Hemophilia A is an inherited bleeding disorder caused by a deficiency or dysfunction of clotting factor VIII. Xyntha Solofuse is an FDA-approved prescription medication used in adults and children with hemophilia A to replace clotting factor VIII to prevent bleeding.
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Xyntha Solofuse Introduction and Uses
Xyntha Solofuse is a brand-name prescription medication. The active ingredient in this product is recombinant antihemophilic factor (rAHF), which is also known as coagulation factor VIII or moroctocog alfa.
Xyntha Solofuse belongs to a drug class called coagulation factors.
A healthcare provider may prescribe Xyntha Solofuse for adults and children with hemophilia A to:
- Treat and control bleeding episodes as they occur
- Manage bleeding before, during, and after surgery
- Reduce the frequency of bleeding episodes through routine preventive treatment
Xyntha Solofuse does not contain von Willebrand factor and is not indicated for the treatment of von Willebrand disease.
Xyntha Solofuse comes in a single-use, prefilled dual-chamber syringe. One chamber contains a white to off-white freeze-dried powder, and the other contains 4 ml of 0.9% sodium chloride solution. The powder must be mixed with the sodium chloride solution before intravenous (IV) infusion.
Xyntha Solofuse is available in nominal strengths of 250, 500, 1,000, 2,000, and 3,000 International Units. The actual factor VIII potency is printed on the product label.
Each Xyntha Solofuse kit contains:
- One plunger rod for assembly
- One sterile infusion set
- Two alcohol swabs
- One bandage
- One gauze pad
- One vented sterile cap
- One package insert
Xyntha Solofuse Mechanism of Action
People with hemophilia A have deficient or dysfunctional clotting factor VIII. Factor VIII is necessary for the blood-clotting process, and a deficiency can cause prolonged or spontaneous bleeding into the joints, muscles, or internal organs.
Xyntha Solofuse temporarily replaces the missing factor VIII, helping the blood form clots and control bleeding.
Xyntha Solofuse Dosing
Your healthcare provider will calculate your dose based on your body weight, desired increase in factor VIII activity, clinical response, and treatment needs. Always use the dose prescribed specifically for you.
The dose and duration of treatment depend on:
- The severity of the factor VIII deficiency
- The location and extent of bleeding
- The type of bleeding episode or surgery
- Your clinical condition and response to treatment
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About Copay AssistanceDosing for the treatment and control of bleeding episodes
Minor bleeding: The dose is individualized to achieve a factor VIII activity level of approximately 20% to 40% of normal. Treatment may be repeated every 12 to 24 hours for at least 1 day, depending on the bleeding episode.
Moderate bleeding: The dose is individualized to achieve a factor VIII activity level of approximately 30% to 60% of normal. Treatment may be repeated every 12 to 24 hours for 3 to 4 days or until bleeding is adequately controlled.
Major bleeding: The dose is individualized to achieve a factor VIII activity level of approximately 60% to 100% of normal. Treatment may be repeated every 8 to 24 hours until the bleeding is controlled.
Dosing for perioperative bleeding management
Minor surgery: The dose is individualized to achieve a factor VIII activity level of approximately 30% to 60% of normal. Treatment may be repeated every 12 to 24 hours as directed by the healthcare provider.
Major surgery: The dose is individualized to achieve a factor VIII activity level of approximately 60% to 100% of normal. Treatment may be repeated every 8 to 24 hours until adequate wound healing is achieved. Treatment may then continue for at least another 7 days to maintain an appropriate factor VIII activity level, as directed by the healthcare provider.
Dosing for routine prevention of bleeding episodes
Recommended starting regimens include:
- Adults and adolescents 12 years or older: 30 IU/kg IV three times weekly
- Children younger than 12 years: 25 IU/kg IV every other day
Children younger than 12 may require higher or more frequent doses because the medication may be cleared from their bodies more quickly.
Your healthcare provider will adjust the dose or frequency based on your bleeding pattern, factor VIII levels, and clinical response.
Xyntha Solofuse Side Effects
Xyntha Solofuse can cause side effects that can range from mild to serious.
Common side effects reported with Xyntha include:
- Headache
- Joint pain
- Fever
- Cough
- Vomiting
- Diarrhea
- Weakness
Serious risks include severe allergic reactions and the development of factor VIII inhibitors.
Contact your healthcare provider about any side effect that concerns you or does not go away. Additionally, seek emergency medical care for signs of a serious allergic reaction.
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Speak to a Specialist and Find outBefore Using Xyntha Solofuse
Before using Xyntha Solofuse for the first time, tell your healthcare provider if you:
- Have had a severe allergic reaction to Xyntha Solofuse, any of its ingredients, or hamster proteins, which may be present in trace amounts
- Are pregnant or planning to become pregnant
- Are breastfeeding or planning to breastfeed
Important Xyntha Solofuse Warnings
Severe allergic reactions
Xyntha Solofuse can cause severe allergic reactions, including anaphylaxis. Anaphylaxis is a potentially life-threatening reaction that may cause breathing problems, swelling, a rapid heartbeat, faintness, or low blood pressure.
Stop using Xyntha Solofuse and seek emergency medical care immediately if you experience:
- Rash, hives, or itching
- Wheezing or difficulty breathing
- Chest tightness
- Swelling of the face, mouth, or throat
- A rapid heartbeat
- Faintness or dizziness
- Blue-colored lips or gums
Development of inhibitors
Your body may develop neutralizing antibodies, called inhibitors, against factor VIII. These inhibitors can reduce or prevent Xyntha Solofuse from working properly.
Your healthcare provider may order blood tests to check for inhibitors if:
- Your factor VIII activity does not increase as expected after treatment
- Bleeding is not controlled with an appropriate dose
How To Use Xyntha Solofuse
Use Xyntha Solofuse exactly as prescribed by your healthcare provider.
You may receive your first dose in a hospital, clinic, or treatment center. If home treatment is appropriate, your healthcare provider will teach you how to prepare and administer the medication safely.
Before using the medication:
- Read and follow the Instructions for Use included with the product
- Wash your hands and work on a clean surface
- Allow the kit to reach room temperature
- Use only the supplies provided or specifically recommended by your healthcare provider
- Check the reconstituted solution before infusion; it should be clear to slightly opalescent and colorless
- Do not use the solution if it contains particles or appears discolored
Contact your healthcare provider immediately if:
- Bleeding is not controlled after treatment
- You administer more than your prescribed dose
- You have difficulty preparing or infusing the medication
Before traveling, speak with your healthcare provider and bring enough medication and infusion supplies for the entire trip.
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Xyntha Solofuse Storage and Handling
- Store unopened Xyntha Solofuse in a refrigerator at 2°C to 8°C (36°F to 46°F) until the expiration date, for up to 36 months from the date of manufacture.
- Within the labeled expiration period, the medication may be stored at room temperature no higher than 25°C (77°F) for up to 3 months.
- Record the date room-temperature storage begins in the space provided on the carton.
- After 3 months at room temperature, use the medication immediately or discard it.
- Do not return the medication to the refrigerator after it has been stored at room temperature.
- Do not use the medication after its labeled expiration date or after 3 months at room temperature, whichever occurs first.
- Do not freeze Xyntha Solofuse.
- Protect it from prolonged exposure to light.
- After reconstitution, keep the syringe upright at room temperature until use.
- Infuse the reconstituted solution within 3 hours after reconstitution or after removing the gray rubber tip cap.
- Discard the solution if it has not been used within 3 hours.
Xyntha Solofuse Cost and Financial Assistance
The cost of Xyntha Solofuse depends on factors such as the prescribed dose, insurance coverage, pharmacy or treatment provider, location, and prior-authorization requirements.
Contact your insurance provider to determine:
- Whether Xyntha Solofuse is covered
- Whether prior authorization is required
- Your expected copayment or coinsurance
- Whether a specialty pharmacy must dispense the medication
Eligible patients may qualify for manufacturer copay assistance or other support programs. Program benefits, eligibility requirements, and annual limits can change. Contact us if you are interested in financial assistance or copay assistance for Xyntha Solofuse.
Xyntha Solofuse vs. Xyntha
Xyntha and Xyntha Solofuse contain the same active ingredient: recombinant antihemophilic factor, also called recombinant factor VIII or moroctocog alfa.
The main difference is the product presentation:
- Xyntha: Supplied as freeze-dried powder in a single-use vial, with a separate prefilled diluent syringe
- Xyntha Solofuse: Supplied in a prefilled dual-chamber syringe containing both the freeze-dried powder and the sodium chloride diluent
Both products must be reconstituted before intravenous administration. Patients should use the presentation prescribed by their healthcare provider and follow the instructions supplied with that specific product.
