What is AFSTYLA 250 IU
AFSTYLA 250 IU is a recombinant antihemophilic factor (recombinant DNA origin), specifically a single-chain version of Factor VIII known as Lonoctocog alfa. It is used in the management of bleeding episodes and for prophylaxis in patients with Hemophilia A (congenital Factor VIII deficiency).
- Formulation: AFSTYLA is supplied as a powder and solvent for solution for injection. The kit includes:
- 1 glass vial of powder (250 IU)
- 1 glass vial of 2.5 mL Water for Injections (WFI)
- 1 filter transfer device 20/20
- 1 administration set (disposable 5 mL syringe, venipuncture set, alcohol swabs, and plaster)
- Indication: It is indicated for use in both adults and children with Hemophilia A for:
- Treatment of bleeding episodes
- Routine prophylaxis to reduce the frequency of bleeding
- Perioperative management (surgical prophylaxis)
- Not suitable for treatment of von Willebrand disease.
How to use AFSTYLA 250 IU
AFSTYLA should be used exactly as prescribed by a healthcare provider experienced in treating Hemophilia A. Proper training in reconstitution and administration technique is essential for patients or caregivers managing the treatment at home.
- Reconstitution Instructions:
- Warm both vials (powder and solvent) to room temperature before use.
- Use the filter transfer device to mix the solvent with the powder.
- Gently swirl until fully dissolved—do not shake.
- Inspect the solution—it should be clear or slightly pearly; do not use if particles or discoloration are present.
- Administration:
- Use the provided administration set.
- Inject intravenously over several minutes as directed by the healthcare provider.
- Discard any unused solution appropriately.
- Frequency of use: Depends on the condition being treated and physician’s assessment (e.g., on-demand treatment vs. prophylaxis).
- Do not mix with other medications in the same infusion line or syringe.
Mode of Action AFSTYLA 250 IU
AFSTYLA (Lonoctocog alfa) is a genetically engineered single-chain recombinant Factor VIII product designed to mimic the function of endogenous Factor VIII in the coagulation cascade.
- Mechanism: Once administered, AFSTYLA is activated by thrombin, transforming it into its active form (Factor VIIIa), which then:
- Acts as a cofactor for Factor IXa
- Accelerates the conversion of Factor X to Factor Xa
- Leads to the generation of thrombin and formation of a stable fibrin clot
- Extended half-life: The single-chain design binds tightly to von Willebrand factor (vWF), increasing stability and half-life in circulation.
- Goal: To temporarily replace the missing or deficient Factor VIII in Hemophilia A patients, thereby restoring normal clotting function.
AFSTYLA 250 IU Interactions AFSTYLA 250 IU
While AFSTYLA has a targeted mechanism and low systemic interaction potential, certain considerations must still be taken into account to ensure safe use.
- Drug Interactions:
- No formal drug interaction studies have been conducted with AFSTYLA.
- It is a biologic agent, and interaction with traditional small-molecule drugs is unlikely.
- Inhibitors:
- Development of neutralizing antibodies (inhibitors) to Factor VIII is a known complication in Hemophilia A treatment.
- Such inhibitors reduce the effectiveness of AFSTYLA and may require specialized treatment options (e.g., bypassing agents).
- Live vaccines: Caution is advised when co-administering with live vaccines. Avoid injection at the same site.
- Laboratory tests: AFSTYLA may interfere with certain coagulation assays; ensure the laboratory is aware of its use.
Dosage of AFSTYLA 250 IU
The dosage of AFSTYLA is individualized based on body weight, severity of Factor VIII deficiency, clinical condition, and desired Factor VIII activity level.
Possible side effects of AFSTYLA 250 IU
As with all protein-based biologics, AFSTYLA may cause adverse reactions. While generally well tolerated, it’s important to monitor for both common and serious side effects.
- Common side effects:
- Headache
- Fever (pyrexia)
- Injection site reactions (pain, redness)
- Nausea or dizziness
- Serious side effects:
- Development of Factor VIII inhibitors (antibodies)
- Allergic reactions including rash, urticaria, or anaphylaxis (rare)
- Thromboembolic events (very rare, mostly in patients with other risk factors)
- Immediate medical attention should be sought if symptoms of hypersensitivity appear such as:
- Swelling of face/lips/throat
- Chest tightness
- Difficulty breathing
AFSTYLA 250 IU Contraindications AFSTYLA 250 IU
AFSTYLA is generally safe when used as prescribed, but there are specific contraindications where it must not be administered.
- Known hypersensitivity:
- To Lonoctocog alfa or any component of the formulation
- Includes known hypersensitivity to hamster proteins (as it is produced in CHO cells)
- History of anaphylaxis to Factor VIII products should be a red flag unless otherwise cleared by a specialist.
- Active inhibitor presence:
- Patients with high-titer inhibitors may not respond to treatment with AFSTYLA
- These cases require alternate therapies such as bypassing agents
Storage of AFSTYLA 250 IU
Proper storage ensures stability and efficacy of the product. Always follow packaging and pharmacist instructions.
- Temperature:
- Store in a refrigerator at 2°C–8°C (36°F–46°F)
- May be kept at room temperature (≤25°C) for up to 3 months; do not return to fridge after this
- Do not freeze—freezing can damage the product.
- Keep in original packaging to protect from light.
- After reconstitution:
- Use immediately
- If not used immediately, the solution may be stored at room temperature and must be used within 4 hours
- Do not use after the expiration date printed on the label.
AFSTYLA 250 IU features an exceptional active ingredient renowned for its potent effects, comprising Lonoctocog alfa. This powerful formulation provides a superior solution for addressing diverse health concerns. With 250 IU/Vial concentration and an easily manageable Powder and Solvent for Solution for Injection, it remains a preferred option for countless individuals seeking effective treatment.
Introduction
All you need to know about AFSTYLA 250 IU .
Welcome to Dwaey, specifically on AFSTYLA 250 IU page.
This medicine contains an important and useful components, as it consists of Lonoctocog alfa.
AFSTYLA 250 IU is available in the market in concentration 250 IU/Vial and in the form of Powder and Solvent for Solution for Injection.
CSL BEHRING GMBH is the producer of AFSTYLA 250 IU and it is imported from GERMANY,
The most popular alternatives of AFSTYLA 250 IU are listed downward .
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Active Substance
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Size
1 Kit [1 Glass Vial (Powder) + 1 Glass Vial (2.5 ml WFI) + 1 filter transfer device 20/20 + 1 administration set (1 disposable 5 ml syringe + 1 venipuncture set + 2 alcohol swabs + 1 non-sterile plaster)]
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Indications
- No indications available.
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Type
Powder and Solvent for Solution for Injection
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Company
Frequently Asked Questions
AFSTYLA 250 IU should be stored according to the instructions provided by CSL BEHRING GMBH .
In general, it is recommended to store AFSTYLA 250 IU in a cool, dry place, away from direct sunlight
and out of the reach of children.
The duration of treatment with AFSTYLA 250 IU may vary depending on the condition being treated
and the guidance of your healthcare provider. It is important to follow the prescribed treatment
plan and continue taking AFSTYLA 250 IU for the recommended duration, even if your symptoms improve.
If you have any concerns or questions about the duration of treatment, consult your healthcare provider.
It is important to check with your healthcare provider or read the medication label for specific
instructions regarding alcohol consumption while taking AFSTYLA 250 IU. Some medications, including
AFSTYLA 250 IU, may have interactions with alcohol that can reduce effectiveness, increase side
effects, or pose other risks to your health. It is best to follow the guidance provided by your
healthcare professional.
If you miss a dose of AFSTYLA 250 IU, take it as soon as you remember. However, if it is close
to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing
schedule. Do not take a double dose to make up for a missed one unless advised by your healthcare provider.
No, do not stop taking AFSTYLA 250 IU without consulting your healthcare provider, even if your
symptoms improve. It is important to complete the full course of treatment as prescribed. Stopping
the medication prematurely may lead to a relapse or incomplete resolution of the condition. If you
have concerns about the duration of treatment, consult your healthcare provider for guidance.
It is important to consult your healthcare provider before taking AFSTYLA 250 IU if you are
pregnant or breastfeeding. They will be able to assess the potential risks and benefits based on your
specific situation. Please note that the safety and suitability of AFSTYLA 250 IU during pregnancy
or breastfeeding may depend on the active substance [Active Substance], concentration 250 IU/Vial,
and the specific recommendations of CSL BEHRING GMBH .
The effects of AFSTYLA 250 IU on your ability to drive or operate machinery can vary depending on
the active substance [Active Substance], concentration 250 IU/Vial, and individual factors.
Some medications may cause drowsiness, dizziness, or other side effects that can impair your judgment
or coordination. It is important to read the medication label or consult your healthcare provider to
understand any potential effects on your ability to perform tasks that require alertness.
The instructions for taking AFSTYLA 250 IU with or without food may vary depending on the medication
and the recommendations of CSL BEHRING GMBH . Some medications may be more effective when taken with
food to enhance absorption or reduce stomach irritation, while others may need to be taken on an empty
stomach for optimal absorption. Read the medication label or consult your healthcare provider for specific instructions.
The use of AFSTYLA 250 IU in children or elderly individuals may depend on various factors, including
the specific medication, type Powder and Solvent for Solution for Injection, and the recommendations of CSL BEHRING GMBH . Some
medications may have specific dosing instructions or precautions for these age groups. Consult your
healthcare provider or read the medication label for information regarding the safe and appropriate use
of AFSTYLA 250 IU in children or elderly individuals.
Dwaey
All medical information published on the Dwaey website aims to increase medical awareness and health education among users. However, it is not a substitute for professional medical advice. Always consult with a specialist doctor. We strongly advise against using any information or medicine found on the site without referring to your healthcare provider.
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