Patient leaflet - Ixazomib 3 mg hard capsules
1. What Ixazomib is and what it is used for
What Ixazomib is
Ixazomib is a cancer medicine that contains ixazomib, a ‘proteasome inhibitor’.
Ixazomib is used to treat a cancer of the bone marrow called multiple myeloma. Its active substance ixazomib works by blocking the action of proteasomes. 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 Ixazomib is used for
Ixazomib is used to treat adults with multiple myeloma. Ixazomib 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. Protein produced by myeloma cells can damage the kidneys. Treatment for multiple myeloma involves killing myeloma cells and reducing the symptoms of the disease.
2. What you need to know before you take Ixazomib
Do not take Ixazomib
- 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 applies to you, talk to your doctor, pharmacist or nurse before taking Ixazomib.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking or during treatment with Ixazomib 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 may have to be adjusted
- you have or have had damage to the smallest blood vessels known as thrombotic microangiopathy (TMA), thrombotic thrombocytopenic purpura (TTP), or haemolytic uremic syndrome (HUS). Tell your doctor if you develop fatigue, fever, bruising, bleeding, decreased urination, swelling, confusion, vision loss, and seizures.
- you have or have had seizures, high blood pressure, headache, changes in mental status, or changes in vision; these are symptoms of a rare condition known as posterior reversible encephalopathy syndrome (PRES).
Your doctor will examine you and you will be monitored closely during treatment. Before starting Ixazomib and during treatment, you will have blood tests to check that you have enough blood cells.
Children and adolescents
Ixazomib is not recommended for use in children and adolescents aged under 18 years.
Other medicines and Ixazomib
Tell your doctor, pharmacist or nurse if you are taking, have recently taken 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 Ixazomib
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 of Ixazomib.
Pregnancy and breast-feeding
Ixazomib is not recommended during pregnancy as it may harm your unborn baby. Breast-feeding should be stopped when taking Ixazomib.
Avoid becoming pregnant or breast-feeding while being treated with Ixazomib. 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 doctor right away if you or your partner becomes pregnant while receiving Ixazomib.
As Ixazomib is given in combination with lenalidomide, you should adhere to the pregnancy prevention programme of lenalidomide because lenalidomide can be harmful to the unborn child.
See the package leaflets for lenalidomide and dexamethasone for additional information on pregnancy and breast-feeding
Driving and using machines
Ixazomib may affect your ability to drive or use machines. You may feel tired and dizzy while taking Ixazomib. Do not drive or operate machines if you have these side effects.
3. How to take Ixazomib
Ixazomib 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.
Ixazomib is used with lenalidomide (a medicine which affects how your immune system works) and dexamethasone (an anti-inflammatory medicine).
Ixazomib, lenalidomide and dexamethasone are taken in 4-week treatment cycles. Ixazomib 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 lenalidomide is 25 mg taken every day 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.
Dosing schedule: Ixazomib 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 Ixazomib √ √ √
Lenalidomide √ √ Daily √ √ Daily √ √ Daily
Dexamethasone √ √ √ √
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 Ixazomib capsules containing 3 mg. If you have side effects, your doctor may prescribe Ixazomib capsules containing 3 mg or 2.3 mg. The doctor may also adjust the doses of the other medicines.
How and when to take Ixazomib
- Take Ixazomib 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. If 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 Ixazomib than you should
Accidental overdose can cause serious side effects. If you take more Ixazomib 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 Ixazomib
You should continue treatment until your doctor tells you to stop.
If you forget to take Ixazomib
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 medicine, ask your doctor or pharmacist. hard capsules
2.3 mg, 3 mg and 4 mg
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 (Stevens-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 (thrombocytopenia) which may increase the risk of nose bleeds and you may easily bruise
- nausea, vomiting and diarrhoea
- numbness, tingling or burning of the hands or feet (peripheral neuropathy)
- swelling of the legs or feet (peripheral 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 from 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 reaction)
Other possible side effects
Tell your doctor or pharmacist if 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 pressure (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 Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ixazomib
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 freeze.
Store in the original package 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 Ixazomib contains
Ixazomib 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 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).
Ixazomib 3 mg hard capsule:
- The active substance 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) and black iron oxide (E172)
- The printing ink contains: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).
Ixazomib 4 mg hard capsule:
- The active substance 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).
What Ixazomib looks like and contents of the pack
Ixazomib 2.3 mg hard capsule: Light pink, size 4, marked “Takeda” on the cap and “2.3 mg” on the body with black ink.
Ixazomib 3 mg hard capsule: Light grey, size 4, marked “Takeda” on the cap and “3 mg” on the body with black ink.
Ixazomib 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 capsules sealed within the blister strip inside a wallet).
Marketing Authorisation Holder
Takeda Pharma A/S
Delta Park 45
2665 Vallensbaek Strand
Denmark
Tel: +44 (0)3333 000181
medinfoemea@takeda.com
Manufacturer
Takeda Ireland Limited
Grange Castle Business Park
Nangor Road
Dublin 22
D22 XR57
Ireland