500 U powder and solvent for solution for injection
susoktokog alfa
What OBIZUR is and what it is used for
OBIZUR contains the active substance susoktokog alfa, anti- hemophilia factor VIII, porcine sequence. Factor VIII is needed for the blood to coagulate and stop bleeding.
In patients with acquired hemophilia, factor VIII does not work properly because the patient has developed antibodies to their factor VIII that neutralize this blood coagulation factor.
OBIZUR is used to treat bleeding in adults with acquired hemophilia (a bleeding disorder caused by a lack of factor VIII activity due to the development of antibodies ). These antibodies have a less neutralizing effect against OBIZUR than against human factor VIII.
OBIZUR restores the missing factor VIII activity and helps the blood to coagulate at the bleeding site.
What you need to know before you are given OBIZUR
You must not be given OBIZUR:
- if you are allergic to susoktokog alfa or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to hamster protein (trace amounts may occur in OBIZUR due to the manufacturing process).
If you are not sure, talk to your doctor before taking this medicine.
This medicine is only to be given to patients in a hospital. It requires monitoring of the patient’s bleeding status.
Warnings and cautions
Talk to your doctor before giving OBIZUR.
Hypersensitivity
There is a small risk that you may have an allergic reaction to OBIZUR. You should be aware of the early signs of allergic reactions (signs and symptoms can be found in section 4). If any of these symptoms occur, the injection should be stopped. Serious symptoms, including difficulty breathing and (almost) fainting, require urgent hospital treatment.
Inhibitors
Your doctor may check if you have inhibitory antibodies to porcine factor VIII
and if these antibodies are increasing.
Your doctor will check the presence of factor VIII in your blood to confirm that you have had enough factor VIII. The doctor will also check if the bleeding is under satisfactory control.
Cardiovascular events
Talk to your doctor if you currently have or have had cardiovascular disease or if you have a known risk of thrombosis (a disease caused by blood clots in the blood vessels), as the risk of developing blood clot-related diseases at high and persistent factor VIII levels cannot be ruled out.
Children and young people
There is no information on the use of OBIZUR in children and adolescents under 18 years of age.
Other medicines and OBIZUR
Tell your doctor if you are taking, have recently taken, or might take any other medicines. No interaction between OBIZUR and other drugs is known.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Driving and using machines
OBIZUR does not affect the ability to drive and use machines.
OBIZUR contains sodium
After reconstitution, this medicinal product contains 4.6 mg sodium (the main ingredient in table salt/table salt) per milliliter. This corresponds to 0.23% of the maximum recommended daily sodium intake for adults. Several vials must be taken per dose.
Tell your doctor if you have been prescribed a low-salt diet.
How OBIZUR is given
The treatment with OBIZUR is carried out by a doctor who has experience in caring for patients with hemophilia (bleeding disorders).
Your doctor will calculate your dose of OBIZUR (in units or E) depending on your condition and your body weight. How often and for how long you receive treatment depends on how well OBIZUR works for you. In most cases, replacement therapy with OBIZUR is a temporary treatment until the bleeding has stopped or the antibodies to your factor VIII have been removed.
Your doctor will check for the presence of antibodies to OBIZUR.
The recommended starting dose is 200 U per kilogram body weight, given as an intravenous injection.
Your doctor will measure your factor VIII activity regularly to determine the next dose and how often you should receive OBIZUR.
The bleeding usually responds within the first 24 hours. Your doctor will adjust the dose one and the duration of OBIZUR until the bleeding has stopped.
The full volume of reconstituted (reconstituted) OBIZUR should be given at a rate of 1 to 2 ml per minute.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In the event of a severe and sudden allergic reaction, injection must be stopped immediately. If any of the following early symptoms occur, you must contact a doctor immediately:
- Swelling of lips and tongue
- A burning and stinging sensation at the injection site
- Chills, redness
- Rash, general itching
- Headache, low blood pressure
- Numbness, malaise, restlessness
- Fast heartbeat, pressure over the chest
- Irritations, vomiting
- Wheezing
Very common side effects (may affect more than 1 in 10 people)
- Development of antibodies and increase of existing antibodies to the drug, which may lead to a lack of effect with continued bleeding.
How to store OBIZUR
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 carton, vial, and prefilled syringe after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C ‑ 8 ° C).
Do not freeze.
The reconstituted solution should be used immediately, but no later than 3 hours after the powder has completely dissolved.
After reconstitution, the solution should be clear and colorless.
Do not administer it if there are particles or discoloration.
As this medicine is used during a hospital stay, the hospital staff is responsible for the proper storage of this medicine before and during its use, as well as for proper disposal.
Name and batch number
It is strongly recommended that each time OBIZUR is administered to a patient, the name and manufacturing batch number of the medicinal product should be noted so that a link between the patient and the manufacturing batch number of the medicinal product can be maintained.
Contents of the pack and other information
Content declaration
- The active substance is susoktokog alfa (anti- hemophilia factor VIII, porcine sequence, produced by recombinant DNA technology). Each powder vial contains 500 U susoktokog alfa.
- The other ingredients in the powder are polysorbate 80, sodium chloride (see also section 2), calcium chloride dihydrate, sucrose, trometamol, trometamol hydrochloride, sodium citrate.
- The solvent is 1 ml of sterile water for injections.
What the medicine looks like and contents of the pack
A package contains 1, 5, or 10 of the following:
- glass vial with 500 U OBIZUR, a white, brittle powder, with butyl rubber stopper coated with FluroTec ® and detachable seal
- pre-filled glass syringe with bromobutyl rubber stopper coated with FluroTec ® foil on contact side with 1 ml sterile water for injections with bromobutyl rubber needle guard and Luer cap adapter
- liquid transfer device with built-in plastic tip
Marketing Authorisation Holder
Baxalta Innovations GmbH
Industriestrasse 67
1221 Vienna
AUSTRIA
Tel: +80066838470
Email: medinfoEMEA@shire.com
Manufacturer
Takeda Manufacturing Austria AG
Industriestrasse 67
1221 Vienna
AUSTRIA
Baxter AG
Industriestrasse 67
1221 Vienna
AUSTRIA
This medicine has been authorized following the rules of “exceptional authorization”. This means that it has not been possible to obtain complete information about this medicine as the disease is rare.
Every year, the European Medicines Agency reviews any new information and updates this leaflet as needed.