AryoSeven (rFVIIa) for Treatment of Bleeding Episodes

AryoSeven contains the active substance called Eptacog alfa belonging to a group of medicines called blood coagulation factors involved in blood clotting.

It is vitamin k-dependent and works by activating the extrinsic pathway of coagulation. It is similar to the human plasma-derived factor Vlla.

AryoSeven is used for the treatment and prevention of bleeding episodes during surgical operations for the following indications:

• Congenital Haemophilia A or B with inhibitors

• Acquired Haemophilia

• Congenital FVII deficiency

• If you ever had an allergic reaction to Eptacog alfa or any of the ingredients in AryoSeven.

• If you ever had an anaphylactic reaction to mouse or bovine proteins.

• If you have had allergic, anaphylactic, or hypersensitivity reactions to this medicine you should avoid the injection of AryoSeven.

• If you have advanced atherosclerotic disease, septicaemia, severe liver disease, coronary heart disease, crush injury, or have recently undergone surgery, or you are at risk of thromboembolic phenomena.

• If you have severe bleeding or the bleeding is not kept under control.

• If you are a factor VII deficient and your bleeding is uncontrolled by the usual recommended dosage

• are pregnant or planning to become pregnant.

• are breastfeeding or planning to breastfeed.

• You should also tell your doctor about other medicines you take:
  • Taking AryoSeven with rFXIII or prothrombin complex concentrates should be avoided.
  • If you use VIII or IX products
  • Co-administration of antifibrinolytics (tranexamic acid) and AryoSeven should be done under your doctor’s supervision.

The use of AryoSeven in adolescents and children is similar to adult patients.

• Use the medicine exactly as prescribed by your doctor.

• Your doctor will recommend the dosage depending on the type of bleeding and body weight.

• Your doctor will administer AryoSeven as soon as a bleeding episode starts.

• You can ask your doctor about the number of injections you can do at home for mild bleedings.

The recommended dosage is 90 μg /kg intravenous bolus injection (over 2-5 min) every 2-3 hours until hemostasis is achieved. Your doctor may increase the dosage in some cases.

The recommended dosage is 90 μg /kg every 2-3 hours until hemostasis is achieved.

The recommended dosage is 15-30 μg /kg every 4-6 hours until hemostasis is achieved.

The recommended dosage is 80-120 μg /kg every 2 hours. At least 3 doses should be administered to achieve effective hemostasis.

The dose of AryoSeven is the same as the dose given to adult patients. However, because AryoSeven will be cleared faster in children and adolescents, the dosing frequency might be increased which will be decided by the doctor.

AryoSeven powder will be administrated as an intravenous bolus injection (over 2-5 min). The powder is available in 1.2 mg, 2.4 mg, and 4.8 mg.

• Allergic reactions: some patients will have allergic, anaphylactic, or hypersensitivity reactions to AryoSeven. If you develop a severe rash, itching, hives, swelling of the lips or face, wheezing, and difficulty breathing taking AryoSeven, seek medical help.

• Thromboembolic events: formation of a blood clot in the bloodstream can cause Thromboembolic events. The clot may plug a vessel in the lungs, heart, brain, gastrointestinal intact, kidney, or lungs. If you develop symptoms including difficulty walking, slurred speech, severe pain in the chest, paining and red swelling in the legs, or paralysis, go to the hospital.

• Inhibitory antibody formation: The probability of antibodies formation against rFVIIa has been reported especially in factor VII deficiency cases that previously have been treated with a plasma-derived factor or human plasma.

Thromboembolic events, Inhibitory antibody formation, rash, hives, fever, urticaria, and Pruritus.

Disseminated intravascular coagulation, alkaline phosphatase, dehydrogenase, arterial thromboembolic events, nausea, headache, alanine aminotransferase, Increase of prothrombin, and injection site reactions.

angioedema, flushing, intracardiac thrombus, and anaphylactic reactions.

• Keep this medicine out of reach of children

• Do not freeze

• Store the powder and solvent in a refrigerator

Active ingredient: recombinant coagulation factor VIIa

Inactive ingredients: calcium chloride dihydrate, sodium chloride, polysorbate 80, and D-mannitol.