NINLARO 2.3 мг Капсулы твердые

Содержание инструкции

1. NINLARO 2.3 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules
   1. What is NINLARO and what is it 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

NINLARO 2.3 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules

ixazomib

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 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

1. What is NINLARO and what is it used for

What is NINLARO
NINLARO is an anti-cancer medicine that contains ixazomib, a “proteasome inhibitor”.
NINLARO is used to treat a bone marrow cancer called multiple myeloma. Its
active substance, ixazomib, works by blocking the action of proteasomes. These are
structures found inside the cell that digest proteins and are important for the
survival of the cell. Because multiple myeloma cells produce many proteins, blocking the action of proteasomes can kill cancer cells.

What is NINLARO used for
NINLARO is used in the treatment of adult patients with multiple myeloma. NINLARO will be given to you together with lenalidomide and dexamethasone, which are other medicines used in the
treatment of multiple myeloma.

What is multiple myeloma
Multiple myeloma is a form of blood cancer that affects a type of cell called
plasma cells. Plasma cells are blood cells that normally produce proteins to
fight infections. In people with multiple myeloma, diseased plasma cells, also called
myeloma cells, can damage the bones. The proteins produced by myeloma cells can damage the kidneys. Treatment for multiple myeloma consists of killing
myeloma cells and reducing 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 any of the other ingredients of this medicine (listed in section 6).

If you are not sure if these apply to you, talk to your doctor, pharmacist or nurse
before taking NINLARO.

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

• you have had bleeding in the past
• you suffer from persistent nausea, vomiting or diarrhoea
• you have previously suffered from nerve problems, such as tingling and numbness
• you have a history of swelling (oedema)
• you suffer from persistent skin rashes or severe skin rashes with peeling skin and ulcers in the mouth (Stevens-Johnson syndrome or toxic epidermal necrolysis, see section 4)
• you currently have or have had in the past problems with your liver or kidneys, as it may be necessary to adjust the dose of the medicine
• you have or have had damage to the small blood vessels known as thrombotic microangiopathy or thrombotic thrombocytopenic purpura. Talk to your doctor if you experience fatigue, fever, bruising, bleeding, decreased urine flow, swelling, confusion, vision loss and seizures.

You will be visited by your doctor and will be closely monitored during treatment. Before
taking NINLARO and during treatment you will undergo blood tests to check that the
number of blood cells is not too low.

Children and adolescents
The use of NINLARO is not recommended in children and adolescents under the age of 18 years.

Other medicines and NINLARO
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines. This includes any medicines you have obtained without a prescription,
such as vitamins or herbal remedies. 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, or
hypericum ( Hypericum perforatum).These medicines should be avoided as they may reduce
the effectiveness of NINLARO.

Pregnancy and breastfeeding
The use of NINLARO during pregnancy is not recommended, as this medicine could be
harmful to the unborn child. Breastfeeding must be stopped during the intake of NINLARO.
During treatment with NINLARO, women must avoid becoming pregnant and must not
breastfeed. If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or
if you are breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
Women of childbearing potential and men capable of fathering a child must use effective
contraceptive methods during treatment and for 90 days after treatment. Women who are using
hormonal contraceptives must also use a barrier method of contraception. Tell your
doctor immediately if you or your partner becomes pregnant during therapy with
NINLARO.
Because NINLARO is administered in combination with lenalidomide, you will need to
adhere to the pregnancy prevention plan provided for the use of lenalidomide, as
lenalidomide can be a medicine dangerous to the unborn child.
See the package leaflets for lenalidomide and dexamethasone for further information on pregnancy and
breastfeeding.

Driving and using machines
NINLARO may affect your ability to drive or use machines. During therapy with
NINLARO, you may feel tired and dizzy. Do not drive or use machines if you experience these
side effects.

3. How to take NINLARO

NINLARO must be prescribed by a doctor experienced in the treatment of multiple myeloma. Take
this medicine following the instructions of your doctor or pharmacist exactly.
NINLARO is used with “lenalidomide” (a medicine that affects the functioning of the immune
system) and “dexamethasone” (an anti-inflammatory).
NINLARO, lenalidomide and dexamethasone are taken according to treatment cycles of 4 weeks.
NINLARO is taken once a week (on the same day of the week) for the first three
weeks of this cycle.
The recommended dose of NINLARO is one 4 mg capsule by mouth. The recommended dose of
lenalidomide is 25 mg every day for the first 3 weeks of a cycle. The recommended dose of
dexamethasone is 40 mg once a week, to be taken on the same day, for all four
weeks of the cycle.

Dosage schedule: taking NINLARO in combination with lenalidomide and
dexamethasone
 When to take the medicine

28-day cycle (4 weeks)
Week 1Week 2Week 3Week 4
Day
1
Days
23 to 28
NINLARO   
Lenalidomide

 every
day

 every
day

 every
day
Days
2 to 7
Day
8
Days
9 to 14
Day
15
Days
16 to 21
Day
22
Dexamethasone    
For further information on their respective uses and effects, read the package leaflets attached to the packs
of the other medicines.
If you have liver or kidney problems, your doctor may prescribe 3 mg NINLARO capsules. If
you experience 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 meals or at least two hours after meals.
• Swallow the capsule whole with water. The capsule must not be crushed, chewed or opened.
• Avoid contact of the capsule contents with your skin. If the powder accidentally comes into contact with your skin, wash it thoroughly with water and soap. If the capsule breaks, clean up the powder, taking care not to disperse it into the air.

If you take more NINLARO than you should
An accidental overdose can cause serious side effects. If you take more NINLARO than
you should, inform your doctor immediately or go to hospital immediately, bringing the
package of the medicine with you.

Duration of treatment with NINLARO
You will need to continue treatment until your doctor tells you to stop.

If you forget to take NINLARO
If you forget a dose or take it late, you should only take the capsule if there are more than 3 days
or 72 hours until the next scheduled dose. Do not take a forgotten dose if there are less than
3 days or 72 hours until the next scheduled dose.
If you vomit after taking the dose, do not take another capsule. Take the next dose
as normal, as scheduled.
If you have any questions about using 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.

Stop using ixazomib and consult your doctor immediately if you notice any of the following symptoms:

• reddish-purple, non-raised, circular or target-like patches on the trunk, often with blisters in the centre, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis, which can affect up to 1 in 1,000 people).

Tell your doctor or pharmacist immediately if you notice any of the following very common serious side effects that can affect more than 1 in 10 people:

• reduction in the number of platelets (thrombocytopenia), with a possible increase in the risk of nosebleeds or bruising
• nausea, vomiting and diarrhoea
• numbness, tingling or burning in the hands and feet (peripheral neuropathy)
• swelling of the legs or feet (peripheral oedema)
• skin rashes that may be itchy, in some or all areas of the body
• cough, chest pain or discomfort, or nasal congestion (bronchitis)

Also, tell your doctor immediately if you notice any of the following rare side effects that can affect up to 1 in 1,000 people:

• severe skin rashes such as the appearance of red to purple papules (Sweet's syndrome)
• muscle weakness, loss of sensation in the toes and feet, or loss of leg movement (transverse myelitis)
• changes in vision, changes in mental status or seizures (reversible posterior encephalopathy syndrome)
• rapid death of cancer cells with possible dizziness, decreased urine output, confusion, vomiting, nausea, swelling, shortness of breath or irregular heartbeat (tumour lysis syndrome)
• a rare blood disease due to the presence of clots (thrombi) with possible fatigue, fever, bruising, bleeding, e.g. nosebleeds, decreased urine output, swelling, confusion, vision loss and seizures (thrombotic microangiopathy, thrombotic thrombocytopenic purpura)
• swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, wheezing, tightness in the chest or dizziness, itchy skin and hives (angioedema or anaphylactic reaction)

Other possible side effects
Tell your doctor or pharmacist if any of the following listed side effects worsen.

Very common: may affect more than 1 in 10 people

• constipation
• back pain
• cold-like symptoms (upper respiratory tract infections)
• feeling tired or weak (fatigue)
• fever (pyrexia)
• joint pain (arthralgia)
• reduction in the number of white blood cells called neutrophils (neutropenia), with a possible increase in the risk of infections
• loss of appetite
• irregular heartbeat (arrhythmia)
• vision disturbances, such as blurred vision, dry or red eyes (conjunctivitis)

Common: may affect up to 1 in 10 people

• reactivation of the chickenpox virus, which can cause painful skin rashes (herpes zoster or shingles)
• low blood pressure (hypotension)
• shortness of breath, persistent cough or wheezing (heart failure)
• yellowing of the skin and eyes (jaundice; may be a sign of liver problems)
• 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 side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex 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, on the
folding carton and on the box after Exp./EXP. The expiry date refers to the last day of that
month.
Do not store at a temperature above 30 °C. Do not freeze.
Store in the original packaging to protect the medicine from moisture.
Remove the capsule from the packaging only immediately before swallowing it.
Do not use this medicine if you notice damage or signs of tampering on the packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NINLARO contains
NINLARO 2.3 mg hard capsules:

• The active ingredient is ixazomib. Each capsule contains 2.3 mg of ixazomib (as 3.3 mg of ixazomib citrate).
• The other 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 capsules:

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

NINLARO 4 mg hard capsules:

• The active ingredient is ixazomib. Each capsule contains 4 mg of ixazomib (as 5.7 mg of ixazomib citrate).
• The other 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).
• The printing ink contains: shellac, propylene glycol, potassium hydroxide and black iron oxide (E172).

Description of the appearance of NINLARO and contents of the pack
NINLARO 2.3 mg hard capsules: light pink in colour, size 4, with “Takeda” written on the cap and “2.3 mg” on the body of the capsule, in black ink.
NINLARO 3 mg hard capsules: light grey in colour, size 4, with “Takeda” written on the cap and “3 mg” on the body of the capsule, in black ink.
NINLARO 4 mg hard capsules: light orange in colour, size 3, with “Takeda” written on the cap and “4 mg” on the body of the capsule, in black ink.
Each pack contains 3 hard capsules (three blister-sealed capsules in a blister strip inside a folding carton. Each of these blisters contains one capsule).

Marketing 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 further information on this medicinal product, 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]

Danmark
Takeda Pharma A/S
Tlf.: +45 46 77 10 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.
Τηλ: +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 Ltd
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
Τηλ: +357 22583333
[email protected]

Sverige
Takeda Pharma AB
Tel: 020 795 079
[email protected]

Latvija
Takeda Latvia SIA
Tel: +371 67840082
[email protected]

United Kingdom (Northern Ireland)
Takeda UK Ltd
Tel: +44 (0) 3333 000 181
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .