Goxblem Bemiltenase alfa Application Scope

Goxblem (Bemiltenase alfa) is used for the treatment of bleeding episodes in adults with congenital hemophilia A or B and high-titer Factor VIII or IX inhibitors (>5 BU), providing a hemostatic treatment approach that bypasses the inhibited FVIII/FIX-dependent coagulation pathway.

Bemiltenase alfa Characteristics

Ingredients: Bemiltenase alfa, a coagulation Factor X (FX) activator purified from Daboia russelii siamensis venom.
Properties: A biological hemostatic agent that promotes coagulation by directly activating Factor X to Factor Xa.
Packaging Specification: 5 U (0.15 μg) per vial
Storage: Store according to the conditions specified in the latest approved package insert.
Expiry Date: Refer to the expiry date indicated on the product packaging.
Executive Standard: Refer to the current approved product standard and package insert.
Approval Number: National Drug Approval No. S20260040.
Date of Revision: Refer to the latest approved package insert for the current revision date.
Manufacturer: Jiangsu BioJeTay Biotechnology Co., Ltd

Guidelines for the Use of Goxblem

Dosage and Administration:
- Recommended Dose: In clinical studies, bemiltenase alfa was administered at 0.10 U/kg for the treatment of bleeding episodes in adult patients with hemophilia A or B with inhibitors.
- Administration: Bemiltenase alfa is administered by intravenous injection every 4 hours for the treatment of bleeding episodes, with a maximum of 6 doses until hemostasis is achieved.
- Missed Dose: If a scheduled dose is missed, patients should consult their healthcare professional and should not administer a double dose to compensate for the missed dose.
Adverse Reactions:
- Common Adverse Reactions: Most reported adverse events were mild (Grade 1); reported events included headache, fatigue, and injection-site reactions. Changes in coagulation-related laboratory parameters may also occur.
- Serious Adverse Reactions: No serious adverse events related to bemiltenase alfa were reported in the phase 1b/2 clinical studies. However, continued clinical monitoring is appropriate because the drug directly promotes coagulation.
Contraindications: Patients with a known hypersensitivity or allergic reaction to bemiltenase alfa or any of the inactive ingredients in the formulation.
Precautions:
- Use under the supervision of a healthcare professional experienced in the management of hemophilia and inhibitor-associated bleeding.
- Monitor patients for clinical signs of thromboembolic events during treatment.
- Use with caution when Goxblem is administered concomitantly with other hemostatic agents.
- Monitor coagulation-related laboratory parameters as clinically appropriate during treatment.

Bemiltenase alfa Interactions

Drug Interactions: Use with other hemostatic agents should be carefully evaluated by a healthcare professional.
Anticoagulants: Concomitant use with anticoagulant or antithrombotic therapies requires careful assessment of bleeding and thrombotic risks.
Other Coagulation Products: Use with other coagulation factor products or bypassing agents should follow professional medical guidance.
Monitoring: Appropriate coagulation and clinical monitoring is recommended when used with other agents affecting hemostasis.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.