NovoSeven

Indications

Coagulation factor VIIa (Eptacog alfa, activated) is a man-made clotting protein used to treat and prevent bleeding in people with certain bleeding disorders. These include haemophilia A or B in patients who have developed inhibitors (antibodies) against factor VIII or IX, acquired haemophilia, inherited factor VII deficiency and Glanzmann thrombasthenia (a platelet disorder) when platelet transfusions do not work. It is used for bleeding episodes and to cover surgery or other procedures.

How It Works

Factor VIIa is one of the body's natural clotting factors. At a site of injury, it works with tissue factor and on the surface of activated platelets to switch on the clotting chain and produce thrombin, which forms a stable clot. Given in larger amounts, it can bypass the missing or blocked factor VIII or IX and stop bleeding.

Dosage and Administration

It is given as an injection into a vein, usually by a doctor or nurse, or at home by a patient or carer trained by a haemophilia centre. The dose and how often it is repeated depend on body weight, the condition, the type and severity of bleeding and the response, and are set by a specialist. The powder is mixed with the supplied solvent just before use.

Interactions

• Combining it with activated or non-activated prothrombin complex concentrates may increase the risk of clots and is generally avoided.
• Antifibrinolytic medicines such as Tranexamic acid may be used alongside it in some situations, as directed by the specialist.
• It should not be mixed with other medicines or infusion fluids in the same syringe.

Contraindications

• Known allergy to the medicine, its ingredients, or mouse, hamster or cow proteins.

Side Effects

Possible effects include fever, rash, itching, headache, nausea, changes in blood pressure and reduced effect of treatment. Uncommon but serious effects are blood clots in veins or arteries, heart attack and stroke, especially in people with existing risk factors. Allergic reactions can occur.

Get urgent medical help if you have chest pain or tightness, sudden breathlessness, painful swelling of a leg, sudden weakness or numbness on one side of the body, trouble speaking or seeing, severe headache, signs of an allergic reaction such as hives, swelling of the face or difficulty breathing, or if bleeding does not stop.

Pregnancy and Lactation

Experience in pregnancy is limited. It is used only if the specialist decides it is clearly needed. It is not known whether it passes into breast milk; the doctor will advise on breastfeeding.

Precautions and Warnings

People with heart disease, liver disease, recent surgery, crush injuries, sepsis or a tendency to form clots are at higher risk of clots and need close monitoring. Keep a record of each dose and batch number. Do not exceed the prescribed dose. Contact your haemophilia centre if bleeding is not controlled.

Overdose

Too much may increase the risk of clots. Seek medical help immediately if a higher dose than prescribed has been given or if signs of a clot appear.

Therapeutic Class

Haemostatic agent; recombinant coagulation factor (bypassing agent).

Storage

Store as directed on the pack, usually at 2 to 25°C. Do not freeze. Keep in the carton to protect from light. Use the mixed solution promptly as instructed. Keep out of the reach of children.