Qalsody – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Qalsody, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you are given 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, pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Qalsody is and what it is used for
Qalsody contains the active substance tofersen which belongs to a group of medicines known as antisense oligonucleotides.
This medicine is used in adults to treat a type of amyotrophic lateral sclerosis (ALS) caused by mutations (changes) in a gene called SOD1 .
ALS caused by mutations in the SOD1 gene is a rare type of motor neuron disease that affects the nerve cells in the brain and spinal cord. Mutations in the SOD1 gene cause a build -up of a toxic form of the SOD1 protein. This causes destruction of motor neurons (the nerve cells responsible for sending instructions to the muscle) , leading to weakness and wasting in the muscles, including those used for breathing and swallowing.
Qalsody works by reducing the build- up of SOD1 protein. This helps to prevent the destruction of motor neurons and may slow the loss of muscle strength.
⚠️ 2. What you need to know before you are given Qalsody
Qalsody must not be given
- if you are allergic to tofersen or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor or nurse before you start treatment if this applies to you.
Warnings and precautions
There is a risk of side effects occurring after Qalsody is given by lumbar puncture procedure (see section 3). This can include headaches, back pain and infection.
24 There have been a small number of reports of patients developing inflammation of the spinal cord (myelitis ) or irritation or injury to the nerve roots ( radiculitis ) after Qalsody is given. You need to know about the symptoms of this while you are on this medicine . See Serious side effects in section 4 of this leaflet.
There have been a small number of reports of patients developing s welling of the optic nerve in the eye ( papill oedema ) and/or an increase in the pressure around the brain (increased intracranial presure) in patients treated with Qalsody. S ee Serious side effects in section 4 of this leaflet.
Tests before treatment You may have a urine test (to check your kidneys) and a blood test (to check that your blood clots properly) before you start treatment. This is because other medicines in the same group as Qalsody can affect the kidneys and the cells in the blood which help clotting. These tests may not be needed every time you are give n Qalsody.
Children and adolescents
This medicine should not be given to children and adolescents under 18 years of age. T he use of this medicine in patients under age of 18 has not been studied .
Other medicines and Qalsody
Tell your doctor if you are taking, have recently taken or might take 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 you are given this medicine.
Pregnancy
Qalsody is not recommended to be used during pregnancy and in women of childbearing potential not using contraception.
Breast -feeding Your doctor will help you to decide whether you should continue breast -feeding or to start treatment with Qalsody. Your doctor will consider the possible benefits of treatment for you compared with the benefits of breast -feeding for your baby.
Driving and using machines
This medicine may affect your ability to drive or use machines.
Do not drive or use machines if you notice a change in your vision with Qalsody.
Qalsody contains sodium
This medicine contains 52 mg sodium (main component of cooking/table salt) in each 15 ml. This is equivalent to 3% of the recommended maximum daily dietary intake of sodium for an adult.
Qalsody contains potassium
This medicine contains less than 1 mmol (39 mg) potassium per 15 ml dose, i.e. essentially ‘potassium -free’.
💊 3. How Qalsody is given
The recommended dose is 100 mg tofersen . The first three doses will be given at 14- day intervals on day 1, day 15 and day 29 of treatment. Qalsody will then be given every 28 days .
25 This medicine is given by intrathecal (into the fluid surrounding the spinal cord) injection into the lower back by a lumbar puncture. This is done by inserting a needle into the space around the spinal cord. This will be done by a doctor experienced in doing lumbar punctures.
How long Qalsody is used for Your doctor will discuss with you how long you will need to receive Q alsody . Do not stop treatment with Qalsody without talking to your doctor.
If you miss a Qalsody injection If you miss a dose o f Qalsody , speak to your doctor so that it can be given as soon as possible .
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects related to the lumbar puncture may occur while Qalsody is being given or afterwards. The side effects can include headache, back pain and infection.
Serious side effects
The most serious side effects seen in patients receiving Qalsody have been i nflammation of the spinal cord ( myelitis ) or irritation and injury of nerve roots ( radiculitis ). Common symptoms may include :
- weakness
- numbness
- abnormal sensations (pins and needles)
- pain.
Swelling of the nerve that connects the eyes with the brain ( papilloedema) and increased pressure around your brain (increased intracranial pressure) ha ve also been reported. Papilloedema can result from increased intracranial pressure. C ommon symptoms may include :
- blurred vision
- double vision
- vision loss
- headache.
Inflammation of the lining around the brain and spinal cord ( aseptic or chemical meningitis ) has been reported. This is not caused by an infection. Common symptoms may include:
- headache
- fever
- neck stiffness
- nausea
- vomiting.
Tell your doctor immediately, if you have any of the symptoms listed above.
Other side effects
Very common (may affect more than 1 in 10 people )
- pain (back pain, pain in arms or legs)
- feeling tired
- muscle and joint pain
- fever
- increase in protein and/or white blood cell count occurring in the fluid that surrounds the brain and spinal cord.
26 Common (may affect up to 1 in 10 people )
- muscle stiffness
- nerve pain , includ ing burning, stabbing, pins and needles sensations.
Tell your doctor if you notice these or any new symptoms that concern you.
Reporting of side effects
If you get any side effects, talk to your doctor , pharmacist or nurse . 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 Qalsody
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 after EXP . The expiry date refers to the last day of that month.
Do not use this medicine if you notice particles in the solution or if the liquid in the vial is not clear and colourless .
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
The vial of Qalsody in its original carton can be stored for up to 14 days at room temperature ( store below 30°C ).
Unopened vials of Qalsody can be removed from and returned to the refrigerator, if necessary.
Unopened vials can be removed from the original carton for not more than 6 hours per day at room temperature for a maximum of 6 days .
📦 6. Contents of the pack and other information
What Qalsody contains
- The active substance is tofersen
- Each 15 ml vial contains 100 mg of tofersen.
- Each ml contains 6.7 mg of tofersen.
- The other ingredients are disodium phosphate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium chloride, sodium dihydrogen phosphate dihydrate, water for injections.
What Qalsody looks like and contents of the pack
Qalsody is a clear , colourless to slightly yellow solution for injection.
Each carton of Q alsody contains one vial.
Marketing Authorisation Holder and Manufacturer
Biogen Netherlands B.V.
Prins Mauritslaan 13 1171 LP Badhoevedorp The Netherlands 27 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Biogen Belgium NV/SA Tél/Tel: + 32 2 2191218 Lietuva Biogen Lithuania UAB Tel: + 370 5 259 6176 България ТП ЕВОФАРМА Teл.: +359 2 962 12 00 Luxembourg/Luxemburg Biogen Belgium NV/SA Tél/Tel: + 32 2 2191218 Česká republika Biogen (Czech Republic) s.r.o.
Tel: + 420 255 706 200 Magyarország Biogen Hungary Kft.
Tel.: + 36 1 899 9883 Danmark Biogen (Denmark) A/S Tlf: + 45 77 41 57 57 Malta Pharma. MT Ltd.
Tel: + 356 21337008 Deutschland Biogen GmbH Tel: + 49 (0) 89 99 6170 Nederland Biogen Netherlands B.V.
Tel: + 31 20 542 2000 Eesti Biogen Estonia OÜ Tel: + 372 618 9551 Norge Biogen Norway AS Tlf: + 47 23 40 01 00 Ελλάδα Genesis Pharma SA Τηλ: + 30 210 8771500 Österreich Biogen Austria GmbH Tel: + 43 1 484 46 13 España Biogen Spain, S.L.
Tel: + 34 91 310 7110 Polska Biogen Poland Sp. z o.o.
Tel.: + 48 22 351 51 00 France Biogen France SAS Tél: + 33 (0)1 41 37 95 95 Portugal Biogen Portugal Sociedade Farmacêutica, Unipessoal, Lda.
Tel: + 351 21 318 8450 Hrvatska Biogen Pharma d.o.o.
Tel: + 385 (0) 1 775 73 22 Ireland Biogen Idec (Ireland) Ltd.
Tel: + 353 (0)1 463 7799 România Ewopharma România SRL Tel: + 40 (0)21 260 13 44 Slovenija Biogen Pharma d.o.o.
Tel: + 386 1 511 02 90 Ísland Icepharma hf Sími: + 354 540 8000 Slovenská republika Biogen Slovakia s.r.o.
Tel: + 421 2 323 340 08 Italia Biogen Italia s.r.l.
Tel: + 39 02 5849901 Suomi/Finland Biogen Finland Oy Puh/Tel: + 358 207 401 200 28 Κύπρος Genesis Pharma Cyprus Ltd Τηλ: + 357 22765715 Sverige Biogen Sweden AB Tel: + 46 8 594 113 60 Latvija Biogen Latvia SIA Tel: + 371 68 688 158 This medicine has been authorised under ‘exceptional circumstances’. This means that because of the rarity of this disease it has been impossible to get complete information on this medicine. The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
This leaflet was last revised in .
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Qalsody (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/23/1783).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.