Octanate

Patient Information Leaflet

Octanate, 50 IU/mL, powder and solvent for solution for injection
Human coagulation factor VIII
Octanate, 100 IU/mL, powder and solvent for solution for injection
Human coagulation factor VIII
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• Please consult your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If any adverse reactions worsen or if any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents:

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

1. What Octanate is and what it is used for

Octanate belongs to a group of medicines known as coagulation factors and contains human coagulation factor VIII. It is a special protein that increases the blood's ability to clot.
Octanate is used in the treatment and prevention of bleeding episodes in patients with haemophilia A. This is a condition in which bleeding lasts longer than expected due to a congenital deficiency of factor VIII in the blood.

2. Important information before using Octanate

It is strongly recommended that each time a dose of Octanate is administered to a patient, the product name and batch number are recorded to maintain traceability of the batch used.
The physician may recommend considering vaccination against hepatitis A and B in patients receiving regular or repeated administration of human Factor VIII products.

When not to use Octanate
Do not use Octanate if the patient is allergic to human blood coagulation Factor VIII or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Octanate, consult a doctor, pharmacist, or nurse.
Octanate contains trace amounts of other human proteins. Any medicinal product containing proteins administered intravenously (by intravenous infusion) may cause allergic reactions (see section 4. Possible side effects).
The development of inhibitors (antibodies) is a known complication that may occur during treatment with any Factor VIII-containing products. These inhibitors, especially at high concentrations, may interfere with effective treatment, and the patient will be closely monitored for their development. If bleeding is not properly controlled with Octanate, inform the doctor immediately.

Information regarding blood and plasma used in the manufacture of Octanate
During the manufacturing of medicines derived from human blood or plasma, specific measures are taken to prevent transmission of infections to patients. These include careful selection of blood and plasma donors to exclude those who may be carriers of infections, as well as testing of all collected samples and plasma pools for the presence of viruses/infections. Manufacturers of these products have implemented steps in the blood or plasma processing procedures designed to inactivate or remove viruses. Despite these measures, when administering medicines prepared from human blood or plasma, it cannot be completely ruled out that transmission of infection may occur. This also applies to unknown or newly emerging viruses or other types of infections.
The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and non-enveloped hepatitis A virus (HAV). The methods used may have limited effectiveness against non-enveloped viruses such as parvovirus B19.
Parvovirus B19 infection may be dangerous for pregnant women (risk of fetal infection) and for individuals with suppressed immune systems or those suffering from certain types of anemia (e.g. sickle cell anemia or abnormal breakdown of red blood cells).

Other medicines and Octanate
Inform the doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take, including those available without a prescription.
No interactions between human Factor VIII and other medicinal products are known. However, Octanate must not be mixed with other medicines during infusion.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning a pregnancy, consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed.

Octanate contains
For one vial of 250 IU:
less than 1 mmol of sodium (23 mg) (main component of table salt) per vial, which may be considered "sodium-free"
For one vial of 500 IU and 1000 IU:
up to 40 mg of sodium (main component of table salt) per vial. This corresponds to 2% of the recommended maximum daily intake of 2 g sodium for an adult.

3. How to use Octanate

Octanate should be administered intravenously after reconstitution with the solvent provided.
Treatment should be initiated under medical supervision.
Dosing for prevention of bleeding: In long-term prophylaxis of bleeding in patients with severe
haemophilia A, factor VIII should be administered at a dose of 20 to 40 IU per kilogram of body weight
every 2 to 3 days. The dose should be adjusted according to the clinical response.
In some cases, more frequent administration or higher doses may be required.
Dose calculation:
Octanate should always be used according to the physician's instructions. In case of doubt, consult
your doctor or pharmacist again.
Plasma factor VIII activity corresponds to the concentration of factor VIII in plasma. It is expressed either
as a percentage (relative to normal human plasma) or in international units (IU). The dose of factor VIII
is expressed in IU.
One International Unit (IU) of factor VIII activity is equivalent to the amount of factor VIII present in
1 ml of normal human plasma. 1 IU of factor VIII per kilogram of body weight raises plasma factor VIII
activity by 1.5%–2% of normal activity. To calculate the required dose, determine the patient's plasma
factor VIII activity. This will allow determination of how much the activity should be increased.
Consult your doctor if you are uncertain about how much the plasma factor VIII activity should be
increased and how to calculate the appropriate dose.
The required dose is calculated using the following formula:
required number of units = body weight (kg) × required increase in factor VIII activity (%) (IU/dL) × 0.5
The amount to be administered and the frequency of administration should always be adjusted according
to the individual patient's clinical response.
In the following bleeding situations, plasma factor VIII activity should not fall below the indicated
plasma activity level (in % of normal values) during the specified period.
The following table may be helpful in determining doses for bleeding episodes or surgical procedures:

The dose and frequency of administration of Octanate will be determined by the physician.
Response to factor VIII may vary among individual patients. Therefore, during treatment,
monitoring of factor VIII levels is recommended to determine the appropriate dose and frequency
of infusion.

Use in children
Clinical studies have not revealed any special dosing requirements in children. Dosing is the same in adults and children, both for treatment and prophylaxis.

Instructions for home use

• Read all instructions carefully and follow them exactly!
• Do not use Octanate after the expiry date stated on the label.
• Maintain sterile conditions during the procedure described below!
• Before administration, visually inspect the prepared solution for solid particles or discoloration.
• The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or contain solid particles.
• Use the prepared solution immediately to avoid microbiological contamination.
• Use only the provided infusion set. Using other injection/infusion equipment may cause additional risks and treatment failure.

Instructions for preparing the solution:

1. Do not use the product immediately after removing it from the refrigerator. Allow the solvent and powder vials to reach room temperature while still closed.
2. Remove the caps from both vials and clean the rubber stoppers with one of the provided alcohol swabs.
3. The transfer set is shown in Fig. 1. Place the solvent vial on a flat surface and hold it firmly. Take the transfer set and turn it over. Place the blue part of the transfer set onto the top of the solvent vial and press firmly until it clicks into place (Fig. 2 + 3). Do not rotate while attaching.

Fig. 1 Fig. 2 Fig. 3

4. Place the powder vial on a flat surface and hold it firmly. Take the solvent vial with the attached transfer set and turn it upside down. Place the white part of the transfer set onto the top of the powder vial and press firmly until it clicks into place (Fig. 4). Do not rotate while attaching. The solvent will automatically flow into the powder vial.

Fig. 4

5. With both vials connected, gently rotate the powder vial until the product is completely dissolved. Dissolution is complete in less than 10 minutes at room temperature. A slight foam may form during preparation. Unscrew the transfer set into two parts (Fig. 5). The foam will disappear.

Discard the empty solvent vial with the blue part of the transfer set.
Fig. 5

Instructions for administering the infusion:
As a precaution, monitor the pulse before and during infusion. If a significant increase in pulse rate occurs, reduce the infusion rate or temporarily interrupt administration.

1. Attach the syringe to the white part of the transfer set. Turn the vial upside down and draw the solution into the syringe (Fig. 6). The solution should be clear or slightly opalescent. After transferring the solution, firmly hold the plunger of the syringe (keeping it pointing downward) and remove the syringe from the transfer set (Fig. 7).

Discard the empty vial together with the white part of the transfer set.

Fig. 6 Fig. 7

2. Clean the selected injection site with one of the provided alcohol swabs.
3. Attach the provided infusion set to the syringe.
4. Insert the needle into the selected vein. If a tourniquet was used to visualize the vein, release it before starting the infusion of Octanate.
5. Blood must not enter the syringe due to the risk of fibrin clot formation.
6. Infuse the solution slowly into the vein, no faster than 2–3 ml per minute. When more than one vial of Octanate powder is used during a single administration, the same infusion set and syringe may be reused. The transfer set is intended for single use only.

Any unused portions or waste materials must be disposed of in accordance with local regulations.

Overdose of Octanate
No symptoms of overdose with human coagulation factor VIII have been observed. However, exceeding the recommended dose is not advised.

Missed dose of Octanate
Do not administer a double dose to make up for a missed dose. Proceed immediately to the next dose and continue dosing as directed by the physician or pharmacist. Contact your physician or pharmacist if you have any further questions regarding the use of this product.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Although rare (may occur in 1 out of 1,000 people), hypersensitivity or allergic reactions have been observed in patients treated with products containing Factor VIII.
You should contact your doctor if any of the following symptoms occur:
vomiting, burning sensation and scalding pain at the infusion site, feeling of pressure in the chest, chills, tachycardia, nausea, tingling sensation, redness, headache, hypotension, urticaria, skin rash, restlessness, swelling of the face, lips, oral cavity, tongue or throat, which may lead to difficulty in swallowing or breathing (angioedema), fatigue (lethargy), wheezing.
Very rarely (may occur in 1 out of 10,000 people), hypersensitivity may lead to a life-threatening allergic reaction called anaphylaxis, which may include shock, as well as some or all of the symptoms described above. In such a case, you should contact your doctor immediately or call emergency services.
Other rare adverse reactions (may occur in 1 out of 1,000 people):
Fever
In children who have not previously been treated with Factor VIII-containing medicines, inhibitory antibodies (see section 2) may develop very frequently (more than 1 in 10 patients). However, in patients who have previously been treated with Factor VIII (more than 150 days of treatment), the risk is uncommon (less than 1 in 100 patients). If this occurs, the patient's medicine may stop working properly and persistent bleeding may occur. If this happens, contact your doctor immediately.
Viral safety information, see section 2. (Special caution should be exercised when using Octanate).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL–02 222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Octanate

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Store in the outer packaging to protect from light.
The reconstituted solution should be used immediately and only during a single administration.
Do not use this medicine if the solution appears cloudy or is not completely dissolved.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Octanate contains
The active substance is human blood coagulation factor VIII.
Volume and concentrations

Other ingredients are:
For the powder: sodium citrate, sodium chloride, calcium chloride, glycine
For the solvent: water for injections
What Octanate looks like and contents of the pack
Octanate is available as a powder and solvent for solution for injection.
The powder is white or pale yellow in colour and may also appear as a compacted mass.
The solvent is a clear, colourless liquid.
Three pack sizes are available, differing in the content of factor VIII and solvent:

• 250 IU/vial: after reconstitution in 5 ml, the concentration is 50 IU/ml
• 500 IU/vial: after reconstitution in 10 ml, the concentration is 50 IU/ml
• 1000 IU/vial: after reconstitution in 10 ml, the concentration is 100 IU/ml

All pack sizes contain:

• 1 pack of intravenous administration equipment (1 transfer set, 1 infusion set, 1 single-use syringe)
• 2 alcohol-impregnated swabs

Not all pack sizes may be available on the market.
Marketing Authorisation Holder
Octapharma (IP) SPRL
Allée de la Recherche 65
1070 Anderlecht
Belgium
For further information, please contact the marketing authorisation holder.
Manufacturer
Octapharma Pharmazeutika Produktionsges.m.b.H
Oberlaaer Str. 235
1100 Vienna
Austria
Octapharma S.A.S
70 – 72 Rue du Maréchal Foch
BP 33
67381 Lingolsheim
France
Octapharma AB
112 75 Stockholm
Sweden