NOVOSEVEN 2 MG ( HUMAN RECOMBINANT COAGULATION FACTOR VII EPTACOG ALFA "ACTIVATED" ) POWDER & SOLVENT FOR SOLUTION FOR IV INJECTION VIAL

Package leaflet: Information for the user
NovoSeven®

• 1 mg (50 KIU)
• 2 mg (100 KIU)
• 5 mg (250 KIU)
• 8 mg (400 KIU)

powder and solvent for solution for injection

eptacog alfa (activated)

Read all of this leaflet carefully before you are given this injection because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What NovoSeven® is and what it is used for
2. What you need to know before you use NovoSeven®
3. How to use NovoSeven®
4. Possible side effects
5. How to store NovoSeven®
6. Contents of the pack and other information

Overleaf: Instructions on how to use NovoSeven®

1. What NovoSeven® is and what it is used for
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 and 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.

2. What you need to know before you use NovoSeven®
Do not use NovoSeven®

• If you are allergic to eptacog alfa (active compound of NovoSeven®) or any of the other ingredients in this medicine (listed in section 6).
• If you are allergic to mouse, hamster or cow proteins (such as cows’ milk).
• If any of these apply to you, do not use NovoSeven®. Talk to your doctor.

Warnings and precautions
Before treatment with NovoSeven®, make sure your doctor knows:

• If you have just had surgery
• If you recently had a crush injury
• If your arteries are narrowed by disease (atherosclerosis)
• If you have an increased risk of blood clots (thrombosis)
• If you have severe liver disease
• If you have a serious blood infection
• 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 conditions apply to you, talk to your doctor before using the injection.

Other medicines and NovoSeven®
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not use NovoSeven® at the same time as prothrombin complex concentrates or rFXIII. You should talk to your doctor before using NovoSeven® if you also use Factor VIII or IX products.

There is limited experience of using NovoSeven® together with medicines called antifibrinolytic drugs (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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you use NovoSeven®.

Driving and using machines
There are no studies on the effect of NovoSeven® on the ability to drive and use machines. However, there is no medical reason to think that it would affect your ability.

NovoSeven® contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free’.

3. How to use NovoSeven®
The NovoSeven® powder must be reconstituted with its solvent and injected into a vein. See overleaf for detailed instructions.

When to treat yourself?
Start treatment of a bleed as early as possible, ideally within 2 hours.

• In cases of a mild or moderate bleed, you should treat yourself as early as possible, ideally at home.
• In case of a severe bleed you should contact your doctor. Usually severe bleeds are treated at the hospital and you can give yourself the first NovoSeven® dose on the way there.

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

• Each time you use NovoSeven®, tell your doctor or hospital as soon as possible.
• If bleeding is not controlled within 24 hours, contact your doctor immediately. You will usually 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 dose will be worked out by your doctor, based on your body weight, 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 micrograms for every 1 kilogram you weigh; you can repeat the injection every 2–3 hours until bleeding is controlled.

Your doctor may recommend a single dose of 270 micrograms for every 1 kilogram you weigh. There is no clinical experience in people over 65 using this single dose.

If you have Factor VII deficiency:

The usual dose range is 15 to 30 micrograms for every 1 kilogram you weigh, for each injection.

If you have Glanzmann’s thrombasthenia:

The usual dose is 90 micrograms (range is 80 to 120 micrograms) for every 1 kilogram you weigh, for each injection.

If you inject more NovoSeven® than you should
If you inject too much NovoSeven®, get medical advice at once.

If you forget an injection of NovoSeven®
If you forget an injection, or if you want to stop the treatment, get your doctor's advice.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Rare (may affect up to 1 in 1,000 treatment episodes)

• Allergic, hypersensitivity or anaphylactic reactions. Signs may include skin rashes, itching, flushing and hives; wheezing or difficulty breathing; feeling faint or dizzy; and severe swelling of the lips or throat, or at the injection site.
• Blood clots in arteries in the heart (which could lead to a heart attack or angina), in the brain (which could lead to a stroke) or in the intestine and kidneys. Signs may include severe pain in the chest, breathlessness, confusion, difficulty with speech or movement (paralysis) or abdominal pain.

Uncommon (may affect up to 1 in 100 treatment episodes)

• Blood clots in the veins in lungs, legs, liver, kidneys or at site of injection. 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®.

Remind your doctor if you have a history of allergic reactions as you may need to be monitored more carefully. In most cases of blood clots, the patients were predisposed to blood clotting disorders.

Other rare side effects
(may affect up to 1 in 1,000 treatment episodes)

• Nausea (feeling sick)
• Headache
• Changes in some liver and blood tests.

Other uncommon side effects
(may affect up to 1 in 100 treatment episodes)

• Allergic skin reactions including rash, itching and hives
• Fever.

Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store NovoSeven®

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is stated on the carton. The expiry date refers to the last day of that month.
• Store powder and solvent below 25°C.
• Store powder and solvent protected from light.
• Do not freeze.
• Use NovoSeven® at once after mixing the powder with the solvent to avoid infection. If you cannot use it immediately, after it has been mixed, you should store it in the vial with the vial adapter and syringe still attached in a refrigerator at 2°C to 8°C for no longer than 24 hours. Do not freeze the mixed NovoSeven® solution and keep it protected from light. Do not store the solution without advice from your doctor or nurse.
• 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 protect the environment.

6. Contents of the pack and other information
What NovoSeven® contains

• The active substance is recombinant coagulation factor VIIa (activated eptacog alfa).
• The other ingredients in the powder are sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, hydrochloric acid, sodium hydroxide. The ingredients in the solvent are histidine, hydrochloric acid, sodium hydroxide, water for injections.

The powder for solution for injection contains: 1 mg/vial (corresponding to 50 KIU/vial), 2 mg/vial (corresponding to 100 KIU/vial), 5 mg/vial (corresponding to 250 KIU/vial) or 8 mg/vial (corresponding to 400 KIU/vial).

After reconstitution, 1 ml of the solution contains 1 mg eptacog alfa (activated).

1 KIU equals 1,000 IU (International Units).

What NovoSeven® looks like and contents of the pack

The powder vial contains white powder and the pre-filled syringe contains a clear colourless solution. The reconstituted solution is colourless. Do not use the reconstituted solution if you notice particles in it or if it is discoloured.

Each NovoSeven® pack contains:

• 1 vial with white powder for solution for injection
• 1 vial adapter
• 1 pre-filled syringe with solvent for reconstitution
• 1 plunger rod

Pack sizes: 1 mg (50 KIU), 2 mg (100 KIU), 5 mg (250 KIU) and 8 mg (400 KIU).

Please refer to outer packaging for present pack size.

Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark
This leaflet was last revised in 04/2022

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