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 contact 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 someone else, even if their symptoms are the same.
• If any of the side effects get worse, or if you notice any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Octanate is and what it is used for
2. What 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 called coagulation factors and contains human coagulation factor VIII. It is a special protein that increases the blood's ability to clot.
Octanate is used for the treatment and prevention of bleeding in patients with haemophilia A. This is a condition in which bleeding lasts longer than expected. It results from 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 be 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 doses 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 components 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 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 medicinal products. These inhibitors, especially at high concentrations, may interfere with effective treatment, and the patient will be closely monitored for inhibitor development. If bleeding in the patient 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 carry infections, as well as testing of all collected samples and plasma pools for the presence of viruses/infections. Manufacturers of these products have incorporated steps in the processing of blood or plasma designed to inactivate or remove viruses. Despite these measures, it cannot be completely excluded that administration of medicines prepared from human blood or plasma may transmit infection, including from 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 also against non-enveloped hepatitis A virus (HAV). However, 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 certain types of anemia (e.g. sickle cell anemia or abnormal red blood cell breakdown).

Other medicines and Octanate
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use, including those available without prescription.
No interactions between human factor VIII and other medicinal products are known. However, Octanate should not be mixed with other medicines during infusion.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning a pregnancy, consult your 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 250 IU vial:
less than 1 mmol sodium (23 mg) (main component of table salt) per vial, which may be considered "sodium-free"
For one 500 IU and 1000 IU vial:
up to 40 mg 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 necessary.
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, the patient's
plasma factor VIII activity should be determined. This will allow determination of how much the
activity needs to 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) x required increase in factor VIII activity
(%) (IU/dl) x 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 (as % 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.
The 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
In clinical studies, no special dosing requirements were observed 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 product after the expiry date stated on the label.
• Aseptic conditions must be maintained during the procedure described below!
• Before administration, visually inspect the prepared solution for particulate matter or discoloration.
• The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or contain particulate matter.
• The prepared solution should be used immediately to avoid microbiological contamination.
• Use only the provided infusion set. Use of 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 the 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-impregnated 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 invert it. Place the blue part of the transfer set onto the top of the solvent vial and press down 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 down 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 swirl the powder vial until the product is completely dissolved. Dissolution is completed in less than 10 minutes at room temperature. Slight foaming may occur 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, pulse rate should be monitored before and during the infusion. In case of a significant increase in pulse rate, reduce the infusion rate or temporarily interrupt administration.

1. Attach the syringe to the white part of the transfer set. Invert the vial and draw the solution into the syringe (Fig. 6). The solution should be clear or slightly opalescent. After transferring the solution, firmly hold the syringe plunger (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-impregnated 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 of the product 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 compensate 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 not everybody will get them.
Although rare (may occur in 1 out of 1000 people), hypersensitivity or allergic reactions have been observed in patients treated with products containing factor VIII.
Contact your doctor immediately if any of the following symptoms occur:
vomiting, burning and stinging pain at the infusion site, chest tightness, chills, tachycardia, nausea, tingling sensation, redness, headache, urticaria, drop in blood pressure, rash, restlessness, swelling of the face, lips, mouth, 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 and part or all of the symptoms described above. In such a case, seek immediate medical attention or call emergency services.
Other rare adverse reactions (may occur in 1 out of 1000 people):
Fever
In children who have not previously been treated with factor VIII-containing medicines, inhibitory antibodies (see section 2) may develop very commonly (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 medication may no longer work 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 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, 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 the medicine.

5. How to store Octanate

Keep the medicine out of the 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 month stated.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Keep 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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 and may also occur in a caked form.
The solvent is a clear, colourless liquid.
Three pack sizes are available, differing in the amount 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 with 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 more detailed 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