Kovaltry 500unit 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
Oct 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Kovaltry 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 protein called Factor VIII. Kovaltry replaces this missing protein, helping your blood to clot normally.
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 are 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 is stored in the refrigerator, allow it to reach room temperature before mixing. Do not heat the medication. Prior to use, the medication must be mixed according to the instructions provided by your doctor. Avoid shaking the medication. Do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color. 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 in a designated needle/sharp disposal container and do not reuse needles or other items. 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
If you are using this medication at home, store unopened containers in the refrigerator, but do not freeze.
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 are 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 is stored in the refrigerator, allow it to reach room temperature before mixing. Do not heat the medication. Prior to use, the medication must be mixed according to the instructions provided by your doctor. Avoid shaking the medication. Do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color. 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 in a designated needle/sharp disposal container and do not reuse needles or other items. 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
If you are using this medication at home, store unopened containers in the refrigerator, but do not freeze.
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 interfere with blood clotting, such as aspirin, NSAIDs (e.g., ibuprofen, naproxen), and certain blood thinners, unless specifically instructed by your doctor.
- Maintain good dental hygiene to prevent gum bleeding.
- Always carry your medication and identification indicating your hemophilia status.
- Follow your prescribed dosing schedule carefully, especially for prophylaxis, to prevent bleeding episodes.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on Factor VIII levels, bleeding severity, and prophylaxis needs. For on-demand treatment of bleeding episodes: 10-50 IU/kg depending on severity. For routine prophylaxis: 20-40 IU/kg every other day or three times per week.
Dose Range:
10 - 50 mg
Condition-Specific Dosing:
prophylaxis:
20-40 IU/kg every other day or 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, individualized)
Infant:
Dosing is weight-based, similar to adults (e.g., 20-40 IU/kg for prophylaxis)
Child:
Dosing is weight-based, similar to adults (e.g., 20-40 IU/kg for prophylaxis)
Adolescent:
Dosing is weight-based, similar to adults (e.g., 20-40 IU/kg for prophylaxis)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations; not renally eliminated
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No 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 50-60 mL/kg (similar to plasma volume)
ProteinBinding:
Binds to von Willebrand factor (vWF) in circulation, which stabilizes Factor VIII and prolongs its half-life.
CnssPenetration:
Limited
Elimination:
HalfLife:
11.9 to 14.5 hours (mean terminal half-life in adults)
Clearance:
Approximately 3-5 mL/hr/kg
ExcretionRoute:
Metabolic degradation (not renally or hepatically excreted as intact protein)
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Within minutes of administration (corresponds to peak Factor VIII activity)
DurationOfAction:
Dependent on half-life and initial dose; typically 2-3 days for prophylactic effect, shorter for acute bleeding.
Confidence:
High
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 immediately or seek 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. However, many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor if they bother you or do not go away:
Irritation at the injection site
Headache
Cough (Advate only)
Signs of a common cold (Advate only)
Nose or throat irritation (Advate only)
Stuffy nose (Advate only)
Joint pain or swelling (Advate only)
* Diarrhea (Advate only)
This is not an exhaustive list of 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.
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 immediately or seek 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. However, many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor if they bother you or do not go away:
Irritation at the injection site
Headache
Cough (Advate only)
Signs of a common cold (Advate only)
Nose or throat irritation (Advate only)
Stuffy nose (Advate only)
Joint pain or swelling (Advate only)
* Diarrhea (Advate only)
This is not an exhaustive list of 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 an allergic reaction: rash, hives, itching, redness, swelling of the face, lips, tongue, or throat, difficulty breathing, wheezing, chest tightness, dizziness, feeling faint, rapid heartbeat.
- Signs of inhibitor development: increased frequency or severity of bleeding episodes, or if your usual dose of Kovaltry doesn't stop bleeding as expected.
- Any new or unusual bleeding or bruising.
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.
Any 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
All of your health problems, as they 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. It is crucial to verify that it is safe to take this medication with all of your other medications and health conditions.
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.
Any 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
All of your health problems, as they 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. It is crucial to verify that it is safe to take this medication with all of your other medications and health conditions.
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 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, bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. These symptoms may indicate 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 generally not associated with severe adverse effects due to the protein nature of Factor VIII, extremely high levels could theoretically increase the risk of thrombotic events (blood clots), though this is not commonly reported with Factor VIII products.
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services immediately. Management is generally supportive. Call 1-800-222-1222 (Poison Control).
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) screening (Bethesda assay)
Rationale: To detect pre-existing inhibitors that would render treatment ineffective.
Timing: Prior to initiation of therapy
Routine Monitoring
Factor VIII activity levels
Frequency: Periodically during treatment, especially during acute bleeding episodes or surgical procedures, and to confirm adequate levels for prophylaxis.
Target: Varies based on clinical situation (e.g., >1% for prophylaxis, 20-40% for minor bleeds, 60-100% for major bleeds/surgery)
Action Threshold: If levels are not achieved as expected, consider inhibitor development or inadequate dosing.
Inhibitor (neutralizing antibody) screening
Frequency: Regularly (e.g., every 3-6 months, or more frequently in high-risk patients like previously untreated patients (PUPs) or after significant exposure to Factor VIII). Also, if expected Factor VIII levels are not achieved or bleeding is not controlled.
Target: Negative (<0.6 Bethesda Units/mL)
Action Threshold: Positive inhibitor titer requires management by a hemophilia treatment center, potentially with immune tolerance induction (ITI) or bypassing agents.
Clinical response to treatment
Frequency: Continuously during therapy
Target: Cessation of bleeding, prevention of bleeding episodes
Action Threshold: Persistent or recurrent bleeding indicates inadequate treatment, potential inhibitor, or other complications.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, nosebleeds, blood in urine/stool, prolonged bleeding from cuts)
- Signs of allergic or hypersensitivity reactions (e.g., rash, hives, itching, facial swelling, tightness in chest, wheezing, dizziness, faintness, low blood pressure)
- Signs of inhibitor development (e.g., lack of expected clinical response to Factor VIII, increased bleeding frequency or severity)
Special Patient Groups
Pregnancy
Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks. Hemophilia A is a genetic disorder, and management during pregnancy requires careful consideration due to potential bleeding complications for the mother and fetus. Factor VIII does not cross the placenta in significant amounts.
Trimester-Specific Risks:
First Trimester:
No specific increased risk of congenital malformations reported.
Second Trimester:
No specific increased risk.
Third Trimester:
Crucial for managing bleeding risk during labor and delivery. Close monitoring of Factor VIII levels is essential.
Lactation
Considered compatible with breastfeeding. Factor VIII is a natural component of human plasma, and its presence in breast milk is unlikely to cause harm to the infant. The benefits of breastfeeding should be weighed against the mother's need for treatment.
Infant Risk:
Low risk to infant.
Pediatric Use
Kovaltry is approved for use in pediatric patients with Hemophilia A. Dosing is weight-based and individualized. Pediatric patients, especially previously untreated patients (PUPs), are at higher risk for inhibitor development, 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 adjustments are generally required based on age alone.
Clinical Information
Clinical Pearls
- Kovaltry is supplied as a lyophilized powder for reconstitution with sterile water for injection. Ensure proper aseptic technique during preparation and administration.
- Administer intravenously over several minutes (e.g., 1-10 mL/min). Do not administer faster than 10 mL/min.
- Do not mix Kovaltry with other intravenous solutions or medications in the same syringe or infusion set.
- Monitor for signs of allergic reactions, especially during the initial administrations. Have epinephrine and other emergency equipment readily available.
- Patients should be educated on self-administration techniques, proper storage (refrigerated, but can be stored at room temperature for a limited time), and disposal of used supplies.
- Regular monitoring for Factor VIII inhibitors is crucial, as inhibitor development can lead to treatment failure and significant morbidity.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Xyntha, Nuwiq, Recombinate, Helixate FS)
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Bypassing agents for patients with inhibitors (e.g., activated prothrombin complex concentrate (aPCC) - FEIBA, recombinant Factor VIIa - NovoSeven RT)
- Non-factor replacement therapies (e.g., Emicizumab (Hemlibra) - a bispecific antibody mimicking Factor VIIIa)
- Gene therapy (e.g., Valoctocogene roxaparvovec (Roctavian) for severe Hemophilia A)
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 managed by specialty pharmacies)
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 overdose, including the medication taken, the amount, and the time it occurred.