Kovaltry 1000unit Inj, 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Recombinant Coagulation 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, a bleeding disorder where the blood does not clot properly. It works by replacing a missing protein in the blood called Factor VIII, which is needed for blood clotting.
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, your doctor or nurse will instruct you on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Administration
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. 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. Discard any unused portion of the opened vial after use.
Disposal
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
If using this medication at home, store unopened containers in the refrigerator. Do not freeze the medication.
Missed Dose
If you miss a dose, contact your doctor for guidance on what to do next.
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, your doctor or nurse will instruct you on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Administration
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. 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. Discard any unused portion of the opened vial after use.
Disposal
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
If using this medication at home, store unopened containers in the refrigerator. Do not freeze the medication.
Missed Dose
If you miss a dose, contact your doctor for guidance on what to do next.
Lifestyle & Tips
- Avoid activities that may cause injury or bleeding, especially contact sports.
- Avoid medications that can increase bleeding risk, such as aspirin and NSAIDs (unless directed by your doctor).
- Maintain good dental hygiene to prevent gum bleeding.
- Carry your medication and identification indicating your hemophilia status at all times.
- Follow your prescribed infusion schedule carefully, even if you feel well.
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:
prophylaxis:
20-40 IU/kg 2-3 times per week
on_demand_minor_bleed:
15-25 IU/kg (target FVIII 30-50%)
on_demand_moderate_bleed:
25-50 IU/kg (target FVIII 50-80%)
on_demand_major_bleed:
50 IU/kg (target FVIII 80-100%)
surgical_prophylaxis:
Pre-operative: 50 IU/kg (target FVIII 80-100%); Post-operative: 25-50 IU/kg every 8-24 hours for 1-14 days
Pediatric Dosing
Neonatal:
Not established (use with caution, weight-based dosing)
Infant:
Weight-based dosing, similar to adults (e.g., 20-40 IU/kg 2-3 times per week for prophylaxis)
Child:
Weight-based dosing, similar to adults (e.g., 20-40 IU/kg 2-3 times per week for prophylaxis)
Adolescent:
Weight-based dosing, similar to adults (e.g., 20-40 IU/kg 2-3 times per week for prophylaxis)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed
Moderate:
No specific adjustment needed
Severe:
No specific adjustment needed
Dialysis:
No specific adjustment needed; not renally cleared
Hepatic Impairment:
Mild:
No specific adjustment needed
Moderate:
No specific adjustment needed
Severe:
No specific adjustment needed
Pharmacology
Mechanism of Action
Kovaltry is a recombinant antihemophilic factor (Factor VIII) that temporarily replaces the deficient coagulation Factor VIII necessary for effective hemostasis in patients with hemophilia A. Factor VIII is an essential 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%
Tmax:
Immediate (post-infusion)
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Approximately 0.05 to 0.07 L/kg
ProteinBinding:
Binds to von Willebrand factor (vWF)
CnssPenetration:
Limited
Elimination:
HalfLife:
Mean terminal half-life: 11.9 to 14.5 hours (adults)
Clearance:
Approximately 2.9 to 4.2 mL/hr/kg
ExcretionRoute:
Metabolic degradation (catabolism)
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon infusion)
PeakEffect:
Immediate (at the end of infusion)
DurationOfAction:
Dependent on half-life and baseline Factor VIII levels, typically 2-3 days for prophylaxis
Safety & Warnings
Side Effects
Urgent 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 that bother you or persist, contact your doctor:
Injection site irritation
Headache
Cough (Advate)
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, 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 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 that bother you or persist, contact your doctor:
Injection site irritation
Headache
Cough (Advate)
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, 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, swelling of the face, lips, tongue, or throat, difficulty breathing, wheezing, dizziness, fainting, chest tightness.
- Signs of bleeding: unusual bruising, prolonged bleeding from cuts, nosebleeds, blood in urine or stool, severe joint or muscle pain, headache with stiff neck.
- Signs that the medicine is not working: continued bleeding despite infusion, new or worsening bleeding episodes.
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 your safety and avoid potential interactions.
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 your safety and avoid potential interactions.
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 evaluations 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 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 evaluations 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 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 unlikely to cause acute toxicity due to the nature of the protein, very high Factor VIII levels could theoretically increase the risk of thrombotic events (blood clots).
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
Baseline Factor VIII activity levels
Rationale: To determine the severity of hemophilia A and guide initial dosing.
Timing: Prior to initiation of therapy
Inhibitor (neutralizing antibody) screening (Bethesda assay)
Rationale: To detect pre-existing inhibitors that may affect treatment efficacy.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response (cessation of bleeding, prevention of bleeds)
Frequency: Continuously during treatment
Target: Bleeding control
Action Threshold: Persistent bleeding or new bleeds may indicate inadequate dosing or inhibitor development.
Factor VIII activity levels
Frequency: Periodically, especially with dose changes, surgery, or inadequate response
Target: Varies by clinical situation (e.g., >1% for prophylaxis, 30-100% for bleeds/surgery)
Action Threshold: Subtherapeutic levels may require dose adjustment; unexpectedly low levels may indicate inhibitor development.
Inhibitor (neutralizing antibody) screening (Bethesda assay)
Frequency: Regularly (e.g., every 3-6 months, or more frequently in previously untreated patients or those with poor response)
Target: <0.6 Bethesda Units (BU)
Action Threshold: Inhibitor titers ≥0.6 BU require specialized management by a hemophilia treatment center.
Signs of hypersensitivity/allergic reactions
Frequency: During and immediately after infusion
Target: Absence of symptoms
Action Threshold: Rash, hives, itching, facial swelling, dyspnea, chest tightness, wheezing, hypotension, anaphylaxis.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, muscle pain, bruising, prolonged bleeding from cuts, nosebleeds, blood in urine/stool)
- Signs of allergic reaction (e.g., rash, hives, itching, facial swelling, dyspnea, chest tightness, wheezing, hypotension)
- Signs of inhibitor development (e.g., lack of expected Factor VIII activity increase, failure to control bleeding with previously effective doses)
Special Patient Groups
Pregnancy
Kovaltry is a recombinant human protein. While there are no adequate and well-controlled studies in pregnant women, Factor VIII is a normal component of human plasma. Use during pregnancy should be considered only if clearly needed and the potential benefits outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
Risk not well-established, but generally considered low due to the nature of the protein.
Second Trimester:
Risk not well-established, but generally considered low due to the nature of the protein.
Third Trimester:
Risk not well-established, but generally considered low due to the nature of the protein. Factor VIII levels naturally increase during pregnancy.
Lactation
It is not known whether Kovaltry is excreted in human milk. However, Factor VIII is a normal component of human plasma. 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. Generally considered compatible with breastfeeding (L3).
Infant Risk:
Low risk to the infant, as Factor VIII is a large protein unlikely to be absorbed intact by the infant.
Pediatric Use
Dosing is weight-based and similar to adults. Pediatric patients, especially previously untreated patients (PUPs), may have a higher risk of inhibitor development. Close monitoring for inhibitors is crucial.
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 clinical response and Factor VIII levels. Monitor for age-related comorbidities.
Clinical Information
Clinical Pearls
- Kovaltry is a full-length, unmodified recombinant Factor VIII product.
- Dosing is highly individualized based on the patient's weight, severity of hemophilia, location and extent of bleeding, and target Factor VIII levels.
- Patients should be educated on the signs of inhibitor development (e.g., lack of expected response to treatment) and allergic reactions.
- Regular monitoring for Factor VIII inhibitors is critical, especially in previously untreated patients (PUPs) and those with a history of inhibitor development.
- Administer intravenously over several minutes (rate should be determined by patient comfort, typically 2-5 mL/minute).
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)
- Extended half-life Factor VIII products (e.g., Eloctate, Adynovate, Jivi, Afstyla)
- Non-factor replacement therapies (e.g., Emicizumab (Hemlibra) - a bispecific antibody mimicking FVIIIa)
- Bypassing agents for patients with inhibitors (e.g., activated prothrombin complex concentrate (aPCC), recombinant Factor VIIa (rFVIIa))
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands USD per vial depending on unit strength and vendor per 1000 IU vial
Insurance Coverage:
Specialty tier, requires prior authorization and 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 details. 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.