NovoSeven ® 1 mg/2 mg/5 mg Solution

NovoSeven ® is a blood coagulation factor. It works by making the blood clot at the site of bleeding, when the body's own clotting factors are not working. NovoSeven ® is used to treat bleeding, and to prevent excessive bleeding after surgery or other important treatments. Early treatment with NovoSeven ® reduces how much you bleed and for how long. It works in all types of bleeds, including joint bleeds. This reduces the need for hospitalisation and days absent from work or school. It is used in certain groups of people:

• if you were born with haemophilia and do not respond normally to factors VIII or IX treatment
• if you have acquired haemophilia
• if you have Factor VII deficiency
• if you have Glanzmann’s thrombasthenia (a bleeding disorder) and your condition cannot be treated effectively with platelet transfusion, or if platelets are not readily available.

NovoSeven ® can also be given to you by a doctor to treat heavy bleeding after delivery of your baby, even if you do not have a bleeding disorder.

Do not use NovoSeven ®:

• if you are hypersensitive (allergic) to eptagoc alfa (the active ingredient), or any of the other ingredients in NovoSeven ® (listed in section 6)
• if you are allergic to mouse, hamster or cow proteins (such as cow’s milk).

If any of these conditions apply to you, do not use NovoSeven ®. Talk to your doctor.

Warnings and precautions

Take special care with NovoSeven ®:

• if you have just had surgery
• if you recently had a crush injury
• if your arteries are narrowed by disease (atherosclerosis)
• if you have a serious blood infection.
• if you have an increased risk of blood clots (thrombosis)
• if you have severe liver disease
• if you are prone to disseminated intravascular coagulation (DIC, a condition where blood clots develop throughout the blood stream) you must be carefully monitored.

If any of these apply to you, talk to your doctor before using the injection.

Other medicines and NovoSeven ®:

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Simultaneous use of NovoSeven ® and prothrombin complex concentrates or rFXIII should be avoided. You should talk to your doctor before using NovoSeven ® if you also use factor VIII or IX products. Experience with simultaneous use of NovoSeven ® and medicines used to reduce the dissolving of blood clots is limited and if you are taking such medicines you should talk to your doctor before using NovoSeven ®. There is limited experience of using NovoSeven ® together with medicines called antifibrinolytic medicines (such as aminocaproic acid or tranexamic acid), which are also used to control bleeding. You should talk to your doctor before using NovoSeven ® with these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before using NovoSeven ®.

Do not share medicines prescribed for you with any other person. Always use NovoSeven ® exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. NovoSeven ® powder must be reconstituted with its solvent and needs to be injected into a vein.

When to treat yourself

Start treatment of a bleed as early as possible, ideally within 2 hours.

• In case of severe bleeds NovoSeven ® will be administered by a doctor or nurse in the surgery or hospital.
• In case of mild or moderate bleeding episodes, it may be given to you to use at home if required.

Do not treat yourself for longer than 24 hours without consulting your doctor:

• Each time you use NovoSeven ®, tell your doctor or hospital at the earliest possible opportunity so that your progress can be monitored.
• If bleeding is not controlled within 24 hours, contact your doctor immediately, you will need hospital care.

Dose

The first dose should be given as early as possible after bleeding has started. Talk to your doctor about when to use the injections and how long to keep using them. The usual dose will be worked out by your doctor, based on your body weight and your condition and type of bleed. To achieve the best results, follow the prescribed dose carefully. Your doctor might change the dose.

If you have haemophilia the usual dose is 90 μg for every 1 kg you weigh, at each injection, you can repeat the injection every 2 – 3 hours until bleeding is controlled. As an alternative, your doctor may recommend a single dose of 270 μg for every 1 kg you weigh, however there is no clinical experience in elderly using this dose. The home therapy should not exceed 24 hours.

If you have factor VII deficiency the usual dose range is 15 to 30 μg for every 1 kg you weigh, for each injection. If you have Glanzmann’s thrombasthenia the usual dose is 90 μg (range is 80 to 120 μg) for every 1 kg you weigh, for each injection. If you have acquired haemophilia the recommended initial dose, administered by intravenous bolus injection, is 90 μg per kg body weight. Following the initial dose of NovoSeven ® further injections may be given if required.

For all use of NovoSeven ®

• Consult your doctor about when to use the injections and how long to keep using them.
• The first dose should be given as early as possible after bleeding has started.

Making up the injection and injecting the solution

See overleaf for detailed instructions. If you inject more NovoSeven ® than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Always take the labelled medicine package with you, whether there are any NovoSeven ® left or not. If you missed a dose of NovoSeven ® If you forget to inject NovoSeven ®, or if you want to stop treatment, get medical advice at once. Do not take a double dose to make up for the forgotten individual dose.

NovoSeven ® can have side effects. Not all side effects reported for NovoSeven ® medicine are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using NovoSeven ®, please consult your health care provider for advice. If any of the following happens, stop using NovoSeven ® and tell your doctor immediately or go to the casualty department at your nearest hospital:

Less frequently occurring:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing, wheezing.
• Rash or itching, flushing and hives.
• Fainting, or dizziness.

These are all very serious side effects. If you have them, you may have had a serious reaction to NovoSeven ®. You may need urgent medical attention or hospitalisation. Tell your doctor immediately if you notice any of the following:

Less frequently occurring:

• Blood clots in arteries leading to heart attacks or strokes. Signs may include severe pain in the chest, breathlessness, confusion, difficulty with speech or movement (paralysis) or abdominal pain.
• Blood clots in veins in the lungs (leading to pulmonary embolism), legs, kidneys. Signs may include difficulty in breathing, red and painful swelling in the leg and abdominal pain.
• Lack of effect or decreased response to treatment. If you notice any of these serious side effects, get medical help immediately; explain that you have been using NovoSeven ®.

Tell your doctor if you notice any of the following:

Less frequently occurring:

• Nausea
• Headache
• Changes in some liver and blood tests
• Fever

People with a history of allergic reactions should be carefully monitored. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects:

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of NovoSeven ®.

Store all medicines out of reach of children.

Store NovoSeven ® powder and solvent at or below 25 °C.

Store NovoSeven ® in original package in order to protect from light.

Avoid freezing NovoSeven ® to prevent damage to the solvent pre-filled syringe.

Do not freeze the reconstituted solution.

After reconstitution of NovoSeven ®, chemical and physical stability has been demonstrated for 6 hours at 25 °C and 24 hours at 2 °C – 8 °C.

Use NovoSeven ® at once after mixing the powder with the solvent to avoid infection. If you cannot use it immediately, after it has been reconstituted, you should store it in the vial with the vial adapter and syringe still attached in a refrigerator at 2 °C – 8 °C for no longer than 24 hours.

Do not use the NovoSeven ® after the expiry date stated on the outer carton and labels.

Discard any unused product as instructed by your health care provider.

How to dispose of NovoSeven ®

Safely dispose of all unused and or expired NovoSeven ® as instructed by your health care provider or return it to your nearest pharmacy. Medicines should not be disposed of via drains, sewerage systems or household waste.