Vihuma - patient leaflet, side effects, dosage

- If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

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

• 3. How to use Vihuma

• 4. Possible side effects

• 5. How to store Vihuma

• 6. Contents of the pack and other information

1. What Vihuma is and what it is used for

Vihuma contains the active substance human recombinant coagulation factor VIII (also called simoctocog alfa). Factor VIII is necessary for the blood to form clots and stop bleeding. In patients with haemophilia A (inborn factor VIII deficiency), factor VIII is missing or does not work properly. Vihuma replaces the missing factor VIII so the blood can clot normally, and can be used in all age groups to treat and prevent bleeding in patients with haemophilia A.

2. What you need to know before you use Vihuma

Do not use Vihuma

• if you are allergic to the active substance simoctocog alfa or any of the other ingredients of this medicine (listed in section 6).

If you are unsure about this, ask your doctor.

Warnings and precautions

Talk to your doctor before using Vihuma.

There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to Vihuma. You should be aware of the early signs of allergic reactions as they are listed in section 4 “Allergic reactions”.

If any of these symptoms occur, stop the injection immediately and contact 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 controlled with Vihuma, tell your doctor immediately.

Cardiovascular events

In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular ris­k.

Catheter-related complications

If you require a central venous access device (CVAD), risk of CVAD-related complications including local infections, presence of bacteria in the blood and catheter site thrombosis should be considered.

Traceability

It is important to keep a record of the batch number of your Vihuma.

So, every time you get a new package of Vihuma, note down the date and the batch number (which is on the packaging after {Lot} and keep this information in a safe place.

Other medicines and Vihuma

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

Pregnancy and breast-feeding

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

Driving and using machines

Vihuma has no influence on your ability to drive and use machines.

Vihuma contains sodium

This medicine contains 18.4 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 0.92 % of the recommended maximum daily dietary intake of sodium for an adult.

3. How to use Vihuma

Treatment with Vihuma will be started by a doctor who is experienced in the care of patients with haemophilia A. Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor or nurse if you are not sure.

Vihuma is usually injected into a vein (intravenously) by your doctor or a nurse. You or someone else might also give your Vihuma injection, but only after receiving adequate training.

Your doctor will calculate your dose of Vihuma (in international units = IU) depending on your clinical condition and body weight, and on whether it is used for prevention or treatment of bleeding. How often you need an injection will depend on how well Vihuma works for you. Usually, treatment for haemophilia A is a life-long treatment.

Prevention of bleeding

The usual dose of Vihuma is 20 to 40 IU per kg body weight, given every 2 to 3 days. However, in some cases, especially in younger patients, more frequent injections or higher doses may be necessary.

Treatment of bleeding

The dose of Vihuma is calculated depending on your body weight and the factor VIII levels to be achieved. The target factor VIII levels will depend on the severity and location of the bleeding.

If you have the impression that Vihuma is not working well enough, talk to your doctor. Your doctor will carry out laboratory tests to make sure that you have adequate factor VIII levels. This is particularly important if you are having major surgery.

Patients developing factor VIII inhibitors

If your factor VIII fails to reach expected levels with Vihuma, or if bleeding is not adequately controlled, it could be due to the development of factor VIII inhibitors. This will be checked by your doctor. You might need a higher dose of Vihuma or a different product to control bleeding. Do not increase the total dose of Vihuma to control your bleeding without consulting your doctor.

Use in children and adolescents

The way Vihuma is used in children and adolescents does not differ from the way it is used in adults. Because factor VIII products may have to be given more often in children and adolescents, a central venous access device (CVAD) may need to be fitted. A CVAD is an external connector that allows medicines to be given into the bloodstream without injection through the skin.

If you use more Vihuma than you should

No symptoms of overdose have been reported. If you have injected more Vihuma than you should, please inform your doctor.

If you forget to use Vihuma

Do not take a double dose to make up for a forgotten dose. Proceed with the next dose immediately and continue as advised by your doctor.

If you stop using Vihuma

Do not stop using Vihuma without consulting your doctor.

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

4. Possible side effects

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

Please stop using this medicine immediately and seek urgent medical advice if: – you notice symptoms of allergic reactions

Allergic reactions may include rash, hives, urticaria (itchy rash), including generalized urticaria, swelling of lips and tongue, shortness of breath, wheezing, tightness of the chest, vomiting, restlessness, low blood pressure, and dizziness. These symptoms can be early symptoms of an anaphylactic shock. If severe, sudden allergic reactions (anaphylactic) occur (very rare: may affect up to 1 in 10,000 people), the injection must be stopped immediately and you must contact your doctor right away. Severe symptoms require prompt emergency treatment.

• - you notice that the medicine stops working properly (bleeding is not stopped or becomes frequent)

For children and adolescents 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.

Common side effects may affect up to 1 in 10 people Hypersensitivi­ty, fever.

Uncommon side effects may affect up to 1 in 100 people

Tingling or numbness (paraesthesia), headache, vertigo, dry mouth, back pain, injection site inflammation, injection site pain, a vague feeling of bodily discomfort (malaise), haemorrhagic anaemia, non-neutralising antibody positive (in previously treated patients).

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Vihuma

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 carton and vial label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store vial in the original package in order to protect from light.

Before the Vihuma powder is made up into a solution, it may be kept at room temperature (up to 25°C) for a single period not exceeding 1 month. Record the date from when you start to store Vihuma at room temperature on the product carton. Do not store Vihuma in the refrigerator again after it has been stored at room temperature.

Use the solution immediately after making it up.

Do not use the medicine if you notice visible signs of deterioration of the tamper proof of packaging especially of the syringe and/or the vial.

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

6. Contents of the pack and other information

What Vihuma contains

Powder:

• – The active substance is recombinant human coagulation factor VIII (simoctocog alfa).

Each powder vial contains 250, 500, 1000, 2000, 2500, 3000 or 4000 IU of simoctocog alfa.

Each reconstituted solution contains approximately 100, 200, 400, 800, 1000, 1200 or 1600 IU/mL of simoctocog alfa.

• – The other ingredients are sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate and poloxamer 188. See section 2, “Vihuma contains sodium”.

Solvent:

Water for injections

What Vihuma looks like and contents of the pack

Vihuma is provided as powder and solvent for solution for injection. The powder is a white to off-white powder in a glass vial. The solvent is water for injections in a glass pre-filled syringe.

After reconstitution, the solution is clear, colourless and free from foreign particles.

Each pack of Vihuma contains:

• – 1 powder vial with 250, 500, 1000, 2000, 2500, 3000 or 4000 IU simoctocog alfa

• – 1 pre-filled syringe with 2.5 mL water for injections

• – 1 vial adapter

• – 1 butterfly needle

• – 2 alcohol swabs

Marketing Authorisation Holder and Manufacturer

Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Swe­den

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien Biotest AG (Germany) Tél/Tel: +49 6103 801–0	Lietuva Biotest AG (Germany) Tel: +49 6103 801–0
Etnrapua Biotest AG (Germany) Ten.: +49 6103 801–0	Luxembourg/Lu­xemburg Biotest AG (Germany) Tél/Tel: +49 6103 801–0
Česká republika Biotest AG (Germany) Tel: +49 6103 801–0	Magyarország Biotest AG (Germany) Tel: +49 6103 801–0
Danmark Biotest AG (Germany) Tlf: +49 6103 801–0	Malta Biotest AG (Germany) Tel: +49 6103 801–0
Deutschland Biotest AG (Germany) Tel: +49 6103 801–0	Nederland Biotest AG (Germany) Tel: +49 6103 801–0
Eesti Biotest AG (Germany) Tel: +49 6103 801–0	Norge Biotest AG (Germany) Tlf: +49 6103 801–0
EMáSa Biotest AG (Germany) Tql: +49 6103 801–0	Österreich Biotest Austria GmbH Tel: +43 1 545 15 61–0
España Biotest AG (Germany) Tel: +49 6103 801–0	Polska Biotest AG (Germany) Tel: +49 6103 801–0
France Biotest AG (Germany) Tél: +49 6103 801–0	Portugal Biotest AG (Germany) Tel: +49 6103 801–0
Hrvatska Biotest AG (Germany) Tél: +49 6103 801–0	Romania Biotest AG (Germany) Tel: +49 6103 801–0
Ireland Biotest AG (Germany) Tel: +49 6103 801–0	Slovenija Biotest AG (Germany) Tel: +49 6103 801–0
Ísland Biotest AG (Germany)	Slovenská republika Biotest AG (Germany)

Srni: +49 6103 801–0	Tel: +49 6103 801–0
Italia Biotest AG (Germany) Tel: +49 6103 801–0	Suomi/Finland Biotest AG (Germany) Puh/Tel: +49 6103 801–0
Kvnpog Biotest AG (Germany) Tql: +49 6103 801–0	Sverige Biotest AG (Germany) Tel: +49 6103 801–0
Latvija Biotest AG (Germany) Tel: +49 6103 801–0	United Kingdom (Northern Ireland) Biotest AG (Germany) Tel: +49 6103 801–0

This leaflet was last revised in

Detailed information on this medicine is available on the web site of the European Medicines Agency:

The following information is intended for healthcare professionals only:

On-demand treatment

The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.

In the case of the following haemorrhagic events, factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dL) in the corresponding period. The following table can be used to guide dosing in bleeding episodes and surgery.

Degree of haemorrhage/ Type of surgical procedure	Factor VIII level required (%) (IU/dL)	Frequency of doses (hours)/ Duration of therapy (days)
Haemorrhage
Early haemarthrosis, muscle bleeding or oral bleeding	20–40	Repeat every 12 to 24 hours. At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
More extensive haemarthrosis, muscle bleeding or haematoma	30–60	Repeat infusion every 12 to 24 hours for 3 to 4 days or more until pain and acute disability are resolved.
Life threatening haemorrhages	60–100	Repeat infusion every 8 to 24 hours until threat is resolved.
Surgery
Minor surgery including tooth extraction	30–60	Every 24 hours, at least 1 day, until healing is achieved.
Major surgery	80–100 (pre- and postoperative)	Repeat infusion every 8–24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL).

• 6. Peel back the paper cover from the pre-filled syringe package. Hold the plunger rod at the end and do not touch the shaft. Screw the threaded end of the plunger rod into the solvent syringe plunger by turning the plunger rod clockwise until a slight resistance is felt.

• 7. Break off the tamper-proof plastic tip from the other end of the solvent syringe by snapping the perforation of the cap. Do not touch the inside of the cap or the syringe tip.

• 8. Remove the adapter packaging from the top of the vial and discard.

• 9. Firmly connect the solvent syringe to the vial adapter by turning clockwise until resistance is felt.

  
  

• 10. Slowly inject all solvent into the powder vial by pressing down the plunger rod.

• 11. Without removing the syringe, gently move or swirl the vial in circles a few times to dissolve the powder. Do not shake. Wait until all the powder dissolves completely.

• 12. Inspect the final solution for particles before administration. The solution should be clear and colourless, practically free from visible particles. Do not use solutions that are cloudy or have deposits.

• 13. Turn the vial attached to the syringe upside down, and slowly draw the final solution into the syringe. Make sure that the entire content of the vial is transferred to the syringe.

  
  

• 14. Detach the filled syringe from the vial adapter by turning the vial counter clockwise and discard the empty vial.

• 15. The solution is now ready and should be used right away. Do not refrigerate.

• 16. Clean the chosen injection site with one of the provided alcohol swabs.

• 17. Attach the provided infusion set to the syringe.

Insert the needle of the infusion set into the chosen vein as you have been taught. If you have used a tourniquet to make the vein easier to see, this tourniquet should be released before you start injecting the solution.

Do not allow any blood to flow back into the syringe, or it may clot and clog the syringe, preventing you from injecting the right dose.

• 18. Inject the solution into the vein at a slow speed, not faster than 4 mL per minute.