OPTIVATE 250 IU 500 IU 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

Optivate 250 IU, 500 IU, 1000 IU powder and solvent for solution for injection

human coagulation factor VIII

Read all of this leaflet carefully before you start using this medicine 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 or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Optivate is and what it is used for

• 2. What you need to know before you use Optivate

• 3. How to use Optivate

• 4. Possible side effects

• 5. How to store Optivate

• 6. Contents of the pack and other information

1. what optivate is and what it is used for

Optivate is a high purity factor VIII concentrate, a protein that is needed for blood to clot. The factor VIII in Optivate is extracted from human blood plasma (the liquid part of blood).

Optivate is used to prevent and treat bleeding in patients with haemophilia A (a congenital factor VIII deficiency in the blood).

Optivate preparation contains human von Willebrand factor.

2. what you need to know before you use optivate- if you are allergic (hypersensitive) to human coagulation factor viii or any of the other

ingredients of this medicine (listed in section 6).

Warnings and precautions

• – If you have a larger or longer bleed than usual and the bleeding does not stop after an injection

of Optivate, speak to your doctor.

• – 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 Optivate, tell your doctor immediately.

• – This medicine may contain small amounts of blood group antibodies originally present in the

plasma from the donors. This is normal and in most cases, these antibodies do not cause any problems. If you need large doses of Optivate and are blood group A, B, or AB, your doctor may need to do a blood test to check if the medicine has had any effect on your red blood cells prescription.

• – Catheter-related complications: If a central venous access device (CVAD) is required, risk of

CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.

Virus safety

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include:

• – careful selection of blood and plasma donors to make sure those at risk of carrying infections

are excluded

• – the testing of each donation and pools of plasma for signs of virus/infections

• – the inclusion of steps in the processing of the blood or plasma that can inactivate or remove

viruses.

Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).

It is strongly recommended that every time you receive a dose of Optivate, the name and batch number of the product are recorded to maintain a record of the batches used.

Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly or repeatedly receive human plasma-derived factor VIII products.

Children and adolescents

The listed warnings and precautions apply to both adults and children.

Other medicines and Optivate

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Optivate does not affect your ability to drive or operate machines.

Optivate contains sodium

This medicine contains approximately 74 mg sodium (main component of cooking/table salt) in each 1000 IU vial. This is equivalent to 4% of the recommended maximum daily dietary intake of sodium for an adult.

3. how to use optivate

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

Optivate should be injected directly in a vein. Before injecting this medicine, you should have received training by your healthcare professional on how to do this.

Use only the recommended injection equipment provided with your medicine.

Your doctor will explain how much you should use and when you should use it.

Your doctor will tell you your dose in terms of the number of full vials nearest to the dose most suited to you. If further treatment is needed, doses may be repeated. Your doctor will advise you if this is necessary.

Adults

To prevent bleeding (prophylaxis), your doctor will calculate the dose for you. This will usually be in the range of 20 to 40 IU per kg of body weight, injected two or three times per week.

How much to use to treat bleeding

The table tells you the approximate dose needed to stop bleeding for different conditions:

Children

How much to use to prevent bleeding

Your doctor will calculate the dose. For children under the age of 6 years, this will usually be in the range of 17 to 30 IU per kg of body weight, injected up to 3 times a week.

When to inject Optivate

• – The medicine should be injected when the first sign of bleeding occurs.

• – The injection should be repeated as necessary to stop the bleeding.

• – Each individual bleed should be judged on its own severity.

• – If you are using this product for the first time, your doctor will supervise you.

Dissolving your medicine before use

Optivate is supplied with the amount of water for injection as shown in the table.

• 1. Optivate must only be dissolved in the water provided with the product.

• 2. Before you remove the cap, make sure that the vials of Optivate and water for injections supplied, are both at room temperature (between 20°C and 30°C).

You can dissolve Optivate using the needle-free Mix2VialTM transfer device included with each pack.

Instructions for reconstitution:

Note: If you have to use more than one vial to make up your required dose, repeat Steps 1 to 6, withdrawing the solution in the vial into the same syringe. The Mix2Vial™ transfer device supplied with your product is sterile and cannot be used more than once.

Do not use this medicine if:

• – the water is not pulled into the product vial (this indicates a loss of vacuum in the vial, so the

product must not be used)

• – the dissolved product and water form a gel or a clot or if the solution is cloudy

• – there are any particles in the syringe.

If any of these happens, tell your doctor or pharmacist, reporting the batch number printed on the vials.

If you use more Optivate than you should

If you think you may be using too much, stop the injection and tell your doctor. If you know you have used too much, tell your doctor as soon as possible.

If you forget to use Optivate

Do not use a double dose to make up for a forgotten dose. Inject your normal dose as soon as you remember and then continue to use as told by your doctor or haemophilia nurse.

If you stop using Optivate

Always talk to your doctor before deciding to stop your treatment.

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

4. possible side effects

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

Stop the infusion and tell your doctor immediately or go to the emergency department of your nearest hospital, if you get any of the following symptoms:

• Swelling around the throat
• Flushing
• Hives (nettle rash)
• Feeling lightheaded or dizzy (low blood pressure)
• Rapid heart beat
• Feeling sick or being sick
• Restlessness
• Tightness in the chest or wheezing
• Tingling sensation

These symptoms may worsen into severe shock. The above allergic-type reactions are very rare (may affect up to 1 in 10,000 people).

Other known side effects include:

• Headache
• Feeling that everything is moving, spinning round or tilting (vertigo)
• Cough
• Sneezing
• Redness of the skin (rashes) or pain at the place where the medicine was injected
• Other skin rashes
• Swelling in the extremities of the body
• Itching
• Raised temperature (fever)
• Sudden shivering and feeling cold and rapid rise in temperature
• Stiffness in muscles and joints
• Sleepiness, lethargy or feeling unwell

For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however, for patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients). If this happens, your or your child's medicines may stop working properly and you or your child may experience persistent bleeding. If this happens, you should contact your doctor immediately.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: Website: 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 optivate

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 containers after “EXP”. The expiry date refers to the last day of that month.

Do not store above 25°C. Do not freeze.

Keep the vials in the outer carton to protect from light.

Do not use this medicine if you notice small bits in the dissolved product. Once reconstituted, Optivate must be used immediately or no more than 1 hour.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist or doctor how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information- the active substance is human coagulation factor viii.

• – The excipients are: sodium chloride, sodium citrate, calcium chloride, polysorbate 20, trehalose,

sodium hydroxide (for pH-adjustment) and hydrochloric acid (for pH-adjustment).

• – Solvent: water for injections

What Optivate looks like and contents of the pack

Optivate is a white or pale yellow powder in quantities of 250 IU (International Units), 500 IU or 1000 IU in glass vials. These vials are closed with a rubber stopper under vacuum, held with a tamper-evident cap.

Optivate should only be reconstituted with the water for injections which is supplied with Optivate in vials.

The Mix2VialTM transfer device is also provided, to enable needle-free, easy and safe reconstitution.

Marketing Authorisation Holder and Manufacturer

Bio Products Laboratory Limited

Dagger Lane

Elstree

Hertfordshire

WD6 3BX

United Kingdom

tel: +44 (0) 20 8957 2255

e-mail:

This medicinal product is authorised in the Member States of the EEA under the following names:

Optivate: Cyprus, Malta, Poland, Portugal, Romania, Slovakia, United Kingdom

This leaflet was last revised in May 2020.

8