Human Coagulation Factor VIII

Octanate belongs to a group of medicines called clotting factors and contains human blood coagulation factor VIII. This is a special protein involved in blood clotting. Octanate is used to treat and prevent bleeding in patients with haemophilia A. This is a condition in which bleeding can go on for longer than expected. It is due to an hereditary lack of coagulation factor VIII in the blood.

Dosage for the prevention of bleeding: If you suffer from severe haemophilia A you should inject 20 to 40 IU of factor VIII per kg body weight every two or three days for long-term prevention. Your dosage should be adjusted according to your response. In some cases shorter dosage intervals or higher dosages may be necessary.

Dosage calculation: Always use Octanate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Factor VIII activity refers to the amount of factor VIII present in the plasma. It is expressed either as a percentage (relative to normal human blood plasma) or in International Units (IU). The dosage of factor VIII is expressed in IU. One IU of factor VIII activity is equivalent to the amount of factor VIII in one ml of normal human blood plasma. One IU of factor VIII per kg body weight raises the plasma factor VIII activity by 1.5%-2% of normal activity. To calculate your dosage, the level of factor VIII activity in your blood plasma is measured. This will indicate by how much the activity needs to be increased. Please consult your doctor if you are uncertain how much your factor VIII activity has to be increased or how to calculate your dosage.

Before and during the factor VIII injection, your pulse rate should be monitored. If a marked increase in the pulse rate occurs, reduce the injection speed or interrupt the administration. After you have reconstituted the powder as described above:

• Remove the protective cover from the filter needle and perforate the rubber stopper of the Octanate vial.
• Remove the cap of the filter needle and attach the syringe.
• Turn the vial with the attached syringe upside-down and draw up the solution into the syringe.
• Clean the chosen injection site with an alcohol swab.
• Remove the filter needle from the syringe and attach the injection needle to the syringe instead.
• Insert the injection needle into the chosen vein.
• Slowly inject the solution into the vein, at a speed of 2–3 ml per minute. Note that if you have used a tourniquet to make the vein easier to see, this tourniquet should be released before you start injecting Octanate.

If you use more than one vial of Octanate concentrate for one treatment, you may use the same injection needle and syringe again. The filter needle is for single use only. Always use a filter needle when drawing up the preparation into a syringe. Only use the injection set provided. The use of other injection/infusion equipment can cause additional risks and treatment failure.

No interactions of Moroctocog alfa (AF-CC) (r-DNA origin) with other medicinal products have been reported.

Hypersensitivity to the active substance or to any of the excipients. Known allergic reaction to hamster protein.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Even though rare (may affect up to 1 in 1,000 people), hypersensitivity or allergic reactions have been observed in patients treated with factor VIII containing products.

Contact your doctor if you suffer from the symptoms: being sick (vomiting), burning and stinging at the infusion site, chest tightness, chills, faster heart beat (tachycardia), feeling sick (nausea), feeling of pins and needles (tingling), flushing, headache, hives (urticaria), low blood pressure (hypotension), rash, restlessness, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), tiredness (lethargy), wheezing.

In very rare (may affect up to 1 in 10,000 people) cases, this hypersensitivity may lead to a severe life-threatening allergic reaction called anaphylaxis, which may include shock, as well as some or all of the symptoms described above. In this case please contact your doctor immediately or call for an ambulance.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. It is strongly recommended that every time Moroctocog alfa (AF-CC) (r-DNA origin) is administered to a patient, the name on the carton and batch number of the product are recorded in order to maintain a link between the patient and the batch number of the medicinal product. Patients can affix one of the peel-off labels found on the vial or prefilled syringe to document the batch number in their diary or for reporting any side effects

Anti-fibrinolytic drugs

• Allow the solvent (water for injections) and the Octanate concentrate in the closed vials to reach room temperature.
• Remove the caps from the vials and clean the rubber stoppers with an alcohol swab.
• Remove the protective cover from the short end of the double-ended needle, making sure not to touch the unprotected tip of the needle. Pierce the centre of the rubber stopper of the water vial with the needle held vertically. The needle should only be inserted as far as the solution can be withdrawn completely.
• Remove the protective cover from the other, long end of the double-ended needle, making sure not to touch the unprotected tip of the needle. Hold the water vial upside-down above the concentrate vial and insert the long end of the needle through the centre of the rubber stopper. The vacuum inside the concentrate vial draws in the water.
• Remove the double-ended needle from the concentrate vial. Gently mix this vial until the concentrate is completely dissolved. Octanate dissolves quickly at room temperature, giving a clear or slightly pearly shimmery solution. The reconstitution time is less than 10 minutes at room temperature.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the label. The expiry date refers to the last day of that month. Store at 2°C-8°C. Do not freeze. Keep the vials in the outer carton in order to protect from light. Use the reconstituted solution immediately and for single use only. Do not use this medicine if you notice cloudy or incompletely dissolved solutions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.