2.3 mg, 3 mg, 4 mg hard capsules
ixazomib
What NINLARO is and what it is used for
What NINLARO is
NINLARO is a cancer drug that contains ixazomib, a “proteasome inhibitor”.
NINLARO is used to treat a bone marrow cancer called multiple myeloma. Its active substance ixazomib acts by blocking the function of proteasomes. These are structures inside the cell that break down proteins and are important for cell survival. Because myeloma cells produce a lot of protein, they can be killed with proteasome inhibitors by blocking the function of proteasomes.
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 blood cancer that affects a type of cell called a plasma cell. A plasma cell is a blood cell that normally produces a protein to fight infection. People with multiple myeloma have cancerous plasma cells, also known as myeloma cells, and they can damage the skeleton. The protein produced by myeloma cells can damage the kidneys. Treatment for multiple myeloma includes killing myeloma cells and reducing the symptoms of the disease.
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 any of the above applies to you, talk to your doctor, pharmacist, or nurse before taking NINLARO.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking NINLARO or during treatment if:
- you have had bleeding in the past
- you have persistent nausea, vomiting or diarrhea
- you have previously had nerve problems such as tingling or numbness
- you have previously had swelling
- you have a long-lasting rash or a severe rash with scaly skin and sores in the oral cavity (Stevens ‑ Johnson syndrome)
- you have or have had liver or kidney problems, as your dose may need to be adjusted
- you have or have had damage to the smallest blood vessels, so-called thrombotic microangiopathy or thrombotic thrombocytopenic purpura. Tell your doctor if you get tiredness, fever, bruising, bleeding, decreased urination, swelling, confusion, vision loss and seizures.
Your doctor will examine you and you will be closely monitored during treatment. Before you start taking NINLARO and during treatment, you will take blood samples to check if you have enough blood cells.
Children and young people
NINLARO is not recommended for children and adolescents under 18 years of age.
Other medicines and NINLARO
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This also applies to any over-the-counter medicines, e.g. vitamin er or herbal remedies. This is because other medicines may 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 effect of NINLARO.
Pregnancy and breastfeeding
NINLARO is not recommended during pregnancy as it may harm the unborn baby. Breast-feeding should be discontinued when taking NINLARO.
Avoid getting pregnant or breastfeeding while being treated with NINLARO. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Whether you are a woman or a man, if you are fertile, you must use an effective contraceptive during treatment and for 90 days after treatment. Women who use hormonal contraceptives should also use barrier contraceptives. Tell your doctor immediately if you or your partner becomes pregnant during treatment with NINLARO.
Because NINLARO is given in combination with lenalidomide, you should follow the contraceptive program for lenalidomide as lenalidomide may be harmful to the unborn baby.
See the Lenalidomide and Dexamethasone Package Leaflet for more information on pregnancy and breastfeeding.
Driving and using machines
NINLARO may affect the ability to drive and use machines. You may feel tired and dizzy after taking NINLARO. Do not drive or use machines if you experience these side effects.
How to take NINLARO
NINLARO must be prescribed for you by a doctor who has experience in treating multiple myeloma. Always take this medicine exactly as your doctor or pharmacist has told you.
NINLARO is used with lenalidomide (a medicine that affects the way 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 a 4 mg capsule taken by mouth.
The recommended dose of lenalidomide is 25 mg taken daily for the first 3 weeks of the cycle. The recommended dose of dexamethasone is 40 mg taken once a week, on the same day for all 4 weeks of the cycle.
| Dosage schedule: NINLARO with lenalidomide and dexamethasone Take the medicine | ||||||||
| 28-day cycle (a 4-week cycle) | ||||||||
| Week 1 | Week 2 | Week 3 | Week 4 | |||||
| Day 1 | Day2 to 7 | Day 8 | Day9 to 14 | Day 15 | Day16 to 21 | Day 22 | Day 23 to 28 | |
| NINLARO | v | v | v | |||||
| Lenalidomide | v | v Daily | v | v Daily | v | v Daily | ||
| Dexamethasone | v | v | v | v |
You should read the package leaflets for these other medicines for more 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 any side effects, your doctor may prescribe NINLARO capsules containing 3 mg or 2.3 mg. Your doctor may also adjust the doses of your other medicines.
How and when to take NINLARO
- Take NINLARO at least one hour before or at least two hours after a meal.
- Swallow the capsule whole with water. The capsule must not be crushed, chewed or opened.
- Do not allow the contents of the capsule to come into contact with your skin. If the powder accidentally comes in contact with your skin, wash thoroughly with soap and water. If a canister breaks, avoid spreading dust during cleaning.
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 seek medical advice immediately. Take the medicine pack with you.
If you forget to take NINLARO
If you miss a dose or a dose delay, take one as long as there are more than 3 days or 72 hours left until the next scheduled dose. Do not take a missed dose if there are less than 3 days or 72 hours left until the next scheduled dose.
If you vomit after taking a dose, do not take an extra dose. Take the next dose as usual when it’s time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
The length of treatment with NINLARO
You should continue treatment until your doctor tells you to stop.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or pharmacist immediately if you get any of the following very common and serious side effects that may affect more than 1 in 10 people:
- low platelet count ( thrombocytopenia ) which can increase the risk of nosebleeds and you can more easily get bruises
- nausea, vomiting and diarrhea
- numbness, stinging or burning sensation in the hands or feet ( peripheral neuropathy )
- swelling of the legs or feet (peripheral edema )
- skin rashes that can itch and occur in a few areas of the body as well as all over the body.
- cough, chest pain or nasal congestion ( bronchitis ).
Also, tell your doctor immediately if you get any of the following rare side effects that may affect up to 1 in 1,000 people:
- severe skin rash such as red or purple bumps (Sweet’s syndrome) or rash with skin flakes and sores in the oral cavity (Stevens ‑ Johnson syndrome)
- muscle weakness, loss of sensation in the toes and feet or difficulty moving the legs (transverse myelitis )
- vision changes, altered state of consciousness or seizures (posterior reversible encephalopathy syndrome)
- cancer cells that die quickly and can cause dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath or heart rhythm disorders (tumor light syndrome)
- rare blood disease caused by blood clots and can cause fatigue, fever, bruising, bleeding e.g. nosebleeds, decreased urination, swelling, confusion, loss of vision and seizures (thrombotic microangiopathy, thrombotic thrombocytopenic purpura).
Other possible side effects are
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Very common side effects that may affect more than 1 in 10 people :
- constipation
- back pain
- cold symptoms (upper respiratory tract infection)
- fatigue or weakness
- decreased white blood cell count called neutrophils ( neutropenia ), which may increase the risk of infection
- no desire to eat (decreased appetite)
- irregular heartbeat ( arrhythmia )
- vision problems, including blurred vision, dry eyes and red eyes ( conjunctivitis ).
Common side effects that may affect up to 1 in 10 people:
- reactivation of chickenpox virus ( shingles ) that can cause rash and pain ( herpes zoster)
- decreased blood pressure ( hypotension )
- shortness of breath or persistent cough or wheezing ( heart failure )
- yellowing of the eyes and skin (jaundice which may be a symptom of hepatic impairment)
- low potassium levels in the blood ( hypokalaemia ).
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 pack, the wallet pack, and the carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C. Do not freeze.
Store in the original package. Moisture sensitive.
Do not remove the capsules from the package until you are taking a dose.
Do not use this medicine if you notice damaged or signs that the medicine pack has been opened.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
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).
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 capsule:
The active substance is ixazomib. Each capsule contains 3 mg of ixazomib (as 4.3 mg of ixazomib citrate).
Other ingredients are:
- In the capsule: microcrystalline cellulose, magnesium stearate and talc.
- The shell of the capsule contains: gelatin, titanium dioxide (E171) and black iron oxide (E172).
- The printing ink 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).
Other ingredients are:
- In the capsule: microcrystalline cellulose, magnesium stearate and talc.
- The shell of the capsule 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).
What the medicine looks like and contents of the pack
NINLARO 2.3 mg hard capsule: Light pink, size 4, marked with “Takeda” on the upper part and “2.3 mg” on the lower part of the housing with black color.
NINLARO 3 mg hard capsule: Light gray, size 4, marked with “Takeda” on the upper part and “3 mg” on the lower part of the housing with black color.
NINLARO 4 mg hard capsule: Light orange, size 3, marked with “Takeda” on the upper part and “4 mg” on the lower part of the housing with black color.
Each pack contains 3 hard capsules (three individual cartons, each containing a blister card in a wallet pack. Each blister 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
Dublin 22
D22 XR57
Ireland
Takeda GmbH
Takeda (Work Singing)
Robert Bosch Straße 8
78224 Singen
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienTakeda BelgiumTel: +32 2 464 06 11takeda-belgium@takeda.com | LithuaniaTakeda, UABTel: +370 521 09 070lt-info@takeda.com |
| BulgariaTakade BulgariaTel .: + 359 2 958 27 36; | Luxembourg / LuxemburgTakeda BelgiumTel: +32 2 464 06 11takeda-belgium@takeda.com |
| Czech RepublicTakeda PharmaceuticalsCzech Republic sroTel: +420 234722722 | HungaryTakeda Pharma Kft.Tel: +361 2707030 |
| DenmarkTakeda Pharma A / STel: +45 46 77 11 11 | MaltaDrugsales LtdTel: +356 21419070safety@drugsalesltd.com |
| GermanyTakeda GmbHTel: +49 0800 825 3325medinfo@takeda.de | The NetherlandsTakeda Nederland bvTel: +31 20 203 5492medinfoEMEA@takeda.com |
| EestiTakeda Pharma ASTel: +372 6177 669 | NorwayTakeda ASTel: +47 6676 3030infonorge@takeda.com |
| GreeceTAKEDA ΕΛΛΑΣ Α.Ε:Ηλ: +30 210 6387800gr.info@takeda.com | AustriaTakeda Pharma Ges.mbHTel: +43 (0) 800-20 80 50 |
| SpainTakeda Pharmacéutica España SATel: +34 917 14 99 00spain@takeda.com | PolandTakeda Pharma sp. z ooTel .: + 48 22 608 13 00 |
| FranceTakeda FranceTel: +33 1 46 25 16 16 | PortugalTakeda Pharmaceuticals Portugal, Lda.Tel: + 351 21 120 1457 |
| CroatiaTakeda Pharmaceuticals Croatia dooTel: +385 1 377 88 96 | RomaniaTakeda Pharmaceuticals SRLTel: +40 21 335 03 91 |
| IrelandTakeda Products Ireland LimitedTel: +353 (0) 1 6420021 | SloveniaTakeda Pharmaceuticals pharmaceutical companyTel: + 386 (0) 59 082 480 |
| IcelandVistor hf.Phone: +354 535 7000vistor@vistor.is | Slovak RepublicTakeda Pharmaceuticals Slovakia sroTel: +421 (2) 20 602 600 |
| ItalyTakeda Italia SpATel: +39 06 502601 | Finland / FinlandTakeda OyPuh / Tel: +358 20 746 5000 |
| .ΠροςA. POTAMITIS MEDICARE LTDTηλ: +357 22583333info@potamitismedicare.com | SwedenTakeda Pharma ABTel: +46 8 731 28 00infosweden@takeda.com |
| LatviaTakeda Latvia SIATel: +371 67840082 | United Kingdom (Northern Ireland)Takeda UK LtdTel: +44 (0) 2830 640 902medinfoemea@takeda.com |