What is AFSTYLA 3000 IU
AFSTYLA 3000 IU is a recombinant coagulation factor VIII product, indicated for the treatment and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency). Its active ingredient is Lonoctocog alfa, a single-chain recombinant factor VIII produced using recombinant DNA technology in a human cell line (HEK 293F) that is modified to express human coagulation factor VIII.
- Form: Powder and solvent for solution for injection
- Kit Contents: 1 vial (powder), 1 vial (2.5 ml Water for Injections), 1 filter transfer device, 1 administration set (including 5 ml syringe, venipuncture set, alcohol swabs, and non-sterile plaster)
- Indication: For routine prophylaxis, on-demand treatment of bleeding episodes, and perioperative management in individuals with hemophilia A
- Type: Recombinant, human coagulation Factor VIII (single-chain)
AFSTYLA is not intended for use in patients with von Willebrand disease or for those with hemophilia B (Factor IX deficiency).
How to use AFSTYLA 3000 IU
AFSTYLA must be reconstituted and administered via intravenous injection. It should be used exactly as prescribed by a healthcare professional experienced in the treatment of hemophilia.
- Reconstitution:
- Bring both vials (powder and solvent) to room temperature (do not exceed 37°C).
- Connect the vials using the filter transfer device provided in the kit.
- Allow the solvent to transfer completely into the powder vial; gently swirl (do not shake) until the powder is fully dissolved.
- The solution should be clear or slightly opalescent. Do not use if particles or discoloration are present.
- Administration:
- Draw the solution into the provided disposable syringe.
- Inject slowly via intravenous route, typically over several minutes.
- Do not mix with other drugs or infusions.
- Dispose of all used materials appropriately.
- Frequency: Based on bleeding severity, individual factor VIII levels, and clinical response.
Always follow healthcare provider instructions strictly and never self-administer unless trained.
Mode of Action AFSTYLA 3000 IU
AFSTYLA (Lonoctocog alfa) works by replacing the deficient or inactive Factor VIII in patients with hemophilia A, thereby restoring the coagulation cascade required for proper blood clot formation.
- Mechanism:
- Once administered intravenously, AFSTYLA enters circulation and functions like endogenous factor VIII.
- It binds to von Willebrand factor, which stabilizes it and prolongs its half-life.
- During the coagulation cascade, activated factor VIII (FVIIIa) acts as a cofactor for factor IXa to convert factor X to Xa, leading to fibrin clot formation.
- Structure Advantage:
- AFSTYLA is a single-chain recombinant FVIII designed to have enhanced binding affinity to von Willebrand factor compared to full-length FVIII.
- This design improves molecular stability and may provide a prolonged half-life, allowing for less frequent injections in some patients.
By promoting thrombin generation and fibrin clot formation, AFSTYLA reduces bleeding and supports wound healing in hemophilia A patients.
AFSTYLA 3000 IU Interactions AFSTYLA 3000 IU
AFSTYLA has a low potential for drug-drug interactions due to its protein-based nature and targeted mechanism. However, certain considerations should be kept in mind:
- Known Interactions:
- No significant drug interactions have been identified in clinical trials.
- AFSTYLA should not be mixed with other intravenous medications in the same infusion line or syringe.
- Immunologic Considerations:
- Inhibitor development (neutralizing antibodies to factor VIII) may reduce effectiveness and require alternative therapy.
- Immune response may be influenced by concomitant immunosuppressants or immune-modifying drugs.
- Lab Testing Interference:
- Use of chromogenic assays based on bovine reagents may underestimate AFSTYLA activity.
- One-stage clotting assay and human chromogenic assays are appropriate for monitoring.
Always consult a hematologist before combining AFSTYLA with any new medication or when interpreting clotting assay results.
Dosage of AFSTYLA 3000 IU
The dosage of AFSTYLA is individualized based on body weight, clinical condition, and pharmacokinetic response. It is expressed in International Units (IU), where 1 IU corresponds to the activity of 1 unit of human factor VIII.
- On-demand treatment of bleeding episodes:
- Mild to moderate bleeds: 20–40 IU/kg
- Major bleeds or life-threatening hemorrhages: 40–60 IU/kg or more
- Prophylaxis:
- Adults and adolescents: 20–50 IU/kg every 3–4 days
- Some patients may benefit from twice-weekly or every-other-day dosing
- Perioperative management:
- Pre-surgery loading doses and post-operative maintenance dosing vary depending on the procedure and bleeding risk.
- Dose adjustments:
- Regular factor VIII activity monitoring is essential.
- Adjust dose based on response and target factor VIII levels.
Dosing should be performed under the supervision of a physician experienced in treating hemophilia A.
Possible side effects of AFSTYLA 3000 IU
AFSTYLA is generally well tolerated, but like all biologics, it may cause side effects. Most reactions are mild and manageable.
- Common side effects:
- Headache
- Injection site reactions (pain, redness, swelling)
- Pyrexia (fever)
- Nausea or abdominal discomfort
- Less common/serious side effects:
- Hypersensitivity reactions (rash, pruritus, urticaria)
- Anaphylaxis (rare but potentially life-threatening)
- Development of neutralizing antibodies (inhibitors) against factor VIII
- Immune response:
- Especially in previously untreated patients (PUPs), inhibitors may develop and reduce efficacy.
Patients should report any adverse reactions to their healthcare provider promptly and seek immediate medical attention for signs of anaphylaxis (e.g., chest tightness, difficulty breathing, dizziness).
AFSTYLA 3000 IU Contraindications AFSTYLA 3000 IU
AFSTYLA is contraindicated in patients with the following conditions:
- Known hypersensitivity:
- To Lonoctocog alfa or any of the excipients (e.g., polysorbate 80, mannitol, histidine)
- To mouse or hamster proteins (residual traces from manufacturing)
- History of severe allergic or anaphylactic reactions:
- Use of AFSTYLA may cause serious reactions in sensitized individuals
- Use in von Willebrand disease:
- AFSTYLA is not indicated for von Willebrand disease and may not be effective
Patients with known inhibitor development should undergo appropriate testing and individualized treatment plans.
Storage of AFSTYLA 3000 IU
Proper storage of AFSTYLA is essential to maintain its stability and effectiveness.
- Unopened vials:
- Store at 2°C–8°C (in a refrigerator)
- May be stored at room temperature (not above 25°C) for a single period of up to 6 months
- Do not return to refrigeration after room temperature storage
- Do not freeze:
- Freezing may damage the vial or affect the efficacy of the product
- After reconstitution:
- Use immediately or within 4 hours if stored at room temperature
- Do not refrigerate the reconstituted solution
- Protect from light and do not use if the solution is cloudy or contains particulates
Always keep AFSTYLA out of reach of children and dispose of expired or unused medication as per local guidelines.
AFSTYLA 3000 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 3000 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 3000 IU .
Welcome to Dwaey, specifically on AFSTYLA 3000 IU page.
This medicine contains an important and useful components, as it consists of Lonoctocog alfa.
AFSTYLA 3000 IU is available in the market in concentration 3000 IU/Vial and in the form of Powder and Solvent for Solution for Injection.
CSL BEHRING GMBH is the producer of AFSTYLA 3000 IU and it is imported from GERMANY,
The most popular alternatives of AFSTYLA 3000 IU are listed downward .
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Active Substance
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Size
1 Kit [1 Glass Vial (Powder) + 1 Glass Vial (5 ml WFI) + 1 filter transfer device 20/20 + 1 administration set (1 disposable 10 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 3000 IU should be stored according to the instructions provided by CSL BEHRING GMBH .
In general, it is recommended to store AFSTYLA 3000 IU in a cool, dry place, away from direct sunlight
and out of the reach of children.
The duration of treatment with AFSTYLA 3000 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 3000 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 3000 IU. Some medications, including
AFSTYLA 3000 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 3000 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 3000 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 3000 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 3000 IU during pregnancy
or breastfeeding may depend on the active substance [Active Substance], concentration 3000 IU/Vial,
and the specific recommendations of CSL BEHRING GMBH .
The effects of AFSTYLA 3000 IU on your ability to drive or operate machinery can vary depending on
the active substance [Active Substance], concentration 3000 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 3000 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 3000 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 3000 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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