SUMMARY CMI
Biostate®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
1. Why am I using Biostate®?
Biostate® contains the active ingredients, human coagulation factor VIII (FVIII) and human von Willebrand factor (VWF) complex. Biostate® is used to prevent or stop bleeding caused by low levels of VWF in von Willebrand disease (VWD) and low levels of FVIII in haemophilia A.
For more information, see Section 1. Why am I using Biostate®? in the full CMI.
2. What should I know before I use Biostate®?
Do not use if you have ever had an allergic reaction to Biostate® or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Biostate®? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Biostate® and affect how it works.
For more information, see Section 3. What if I am taking other medicines? in the full CMI.
4. How do I use Biostate®?
Your doctor will be responsible for determining what dose is appropriate to your condition and will prescribe the dosage to inject based on the severity of your disease, the site and intensity of the bleeding, your clinical condition and your body weight.
More instructions can be found in Section 4. How do I use Biostate®? in the full CMI.
5. What should I know while using Biostate®?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using Biostate®? in the full CMI.
6. Are there any side effects?
Like all medicines, Biostate® can cause side effects, although not everybody gets them. The common side effects are fever, headache and allergic reactions. The more serious side effects are dizziness, a severe allergic reaction, chest pain and shortness of breath or difficulty breathing.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
FULL CMI
Biostate®
Active ingredient(s): Human coagulation factor VIII and human von Willebrand factor complex
Consumer Medicine Information (CMI)
This leaflet provides important information about using Biostate®. You should also speak to your doctor, pharmacist or Haemophilia Treatment Centre if you would like further information or if you have any concerns or questions about using Biostate®.
Where to find information in this leaflet:
1. Why am I using Biostate®?
2. What should I know before I use Biostate®?
3. What if I am taking other medicines?
4. How do I use Biostate®?
5. What should I know while using Biostate®?
6. Are there any side effects?
7. Product details
1. Why am I using Biostate®?
Biostate® contains human coagulation factor VIII (FVIII) and human von Willebrand factor (VWF) complex as the active ingredients. Biostate® is a product made from human plasma (this is the liquid part of the blood) and is presented as a powder and diluent. Both FVIII and VWF are blood proteins that are essential for normal blood clotting.
Biostate® is used in patients with von Willebrand Disease (VWD), a bleeding disorder resulting from low levels of VWF or abnormal VWF. Individuals with VWD tend to take longer than normal to form blood clots, and tend to bleed from the skin and mucous membranes such as the nose, mouth and intestines. Because VWF provides stability for the fragile FVIII protein in the blood, patients with VWD may also have low FVIII levels.
Biostate® is also used in patients with haemophilia A, a bleeding disorder, in which there are low levels of FVIII or abnormal FVIII. Individuals with low levels or abnormal FVIII have difficulty in forming blood clots, with these clots often taking longer than normal to be made. Sometimes the individual may bleed unexpectedly into their joints, muscles or internal organs.
2. What should I know before I use Biostate®?
Warnings
Do not use Biostate® if:
you are allergic to human coagulation factor VIII, human von Willebrand factor or any of the ingredients listed at the end of this leaflet.
Record of use
It is strongly recommended that every time Biostate® is given, you record the date of administration, the batch number and the injected volume in your treatment diary.
Check with your doctor if you:
- have any other medical conditions including a known risk of developing blood clots
- take any medicines for any other condition
- have allergies to other medicines.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or are planning to have a baby.
Talk to your doctor if you are breastfeeding or plan to breastfeed.
During pregnancy and breastfeeding, Biostate® should be given only if it is clearly needed.
Thrombosis / Blood clots
If you have a known risk of developing blood clots, you must be monitored for early signs of thrombosis (blood clotting). Your doctor should give you treatment to prevent thrombosis.
Virus safety
Biostate® is manufactured from human plasma (the liquid component of blood) collected by Australian Red Cross Lifeblood. When products are made from human blood and injected into you, it is possible that viruses or other substances could be present in the product and cause an illness. These could be viruses such as hepatitis, human immunodeficiency virus (HIV), or parvovirus B19 and theoretically the Creutzfeldt-Jakob Disease (CJD) agent. There could also be other infectious agents some of which may not yet have been discovered.
To reduce the risk of this happening, strict controls are applied when selecting blood donors and donations. In addition, extra steps are taken when manufacturing this product. Biostate® is specially treated to remove and kill viruses. This special treatment is considered effective against certain viruses known as enveloped viruses (such as HIV and hepatitis B and C), and also the non-enveloped virus, hepatitis A. They may be of limited value against non-enveloped viruses such as parvovirus B19. Despite these safety measures, such products may still potentially transmit disease.
Vaccines are available against some of these viruses and your doctor will be able to help you decide whether it is worthwhile having any of those vaccines.
Please discuss the risks and benefits of Biostate® with your doctor.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop, as these might affect Biostate®.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Biostate®.
4. How do I use Biostate®?
How much to use
The dosage and administration of Biostate® must be carefully controlled. Your doctor will be responsible for determining what dose is appropriate to your condition. In some cases, especially in younger patients, higher doses may be needed.
The amount of VWF and FVIII you need to take and the duration of treatment depend on:
- the severity of your disease
- the site and intensity of the bleeding
- your clinical condition
- your body weight
Follow the instructions provided by your doctor. Your Haemophilia Treatment Centre will provide detailed instructions on how to use Biostate® when treating at home.
When to use Biostate®
Always take Biostate® exactly as your doctor has told you. Check with your doctor if you are not sure.
How to prepare Biostate® for injection
General Instructions
- The powder must be mixed with the solvent (liquid) and withdrawn from the vial under sterile conditions.
- Biostate® must not be mixed with other medicines, diluents or solvents.
- The solution should be clear or slightly opalescent, yellow to colourless, i.e. it might be sparkling when held up to the light but must not contain any obvious particles. After filtering or withdrawal (see below) the solution should be checked by eye, before it is used. Do not use the solution if it is visibly cloudy or if it contains flakes or particles.
The following steps are provided as a guide only. For further information, contact your doctor or Haemophilia Treatment Centre.
You will need one 5 mL Water for Injections (WFI) vial for each 250 IU and 500 IU (100 IU/mL) vial of Biostate®, or one 10 mL WFI vial for each 500 IU (50 IU/mL) and 1000 IU vial of Biostate®. You will also need one Mix2Vial™ transfer set per Biostate® vial.
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If the seal of the lid is not intact or you have any other concerns about the integrity of the Mix2Vial™, do not use it but return it to your Haemophilia Treatment Centre or Australian Red Cross Lifeblood. | |
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If water is not drawn into the vial, it means that there is no vacuum in the vial and the seal may be faulty. Do not use the product but return it to your Haemophilia Treatment Centre or Australian Red Cross Lifeblood. The Mix2Vial™ is intended to filter the contents of a single vial of Biostate® only. If multiple vials of Biostate® are to be given, a separate Mix2Vial™ must be used for each vial. | |
With the WFI and Biostate® vials still attached to the Mix2Vial™, gently swirl the Biostate® vial until the substance is fully dissolved. Do not shake as this could damage the product. The solution should be clear or slightly opalescent. It might sparkle when held up to the light but must not contain any obvious particles. Do not use solutions that are cloudy or contain flakes or particles. If a clot or gel forms do not use the product but return it to your Haemophilia Treatment Centre or Australian Red Cross Lifeblood. | |
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One large syringe may be used to withdraw Biostate® from multiple vials. Use Biostate® as soon as you can after preparation. (Make sure it is used for one person on one occasion only). The solution must not be stored for longer than 8 hours and the infusion should be completed as soon as practicable, as Biostate® does not contain an antimicrobial preservative. Any unused portion remaining in the vial must be discarded appropriately.
Do not refrigerate the Biostate® reconstituted solution.
How to administer Biostate®
Your doctor or Haemophilia Treatment Centre will instruct you on how to administer Biostate®. You should always follow these specific instructions, even if they are different to what is in this leaflet.
The steps listed below are provided as a guide on how to inject Biostate®. If you are unsure of the steps, please contact your doctor or Haemophilia Treatment Centre before using.
Should any of the symptoms listed under ‘Side effects’ develop, stop the infusion immediately and contact your Haemophilia Treatment Centre.
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If you forget to use Biostate®
Biostate® should be used as prescribed by your doctor, either as an ongoing regular schedule to prevent bleeds (prophylaxis), or as required to treat a bleeding episode or manage a surgery. If you miss a dose, follow your doctor's instructions or contact your doctor or Haemophilia Treatment Centre.
If you use too much Biostate®
Cases of overdose have been observed. No severe adverse reactions were associated with these cases. The risk of blood clots cannot be excluded in cases of major overdose, especially in patients with VWD. If you have any questions, consult your doctor.
If you think that you have used too much Biostate®, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), or - contact your doctor or Haemophilia Treatment Centre, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Biostate®?
Things you should do
Call your doctor straight away if you:
- If you have any concerns about using this medicine, talk to your doctor. Follow your doctor's advice even if it is different from what this leaflet says.
- Stop using this product immediately and contact your doctor if any side effects occur.
- Notice signs of any side effects - patients may react differently to the same dose. Contact your doctor or Haemophilia Treatment Centre immediately.
- Notice any signs of serious side effects. It may be necessary to stop using the medicine immediately.
Remind any doctor, dentist, pharmacist or other health carer you visit that you are using Biostate®.
Things you should not do
- Do not refrigerate Biostate® once it has been prepared.
- Do not share your medicine with anyone else, even if they have the same condition as you
- Do not mix Biostate® with other medicines or diluents that are not listed on the carton packaging.
Factor VIII / VWF Inhibition
Treatment with factor VIII products such as Biostate® may sometimes lead to the formation of antibodies (inhibitors) which neutralise factor VIII or VWF and reduce the effectiveness of the treatment. Your doctor will monitor you for development of these inhibitors and if they suspect that an inhibitor is present, the level of inhibitor will be measured using the appropriate laboratory tests. In some patients, inhibitors can be successfully overcome with larger doses of Biostate®, but for some patients it may be necessary to switch to a different treatment.
Driving or using machines
Biostate® does not affect your ability to drive and use machines.
Be careful before you drive or use any machines or tools until you know how Biostate® affects you.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Store at 2°C to 8°C. (Refrigerate, do not freeze). Biostate® can be stored at 25°C or below for a single period of 6 months. The product must not be returned to refrigeration after storage at 25°C or below.
Protect from light.
Do not use this medicine after the expiry date, which is stated on the label and carton.
The reconstituted product should be used as soon as practicable.
Keep it where young children cannot reach it.
When to discard your medicine (as relevant)
Do not use Biostate® after the expiry date detailed on the carton packaging.
Discard the solution if it is not administered within 8 hours of reconstitution. Discard any used portion remaining in the vial.
Getting rid of any unwanted medicine
Any unused portion remaining in the vial must be discarded appropriately.
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention. Furthermore, individual patients may react differently to the same dose of the same medicine. This applies to Biostate®, although severe reactions after Biostate® injection are rare.
See the information below and, if you need to, ask your doctor, Haemophilia Treatment Centre or pharmacist if you have any further questions about side effects.
Less serious side effects
Less serious side effects | What to do |
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
| Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Tell your doctor, Haemophilia Treatment Centre or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Biostate® contains
Active ingredients (main ingredients) | Human coagulation factor VIII Human von Willebrand factor |
Other ingredients (inactive ingredients) | Sucrose Sodium citrate dihydrate Sodium chloride Trometamol Calcium chloride dihydrate Human albumin Human plasma proteins |
This product is packaged in latex free materials.
Do not take this medicine if you are allergic to any of these ingredients.
What Biostate® looks like
Biostate® is a white or pale yellow powder contained in a glass vial. Biostate® is registered in four presentations as follows.
250 IU FVIII/600 IU VWF: AUST R 73032
500 IU FVIII/1200 IU VWF: AUST R 79993
500 IU FVIII/1200 IU VWF: AUST R 150648
1000 IU FVIII/2400 IU VWF: AUST R 150657
Each pack size contains:
250 IU vial of Biostate® (with a FVIII concentration of 50 IU/mL and a VWF concentration of 120 IU/mL), 5 mL vial of Water for Injections, and a Mix2Vial™ transfer set.
500 IU vial of Biostate® (with a FVIII concentration of 50 IU/mL and a VWF concentration of 120 IU/mL), 10 mL vial of Water for Injections, and a Mix2Vial™ transfer set.
500 IU vial of Biostate®, (with a FVIII concentration of 100 IU/mL and a VWF concentration of 240 IU/mL), 5 mL vial of Water for Injections, and a Mix2Vial™ transfer set.
1000 IU vial of Biostate®, (with a FVIII concentration of 100 IU/mL and a VWF concentration of 240 IU/mL), 10 mL vial of Water for Injections, and a Mix2Vial™ transfer set.
Who distributes Biostate®
Sponsor
CSL Behring (Australia) Pty Ltd
ABN 48 160 734 761
189-209 Camp Road
Broadmeadows VIC 3047
Australia
Distributor
Australian Red Cross Lifeblood
This leaflet was prepared in September 2024.
® Registered trademark of CSL Limited
™ Mix2Vial is a trademark of West Pharmaceutical Services, Inc. or a subsidiary thereof
Published by MIMS December 2024