What is AFSTYLA 2000 IU
AFSTYLA 2000 IU is a recombinant human coagulation factor VIII used for the treatment and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency). It contains Lonoctocog alfa, a single-chain recombinant factor VIII produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.
- It is indicated in both adults and children with hemophilia A.
- AFSTYLA is not indicated for the treatment of von Willebrand disease.
- The product is supplied as a lyophilized powder with a solvent (Water for Injection - WFI) and a complete administration kit.
- Designed for intravenous use after reconstitution.
The product is engineered for enhanced stability and prolonged activity in the bloodstream compared to conventional factor VIII products, offering the potential for less frequent dosing in prophylaxis.
How to use AFSTYLA 2000 IU
AFSTYLA must be used under the supervision of a healthcare provider experienced in the treatment of hemophilia. Administration should be carried out following sterile technique and proper reconstitution procedures.
- Bring the powder and solvent to room temperature before reconstitution.
- Use the filter transfer device provided in the kit to mix the powder with the 2.5 ml WFI.
- Gently swirl (do not shake) until the powder is fully dissolved, resulting in a clear or slightly opalescent solution.
- Draw the reconstituted solution into the provided 5 ml syringe through the filter.
- Inject intravenously at a rate not exceeding 10 ml per minute.
- Inspect the solution before use. Do not use if it contains particulate matter or is discolored.
- Do not mix AFSTYLA with other medicinal products or infusions in the same syringe or tubing.
- Dispose of all used equipment safely, following standard biohazard protocols.
Mode of Action AFSTYLA 2000 IU
Lonoctocog alfa, the active component in AFSTYLA, is a recombinant single-chain factor VIII molecule designed to have an increased affinity for von Willebrand factor (VWF). This enhanced binding improves its stability and prolongs its half-life.
- After intravenous administration, AFSTYLA temporarily replaces the missing or deficient factor VIII, restoring the coagulation cascade.
- It activates the intrinsic pathway of blood coagulation by acting as a cofactor for activated factor IX (FIXa), leading to the conversion of factor X to its activated form (FXa).
- FXa then converts prothrombin to thrombin, which in turn converts fibrinogen to fibrin, forming a stable blood clot.
By replenishing factor VIII levels, AFSTYLA enables the body to control and prevent bleeding episodes. Its single-chain structure contributes to a longer duration of activity, offering effective hemostasis with reduced dosing frequency compared to standard factor VIII products.
AFSTYLA 2000 IU Interactions AFSTYLA 2000 IU
AFSTYLA does not have any known pharmacological drug-drug interactions in the classical sense, as it is a biological replacement therapy. However, there are important considerations to be aware of in clinical practice:
- Anti-Factor VIII inhibitors: Patients may develop neutralizing antibodies (inhibitors) against factor VIII, which can reduce or nullify the effect of AFSTYLA.
- Laboratory assay interference: Some aPTT-based assays may give misleading results when measuring factor VIII activity in patients receiving AFSTYLA. Chromogenic substrate assays are recommended for accurate monitoring.
- Concomitant use with other coagulation factors: Caution is required when administering with other clotting agents or antifibrinolytics (e.g., tranexamic acid), as this may potentiate the risk of thrombosis.
Clinicians should monitor factor VIII activity levels during treatment and watch for reduced response or signs of inhibitor development, especially in previously untreated patients (PUPs).
Dosage of AFSTYLA 2000 IU
The dosage of AFSTYLA depends on the patient’s body weight, clinical condition, and whether it is being used for prophylaxis or treatment of bleeding episodes. Dose should always be individualized based on clinical response and factor VIII activity levels.
- On-demand treatment of bleeding: 20–50 IU/kg depending on severity and location of the bleed.
- Major surgery: Initial dose of 40–60 IU/kg, with maintenance doses every 8–24 hours to maintain desired factor VIII levels.
- Prophylaxis:
- Children & adolescents: 15–50 IU/kg, 2–3 times per week.
- Adults: 20–40 IU/kg, every 2–3 days or 2× weekly depending on bleeding phenotype.
The 2000 IU kit is typically suited for older children, adolescents, or adults depending on the calculated dose. Dose adjustments should be based on pharmacokinetic profiling when available.
Possible side effects of AFSTYLA 2000 IU
AFSTYLA is generally well tolerated; however, like all protein-based therapies, it may cause adverse effects. Most side effects are mild to moderate in severity.
- Common side effects:
- Headache
- Dizziness
- Injection site reactions (e.g., pain, redness, swelling)
- Less common but serious effects:
- Development of factor VIII inhibitors (neutralizing antibodies)
- Hypersensitivity or allergic reactions (e.g., rash, itching)
- Anaphylaxis (rare but potentially life-threatening)
- Laboratory abnormalities: In rare cases, abnormal clotting test results due to assay interference.
Patients should be advised to seek immediate medical attention if they experience signs of allergic reaction such as swelling of the face, difficulty breathing, or chest tightness.
AFSTYLA 2000 IU Contraindications AFSTYLA 2000 IU
AFSTYLA is contraindicated in patients with the following conditions:
- Known hypersensitivity to Lonoctocog alfa, to any of the excipients (e.g., mannitol, polysorbate 80), or to mouse/hamster proteins used in production.
- History of anaphylactic reaction to recombinant factor VIII products.
Caution is also advised in:
- Patients with a history of inhibitor formation (may lead to reduced efficacy).
- Pregnant and breastfeeding women (no adequate data; use only if clearly needed).
Each patient must be evaluated individually, and a thorough allergy history should be taken before initiating therapy.
Storage of AFSTYLA 2000 IU
Proper storage of AFSTYLA is essential to ensure its efficacy and safety. Follow these guidelines strictly:
- Store in a refrigerator at 2°C to 8°C (36°F to 46°F).
- Do not freeze. Freezing may damage the product or container.
- The product may be stored at room temperature (up to 25°C or 77°F) for a single period not exceeding 6 months. Once removed from refrigeration, do not return it to the refrigerator.
- Keep the vial in the original carton to protect from light.
- After reconstitution, the solution should be used immediately. If not used right away, it can be stored for up to 4 hours at room temperature. Do not refrigerate after reconstitution.
Discard any unused reconstituted solution and materials according to local regulations for medical waste.
AFSTYLA 2000 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 2000 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 2000 IU .
Welcome to Dwaey, specifically on AFSTYLA 2000 IU page.
This medicine contains an important and useful components, as it consists of Lonoctocog alfa.
AFSTYLA 2000 IU is available in the market in concentration 2000 IU/Vial and in the form of Powder and Solvent for Solution for Injection.
CSL BEHRING GMBH is the producer of AFSTYLA 2000 IU and it is imported from GERMANY,
The most popular alternatives of AFSTYLA 2000 IU are listed downward .
-
Active Substance
-
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)]
-
Indications
- No indications available.
-
Type
Powder and Solvent for Solution for Injection
-
Company
Frequently Asked Questions
AFSTYLA 2000 IU should be stored according to the instructions provided by CSL BEHRING GMBH .
In general, it is recommended to store AFSTYLA 2000 IU in a cool, dry place, away from direct sunlight
and out of the reach of children.
The duration of treatment with AFSTYLA 2000 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 2000 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 2000 IU. Some medications, including
AFSTYLA 2000 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 2000 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 2000 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 2000 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 2000 IU during pregnancy
or breastfeeding may depend on the active substance [Active Substance], concentration 2000 IU/Vial,
and the specific recommendations of CSL BEHRING GMBH .
The effects of AFSTYLA 2000 IU on your ability to drive or operate machinery can vary depending on
the active substance [Active Substance], concentration 2000 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 2000 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 2000 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 2000 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.
Related Products
0 Comments