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Alphanate SD/HT
Alphanate SD/HT is a plasma-derived Factor VIII concentrate that replaces deficient clotting factor VIII to restore hemostasis in patients with hemophilia A.
Alphanate SD/HT is a plasma-derived Factor VIII concentrate that replaces deficient clotting factor VIII to restore hemostasis in patients with hemophilia A. Used for Hemophilia A (congenital Factor VIII deficiency) — treatment and prevention of bleeding episodes, Perioperative management in hemophilia A patients.
At a glance
| Generic name | Alphanate SD/HT |
|---|---|
| Also known as | Anti-hemophilic (human) coagulation factor VIII, Alphanate® Factor VIII/VWF concentrate (Human) |
| Sponsor | Grifols Biologicals, LLC |
| Drug class | Clotting factor concentrate; Factor VIII replacement therapy |
| Target | Factor VIII (antihemophilic factor) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
This product contains human antihemophilic factor (Factor VIII) derived from pooled human plasma and processed through solvent/detergent viral inactivation. It works by substituting for the missing or deficient Factor VIII, a critical cofactor in the intrinsic coagulation cascade that is essential for the formation of the tenase complex and subsequent thrombin generation. By restoring Factor VIII activity, the drug enables normal blood clot formation in hemophilia A patients.
Approved indications
- Hemophilia A (congenital Factor VIII deficiency) — treatment and prevention of bleeding episodes
- Perioperative management in hemophilia A patients
Common side effects
- Inhibitor development (alloimmunization to Factor VIII)
- Thrombosis
- Hypersensitivity reactions
- Headache
- Fever
Key clinical trials
- Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A (PHASE4)
- Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |