a vein.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions carefully. Read all accompanying information and adhere to the guidelines provided. This medication is administered via intravenous injection. If you are responsible for self-administering the injection, your doctor or nurse will provide personalized instruction on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Prior to mixing, if the medication has been refrigerated, allow it to reach room temperature. Do not apply heat to the medication. Mixing is required before use; follow the specific instructions provided by your doctor. Avoid shaking the medication. Do not use the solution if it appears cloudy, is leaking, contains particles, or has changed color. After mixing, do not refrigerate the medication. Use the medication within 3 hours of preparation. Discard any unused portion of the opened vial after administration. Dispose of needles and other sharp objects in a designated disposal container. Do not reuse needles or any other components. When the disposal container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
For home administration, store unopened containers in the refrigerator. Avoid freezing the medication.
Missed Dose
If you miss a dose, contact your doctor promptly to determine the appropriate course of action.
To ensure safe and effective use, follow your doctor's instructions carefully. Read all accompanying information and adhere to the guidelines provided. This medication is administered via intravenous injection. If you are responsible for self-administering the injection, your doctor or nurse will provide personalized instruction on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Prior to mixing, if the medication has been refrigerated, allow it to reach room temperature. Do not apply heat to the medication. Mixing is required before use; follow the specific instructions provided by your doctor. Avoid shaking the medication. Do not use the solution if it appears cloudy, is leaking, contains particles, or has changed color. After mixing, do not refrigerate the medication. Use the medication within 3 hours of preparation. Discard any unused portion of the opened vial after administration. Dispose of needles and other sharp objects in a designated disposal container. Do not reuse needles or any other components. When the disposal container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
For home administration, store unopened containers in the refrigerator. Avoid freezing the medication.
Missed Dose
If you miss a dose, contact your doctor promptly to determine the appropriate course of action.
Lifestyle & Tips
- Always carry your medication and supplies with you, especially when traveling.
- Wear or carry a medical alert identification (e.g., bracelet, wallet card) stating you have hemophilia A.
- Avoid activities that carry a high risk of injury or bleeding.
- Avoid medications that interfere with blood clotting, such as aspirin and NSAIDs (e.g., ibuprofen, naproxen), unless specifically approved by your doctor.
- Maintain good dental hygiene to prevent gum bleeding.
- Follow your prescribed dosing schedule carefully, whether for prophylaxis or on-demand treatment.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on patient's Factor VIII level, type of bleeding, and clinical condition. For prophylaxis: 20-40 IU/kg 2-3 times per week. For on-demand treatment: 10-50 IU/kg depending on bleed severity.
Dose Range:
10 - 50 mg
Condition-Specific Dosing:
prophylaxis:
20-40 IU/kg 2-3 times per week
on_demand_minor_bleed:
10-20 IU/kg to achieve 20-40% FVIII activity
on_demand_moderate_bleed:
20-40 IU/kg to achieve 40-80% FVIII activity
on_demand_major_bleed:
30-50 IU/kg to achieve 60-100% FVIII activity
Pediatric Dosing
Neonatal:
Not established (use with caution, consult specialist)
Infant:
Individualized based on patient's Factor VIII level, type of bleeding, and clinical condition. Similar to adult dosing on a per-kg basis.
Child:
Individualized based on patient's Factor VIII level, type of bleeding, and clinical condition. Similar to adult dosing on a per-kg basis.
Adolescent:
Individualized based on patient's Factor VIII level, type of bleeding, and clinical condition. Similar to adult dosing on a per-kg basis.
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 removed by dialysis.
Hepatic Impairment:
Mild:
No specific adjustment needed
Moderate:
No specific adjustment needed
Severe:
No specific adjustment needed
Pharmacology
Mechanism of Action
Kovaltry (Antihemophilic Factor (Recombinant)) is a recombinant DNA-derived coagulation Factor VIII. It temporarily replaces the missing coagulation Factor VIII that is needed for effective hemostasis in patients with hemophilia A (congenital Factor VIII deficiency). Factor VIII acts as a cofactor for Factor IXa in the activation of Factor X to Factor Xa, which ultimately leads to the formation of a stable fibrin clot.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable (immediate effect with IV administration)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately 40-60 mL/kg
ProteinBinding:
Binds to von Willebrand factor (vWF) in circulation, which stabilizes Factor VIII and protects it from degradation.
CnssPenetration:
No
Elimination:
HalfLife:
Approximately 10-14 hours (terminal half-life)
Clearance:
Approximately 2.5-5.0 mL/hr/kg
ExcretionRoute:
Metabolic degradation and cellular uptake
Unchanged:
Not applicable (protein catabolism)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Immediate (within minutes of administration)
DurationOfAction:
Dependent on half-life and initial dose, typically 24-48 hours for a single dose to maintain hemostatic levels.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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, 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, contact your doctor for advice:
Injection site irritation
Headache
Cough (Advate only)
Common cold symptoms
Nose or throat irritation
Stuffy nose
Joint pain or swelling
* Diarrhea
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, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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, 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, contact your doctor for advice:
Injection site irritation
Headache
Cough (Advate only)
Common cold symptoms
Nose or throat irritation
Stuffy nose
Joint pain or swelling
* Diarrhea
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 an allergic reaction: hives, rash, itching, swelling (especially of the face, lips, tongue, or throat), dizziness, chest tightness, difficulty breathing, wheezing.
- Signs that the medicine is not working or you have developed inhibitors: increased frequency or severity of bleeding, bleeding that does not stop with your usual dose.
- Signs of a blood clot: pain, swelling, warmth, or redness in an arm or leg; shortness of breath; chest pain; sudden numbness or weakness on one side of the body.
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 hamster or mouse protein, as this may be relevant to your treatment.
Potential interactions with other medications or health conditions. To ensure safe treatment, disclose all of your:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ 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 starting, stopping, or changing the dose of any medication, including this one, to guarantee safe and effective 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 allergic reaction you experienced, including any symptoms that occurred.
If you have an allergy to hamster or mouse protein, as this may be relevant to your treatment.
Potential interactions with other medications or health conditions. To ensure safe treatment, disclose all of your:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ 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 starting, stopping, or changing the dose of any medication, including this one, to guarantee safe and effective 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 exams 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. This could be an indication that your current dose is not effective.
Before traveling, consult with your doctor and 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.
Regular blood tests and other laboratory exams 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. This could be an indication that your current dose is not effective.
Before traveling, consult with your doctor and 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 an overdose is unlikely to cause acute toxicity, very high levels of Factor VIII could theoretically increase the risk of thrombotic events (blood clots).
What to Do:
In case of suspected overdose, seek immediate medical attention. Management would be supportive and focused on monitoring for and treating any thrombotic complications. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity level
Rationale: To establish baseline deficiency and guide initial dosing.
Timing: Prior to first administration and periodically.
Inhibitor (neutralizing antibody) screening
Rationale: To detect the presence of antibodies against Factor VIII, which can render treatment ineffective.
Timing: Prior to first administration, especially in previously untreated patients (PUPs).
Routine Monitoring
Factor VIII activity level
Frequency: Periodically, especially during acute bleeding episodes or surgical procedures, to ensure adequate hemostatic levels are achieved.
Target: Dependent on clinical situation (e.g., 20-40% for minor bleeds, 80-100% for major surgery).
Action Threshold: If levels are not within target range, adjust dose or frequency.
Inhibitor (neutralizing antibody) screening
Frequency: Regularly (e.g., every 3-6 months) in all patients, and particularly if expected clinical response is not achieved.
Target: Negative (less than 0.6 Bethesda Units/mL)
Action Threshold: If inhibitors are detected, consider alternative treatments (e.g., bypassing agents) or immune tolerance induction.
Clinical response (bleeding episodes)
Frequency: Continuously
Target: Cessation of bleeding, prevention of new bleeds.
Action Threshold: Persistent or recurrent bleeding indicates inadequate treatment or inhibitor development.
Symptom Monitoring
- Signs of allergic reaction (hives, rash, itching, swelling, dizziness, chest tightness, difficulty breathing)
- Signs of inhibitor development (increased frequency or severity of bleeding, lack of response to usual doses)
- Signs of thrombosis (pain, swelling, redness in a limb, shortness of breath, chest pain)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Factor VIII is a large protein and is not expected to cross the placenta in significant amounts. Hemophilia A is rare in women, but management of bleeding during pregnancy and delivery is critical.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk for teratogenicity due to large molecular size.
Second Trimester:
Continued monitoring of Factor VIII levels may be necessary as pregnancy progresses.
Third Trimester:
Increased risk of bleeding during delivery; Factor VIII levels should be closely monitored and maintained at hemostatic levels.
Lactation
L3 (Moderate risk). It is not known whether Kovaltry is excreted in human milk. However, Factor VIII is a large protein and is unlikely to be excreted into breast milk in significant amounts. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Kovaltry and any potential adverse effects on the breastfed infant.
Infant Risk:
Low risk of systemic effects in the infant due to poor oral absorption of large proteins.
Pediatric Use
Kovaltry is approved for use in pediatric patients with hemophilia A, including neonates. Dosing is weight-based and individualized. Close monitoring for inhibitor development is crucial, especially 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. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Kovaltry is a full-length, unmodified recombinant Factor VIII product, which may offer a more natural pharmacokinetic profile compared to some B-domain deleted products.
- Always reconstitute Kovaltry immediately before use and administer within 3 hours of reconstitution.
- Ensure proper aseptic technique during reconstitution and administration to prevent contamination.
- Patients should be educated on self-administration techniques, signs of bleeding, and symptoms of allergic reactions or inhibitor development.
- Regular monitoring for Factor VIII inhibitors is critical, especially in the first 50 exposure days or during periods of intensive treatment.
- For surgical prophylaxis, Factor VIII levels should be raised to appropriate hemostatic levels prior to surgery and maintained post-operatively.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Nuwiq, Recombinate, Xyntha)
- 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), concizumab (in development), fitusiran (in development))
- Desmopressin (DDAVP) for mild hemophilia A
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per vial (e.g., $3,000 - $6,000+ for 3000 IU) per 3000 IU vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered under medical benefit)
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.