Turoctocog Alfa｜Hemophiliac｜HongKong DengYue Medicine

Turoctocog Alfa Application Scope

Turoctocog Alfa is primarily used in the treatment of hemophilia A (a genetic disorder caused by a deficiency of factor VIII). It is indicated for prophylaxis and on-demand treatment of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency). It can be used in both adult and pediatric populations to prevent or control bleeding, including surgery-related bleeding. It may also be used in cases where other therapies are not sufficient or appropriate.

Turoctocog Alfa Characteristics

Ingredients:

• Active ingredient: Turoctocog Alfa (recombinant human coagulation factor VIII)
• Excipients: Sucrose, sodium chloride, and other stabilizers.

Properties:

• Formulation: Lyophilized powder for reconstitution into a solution for intravenous administration.
• Mechanism of action: Recombinant factor VIII works by replacing the deficient factor VIII in the clotting cascade, restoring normal blood coagulation in patients with hemophilia A.
• Purity: Highly purified, recombinant factor VIII that does not contain any human-derived proteins.

Specification:

• Available in various strengths: 250 IU, 500 IU, 1000 IU, and 2000 IU (International Units per vial).
• Reconstitution: The powder is reconstituted with a supplied solvent to produce an intravenous solution.

Packaging Specification:

• Each vial contains a certain number of IU (based on dosage requirement).
• Typically packaged in a box with a vial, solvent, and instructions.

Storage:

• Store in a refrigerator at 2–8°C (36–46°F). Do not freeze.
• The reconstituted solution should be used immediately or within 3 hours if stored at room temperature (not above 25°C).
• Keep away from light.

Expiry Date:

• Usually 36 months from the manufacturing date. Check the specific expiry date on the packaging.

Executive Standard:

• Manufactured according to Good Manufacturing Practices (GMP) and regulatory standards for biopharmaceutical products.

Approval Number:

• Specific to the country of registration, for example, FDA approval (U.S.), EMA approval (Europe), or CFDA approval (China).

Date of Revision:

• [Insert date of last revision as per the manufacturer’s updated package insert.]

Manufacturer:

• Novo Nordisk or another licensed manufacturer of Turoctocog Alfa (depending on the region).

Guidelines for the Use of Turoctocog Alfa

Dosage and Administration:

• Prophylactic treatment: The typical dosing schedule is every 3 to 4 days to prevent bleeding episodes, but this depends on the individual’s condition.
• On-demand treatment: When a bleeding episode occurs, the dose is based on the severity of the bleeding and the patient’s body weight.
• Surgical treatment: Higher doses are often required in preparation for surgery and during the post-surgical period to maintain hemostasis.
• Administer via intravenous injection after reconstitution of the powder.

Adverse Reactions:

• Common side effects: Headache, fever, infusion site reactions, rash, and pruritus.
• Serious side effects: Anaphylaxis, development of inhibitors (antibodies against factor VIII), thrombosis, and other clotting-related issues.
• Immunogenicity: There is a risk of the body developing inhibitors to factor VIII, which could reduce the efficacy of the treatment.

Contraindications:

• Known hypersensitivity to any ingredient in the formulation.
• History of severe allergic reactions to factor VIII products (e.g., anaphylaxis).
• Caution in patients with pre-existing thromboembolic conditions (e.g., deep vein thrombosis, pulmonary embolism).

Precautions:

• Regular monitoring of factor VIII activity levels and inhibitor testing is necessary to ensure effective treatment.
• In patients with a history of cardiovascular disease, treatment must be administered with caution due to the increased risk of thrombotic complications.
• Pregnancy and lactation: The safety of Turoctocog Alfa during pregnancy and breastfeeding has not been fully established. Use only if the benefit outweighs the potential risk.

Turoctocog Alfa Interactions

Drug Interactions:

• There are no significant drug interactions known for Turoctocog Alfa. However, combining it with other medications that affect clotting (e.g., anticoagulants) should be done with caution.
• Some treatments for hemophilia inhibitors (like immune tolerance therapy) might interact with Turoctocog Alfa and require adjusted dosing.

This template provides a general outline for Turoctocog Alfa. Always consult the specific product information and package insert for precise guidelines and recommendations.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from HongKong DengYue Medicine. It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.