InfoCons Consumer Protection informs you – Ninlaro – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start taking th is 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.
• 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 , pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this le aflet 1. What NINLARO is and what it is used for 2. What you need to know before you take NINLARO 3. How to take NINLARO 4. Possible side effects 5. How to store NINLARO 6. Contents of the pack and other information

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

What NINLARO is NINLARO is a cancer medicine that contains ixazomib, a ‘proteasome inhibitor’.

NINLARO is used to treat a cancer of the bone marrow called multiple myeloma. Its active substance ixazomib works by blocking the action of proteasome s. These are structures inside the cell that digest proteins and are important for cell survival. Because myeloma cells produce a lot of proteins, blocking the action of proteasomes can kill the cancerous cells.

What NINLARO is used for

NINLARO is used to treat adults with multiple myeloma . NINLARO will be given to you together with lenalidomide and dexamethasone, which are other medicines used to treat multiple myeloma .

What multiple myeloma is Multiple myeloma is a cancer of the blood which affects a type of cell, called the plasma cell . A plasma cell is a blood cell that normally produces proteins to fight infections. People with multiple myeloma have cancerous plasma cells, also called myeloma cells , which can damage the bones.

Prote in produced by myeloma cells can damage the kidneys. Treatment for multiple myeloma involves killing myeloma cells and reduc ing the symptoms of the disease.

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

Do not take NINLARO

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

If you are uncertain whether the condition above appl ies to you, talk to your doctor, pharmacist or nurse before taking NINLARO.

43 Warnings and preca utions Talk to your doctor , pharmacist or nurse before taking or during treatment with NINLARO if:

• you have a history of bleeding
• you have persistent nausea, vomiting or diarrhoea
• you have a history of nerve problems, to include tingling and numbness
• you have a history of swelling
• you have a persistent rash or a severe skin rash with skin peeling and mouth sores (Stevens Johnson syndrome or toxic epidermal necrolysis , see section 4)
• you have or have had liver or kidney problems as your dose ma y have to be adjusted
• you have or have had damage to the small est blood vessels known as thrombotic microangiopathy or thrombotic thrombocytopenic purpura. Tell your doctor if you develop fatigue, fever, bruising, bleeding, decreased urination, swelling, c onfusion, vision loss, and seizures .

Your doctor will examine you and you will be monitored closely during treatment. Before starting NINLARO and during treatment, you will have blood test s to check that you have enough blood cells.

Children and adolescents

NINLARO is not recommended for use in children and adolescents aged under 18 years.

Other medicines and NINLARO

Tell your doctor, pharmacist or nurse if you are taking, have recently ta ken or might take any other medicines. This includes any medicines obtained without a prescription, such as vitamins or herbal remedies. This is because other medicines can affect the way NINLARO works. In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines: carbamazepine, phenytoin, rifampicin and St. John’s wort (Hypericum perforatum ). These medicines should be avoided as they may reduce the effectiveness o f NINLARO.

Pregnancy and breast -feeding NINLARO is not recommended during pregnancy as it may harm your unborn baby. Breast -feeding should be stopped when taking NINLARO.

Avoid becoming pregnant or breast -feeding while being treated with NINLARO. If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are a woman of childbearing potential or a man who can father a child, you must use effective contraception during and for 90 days after treatment. Women using hormonal contraceptives should additionally use a barrier method of contraception. Tell d octor right away if you or your partner become s pregnant while receiving NINLARO.

As NINLARO is given in combination with lenalidomide, you should adhere to the pregnancy prevention programme of lenalidomide because lenalidomide can be harmful to the unbor n child.

See the package leaflet s for lenalidomide and dexameth asone for additional information on pregnancy and breast -feeding

Driving and using machines

NINLARO may affect your ability to drive or use machines. You may feel tired and dizzy while taking NINLARO. Do not drive or operate machines if you have these side effects.

💊 3. How to take NINLARO

NINLARO must be prescribed to you by a doctor with experience of treating multiple myeloma.

Always take this medicine exactly as your doctor or pharmacist has told you.

44 NINLARO is used with lenalidomide (a medicine which affects how your immune system works) and dexamethasone (an anti -inflammatory medicine).

NINLARO , lenalidomide and dexamethasone are taken in 4-week treatment cycles. NINLARO is taken once a week (on the same day of the week) for the first 3 weeks of this cycle. The recommended dose is one 4 mg capsule taken by mouth .

The recommended dose of l enalid omide is 25 mg taken every day for the first 3 weeks of the cycle.

The recommen ded dose of dexamethasone is 40 mg taken once a week o n the same day for all 4 weeks of the cycle.

You should read the Package Leaflets of these other medicines for further information on their use and effects.

If you have liver or kidney problems , your doctor may prescribe NINLARO capsules containing 3 mg.

If you have side effects, your doctor may prescribe NINLARO capsules containing 3 mg or 2.3 mg.

The doctor may also adjust the doses of the other medicines.

How and when to take NINLARO

• Take NINLARO at least one hour before or at least two hours after food.
• Swallow the capsule whole with water. Do not crush, chew or open the capsule.
• Do not let the contents of the capsule come into contact with your skin. I f the powder accidentally comes into contact with your skin, wash it off thoroughly with soap and water. If the capsule breaks, clean up the powder, taking care that it does not cause dust in the air.

If you take more NINLARO than you should

Accidental overdose can cause serious side effects. If you take more NINLARO than you should, talk to a doctor immediately or go to a hospital straight away. Take the medicine pack with you.

Duration of the treatment with NINLARO You should continue treatment until your doctor tells you to stop.

If you forget to take NINLARO

If a dose is missed or delayed , you should take the dose as long as the next scheduled dose is more than 3 days or 72 hours away. Do not take a missed dose if it is within 3 days or 72 hours of your next scheduled dose.

If you vomit after taking a dose, do not take an extra dose. Take the next dose, as normal, when it is due.

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

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Dosing schedule: NINLARO taken with lenalidomide and dexamethasone Take medicine 28-day cycle (a 4 -week cycle) Week 1 Week 2 Week 3 Week 4 Day 1 Days 2 to 7 Day 8 Days 9 to 14 Day 15 Days 16 to 21 Day 22 Days 23 to 28 NINLARO    Lenalidomide  Daily  Daily  Daily Dexamethasone     45 Stop using ixazomib and seek medical attention immediately if you notice any of the following symptoms:

• reddish non -elevated, target -like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu -like symptoms (S tevens -Johnson syndrome, toxic epidermal necrolysis, which may affect up to 1 in 1 000 people).

Tell your doctor or pharmacist straight away if you notice any of these following very common serious side effects which may affect more than 1 in 10 people:

• low platelet counts (thromboc ytopenia) which may increase the risk of nose bleeds and you may easily bruis e
• nausea, vomiting and diarrhoea
• numbness, tingling or burning of the hands or feet (peripheral neuropathy)
• swelling of the legs or feet (per ipheral oedema)
• skin rash that may be itchy and in a few areas or all over the body
• cough, chest soreness or pain, or nasal congestion (bronchitis) Additionally, tell a doctor immediately if you notice any of these following rare side effects which may affect up to 1 in 1 000 people:
• severe skin rashes such as red to purple bumps (Sweet’ s syndrome)
• muscle weakness, loss of feelings of the toes and feet or loss of leg movement (transverse myelitis)
• changes in vision, changes in mental status, or seizures (posterior reversible encephalopathy syndrome)
• rapid death of cancer cells that may cause dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances (tumour lysis syndrome)
• rare blood condition resulting fro m blood clots that may cause fatigue, fever, bruising, bleeding e.g. nose bleeds, decreased urination , swelling, confusion, vision loss, and seizures (thrombotic microangiopathy, thrombotic thrombocytopenic purpura)
• swelling of the face, lips, tongue or throat, trouble breathing or swallowing, wheezing, chest tightness or dizziness, skin itching and hives (angioedema or anaphylactic r eaction) Other possible side effects Tell your doctor or pharmacist i f any of the side effects below become severe.

Very common : may affect more than 1 in 10 people

• constipation
• back pain
• cold-like symptoms (upper respiratory tract infection)
• feeling tired or weak (fatigue)
• fever (pyrexia)
• joint pain (arthralgia)
• lowered white blood cells called neutrophils (neutropenia) that may increase the risk of infection
• not feeling like eating (decreased appetite)
• irregular heart rate (arrhythmia)
• vision conditions including blurred vision, dry eye and pink eye (conjunctivitis)

Common : may affect up to 1 in 10 people

• reactivation of the chicken pox virus (shingles) that can cause a skin rash and pain (herpes zoster)
• lowered blood press ure (hypotension)
• shortness of breath or persistent coughing or wheezing (heart failure)
• yellow discoloration of eyes and skin (jaundice which could be a symptom of liver impairment)
• low levels of potassium in the blood (hypokalaemia)

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 NINLARO

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 blister, wallet and carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30 °C. Do not freez e.

Store in the original packag e in order to protect from moisture .

Do not remove the capsule until you need to take a dose .

Do not use this medicine if you notice any damage or signs of tampering to medicine packaging.

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 NINLARO contains

NINLARO 2.3 mg hard capsule:

• The active substance is ixazomib. Each capsule contains 2.3 mg of ixazomib (as 3.3 mg of ixazomib citrate) .
• The o ther ingredients are:
• In the capsule: microcrystalline cellulose, magnesium stearate and talc.
• The capsule shell contains: gelatin, titanium dioxide (E171) and red iron oxide (E172)
• The printing ink contains: shellac, propylene glycol, potassium hydroxide, and black iron oxide ( E172).

NINLARO 3 mg hard capsule:

• The active substance is ixazomib. Each capsule contains 3 mg of ixazomib (as 4.3 mg of ixazomib citrate) .
• The o ther ingredients are:
• In the capsule: microcrystalline cellulose, magnesium stearate and talc.
• The capsule shell contains: gelatin, titanium dioxide (E171) and black iron oxide (E172)
• The printing in k contains: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

NINLARO 4 mg hard capsule:

• The active substance is ixazomib. Each capsule contains 4 mg of ixazomib (as 5.7 mg of ixazomib citrate).
• The o ther ingredients are:
• In the capsule: microcrystalline cellulose, magnesium stearate and talc.
• The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172) 47 • The printing ink contains: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

What NINLARO looks like and contents of the pack

NINLARO 2.3 mg hard capsule: Light pink, size 4, mark ed “Takeda” on the cap and “2.3 mg” on the body with black ink.

NINLARO 3 mg hard capsule: Light grey, size 4, marked “Takeda” on the cap and “3 mg” on the body with black ink.

NINLARO 4 mg hard capsule: Light orange, size 3, marked “Takeda” on the cap and “4 mg” on the body with black ink.

Each pack contains 3 hard capsules ( Three blister s sealed within the blister strip inside a wallet. E ach blister contain s one capsule ).

Mar keting Authorisation Holder Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark

Manufacturer

Takeda Ireland Limited Grange Castle Business Park Nangor Road Dublin 22 D22 XR57 Ireland Takeda GmbH Takeda (Werk Singen) Robert Bosch Strasse 8 78224 Singen Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Takeda Belgium NV Tél/Tel : +32 2 464 06 11 [email protected] Lietuva Takeda, UAB Tel: +370 521 09 070 [email protected] България Такеда България ЕООД Тел.: + 359 2 958 27 36 [email protected] Luxembourg/Luxemburg Takeda Belgium NV Tél/Tel : +32 2 464 06 11 [email protected] Česká republika Takeda Pharmaceuticals Czech Republic s.r.o.

Tel: +420 234 722 722 [email protected] Magyarország Takeda Pharma Kft.

Tel.: +36 1 270 7030 [email protected] 48 Danmark Takeda Pharma A/S Tlf.: +45 46 77 1 0 10 [email protected] Malta Drugsales Ltd Tel: +356 21419070 [email protected] Deutschland Takeda GmbH Tel: +49 ( 0)800 825 3325 [email protected] Nederland Takeda Nederland B.V.

Tel: +31 20 203 5492 [email protected] Eesti Takeda Pharma OÜ Tel: +372 6177 669 [email protected] Norge Takeda AS Tlf: +47 800 800 30 [email protected] Ελλάδα Takeda ΕΛΛΑΣ Α.Ε.

Tηλ: +30 210 6387800 [email protected] Österreich Takeda Pharma Ges.m.b.H.

Tel: +43 (0) 800 -20 80 50 [email protected] España Takeda Farmacéutica España , S.A.

Tel: +34 917 90 42 22 [email protected] Polska Takeda Pharma Sp. z o.o .

Tel.: + 48223062447 [email protected] France Takeda France SAS Tél: + 33 1 40 67 33 00 [email protected] Portugal Takeda Farmacêuticos Portugal, Lda.

Tel: + 351 21 120 1457 [email protected] Hrvatska Takeda Pharmaceuticals Croatia d.o.o.

Tel: +385 1 377 88 96 [email protected] România Takeda Pharmaceuticals SRL Tel: +40 21 335 03 91 [email protected] Ireland Takeda Products Ireland L td Tel: 1800 937 970 [email protected] Slovenija Takeda Pharmaceuticals farmacevtska družba d.o.o.

Tel: + 386 (0) 59 082 480 [email protected] Ísland Vistor hf.

Sími : +354 535 7000 [email protected] Slovenská republika Takeda Pharmaceuticals Slovakia s.r.o.

Tel: +421 (2) 20 602 600 [email protected] Italia Takeda Italia S.p.A.

Tel: +39 06 502601 [email protected] Suomi/Finland Takeda Oy Puh/Tel: 0800 774 051 [email protected] Κύπρος A.POTAMITIS MEDICARE LTD Tηλ: +357 22583333 a.potamitismedicare @cytanet .com.cy Sverige Takeda Pharma AB Tel: 020 795 079 [email protected] 49 Latvija Takeda Latvia SIA Tel: +371 67840082 [email protected] United Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 ( 0) 3333 000 181 medinfo EMEA @takeda.com

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 Ninlaro (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/16/1094).

⚠️ 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.