Kovaltry 2000unit Inj, 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Coagulation Factor
Pharmacologic Class
Recombinant Factor VIII
Pregnancy Category
Not available
FDA Approved
Oct 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. Hemophilia A is a genetic bleeding disorder where the blood doesn't clot properly because of a missing or low level of a protein called Factor VIII. Kovaltry replaces this missing Factor VIII, helping your blood to clot normally and stop bleeding.
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 injection into a vein. If you are responsible for self-administration, your doctor or nurse will provide personalized instruction on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Handling
If the medication is stored in the refrigerator, allow it to reach room temperature before mixing. Do not apply heat to 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. Additionally, do not use the solution if its color has changed. 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 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
For home administration, store unopened containers in the refrigerator. Avoid freezing the medication.
Missed Dose
If you miss a dose, contact your doctor for guidance on 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 injection into a vein. If you are responsible for self-administration, your doctor or nurse will provide personalized instruction on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Handling
If the medication is stored in the refrigerator, allow it to reach room temperature before mixing. Do not apply heat to 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. Additionally, do not use the solution if its color has changed. 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 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
For home administration, store unopened containers in the refrigerator. Avoid freezing the medication.
Missed Dose
If you miss a dose, contact your doctor for guidance on the appropriate course of action.
Lifestyle & Tips
- Always carry your medication and supplies with you.
- Wear or carry a medical alert identification (e.g., bracelet, 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 advised by your doctor.
- Maintain good dental hygiene to prevent gum bleeding.
- Follow your doctor's instructions for regular infusions, even if you feel well, to prevent bleeding episodes.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Prophylaxis: 20-40 IU/kg 2-3 times per week. On-demand: 10-50 IU/kg depending on bleed severity.
Dose Range:
10 - 50 mg
Condition-Specific Dosing:
mild_moderate_hemorrhage:
10-20 IU/kg
major_hemorrhage_surgery:
30-50 IU/kg
Pediatric Dosing
Neonatal:
Not established (use based on clinical need and Factor VIII levels)
Infant:
Prophylaxis: 20-40 IU/kg 2-3 times per week. On-demand: 10-50 IU/kg depending on bleed severity.
Child:
Prophylaxis: 20-40 IU/kg 2-3 times per week. On-demand: 10-50 IU/kg depending on bleed severity.
Adolescent:
Prophylaxis: 20-40 IU/kg 2-3 times per week. On-demand: 10-50 IU/kg depending on bleed severity.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific adjustment needed; not renally cleared.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Antihemophilic Factor (Recombinant) is a glycoprotein that temporarily replaces the missing coagulation Factor VIII, which is necessary for effective hemostasis. 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 thrombin and fibrin clot.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Immediate (after completion of infusion)
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Approximately 40-60 mL/kg
ProteinBinding:
Binds to von Willebrand factor (vWF) in plasma, which stabilizes Factor VIII and prolongs its half-life.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10-14 hours (terminal half-life)
Clearance:
Approximately 3-5 mL/hr/kg
ExcretionRoute:
Metabolic degradation and cellular uptake
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon infusion)
PeakEffect:
Immediate (at the end of infusion)
DurationOfAction:
Dependent on half-life and Factor VIII levels achieved; typically 2-3 days for prophylactic effect.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
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 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:
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 a complete list of possible side effects. If you have questions or concerns about side effects, 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 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:
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 a complete list of possible side effects. If you have questions or concerns about side effects, 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 allergic reaction: rash, hives, itching, facial swelling, shortness of breath, chest tightness, dizziness, faintness, rapid heartbeat.
- Signs of inhibitor development: increased frequency or severity of bleeding episodes despite regular treatment, or if your usual dose doesn't stop a bleed.
- Signs of blood clots (rare): pain, swelling, warmth, redness in a limb; sudden chest pain; shortness of breath; sudden vision changes.
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 making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication. Your doctor will help you determine whether it is safe to take this medication in combination with 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 making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication. Your doctor will help you determine whether it is safe to take this medication in combination with 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 or 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, and your doctor may need to adjust your treatment.
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. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision about your treatment.
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 dose is not effective, and your doctor may need to adjust your treatment.
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. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
- While overdose is rare, very high levels of Factor VIII could theoretically increase the risk of thrombotic events (blood clots), though this is not commonly observed with recombinant Factor VIII products.
What to Do:
In case of suspected overdose, contact your healthcare provider immediately or call emergency services. Management would be supportive and aimed at monitoring for and treating any potential thrombotic complications. For general poison control, call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity levels
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy
Inhibitor (neutralizing antibody) screen
Rationale: To detect pre-existing inhibitors, which can render treatment ineffective.
Timing: Prior to initiation of therapy
Routine Monitoring
Factor VIII activity levels
Frequency: Periodically, especially during major bleeding episodes, surgery, or when adjusting dose.
Target: Varies by clinical situation (e.g., >30% for minor bleeds, >80-100% for major surgery).
Action Threshold: If levels are not therapeutic or unexpected, investigate for inhibitors or adjust dose.
Inhibitor (neutralizing antibody) screen (Bethesda assay)
Frequency: Regularly (e.g., every 3-6 months for severe hemophilia A, or if clinical response is poor).
Target: <0.6 Bethesda Units (BU)/mL
Action Threshold: >0.6 BU/mL indicates inhibitor presence, requiring alternative treatment strategies.
Clinical response (cessation of bleeding, absence of new bleeds)
Frequency: Continuously during therapy.
Target: Effective hemostasis.
Action Threshold: Persistent or recurrent bleeding despite adequate dosing suggests inhibitor development or other complications.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from cuts, blood in urine/stools)
- Signs of allergic or hypersensitivity reactions (e.g., rash, hives, itching, facial swelling, shortness of breath, chest tightness, dizziness, faintness)
- Signs of inhibitor development (e.g., decreased efficacy, increased bleeding frequency/severity despite adequate dosing)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Kovaltry in pregnant women. Animal reproduction studies have not been conducted. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus. Hemophilia A is a genetic disorder, and genetic counseling may be appropriate.
Trimester-Specific Risks:
First Trimester:
Risk unknown; Factor VIII is a naturally occurring protein.
Second Trimester:
Risk unknown; Factor VIII is a naturally occurring protein.
Third Trimester:
Risk unknown; Factor VIII is a naturally occurring protein.
Lactation
It is not known whether Kovaltry is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Kovaltry and any potential adverse effects on the breastfed infant from Kovaltry or from the underlying maternal condition. Factor VIII is a large protein, making transfer into breast milk unlikely.
Infant Risk:
Low risk expected due to large molecular size and protein nature, unlikely to be absorbed intact by the infant.
Pediatric Use
Kovaltry is approved for use in pediatric patients, including neonates, infants, children, and adolescents. Dosing is weight-based and similar to adults. Close monitoring for inhibitor development is crucial, especially in previously untreated patients (PUPs) and minimally treated patients (MTPs).
Geriatric Use
Clinical studies of Kovaltry 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 third-generation recombinant Factor VIII product, meaning it is not derived from human plasma and is manufactured without human or animal protein additives in the cell culture or purification process.
- Individualize dosing based on patient's Factor VIII levels, clinical response, and type/severity of bleeding.
- Patients should be educated on self-administration techniques and proper storage of the product.
- Regular monitoring for Factor VIII inhibitors is critical, especially in the first 50 exposure days or during periods of increased bleeding.
- Patients should be advised to report any signs of allergic reactions immediately.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Nuwiq, Recombinate, Xyntha, Hemlibra (emicizumab - non-factor VIII replacement), Alprolix, Adynovate)
- Plasma-derived Factor VIII products
- Bypassing agents (e.g., FEIBA, NovoSeven RT) for patients with inhibitors
- Desmopressin (DDAVP) for mild hemophilia A (not for severe hemophilia A or patients with inhibitors)
- Antifibrinolytics (e.g., tranexamic acid, aminocaproic acid) as adjunctive therapy
Cost & Coverage
Average Cost:
Highly variable, typically thousands of dollars per vial depending on unit strength and quantity. per vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by major medical and pharmacy benefit plans for approved indications)
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.