drugs

Obizur - Susoctocog alfa

What is Obizur - Susoctocog alfa used for?

Obizur is a medicine used to treat bleeding episodes in adult patients with acquired haemophilia, a bleeding disorder caused by the spontaneous development of antibodies that deactivate factor VIII. Factor VIII is one of the proteins necessary for normal blood coagulation.

Obizur contains the active substance susoctocog alfa.

How is Obizur - Susoctocog alfa used?

Obizur can only be obtained with a prescription and treatment must be carried out under the supervision of a doctor experienced in treating haemophilia. Obizur is available as a powder and solvent, which are mixed together to form a solution for injection into a vein. The dose and frequency of administration, as well as the duration of therapy, are adjusted according to the patient's condition and requirements, as well as the severity of the bleeding episode. For more information, see the summary of product characteristics (included with EPAR).

How does Obizur - Susoctocog alfa work?

Patients with acquired hemophilia caused by antibodies against factor VIII have blood clotting problems including bleeding from joints, muscles or internal organs. The active substance in Obizur, susoctocog alfa, works in the body in the same way as the human factor VIII, but has a slightly different shape. Consequently, it will not be easily recognized by antibodies and can replace the human factor VIII which has been inactivated, favoring blood coagulation and bleeding control.

What benefit has Obizur - Susoctocog alfa shown during the studies?

Obizur was studied in one main study involving 28 adult patients with acquired haemophilia caused by antibodies against factor VIII, in which a severe haemorrhagic episode was underway. Obizur was not compared with other medicines. The response to Obizur was considered positive if the bleeding stopped or was reduced, while it was considered negative if the bleeding continued or worsened. All 28 patients showed a positive response within 24 hours of starting therapy with Obizur; in 24 patients out of 28 bleeding stopped completely.

What is the risk associated with Obizur - Susoctocog alfa?

Hypersensitivity (allergic) reactions may be observed with Obizur, which may include angioedema (swelling of the subcutaneous tissues), burning and irritation at the injection site, chills, redness, generalized urticaria, headache, urticaria, hypotension (reduction in blood pressure). ), tiredness or restlessness, nausea or vomiting, tachycardia (rapid heart beat), thoracic constriction, wheezing and vellichio (tickling). In some cases the reactions may worsen (anaphylaxis) and be associated with sudden and dangerous decreases in blood pressure. Obizur should not be used in people who have had a severe allergic reaction to susoctocog alfa, to any of the other ingredients or to hamster protein. Patients with acquired haemophilia caused by antibodies against factor VIII may develop antibodies against susoctocog alfa.

For the full list of all side effects reported with Obizur, see the package leaflet.

Why has Obizur - Susoctocog alfa been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Obizur's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted the lack of specific therapies for acquired haemophilia caused by antibodies against factor VIII. The results of the main study showed that Obizur is effective in treating severe bleeding episodes in adults affected by the disorder. Regarding safety, the committee is aware of the possibility that allergic reactions may occur and antibodies develop against the medicine, but believes that the benefits of the medicine outweigh its negative effects.

Obizur was authorized in "exceptional circumstances" because complete information on Obizur could not be obtained due to the rarity of the disease. Every year the European Medicines Agency will review the new information available and this summary will be updated accordingly.

What information is still awaited for Obizur - Susoctocog alfa?

Since Obizur was authorized in exceptional circumstances, the company that markets Obizur will establish and manage a patient registry to collect and analyze short and long term data on the efficacy and safety of Obizur in patients with acquired haemophilia caused by antibodies against factor VIII.

What measures are being taken to ensure the safe and effective use of Obizur - Susoctocog alfa?

A risk management plan has been developed to ensure that Obizur is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Obizur, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Obizur will provide all healthcare professionals who could use the medicine with informational materials containing information on how to calculate the dose.

More information on Obizur - Susoctocog alfa

For more information about treatment with Obizur, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.