Kovaltry 250unit 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
Jun 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 needed for blood to clot properly.
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. Mix the medication as directed by your doctor. Avoid shaking the vial. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution 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 used 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 or concerns, consult your doctor or pharmacist.
Storage
If you are 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 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, 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. Mix the medication as directed by your doctor. Avoid shaking the vial. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution 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 used 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 or concerns, consult your doctor or pharmacist.
Storage
If you are 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 to determine the best course of action.
Lifestyle & Tips
- Follow your prescribed dosing schedule carefully, even if you feel well.
- Learn how to self-infuse if recommended by your healthcare provider.
- Keep a detailed record of all infusions, including date, time, dose, and reason for infusion.
- Avoid activities that carry a high risk of injury or bleeding.
- Wear medical alert identification (e.g., bracelet or necklace) indicating you have Hemophilia A.
- Inform all healthcare providers (including dentists) that you have Hemophilia A and are on Factor VIII therapy.
- Store the medication as directed (refrigerated, but can be stored at room temperature for a limited time).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on patient's Factor VIII level, type of bleeding, and clinical condition. For on-demand treatment of bleeding episodes: 20-40 IU/kg. For routine prophylaxis: 20-50 IU/kg 2-3 times per week.
Dose Range:
20 - 50 mg
Condition-Specific Dosing:
onDemandBleeding:
20-40 IU/kg
routineProphylaxis:
20-50 IU/kg 2-3 times per week
surgicalProphylaxis:
Pre-operative: 30-60 IU/kg to achieve FVIII activity of 80-120% of normal. Post-operative: 20-40 IU/kg every 24-48 hours for 3-14 days depending on wound healing.
Pediatric Dosing
Neonatal:
Not established (limited data in neonates, generally used in infants >1 month)
Infant:
Dosing is weight-based, similar to adults (e.g., 20-50 IU/kg 2-3 times per week for prophylaxis).
Child:
Dosing is weight-based, similar to adults (e.g., 20-50 IU/kg 2-3 times per week for prophylaxis).
Adolescent:
Dosing is weight-based, similar to adults (e.g., 20-50 IU/kg 2-3 times per week for prophylaxis).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Dialysis:
No specific dose adjustment recommended; Factor VIII is a large protein and not significantly cleared by dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Kovaltry (damoctocog alfa pegol) is a recombinant coagulation Factor VIII (rFVIII) that temporarily replaces the missing 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, which ultimately leads to the formation of thrombin and fibrin clot formation. By providing exogenous Factor VIII, Kovaltry restores the hemostatic process.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (IV administration)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.05-0.07 L/kg
ProteinBinding:
Binds to von Willebrand Factor (vWF)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 14-19 hours (terminal half-life, extended due to PEGylation)
Clearance:
Approximately 2.5-3.5 mL/hr/kg
ExcretionRoute:
Primarily non-renal (proteolytic degradation)
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Immediate (within minutes of infusion)
DurationOfAction:
Extended, allowing for less frequent dosing (e.g., 2-3 times per week for prophylaxis) due to PEGylation which prolongs half-life.
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 emergency 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:
Common side effects:
+ Irritation at the injection site
+ Headache
* Advate-specific side effects:
+ Cough
+ Signs of a common cold
+ 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 not mentioned here. 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 emergency 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:
Common side effects:
+ Irritation at the injection site
+ Headache
* Advate-specific side effects:
+ Cough
+ Signs of a common cold
+ 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 not mentioned here. 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 allergic reaction: rash, hives, itching, facial swelling, shortness of breath, chest tightness, dizziness, faintness. Seek immediate medical attention.
- Signs of inhibitor development: increased frequency or severity of bleeding, bleeding that doesn't stop with your usual dose of Kovaltry. Report these to your doctor immediately.
- Signs of blood clots (rare): pain, swelling, warmth, redness in a limb; sudden chest pain; shortness of breath; sudden vision changes; slurred speech. Seek immediate medical attention.
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 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 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 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 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 product, very high levels of Factor VIII 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. Management would be supportive and aimed at monitoring for and treating any thrombotic complications. Call 1-800-222-1222 (Poison Control).
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) screening
Rationale: To detect pre-existing inhibitors to Factor VIII, which can render treatment ineffective.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor VIII activity levels
Frequency: Periodically, especially during prophylaxis or before/after surgery, or if bleeding is not controlled.
Target: Dependent on clinical situation (e.g., >1% for prophylaxis, 80-120% for major surgery).
Action Threshold: If levels are not therapeutic or bleeding persists, adjust dose or investigate for inhibitors.
Inhibitor (neutralizing antibody) screening
Frequency: Regularly (e.g., every 3-6 months, or more frequently in newly treated patients or if treatment efficacy decreases).
Target: Negative (Bethesda Units <0.6 BU/mL)
Action Threshold: If inhibitors develop (>0.6 BU/mL), consider alternative treatments (e.g., bypassing agents).
Clinical response (bleeding episodes)
Frequency: Continuously
Target: Reduction or cessation of bleeding episodes.
Action Threshold: Persistent or recurrent bleeding may indicate inadequate dosing, inhibitor development, or other complications.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from minor cuts, blood in urine/stools, nosebleeds, headaches with stiff neck)
- Signs of allergic reaction (e.g., rash, hives, itching, facial swelling, shortness of breath, chest tightness, dizziness, faintness)
- Signs of inhibitor development (e.g., increased frequency or severity of bleeding, poor response to Factor VIII treatment)
Special Patient Groups
Pregnancy
Kovaltry is classified as Pregnancy Category C. There are no adequate and well-controlled studies of Kovaltry in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Risk cannot be ruled out; use only if clearly needed.
Second Trimester:
Risk cannot be ruled out; use only if clearly needed.
Third Trimester:
Risk cannot be ruled out; use only if clearly needed.
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. Generally considered low risk due to large molecular size.
Infant Risk:
Low risk, but data are limited.
Pediatric Use
Kovaltry is approved for use in pediatric patients, including neonates (though limited data in neonates <1 month). Dosing is weight-based and similar to adults. Children, especially younger ones, may have higher Factor VIII clearance and may require higher or more frequent dosing.
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. No specific dose adjustment is generally required based on age alone, but individual patient response and comorbidities should be considered.
Clinical Information
Clinical Pearls
- Kovaltry is a PEGylated recombinant Factor VIII, which provides an extended half-life compared to conventional Factor VIII products, allowing for less frequent prophylactic dosing.
- Patients should be monitored for the development of Factor VIII inhibitors, especially in the first 50 exposure days or if bleeding control becomes difficult.
- Allergic-type hypersensitivity reactions are possible; patients should be informed of early signs and symptoms and advised to discontinue use and seek immediate medical attention if they occur.
- The dose and duration of treatment depend on the severity of the Factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition.
- Reconstitution should be done carefully using the provided diluent and administration set. Do not shake the vial.
- Kovaltry is for intravenous administration only.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Nuwiq, Recombinate, Xyntha, Hemlibra (emicizumab - a bypassing agent, not FVIII replacement), Alprolix, Adynovate)
- Plasma-derived Factor VIII products (e.g., Humate-P, Wilate)
- Bypassing agents (e.g., FEIBA, NovoSeven RT) for patients with inhibitors
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid) as adjunctive therapy for certain bleeding types.
Cost & Coverage
Average Cost:
Highly variable, typically thousands to tens of thousands of USD per vial depending on unit strength and market. per vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high co-pays or co-insurance)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.