GNH USA

Europe — EMA

Obizur (Susoctocog Alfa)

GNH USA supplies Obizur (Susoctocog Alfa), a recombinant factor VIII product for hemophilia A treatment. Request a quote for global supply.

Request sourcing

1
Pack/s

What is Susoctocog Alfa?

Susoctocog alfa, the active ingredient in Obizur, is a recombinant factor VIII (rFVIII) product presented as an intravenous solution for IV use. It treats hemophilia A by replacing deficient clotting factor VIII in patients with this inherited bleeding disorder. GNH USA supplies Obizur as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and clinics worldwide.

GNH USA supplies Obizur as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and clinics worldwide.

What is Susoctocog Alfa used for?

Obizur is a recombinant factor VIII product used in the management of hemophilia A, a disorder of the clotting cascade.

- On‑demand treatment of bleeding episodes: Provides rapid clotting factor replacement to stop active bleeding. - Peri‑operative management: Raises factor VIII levels before surgery or invasive procedures to reduce bleeding risk. - Routine prophylaxis: Regular infusions to maintain baseline factor VIII activity and prevent spontaneous bleeds. - Immune tolerance induction: Used in some protocols to reduce inhibitor development against factor VIII. - Post‑trauma replacement: Restores factor VIII after traumatic injury in hemophilia A patients.

What are the side effects of Susoctocog Alfa?

Adverse reactions to Obizur are generally related to its protein nature and the intravenous route.

Common Side Effects: - Headache - Fever - Nausea - Injection site erythema - Mild arthralgia - Transient elevation of liver enzymes

Serious or Rare Side Effects: - Development of inhibitors (neutralizing antibodies) to factor VIII - Anaphylactic or severe hypersensitivity reactions - Thromboembolic events - Severe hypertension - Renal impairment - Disseminated intravascular coagulation (DIC)

What precautions apply to Susoctocog Alfa?

When using Obizur, clinicians should consider several safety and handling measures.

- Inhibitor monitoring: Test for factor VIII inhibitors before and during therapy. - Allergy assessment: Evaluate history of hypersensitivity to plasma‑derived or recombinant clotting factors. - Renal function: Monitor renal parameters in patients with pre‑existing kidney disease. - Cardiovascular status: Observe blood pressure and signs of thrombosis, especially in high‑risk patients. - Concomitant anticoagulants: Adjust dosing if the patient is receiving anticoagulant therapy. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Susoctocog Alfa interact with?

Obizur may interact with other agents that affect hemostasis or immune response.

Major Interactions (Avoid): - Concurrent use of activated pro‑thrombin complex concentrates (aPCC) may increase thrombotic risk. - High‑dose bypassing agents combined with Obizur can precipitate uncontrolled clot formation.

Moderate Interactions (Monitor Closely): - Antifibrinolytics (e.g., tranexamic acid) may enhance clot stability; monitor for excessive clotting. - Immunosuppressants may alter inhibitor development; regular inhibitor screening is advised. - Certain antibiotics (e.g., beta‑lactams) have been associated with rare hypersensitivity when given with recombinant proteins. - Vaccines administered intramuscularly should be spaced to avoid overlapping immune activation.

Frequently asked questions

What is Obizur used for?+
Obizur is indicated for the treatment and prevention of bleeding episodes in patients with hemophilia A. It replaces the missing clotting factor VIII, helping to control bleeding during spontaneous bleeds, surgery, or trauma, and can also be used in prophylactic regimens to reduce the frequency of bleeds.
How does Susoctocog alfa work?+
Susoctocog alfa is a recombinant form of human factor VIII. It binds to von Willebrand factor and participates in the intrinsic coagulation cascade, restoring the conversion of factor X to Xa and promoting thrombin generation, which leads to fibrin clot formation and stops bleeding.
What is the usual dose of Obizur?+
The dose of Obizur is individualized by the prescribing clinician based on the patient’s weight, severity of bleeding, and target factor VIII activity level. Dosing regimens are determined by the treating physician and adjusted according to clinical response and laboratory monitoring.
Is Obizur safe during pregnancy or breastfeeding?+
Safety data for Obizur in pregnancy and lactation are limited. Use is generally reserved for pregnant or nursing patients only when the potential benefit justifies any potential risk to the fetus or infant, and decisions should be made in consultation with a specialist.
How do I order Obizur from GNH USA?+
To order Obizur, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain if needed) and import documentation.
How does Obizur compare with other factor VIII products?+
Obizur is a recombinant factor VIII product, offering a high purity profile and reduced risk of pathogen transmission compared with plasma‑derived concentrates. Its pharmacokinetic profile is comparable to other rFVIII therapies, but individual patient response and inhibitor risk may differ, influencing product selection.
What are the storage and handling requirements for Obizur?+
Obizur should be stored at 2‑8 °C in a refrigerator, protected from light, and must not be frozen or shaken. Before administration, allow the solution to reach room temperature and inspect for particulate matter or discoloration.
How is Obizur administered?+
Obizur is given as an intravenous infusion. The rate and volume are determined by the prescriber, and the infusion is typically performed in a clinical setting with appropriate monitoring for infusion‑related reactions.
What are the most serious risks associated with Obizur?+
The most serious risks include the development of neutralizing antibodies (inhibitors) against factor VIII, severe hypersensitivity reactions such as anaphylaxis, and rare thrombotic events. Patients should be monitored closely for signs of these complications.
Who should not use Obizur?+
Obizur is contraindicated in patients with known hypersensitivity to susoctocog alfa or any of its excipients. Caution is also advised for individuals with a history of inhibitor development or severe cardiovascular disease, and use should be evaluated by a specialist.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Susoctocog Alfa
Route
Intravenous Use
Manufacturer
Baxalta Innovations Gmbh
Origin
EU

Related products