What Luvica is and what it is used for
Luvica is an anticancer medicine that contains the active substance Ibrutinib. It belongs to a class of medicines called protein kinase inhibitors.
What Luvica is used for
It is used to treat the following blood cancers in adults:
How Luvica works
In MCL, CLL and WM, Luvica works by blocking Bruton’s tyrosine kinase, a protein in the body that helps these cancer cells grow and survive. By blocking this protein, Luvica helps kill and reduce the number of cancer cells. It also slows down the worsening of the cancer.
What you need to know before you take Luvica
Do not take Luvica:
Warnings and precautions
Talk to your doctor or pharmacist before taking Luvica
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Luvica.
When taking Luvica, tell your doctor immediately if you notice or someone notices in you: memory loss, trouble thinking, difficulty walking or sight loss – these may be due to a very rare but serious brain infection which can be fatal (Progressive Multifocal Leukoencephalopathy or PML).
Tell your doctor immediately if you notice or someone notices in you: sudden numbness or weakness in the limbs (especially on one side of the body), sudden confusion, trouble speaking or understanding speech, sight loss, difficulty walking, loss of balance or lack of coordination, sudden severe headache with no known cause. These may be signs and symptoms of stroke.
Tell your doctor immediately if you develop left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder (these may be symptoms of rupture of the spleen) after you stop taking Luvica.
Tell your doctor immediately if you notice breathlessness, difficulty breathing when lying down, swelling of the feet, ankles or legs and weakness/tiredness (these may be signs of heart failure) during treatment with Luvica.
You may experience viral, bacterial, or fungal infections during treatment with Luvica. Contact your doctor if you have fever, chills, weakness, confusion, body aches, cold or flu symptoms, feel tired or feel short of breath, yellowing of the skin or eyes (jaundice). These could be signs of an infection.
Hemophagocytic lymphohistiocytosis
There have been rare reports of excessive activation of white blood cells associated with inflammation (hemophagocytic lymphohistiocytosis), which can be fatal if not diagnosed and treated early. If you experience multiple symptoms such as fever, swollen glands, bruising, or skin rash, contact your doctor immediately.
Tests and check-ups before and during treatment
Tumour lysis syndrome (TLS): Unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have happened during treatment of cancer and sometimes even without treatment. This may lead to changes in kidney function, abnormal heartbeat, or seizures. Your doctor or another healthcare provider may do blood tests to check for TLS.
Lymphocytosis: Laboratory tests may show an increase in white blood cells (called “lymphocytes”) in your blood in the first few weeks of treatment. This is expected and may last for a few months. This does not necessarily mean that your blood cancer is getting worse. Your doctor will check your blood counts before or during the treatment and in rare cases they may need to give you another medicine. Talk to your doctor about what your test results mean.
Events related to the liver: Your doctor will do some blood tests to check whether your liver is working properly or that you do not have a liver infection, known as viral hepatitis, or whether hepatitis B has become active again, which could be fatal.
Children and adolescents
Luvica should not be used in children and adolescents. This is because it has not been studied in these age groups.
Other medicines and Luvica
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, herbal medicines and supplements. This is because Luvica may affect the way some other medicines work. Also some other medicines can affect the way Luvica works.
Luvica may make you bleed more easily. This means you should tell your doctor if you take other medicines that increase your risk of bleeding. This includes:
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Luvica.
Also tell your doctor if you take any of the following medicines – The effects of Luvica or other medicines may be influenced if you take Luvica together with any of the following medicines:
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Luvica.
If you are taking digoxin, a medicine used for heart problems, or methotrexate, a medicine used to treat other cancers and to reduce the activity of the immune system (e.g., for rheumatoid arthritis or psoriasis), it should be taken at least 6 hours before or after Luvica.
Luvica with food
Do not take Luvica with grapefruit or Seville oranges (bitter oranges) – this includes eating them, drinking the juice or taking a supplement that might contain them. This is because it can increase the amount of Luvica in your blood.
Pregnancy and breast-feeding
Do not get pregnant while you are taking this medicine. Luvica should not be used during pregnancy. There is no information about the safety of Luvica in pregnant women.
Women of childbearing age must use a highly effective method of birth control during and up to three months after receiving Luvica, to avoid becoming pregnant while being treated with Luvica.
Driving and using machines
You may feel tired or dizzy after taking Luvica, which may affect your ability to drive or use any tools or machines.
Luvica contains sodium
Luvica contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially
‘sodium-free’.
How to take Luvica
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
How much to take
Mantle cell lymphoma (MCL)
The recommended dose of Luvica is 560 mg once a day.
Chronic lymphocytic leukaemia (CLL)/ Waldenstrom’s macroglobulinaemia (WM)
The recommended dose of Luvica is 420 mg once a day.
Your doctor may adjust your dose.
Taking this medicine
If you take more Luvica than you should
If you take more Luvica than you should, talk to a doctor or go to a hospital straight away. Take the capsules and this leaflet with you.
If you forget to take Luvica
If you stop taking Luvica
Do not stop taking this medicine unless your doctor tells you. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
Stop taking Luvica and tell a doctor straight away if you notice any of the following side effects:
Itchy bumpy rash, difficulty breathing, and swelling of your face, lips, tongue or throat – you may be having an allergic reaction to the medicine.
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Not known (frequency cannot be estimated from available data):
How to store Luvica
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.
Further information
What Luvica contains
The other ingredients are:
What Luvica looks like and contents of the pack
Luvica 140 mg capsules are hard gelatin capsules with opaque white cap and opaque white body, containing white to off-white granular powder.
It is supplied in the boxes of an opaque white HDPE bottle, each one contains 90 capsules.
Manufactured by:
Actero Middle East Pharmaceutical Company, Karaj, Iran