InfoCons Consumer Protection informs you – Joenja – Package Leaflet

Before anything else

Read all of this leaflet carefully before you or your child start taking 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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Joenja is and what it is used for

Joenja contains the active substance leniolisib, which belongs to a group of medicines called immunostimulants (medicines that increase the ability of the immune system, the body’s natural defences, to fight infection and disease) .

Joenja is used in adult s and adolescents aged 12 years and older, and who weigh 45 kg or more, to treat activated phosphoinositide 3- kinase delta syndrome (APDS) . In people with APDS, the immune system does not work properly, leaving them unable to fight infections.

The active substance in Joenja, leniolisib, blocks the activation of a protein known as phosphoinositide 3-kinase delta (PI3Kδ), which is involved in regulating the immune system. In people with APDS there is excessive activity of PI3Kδ. By blocking the excessive activity of PI3Kδ, leniolisib helps to normalise the immune system, thereby potentially slowing down disease progression.

⚠️ 2. What you need to know before you take Joenja

Do not take Joenja

• if you are allergic to leniolisib or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information” )

Warnings and precautions

Tell your doctor right away if you become ill while taking Joenja.

Serious and sometimes fatal infections, severe skin reactions (rash, itching, peeling of the skin) , breathing difficulties , severe diarrhoea or colitis (inflammation of the intestines) , and liver problems have occurred in patients receiving other PI3K δ inhibitors for the treatment of conditions other than APDS . These serious events were not reported in the Joenja clinical trials .

Children and adolescents

Do not give Joenja to children under 12 years or below the weight of 45 kg because it has not been studied in this age group.

Other medicines and Joenja

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor or pharmacist if you are taking any of the following medicines as they should not be taken with Joenja:

The following medicines may increase the risk of side effects with Joenja by increasing the levels of Joenja in the blood:

• cobicistat, elvitegravir, indinavir, lopinavir, ritonavir, saquinavir, tipranavir – used to treat human immunodeficiency virus (HIV) infection
• curcumin – an herbal medicine for inflammation
• cyclosporine – used to treat organ rejection post -transplant
• danoprevir, ombitasvir, paritaprevir – used to treat hepatitis C (HCV)
• itraconazole, ketoconazole, posaconazole, voriconazole – used to treat fungal infections
• telithromycin, troleandomycin – used to treat bacterial infections The following medicines may decrease how well Joenja works by decreasing the amount of Joenja in the blood:
• antacid (aluminium- , magnesium -, and calcium -based antacids, sodium bicarbonate ) – for heartburn or indigestion due to excess stomach acid (see section 3, “How to take Joenja” )
• avasimibe – used to treat build -up of cholesterol plaque in the arteries
• bosentan – used to treat pulmonary artery hypertension (PAH)
• carbamazepine, phenobarbital, phenytoin – used to treat epilepsy
• efavirenz, etravirine – used to treat human immunodeficiency virus (HIV) infection
• mitotane – cancer therapy
• modafinil – for the treatment of excessive daytime sleepiness (narcolepsy)
• nafcillin, rifabutin, rifampicin – for bacterial infections
• St. John’s Wort (Hypericum perforatum) – an herbal medicine for depression and sleep problems Joenja may increase the risk of side effects of the following medicines by increasing the amount of these medicines in the blood :
• adefovir –used to treat hepatitis B (HBV)
• baricitinib – used to treat rheumatoid arthritis
• benzylpenicillin (penicillin G), cefaclor, ceftizoxime, ciprofloxacin – for bacterial infections
• bumetanide, furosemide – used to rid your body of salt (sodium) and water
• famotidine – used to prevent and treat heartburn or indigestion due to excess stomach acid
• irinotecan – for treatment of colon or rectal cancer
• letermovir – to prevent cytomegalovirus (CMV) infection
• methotrexate – cancer therapy
• oseltamivir carboxylate – used to treat the influenza virus
• rosuvastatin, pitavastatin – for lowering cholesterol 26 • tenofovir – used to treat HBV and HIV If you are not sure if the above applies to you, ask your doctor.

Pregnancy, breast -feeding and fertility If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advi ce before taking this medicine.

Your doctor will do a test to see if you are pregnant before beginning treatment with Joenja.

Pregnancy

Joenja is not recommended during pregnancy. Animal studies suggest that this medicine may cause harm to your unborn baby. There is no information about the safety of this medicine in pregnant women.

Joenja is not recommended f or women who could become pregnant, unless they are using highly effective methods of contraception during treatment , and for at least 1 week after the last dose of Joenja. Ask your doctor about suitable methods of contraception.

If you think you may be pregnant after starting treatment with Joenja, tell your doctor immediately.

Breast -feeding Do not breast -feed while taking Joenja. If you are breast -feeding or are planning to breast -feed, tell your doctor before taking this medicine. This is because it is not known if Joenja can pass into your breast milk or if this would affect your baby.

Fertility

No human data on the effect of leniolisib on fertility are available. Animal studies suggest a possible risk of Joenja affecting male fertility. Tell your doctor before taking this medicine.

Driving and using machines

This medicine has no or negligible influence on your ability to drive or use machines.

Joenja contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Joenja contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film -coated tablet, that is to say essentially ‘sodium -free’.

💊 3. How to take Joenja

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

The recommended dose is One 70 mg tablet twice daily, approximately 12 hours apart in adult and adolescent patients from 12 years or older who weigh more than 45 kg.

If vomiting occurs within 1 hour after taking the tablet, take another tablet right away. If you vomit more than 1 hour after taking the tablet, wait and take the next dose at your usual scheduled time.

Joenja is for oral use. This medicine can be taken with or without meals . The tablets should be swallowed whole. Do not split, crush, or chew the tablets.

27 Take antacids 2 hours before or 2 hours after taking Joenja. Joenja may interact with other medicines (see section 2, “Other medicines and Joenja”).

If you take more Joenja than you should

Contact your doctor or nearest emergency department immediately for advice if this occurs. Keep the bottle and this leaflet with you so that you can easily describe what you have taken.

If you forget to take Joenja

If you forget to take Joenja at your usual time, take the tablet as soon as you remember. Do not take a tablet if you miss a dose by more than 6 hours. W ait and take the next dose at your usual scheduled time. Do not take a double dose to make up for a missed dose.

If you stop taking Joenja

Do not stop taking this medicine unless your doctor tells you to.

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

❗ 4. Possible side effects

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

Side effects may occur with following frequencies:

Very common (may affect more than 1 in 10 people)

• headache
• vomiting
• hair loss
• increased weight
• decrease in levels of neutrophils, a type of white blood cell

Common (may affect up to 1 in 10 people)

• dyspepsia (indigestion)
• rash
• atopic dermatitis (itchy, red, and dry skin in people prone to allergies)
• tiredness

Not known (frequency cannot be estimated from the available data)

• allergic reaction ( hypersensitivity) including itching, skin redness, hives, rash, difficulty breathing or swallowing

Additional side effects in adolescents

Side effects were similar between adolescent and adult patients in the clinical trials of Joenja.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Joenja

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 bottle after EXP. The expiry date refers to the last day of that month.

28 This medicinal product does not require any special storage conditions.

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 Joenja contains

• The active substance is leniolisib. Each film -coated tablet contains leniolisib phosphate equivalent to 70 mg leniolisib.
• The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), hypromellose (E464), sodium starch glycolate (Type A), magnesium stearate (E572), c olloidal anhydrous silica (E551), titanium dioxide (E171), iron oxide monohydrate yellow (E172), iron oxide red

(E172), talc (E553b), polyethylene glycol (E1521) (see section 2 “Joenja contains lactose and sodium” ).

What Joenja looks like and contents of the pack

Joenja 70 mg film- coated tablets are yellow, oval -shaped, biconvex, bevelled edge film -coated tablets, debossed with “70” on one side and “LNB” on the other side.

Each pack contains 1 bottle with 60 tablets.

Marketing Authorisation Holder and Manufacturer

Pharming Technologies B.V.

Darwinweg 24 2333 CR Leiden The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 Lietuva Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 България Pharming Technologies B.V.

Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 Luxembourg/Luxemburg Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 Česká republika Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 Magyarország Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 Danmark Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden Malta Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden 29 The Netherlands Tel: +31 (0)71 5247 400 The Netherlands Tel: +31 (0)71 5247 400 Deutschland Pharming Technologies B.V.

Darwinweg 24 2333 CR Leiden The Netherlands Tel: + 49 (0)157 359 907 28 Nederland Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 Eesti Pharming Technologies B.V.

Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 Norge Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 Ελλάδα Pharming Technologies B.V.

Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 Österreich Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 España Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: + 34 (0)900 75 13 23 Polska Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 France Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: + 33 (0)805 98 79 70 Portugal Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 Hrvatska Pharming Technologies B.V.

Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 Ireland Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 România Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 Slovenija Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 Ísland Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Slovenská republika Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands 30 Tel: +31 (0)71 5247 400 Tel: +31 (0)71 5247 400 Italia Pharming Technologies B.V.

Darwinweg 24 2333 CR Leiden The Netherlands Tel: + 39 (0)800 14 39 68 Suomi/Finland Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 Κύπρος Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 Sverige Pharming Technologies B.V. Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400 Latvija Pharming Technologies B.V.

Darwinweg 24 2333 CR Leiden The Netherlands Tel: +31 (0)71 5247 400

This leaflet was last revised in

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.

Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: 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 Joenja (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/26/2034).

⚠️ 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.