Patient leaflet - Novoseven 1 mg (50 Kiu) powder and solvent for solution for injection

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 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

Regulatory Operations

Insert: 2010-470x462-007 LIFT - Current 3

1 language

Patient, prof

NovoSeven®

1 mg (50 KIU)

2 mg (100 KIU)

5 mg (250 KIU)

8 mg (400 KIU)

8-9049-01-001-9

NovoSeven® is a trademark owned by Novo Nordisk Health Care AG, Switzerland

Novo Nordisk A/S

VV-LAB-096674

1.0

Overview

Vial with NovoSeven® powder

Plastic cap

Rubber stopper (under plastic cap)

Vial adapter

Protective cap

Spike (under protective paper)

Protective

paper

Pre-filled syringe with solvent

Syringe cap

Syringe tip

(under syringe

cap)

Plunger Instructions on how to use NovoSeven® READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOSEVEN®

NovoSeven® is supplied as a powder. Before injection (administration) it must be reconstituted with the solvent supplied in the syringe. The solvent is a histidine solution. The reconstituted NovoSeven® must be injected into your vein (intravenous injection). The equipment in this package is designed to reconstitute and inject NovoSeven®.

You will also need an administration set (tubing and butterfly needle, sterile alcohol swabs, gauze pads and plasters). These devices are not included in the NovoSeven® package.

Do not use the equipment without proper training from your doctor or nurse.

Always wash your hands and ensure that the area around you is clean.

When you prepare and inject medication directly into the vein, it is important to use a clean and germ free (aseptic) technique. Improper technique can introduce germs that can infect the blood.

Do not open the equipment until you are ready to use it.

Do not use the equipment if it has been dropped, or if it is damaged. Use a new package instead.

Do not use the equipment if it is expired. Use a new package instead. The expiry date is printed after ‘EXP’ on the outer carton, on the vial, on the vial adapter and on the pre-filled syringe.

Do not use the equipment if you suspect it is contaminated. Use a new package instead.

Do not dispose of any of the items until after you have injected the reconstituted solution.

The equipment is for single use only.

1. Prepare the vial and the syringe
• Take out the number of NovoSeven® packages you need.
• Check the expiry date.
•
Check the name, strength
and colour of the package,
to make sure it contains the
correct product.
•
Wash your hands and dry
them properly using a clean
towel or air dry.
•
Take the vial, the vial adapter
and the pre-filled syringe out
of the carton. Leave the
plunger rod untouched in the carton.
•
Bring the vial and the pre-filled syringe to room
temperature (not above
37°C). You can do this by
holding them in your hands
until they feel as warm as
your hands.
•
Do not use any other way
to warm the vial and
pre-filled syringe.
A
•
Remove the plastic cap
from the vial.
If the plastic cap is loose or missing, do not use the vial.
•
Wipe the rubber stopper
with a sterile alcohol swab
and allow it to air dry for
a few seconds before use to
ensure that it is as germ free
as possible.
•
Do not touch the rubber stopper with your fingers as this can transfer germs.
B
- Remove the protective
  paper from the vial adapter. If the protective paper is
  not fully sealed or if it is broken, do not use the vial adapter.
  Do not take the vial adapter out of the
  protective cap with your fingers. If you touch the spike on the vial adapter germs from your fingers can be transferred.
  C
  1. 4. Reconstitute the powder with the solvent
- Place the vial on a flat and solid surface.
- Turn over the protective
  cap, and snap the vial adapter onto the vial.
  Once attached, do not remove the vial adapter from the vial.
  D
- Lightly squeeze the
  protective cap with your thumb and index finger as shown.
  Remove the protective cap
  from the vial adapter.
  Do not lift the vial adapter
  from the vial when
  removing the protective cap.
  E
  - Grasp the plunger rod by the
    wide top-end and take it out of the carton. Do not touch the sides or the thread of
    the plunger rod. If you
    touch the sides or the thread, germs from your fingers can
    be transferred.
    Immediately connect the
    plunger rod to the syringe by turning it clockwise into the
    plunger inside the pre-filled
    syringe until resistance is felt.
    - Hold the pre-filled syringe
      slightly tilted with the vial
      pointing downwards.
    - Push the plunger rod to
      inject all the solvent into
      the vial.
      I
    - Keep the plunger rod pressed down and swirl
      the vial gently until all the
      powder is dissolved.
      Do not shake the vial as this will cause foaming.
    - Check the reconstituted
      solution. It must be
      colourless. If you notice
      visible particles or discolouration, do not
      use it. Use a new
      package instead.
      J
    - Keep the plunger rod pushed completely in.
    - Turn the syringe with the
      vial upside down.
    - Stop pushing the plunger rod and let it move back on
      its own while the reconstituted
      solution fills the syringe.
    - Pull the plunger rod
      slightly downwards to
      draw the reconstituted
      solution into the syringe.
    - In case you only need part of
      the reconstituted solution,
      use the scale on the syringe
      to see how much of the
      solution you withdraw, as
      instructed by your doctor
      or nurse.
    - If, at any point, there is too
      much air in the syringe, inject
      the air back into the vial.
    - While holding the vial upside
      down, tap the syringe
      gently to let any air bubbles
      rise to the top.
    - Push the plunger rod slowly
      until all air bubbles are gone.
      K
      L
      Disposal
      - After injection, safely dispose of the syringe with the administration set, the vial with the vial adapter, any unused NovoSeven® and other waste materials as instructed by your doctor or nurse.
      - Do not throw it out with the ordinary household waste.
        M

Do not disassemble the equipment before disposal.

Do not reuse the equipment.

2.
Attach the vial adapter 3. Attach the plunger rod and
the syringe
- Remove the syringe cap
  from the pre-filled syringe by bending it down until the
  perforation breaks.
  Do not touch the syringe tip under the syringe cap.
  If you touch the syringe tip,
  germs from your fingers can
  be transferred.
  If the syringe cap is loose or missing, do not use the pre-filled syringe.
  G
- Screw the pre-filled
  syringe securely onto the
  vial adapter until resistance
  is felt.
  H
  Plunger rod Contents

The package contains:

1 vial with NovoSeven®
powder
1 vial adapter
1 pre-filled syringe with
solvent
1 plunger rod (placed
under the syringe)
If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.
1. 5. Inject the reconstituted solution

NovoSeven® is now ready to inject into your vein.

Inject the reconstituted solution as instructed by your doctor or nurse.
Inject slowly over 2 to 5 minutes.

Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or a subcutaneous port:

Use a clean and germ free (aseptic) technique. Follow the instructions for proper use for your connector and CVAD in consultation with your doctor or nurse.
Injecting into a CVAD may require using a sterile 10 ml plastic syringe for withdrawal of the reconstituted solution.
If the CVAD line needs to be flushed before or after
NovoSeven® injection, use sodium chloride 9 mg/ml solution for injection.

Use the reconstituted NovoSeven® at once to avoid infections.

If you cannot use it at once, see section 5 How to store NovoSeven® on the other side of this leaflet. Do not store the reconstituted solution without advice from your doctor or nurse.

Scale

Unscrew the vial adapter
with the vial.
Do not touch the syringe
tip. If you touch the syringe
tip, germs from your fingers
can be transferred.
Thread Wide top end

F

Injecting NovoSeven® with pre-filled syringe via needleless connectors for intravenous (IV) catheters Caution: The pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock connections. Some needleless connectors with an internal spike are incompatible with the pre-filled syringe. This incompatibility may prevent administration of the drug and/or result in damage to the needleless connector. Follow the instructions for use for the needleless connector. Administration through a needleless connector may require withdrawal of the reconstituted solution into a standard 10 ml sterile luer-lock plastic syringe. This should be done right after step J.