What is ADVATE 500 IU
What is ADVATE 500 IU?
ADVATE 500 IU is a recombinant coagulation factor VIII used for the treatment and prevention of bleeding episodes in individuals with hemophilia A (congenital factor VIII deficiency). It does not contain human plasma-derived proteins and is produced using recombinant DNA technology in genetically modified Chinese Hamster Ovary (CHO) cells.
- Generic Name: Octocog alfa
- Form: Powder for solution (lyophilized powder) + solvent vial
- Packaging: 1 vial of powder + 1 vial of 5 ml solvent + administration kit (syringe, butterfly infusion set, alcohol swabs, and dermaplasts)
- Therapeutic Class: Antihemorrhagic Agent, Coagulation Factor
- Indication: Prevention and control of bleeding in hemophilia A; perioperative management; routine prophylaxis to reduce bleeding frequency
- Not indicated for: von Willebrand disease or other coagulation disorders
ADVATE is typically administered intravenously and should be used under the supervision of a healthcare professional experienced in hemophilia management.
How to use ADVATE 500 IU
Administration of ADVATE 500 IU should be carried out with strict aseptic technique and typically under medical supervision, especially for the first dose. It may be self-administered after proper training.
- Preparation:
- Bring both powder and solvent vials to room temperature before reconstitution.
- Clean the tops of both vials with an alcohol swab.
- Reconstitute the powder by transferring the solvent using the provided transfer device or syringe.
- Gently swirl (do not shake) until the powder is fully dissolved.
- Administration:
- Inspect the solution; it should be clear and colorless. Do not use if particulate matter is visible.
- Use the provided syringe and butterfly infusion set for intravenous injection.
- Infuse over several minutes as directed by a healthcare provider (usually 1–2 ml/min).
- Disposal:
- Safely dispose of used syringes, needles, and vials in a sharps container.
Always follow your doctor’s instructions regarding dosing schedule and frequency. Missed doses should be managed under medical guidance.
Mode of Action ADVATE 500 IU
Octocog alfa in ADVATE is a recombinant form of human coagulation factor VIII. It functions as a key component in the blood clotting cascade.
- Role of Factor VIII:
- Acts as a cofactor for factor IXa to activate factor X in the intrinsic coagulation pathway.
- This leads to the conversion of prothrombin to thrombin and subsequently fibrin clot formation.
- Mechanism in Hemophilia A:
- Individuals with hemophilia A have deficient or defective endogenous factor VIII.
- Without adequate factor VIII, clotting is delayed, causing prolonged bleeding episodes.
- Therapeutic Effect:
- Administration of Octocog alfa temporarily replaces the missing clotting factor.
- Reduces or prevents spontaneous or trauma-induced bleeding.
Recombinant technology ensures viral safety and consistent quality, making ADVATE a preferred option for long-term prophylaxis and on-demand treatment.
ADVATE 500 IU Interactions ADVATE 500 IU
Though ADVATE has a relatively safe interaction profile, there are important considerations for co-administered drugs and biologicals:
- No known pharmacokinetic interactions: ADVATE is a biological product, and interactions like those with small-molecule drugs are uncommon.
- Inhibitor formation:
- Patients may develop neutralizing antibodies (inhibitors) to factor VIII.
- This reduces or nullifies the clinical effect of ADVATE and may necessitate the use of bypassing agents.
- Vaccinations:
- May be administered concurrently but at a separate site and via a different route (i.e., not IV).
- Concurrent anticoagulants or antiplatelets:
- Generally not recommended as they may increase bleeding risk in hemophilia patients even when using ADVATE.
Always inform your healthcare provider about any medications, supplements, or therapies being used before starting ADVATE treatment.
Dosage of ADVATE 500 IU
ADVATE dosage is individualized based on the severity of factor VIII deficiency, body weight, and clinical situation (e.g., bleeding control vs. prophylaxis).
- Dosing Formula:
- IU required = Body Weight (kg) × Desired FVIII Rise (%) × 0.5
- On-demand Treatment:
- Mild bleeding (e.g., oral or superficial muscle bleed): 10–20 IU/kg
- Moderate bleeding (e.g., muscle or joint bleed): 20–40 IU/kg
- Severe bleeding (e.g., CNS or GI bleed): 40–60 IU/kg
- Prophylaxis:
- Typical regimen: 20–40 IU/kg every other day or 3 times per week
- Children may require more frequent dosing due to higher clearance rates
- Surgical Prophylaxis:
- Preoperative loading dose: 30–60 IU/kg
- Postoperative doses adjusted as per clinical response
Plasma FVIII levels should be monitored to guide ongoing therapy, particularly during surgery or major bleeding episodes.
Possible side effects of ADVATE 500 IU
Most patients tolerate ADVATE well, but like all biologics, it carries the risk of certain adverse effects.
- Common Side Effects:
- Headache
- Dizziness
- Nausea
- Fever (pyrexia)
- Injection site reactions (pain, swelling, redness)
- Serious Side Effects:
- Development of inhibitors (neutralizing antibodies)
- Allergic or anaphylactic reactions (rare)
- Chest tightness, rash, hypotension (requires emergency care)
- Long-term concerns:
- Loss of efficacy if inhibitor formation occurs
- Psychological burden due to frequent IV infusions in pediatric or adolescent patients
Report any unusual or severe reactions to a healthcare provider immediately. Regular monitoring is advised to assess for inhibitor development, particularly in previously untreated patients (PUPs).
ADVATE 500 IU Contraindications ADVATE 500 IU
ADVATE is generally well tolerated but has specific contraindications:
- Known hypersensitivity:
- To Octocog alfa or any excipient (e.g., mannitol, trehalose, sodium chloride)
- Includes allergic reactions to mouse or hamster proteins (as it’s derived from CHO cells)
- Patients with inhibitors:
- Presence of high-titer inhibitors to factor VIII may render ADVATE ineffective
- These patients may require alternative agents (e.g., bypassing agents)
- Use in other bleeding disorders:
- Not to be used in patients with von Willebrand disease or acquired factor deficiencies not related to FVIII
Allergy history and previous exposure reactions should be discussed with a healthcare professional before administration.
Storage of ADVATE 500 IU
Proper storage is essential to maintain the stability and effectiveness of ADVATE.
- Unopened Vials:
- Store in a refrigerator (2°C to 8°C) until the expiration date
- Can be kept at room temperature (up to 25°C) for a single period of 6 months
- Record the date the product is removed from refrigeration if stored at room temperature
- Do Not:
- Freeze the product
- Expose to direct sunlight
- Use beyond the expiry date
- Reconstituted Solution:
- Should be used immediately within 3 hours of preparation
- Do not refrigerate or store the solution after reconstitution
- Disposal:
- Dispose of all used components safely in accordance with local regulations
Always follow the manufacturer’s storage guidelines included in the package insert for optimal results.
ADVATE 500 IU features an exceptional active ingredient renowned for its potent effects, comprising Octocog alfa (Coagulation factor VIII, recombinant). This powerful formulation provides a superior solution for addressing diverse health concerns. With 500 IU/Vial concentration and an easily manageable Injection/Powder for, it remains a preferred option for countless individuals seeking effective treatment.
Introduction
All you need to know about ADVATE 500 IU .
Welcome to Dwaey, specifically on ADVATE 500 IU page.
This medicine contains an important and useful components, as it consists of Octocog alfa (Coagulation factor VIII, recombinant).
ADVATE 500 IU is available in the market in concentration 500 IU/Vial and in the form of Injection/Powder for.
TAKEDA MANUFACTURING AUSTRIA AG is the producer of ADVATE 500 IU and it is imported from AUSTRIA,
The most popular alternatives of ADVATE 500 IU are listed downward .
-
Active Substance
Octocog alfa (Coagulation factor VIII, recombinant)
-
Size
1 Vial (Powder) + 1 Solvent Vial (5ml) + Kit (2 Alcohol Swabs + 2 Dermaplasts + 1 Syringe + 1 Butterfly Infusion Set)
-
Indications
- No indications available.
-
Type
-
Company
TAKEDA MANUFACTURING AUSTRIA AG
Frequently Asked Questions
ADVATE 500 IU should be stored according to the instructions provided by TAKEDA MANUFACTURING AUSTRIA AG.
In general, it is recommended to store ADVATE 500 IU in a cool, dry place, away from direct sunlight
and out of the reach of children.
The duration of treatment with ADVATE 500 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 ADVATE 500 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 ADVATE 500 IU . Some medications, including
ADVATE 500 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 ADVATE 500 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 ADVATE 500 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 ADVATE 500 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 ADVATE 500 IU during pregnancy
or breastfeeding may depend on the active substance [Active Substance], concentration 500 IU/Vial,
and the specific recommendations of TAKEDA MANUFACTURING AUSTRIA AG.
The effects of ADVATE 500 IU on your ability to drive or operate machinery can vary depending on
the active substance [Active Substance], concentration 500 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 ADVATE 500 IU with or without food may vary depending on the medication
and the recommendations of TAKEDA MANUFACTURING AUSTRIA AG. 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 ADVATE 500 IU in children or elderly individuals may depend on various factors, including
the specific medication, type Injection/Powder for, and the recommendations of TAKEDA MANUFACTURING AUSTRIA AG. 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 ADVATE 500 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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