Adynovi - patient leaflet, side effects, dosage

Patient leaflet - Adynovi

- 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 ADYNOVI is and what it is used for
2. What you need to know before you use ADYNOVI
3. How to use ADYNOVI
4. Possible side effects
5. How to store ADYNOVI
6. Contents of the pack and other information

1. What ADYNOVI is and what it is used for

ADYNOVI contains the active substance rurioctocog alfa pegol, pegylated human coagulation factor VIII. The human coagulation factor VIII has been modified to prolong its duration of action. Factor VIII is necessary for the blood to form clots and stop bleedings. In patients with haemophilia A (inborn lack of factor VIII), it is missing or not working properly.

ADYNOVI is used for the treatment and prevention of bleeding in patients from 12 years of age with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).

2. What you need to know before you use ADYNOVI

Do not use ADYNOVI

– if you are allergic to rurioctocog alfa pegol, octocog alfa or any of the other ingredients of this

medicine (listed in section 6)

– if you are allergic to mouse or hamster proteins

If you are unsure about this, ask your doctor.

Warnings and precautions

It is important to keep a record of the batch number of your ADYNOVI. So, every time you get a new package of ADYNOVI, note down the date and the batch number (which is on the packaging after {abbreviation used for batch number} ) and keep this information in a safe place.

Talk to your doctor before using ADYNOVI.

There is a rare risk that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ADYNOVI. You should be aware of the early signs of allergic reactions such as rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, and dizziness. These could be early symptoms of anaphylactic shock; additional symptoms may include extreme dizziness, loss of consciousness, and extreme difficulty in breathing.

If any of these symptoms occur, stop the injection immediately and contact your doctor. Severe symptoms, including difficulty in breathing and (near) fainting, require prompt emergency treatment.

If you suffer from cardiac disease, please inform your doctor, as there is an increased risk of blood clotting (coagulation) complications.

Patients developing factor VIII inhibitors

The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines. These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors. If you or your child's bleeding is not being controlled with ADYNOVI, tell your doctor immediately.

Catheter-related complications

If you require a central venous access device (CVAD), risk of CVAD-related complications including local infections, presence of bacteria in the blood and catheter site thrombosis should be considered.

Children and adolescents

ADYNOVI can be used only in adolescents and adults (12 years and above). The listed warnings and precautions also apply to adolescents.

Other medicines and ADYNOVI

Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

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 using this medicine. Haemophilia A occurs only rarely in women. Therefore no experience regarding the use of ADYNOVI during pregnancy and breast-feeding is available.

Driving and using machines

ADYNOVI has no influence on your ability to drive or to use machines.

ADYNOVI contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

3. How to use ADYNOVI

Treatment with ADYNOVI will be started and supervised by a doctor who is experienced in the care of patients with haemophilia A.

Your doctor will calculate your dose of ADYNOVI depending on your condition and body weight, and on whether it is used for prevention or treatment of bleeding. The frequency of administration will depend on how well ADYNOVI is working for you. Usually, the replacement therapy with ADYNOVI is a life-long treatment.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Prevention of bleeding

The usual dose of ADYNOVI is 40 to 50 IU per kg body weight, administered 2 times per week.

Treatment of bleeding

The dose of ADYNOVI is calculated depending on your body weight and the factor VIII levels to be achieved. The target factor VIII levels will depend on the severity and location of the bleeding.

If you think that the effect of ADYNOVI is insufficient, talk to your doctor.

Your doctor will perform appropriate laboratory tests to make sure that you have adequate factor VIII levels. This is particularly important if you are having major surgery.

Use in children and adolescents

ADYNOVI can be used only in adolescents and adults (12 years and above). The dose in adolescents is also calculated to body weight and is the same dose as for adults.

How ADYNOVI is given

ADYNOVI is usually injected into a vein (intravenously) by your doctor or nurse. You or someone else might also administer ADYNOVI as an injection, but only after receiving adequate training. Detailed instructions for self-administration are given at the end of this package leaflet.

If you use more ADYNOVI than you should

Always use ADYNOVI exactly as your doctor has told you. You should check with your doctor if you are not sure. If you inject more ADYNOVI than recommended, tell your doctor as soon as possible.

If you forget to use ADYNOVI

Do not inject a double dose to make up for a forgotten dose. Proceed with the next injection as scheduled and continue as advised by your doctor.

If you stop using ADYNOVI

Do not stop using ADYNOVI without consulting your doctor.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

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

If severe, sudden allergic reactions (anaphylactic) occur, the injection must be stopped immediately. You must contact your doctor immediately if you have any of the following early symptoms of allergic reactions:

– rash, hives, wheals, generalised itching,
– swelling of lips and tongue,
– difficulty in breathing, wheezing, tightness in the chest,
– general feeling of being unwell,
– dizziness and loss of consciousness.

Severe symptoms, including difficulty in breathing and (nearly) fainting, require prompt emergency treatment.

For patients who have received previous treatment with Factor VIII (more than 150 days of treatment) inhibitor antibodies (see section 2) may form uncommonly (less than 1 in 100 patients). If this happens your medicine may stop working properly and you may experience persistent bleeding. If this happens, you should contact your doctor immediately.

Very common side effects (may affect greater than 1 in 10 people)

Headache

Common side effects (may affect up to 1 in 10 people)

Nausea

Diarrhoea

Rash

Dizziness

Hives

Uncommon side effects (may affect up to 1 in 100 people)

Flushing, allergic reaction (hypersensitivity)

Factor VIII inhibitors (for patients who have received previous treatment with Factor VIII (more than 150 days of treatment))

Increase in some type of white blood cells

Infusion reaction

Redness of the eye

Adverse drug reaction of the skin

Additional side effects in children

Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

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

5. How to store ADYNOVI

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 and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

During the shelf life the powder vial may be kept at room temperature (up to 30 °C) for a single period not exceeding 3 months. In this case, this medicine expires at the end of this 3-month period or the expiration date printed on the product vial, whichever is earlier. Please record the end of the 3-month storage at room temperature on the product carton. The product may not be returned to refrigerated storage after storage at room temperature. Do not refrigerate the solution after preparation.

Use the product within 3 hours once the powder is completely dissolved.

The product is for single use only. Discard any unused solution appropriately.

Do not throw away any medicines via waste water 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 ADYNOVI contains

– The active substance is rurioctocog alfa pegol (pegylated human coagulation factor VIII

produced by recombinant DNA technology). Each powder vial contains nominally 250, 500, 1 000, 2 000 or 3 000 IU rurioctocog alfa pegol.

– The solvent vial contains 5 ml of sterilised water for injections.
– The other ingredients are mannitol, trehalose dihydrate, histidine, glutathion, sodium chloride,

calcium chloride dihydrate, tris(hydroxymethyl)aminomethane, polysorbate 80 and sterilised water for injections. ADYNOVI contains sodium, see section 2.

What ADYNOVI looks like and contents of the pack

ADYNOVI is provided as a powder and solvent for solution for injection. The powder is a white to off-white crumbly powder. The solvent is a clear, colourless solution. After reconstitution, the solution is clear, colourless and free from foreign particles.

Each pack contains one powder vial, one solvent vial and a device for reconstitution (BAXJECT II Hi-Flow).

Marketing Authorisation Holder

Baxalta Innovations GmbH

Industriestrasse 67

A-1221 Vienna

Tel: + 800 66838470

e-mail:

Manufacturer

Baxalta Belgium Manufacturing SA

Boulevard René Branquart 80

B-7860 Lessines

Belgium

This leaflet was last revised in.

Detailed information on this medicine is available on the European Medicines Agency web site:

Instructions for preparation and administration

Use only the solvent and the reconstitution device for preparation of the solution that are provided with each package of ADYNOVI. The powder must not be mixed with other medicinal products or solvents or used with other reconstitution devices.

It is strongly recommended that every time ADYNOVI is administered, the name and batch number of the product are recorded. Peel-off labels are provided on the powder vial.

Instructions for reconstitution

Do not use after the expiry date stated on the labels and carton.
Do not use if the BAXJECT II Hi-Flow device, its sterile barrier system or its packaging is

damaged or shows any sign of deterioration.

1. Use antiseptic technique (clean and low-germ conditions) and a flat work surface during the reconstitution procedure.
2. Allow the vials of powder and solvent to reach room temperature (between 15 °C and 25 °C) before use.
3. Remove plastic caps from the powder and solvent vials.
4. Clean rubber stoppers with an alcohol wipe and allow to dry prior to use.
5. Open the BAXJECT II Hi-Flow device package by peeling away the lid, without touching the

inside (Figure A). Do not remove the device from the package.

6. Turn the package over. Press straight down to fully insert the clear plastic spike through the solvent vial stopper (Figure B).
7. Grip the BAXJECT II Hi-Flow package at its edge and pull the package off the device (Figure C). Do not remove the blue cap from the BAXJECT II Hi-Flow device. Do not touch the exposed purple plastic spike.
8. Turn the system over so that the solvent vial is on top. Quickly insert the purple plastic spike

fully into the powder vial stopper by pushing straight down (Figure D). The vacuum will draw the solvent into the powder vial.

9. Swirl gently until the powder is completely dissolved. Do not refrigerate after reconstitution.

Figure A

Figure B

Figure C

Figure D Figure E Figure F

Instructions for injection

Important note:

Inspect the prepared solution for particulate matter and discolouration prior to administration

(the solution should be clear, colourless and free from particles).

Do not use ADYNOVI if the solution is not fully clear or not completely dissolved.

1. Remove the blue cap from the BAXJECT II Hi-Flow device (Figure E). Do not draw air into the syringe. Connect the syringe to the BAXJECT II Hi-Flow device. Use of a Luer-lock syringe is recommended.
2. Turn the system upside down (powder vial now on top). Draw the reconstituted solution into the syringe by pulling the plunger back slowly (Figure F).
3. Disconnect the syringe; attach a suitable needle and inject intravenously. If a patient is to receive more than one vial of ADYNOVI, the contents of multiple vials may be drawn into the same syringe.

A separate BAXJECT II Hi-Flow device is required to reconstitute each vial of ADYNOVI with the solvent.

4. Administer over a period of up to 5 minutes (maximum infusion rate 10 ml per min).
5. Discard any unused solution appropriately.