New Device advances Treatment for Haemophilia A Patients
Pfizer Australia has announced the launch of a new device offering a more convenient treatment option for haemophilia A patients, which also makes handling safer as a result of elimination of the transfer step.
The XYNTHA Prefilled Dual-Chamber Syringe is a first-of-its-kind device for the administration of XYNTHA® moroctocog alfa (rch) Recombinant Coagulation Factor VIII. It was recently approved by the Therapeutic Goods Administration.
Pfizer Australia, General Manager Specialty Care, Brad Edwards said the device’s all-in-one innovative design keeps patient safety at its core, while simplifying the care and treatment of haemophilia.
“When it comes to treatment for patients with haemophilia A, safety is a primary concern,” said Mr Edwards.
“For the first time, both the XYNTHA powder and the diluent are supplied within a pre-filled dual chamber syringe. The inclusive system eliminates the transfer step, which simplifies the reconstitution process and as a result lessens the risk of contamination. This offers both healthcare providers and patients a greater sense of security.”
In Australia, one in 7,000 males live with haemophilia. Haemophilia A is a rare, inherited bleeding disorder caused by the absence or deficiency of factor VIII, a protein that helps blood to clot. Most patients with haemophilia are dependent on factor VIII replacement therapy.
The Prefilled Dual-Chamber Syringe is available for haemophilia A patients who use XYNTHA, a recombinant factor VIII product indicated for both the control and prevention of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency or classic haemophilia) and for surgical prophylaxis in patients with haemophilia A.
The device is used to deliver XYNTHA by intravenous (IV) infusion after reconstitution of a freeze-dried powder with the diluent (0.9% Sodium Chloride) and is available in a range of dosing options (250, 500, 1000, 2000 and 3000IU).
Patients can access the device from their healthcare provider at their affiliated Haemophilia Treatment Centre in public hospitals.
“The approval of the Dual-Chamber Syringe further positions Pfizer as a leader in innovation and highlights our commitment to advancing life-saving treatments for the haemophilia community,” says Mr Edwards.
XYNTHA® Minimum Product Information
moroctocog alfa (rch) 250, 500, 1000 and 2000 IU powder for injection vial. moroctocog alfa (rch) 250, 500, 1000, 2000 and 3000 IU powder for injection in a prefilled syringe*.Indications: Control and prevention of haemorrhagic episodes in patients with haemophilia A. Contraindications: Known history of hypersensitivity to any of the constituents or to hamsterproteins. Precautions: Factor VIII inhibitors (neutralising antibodies), less than expected therapeutic effect, switching between factor VIII products, allergies, pregnancy: category B2, lactation, paediatric use. See full PI for details. Adverse Effects: Uncommon: factor VIII inhibition, headache, vomiting. Rare or Very Rare:neuropathy, haemorrhage/haematoma, angina pectoris, tachycardia, dyspnoea, others – see full PI for details. As with any intravenous protein product, allergic type hypersensitivity reactions are possible. Dosage and Administration: Complex, see full PI for detailed dosing instructions. Before prescribing, please review full Product Information available from Pfizer Australia Pty Ltd.* Please note changes to Product Information® Registered trademark.V10811. Please review Product Information before prescribing, available on request 1800 675 229.