Octanate Lv

Package Leaflet: Information for the User

Octanate LV, 100 IU/ml, powder and solvent for solution for injection

Human coagulation factor VIII Octanate LV, 200 IU/ml, powder and solvent for solution for injection

Human coagulation factor VIII

You should read the leaflet carefully before using the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Contents of the pack:

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

1. What Octanate LV is and what it is used for

Octanate LV 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 LV is used to treat and prevent bleeding in patients with hemophilia A. This is a condition where bleeding is prolonged compared to what is expected. It results from a congenital deficiency of factor VIII in the blood.

2. Before you use Octanate LV

It is strongly recommended that every time you administer a dose of Octanate LV to a patient, you record the name and batch number of the product in order to keep track of the batch used. Your doctor may recommend considering vaccination against viral hepatitis A and B if you regularly or repeatedly receive human factor VIII products.

When not to use Octanate LV

if you are allergic to human coagulation factor VIII or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Octanate LV, you should consult your doctor, pharmacist, or nurse. Octanate LV contains small amounts of other human proteins. Any medicine that contains proteins and is administered intravenously (into a vein) can cause allergic reactions (see section 4. Possible side effects). 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, can disrupt proper treatment, and you will be closely monitored for the development of these inhibitors. If bleeding in you is not properly controlled with Octanate LV, you should immediately tell your doctor.

Information about blood and plasma used to manufacture Octanate LV

When manufacturing medicines from human blood or plasma, certain measures are taken to prevent the transmission of infections to patients. These include careful selection of blood and plasma donors to ensure that donors who may be carriers of infections are excluded, as well as testing all donated samples and plasma pools for the presence of viruses/infections. The manufacturers of these products have implemented steps in the blood or plasma processing procedure to inactivate or remove viruses. Despite these measures, when administering medicines prepared from human blood or plasma, it cannot be completely excluded that the 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), and hepatitis C virus (HCV), as well as non-enveloped hepatitis A virus (HAV). The methods used may have limited effectiveness against non-enveloped viruses, such as parvovirus B19. Parvovirus B19 infection can be serious for pregnant women (fetal infection) and for individuals whose immune system is suppressed or who have certain types of anemia (e.g., sickle cell anemia or abnormal red blood cell breakdown).

Other medicines and Octanate LV

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription. No interactions between human factor VIII and other medicinal products are known. However, you should not mix Octanate LV with other medicines during infusion.

Pregnancy and breastfeeding

Before using any medicine, you should consult your doctor or pharmacist.

Driving and using machines

No effect on the ability to drive and use machines has been observed.

Octanate LV contains

up to 40 mg of sodium (the main component of common salt) per vial, which is 2% of the recommended maximum intake of 2 g of sodium for an adult.

3. How to use Octanate LV

Octanate LV should be administered intravenously after reconstitution with the provided solvent. Treatment should be initiated under medical supervision. Dosing for prophylaxis:For long-term prophylaxis of bleeding in patients with severe hemophilia A, factor VIII should be administered at a dose of 20 to 40 IU per kilogram of body weight at intervals of 2 to 3 days. The dose should be adjusted according to clinical response. In some cases, it may be necessary to administer the medicine at shorter intervals or in higher doses.

Dose calculation:

Octanate LV should always be used according to the doctor's recommendations. If you have any doubts, you should contact your doctor or pharmacist again. The activity of factor VIII in plasma corresponds to the factor VIII content in plasma. It is expressed either as a percentage (compared 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 in 1 ml of normal human plasma. 1 IU of factor VIII per kilogram of body weight increases the plasma factor VIII activity by 1.5% to 2% of normal activity. To calculate the required dose, you should determine the factor VIII activity in your plasma. This will allow you to determine how much the activity should be increased. You should consult your doctor if you are unsure how much the factor VIII activity in your plasma should be increased and how to calculate the required dose. The required dose is calculated using the following formula: required units = body weight (kg) x required increase in factor VIII activity (%) x 0.5. The amount to be administered and the frequency of administration of the product should always be adjusted according to the individual patient's clinical efficacy. In the following cases of bleeding, factor VIII activity should not fall below the specified level of plasma activity (as a percentage of normal values) during the specified period.

The dose and frequency of administration of Octanate LV will be determined by your doctor. The response to factor VIII may vary among individual patients. Therefore, during treatment, it is recommended to determine factor VIII levels to establish the appropriate dose and frequency of infusion.

Use in children

No special requirements for dosing in children have been found in clinical trials. Dosing is the same for adults and children, both for treatment and prophylaxis.

Home infusion instructions

• You should read all instructions and follow them carefully!
• Do not use the Octanate LV product after the expiration date stated on the label.
• During the procedure described below, you should maintain sterile conditions!
• Before administration, you should 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 prevent microbial contamination.
• Only use 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 directly after removing it from the refrigerator. Leave the solvent and powder in closed vials until they reach room temperature.
• 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. Place the blue part of the transfer set on top of the solvent vial and press firmly until it clicks (Fig. 2 + 3). Do not turn during connection.

Fig. 1
Fig. 3
Fig. 2

• 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 on top of the powder vial and press firmly until it clicks (Fig. 4). Do not turn during connection. 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 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 performing the injection:

As a precaution, you should check your pulse before and during injection. If you experience a significant increase in heart rate, you should reduce the injection rate or interrupt the administration of the medicine for a short time.

• 1. Connect 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, hold the syringe plunger firmly (with the syringe pointing downwards) and remove the syringe from the transfer set (Fig. 7).

Discard the empty powder vial along 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. Connect the provided infusion set to the syringe.
• 4. Insert the needle into the selected vein. If a tourniquet is used to make the vein visible, release the tourniquet before starting the injection of Octanate.

• 5. Blood must not enter the syringe due to the risk of forming fibrin clots.
• 6. Administer the solution slowly into the vein, no faster than 2-3 ml per minute. If using more than one powder vial of Octanate during a single administration, it is possible to reuse the same infusion set and syringe. The transfer set is for single use only.

Any unused product or waste material should be disposed of in accordance with local regulations.

Using more than the recommended dose of Octanate LV

No symptoms of overdose of human factor VIII have been observed. However, it is recommended not to exceed the recommended dose.

Missing a dose of Octanate LV

Do not use a double dose to make up for a missed dose. You should proceed to the next dose and continue dosing as recommended by your doctor or pharmacist. If you have any other questions about using this product, you should contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, Octanate LV can cause side effects, although not everybody gets them. Although they are rare(occurring in 1 to 10 out of 10,000 patients), allergic or hypersensitivity reactions have been observed in patients treated with factor VIII products. You should contact your doctor if you experience any of the following symptoms: nausea, burning sensation and stinging pain at the infusion site, feeling of pressure in the chest, chills, tachycardia, vomiting, tingling sensation, redness, headache, hives, low blood pressure, rash, restlessness, swelling of the face, lips, mouth, tongue, or throat, which may lead to difficulty swallowing or breathing (angioedema), fatigue (lethargy), wheezing. Very rarely(occurring in less than 1 out of 10,000 patients), hypersensitivity may lead to a life-threatening allergic reaction called anaphylaxis, which can include shock, as well as any of the above symptoms. In such a case, you should immediately contact your doctor or call emergency services. Other rare side effects (occurring in 1 to 10 out of 10,000 patients) include fever. In children who have not been previously treated with factor VIII medicines, inhibitory antibodies (see section 2) may develop very frequently (more than 1 in 10 patients). However, in patients who have been previously treated with factor VIII (more than 150 days of treatment), the risk is not very common (less than 1 in 100 patients). If this happens, the patient's medicines may stop working properly, and the patient may experience persistent bleeding. If this happens, you should immediately contact your doctor. Information related to viral safety, see section 2. (You should be particularly careful when using Octanate LV). Reporting of side effects If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Octanate LV

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

6. Contents of the pack and other information

What Octanate LV contains

The active substanceof the medicine is human coagulation factor VIII.

Volume and concentrations

The other ingredients are: For the powder: sodium citrate, sodium chloride, calcium chloride, glycine For the solvent: water for injections

What Octanate LV looks like and contents of the pack

Octanate LV is a powder and solvent for solution for injection. The powder is white or pale yellow and may be in the form of a cake. The solvent is a clear, colorless liquid. Two strengths of the medicinal product are available, differing in factor VIII content and solvent: 100 IU/ml powder and solvent 200 IU/ml powder and solvent

• Powder, 500 IU, in a vial with a rubber stopper and flip-off cap
• 5 ml solvent in a vial with a rubber stopper and flip-off cap
• 1 package with equipment for intravenous injection (1 transfer set, 1 infusion set, 1 disposable syringe)
• 2 alcohol swabs.

200 IU/ml powder and solvent

• Powder, 1,000 IU, in a vial with a rubber stopper and flip-off cap
• 5 ml solvent in a vial with a rubber stopper and flip-off cap
• 1 package with equipment for intravenous injection (1 transfer set, 1 infusion set, 1 disposable syringe)
• 2 alcohol swabs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Octapharma (IP) SPRL, Allée de la Recherche 65, 1070 Anderlecht, Belgium

Manufacturer

Octapharma Pharmazeutika Produktionsges.m.b.H, Oberlaaer Str. 235, 1100 Vienna, Austria Octapharma S.A.S, 72 rue du Maréchal Foch, 67380 Lingolsheim, France Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Sweden This medicinal product is authorised in the Member States of the European Economic Area under the following names: Octanate LV: Austria, Cyprus, Denmark, France, Netherlands, Malta, Poland, Romania, Spain, Sweden, United Kingdom Octafil LV: Finland Octanate: Belgium, Czech Republic, Germany, Ireland, Italy, Latvia, Lithuania, Luxembourg, Portugal Octanate Kons: Slovenia Date of last revision of the leaflet:26.03.2021