Ninlaro

Ixazomib citrate.

NINLARO 2.3 mg hard capsule: Light pink, size 4, marked "Takeda" on the cap and "2.3 mg" on the body with black ink.
Each hard capsule contains ixazomib citrate equivalent to 2.3 mg of ixazomib (as 3.3 mg of ixazomib citrate).
NINLARO 3 mg hard capsule: Light grey, size 4, marked "Takeda" on the cap and "3 mg" on the body with black ink.
Each hard capsule contains ixazomib citrate equivalent to 3 mg of ixazomib (as 4.3 mg of ixazomib citrate).
NINLARO 4 mg hard capsule: Light orange, size 3, marked "Takeda" on the cap and "4 mg" on the body with black ink.
Each hard capsule contains ixazomib citrate equivalent to 4 mg of ixazomib (as 5.7 mg of ixazomib citrate).
Excipients/Inactive Ingredients: NINLARO 2.3 mg hard capsule: 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 capsule: 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).
NINLARO 4 mg hard capsule: 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).

NINLARO is a cancer medicine that contains ixazomib, a 'proteasome inhibitor'.
NINLARO is used to treat 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.

NINLARO is used to treat adults with multiple myeloma. NINLARO will be given together with lenalidomide and dexamethasone.

NINLARO must be prescribed by a doctor with experience of treating multiple myeloma. This medicine should always be taken exactly as prescribed.
NINLARO is used with lenalidomide and dexamethasone.
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 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. (See table.)

Click on icon to see table/diagram/image

The package leaflets of these other medicines should be read for further information on their use and effects.
In patients who have liver or kidney problems, NINLARO capsules containing 3 mg may be prescribed. In case of side effects, NINLARO capsules containing 3 mg or 2.3 mg may be prescribed. The doses of the other medicines may also be adjusted.
How and when to take NINLARO: NINLARO should be taken at least one hour before or at least two hours after food.
The capsule should be swallowed whole with water. The capsule should not be crushed, chewed or opened.
The contents of the capsule should not come into contact with the skin. If the powder accidentally comes into contact with the skin, it should be washed off thoroughly with soap and water. If the capsule breaks, the powder should be cleaned up, taking care that it does not cause dust in the air.
Duration of the treatment with NINLARO: Treatment should be continued until instructed to stop.
Forgotten intake of NINLARO: If a dose is missed or delayed, the dose should be taken as long as the next scheduled dose is more than 3 days or 72 hours away. A missed dose should not be taken if it is within 3 days or 72 hours of the next scheduled dose.
In case of vomiting after taking a dose, an extra dose should not be taken. The next dose should be taken, as normal, when it is due.

Accidental overdose can cause serious side effects. Patients who take more NINLARO than they should must seek medical attention immediately.

NINLARO should not be taken by patients who are allergic to ixazomib or to any of the other ingredients of this medicine (listed in Description).

Before or during treatment with NINLARO, caution should be exercised in: patients who have a history of bleeding; patients who have persistent nausea, vomiting or diarrhoea; patients who have a history of nerve problems, including tingling and numbness; patients who have a history of swelling; patients who have a persistent rash or Stevens-Johnson syndrome; patients who have or have had liver or kidney problems as the dose may have to be adjusted; patients who have or have had thrombotic microangiopathy or thrombotic thrombocytopenic purpura. The occurrence of fatigue, fever, bruising, bleeding, decreased urination, swelling, confusion, vision loss, and seizures should be monitored.
Patients should be examined and monitored closely during treatment. Before starting NINLARO and during treatment, blood tests should be performed.
Driving and using machines: NINLARO may affect the ability to drive or use machines. Tiredness and dizziness may occur while taking NINLARO. Patients should not drive or operate machines if these side effects occur.
Use in Children: NINLARO is not recommended for use in children and adolescents aged under 18 years.

NINLARO is not recommended during pregnancy as it may harm the unborn baby. Breast-feeding should be stopped when taking NINLARO.
Pregnancy or breast-feeding should be avoided while being treated with NINLARO. Patients who are pregnant or breast-feeding, think they may be pregnant or are planning to have a baby should be advised before taking this medicine.
Women of childbearing potential or men who can father a child must use effective contraception during and for 90 days after treatment. Women using hormonal contraceptives should additionally use a barrier method of contraception.
As NINLARO is given in combination with lenalidomide, patients 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common serious side effects (may affect more than 1 in 10 people): thrombocytopenia; nausea, vomiting and diarrhoea; peripheral neuropathy; peripheral oedema; skin rash that may be itchy and in a few areas or all over the body; bronchitis.
Rare side effects (may affect up to 1 in 1,000 people): Sweet's syndrome or Stevens-Johnson syndrome; transverse myelitis; posterior reversible encephalopathy syndrome; tumour lysis syndrome; thrombotic microangiopathy, thrombotic thrombocytopenic purpura.
Other possible side effects: The following side effects may become severe.
Very common side effects (may affect more than 1 in 10 people): constipation; back pain; upper respiratory tract infection; fatigue; neutropenia; decreased appetite; arrhythmia; vision conditions including blurred vision, dry eye and conjunctivitis.
Common side effects (may affect up to 1 in 10 people): herpes zoster; hypotension; heart failure; jaundice; hypokalaemia.
Reporting of side effects: Side effects should be reported. This includes any possible side effects not previously listed. By reporting side effects, patients can help provide more information on the safety of this medicine.

Carbamazepine, phenytoin, rifampicin and St. John's wort (Hypericum perforatum) should be avoided as they may reduce the effectiveness of NINLARO.

This medicine should not be used if any damage or signs of tampering to medicine packaging are noticed.
Medicines should not be thrown away via wastewater or household waste. Patients should be advised how to throw away medicines no longer used. These measures will help protect the environment.

Store in the original package in order to protect from moisture. The capsule should not be removed until a dose is needed.

Targeted Cancer Therapy

L01XG03 - ixazomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.

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