What you need to know before you take Luvica

Do not take Luvica:

• If  you are allergic to Luvica or any of the other ingredients of this medicine (listed in section 6)
•  If you are taking a herbal medicine called St. John’s Wort, used for depression. If you are not sure about this, talk to your doctor, pharmacist or nurse before taking this medicine.

 

Warnings and precautions

Talk to your doctor or pharmacist before taking Luvica

• If you have ever had unusual bruising or bleeding or are on any medicines or supplements that increase your risk of bleeding (see section “Other medicines and Luvica”)
• If you have irregular heart beat or have a history of irregular heart beat or severe heart failure, or if you feel any of the following: shortness of breath, weakness, dizziness, light-headedness, fainting or near fainting, chest pain or swollen legs
• If you have liver problems, including if you ever had or now have a hepatitis B infection (a liver infection)
• If you have high blood pressure
• If you have recently had any surgery, especially if this might affect how you absorb food or medicines from your stomach or gut
• If you are planning to have any surgery– your doctor may ask you to stop taking Luvica for a short time (3 to 7 days) before and after your surgery
• If you have kidney problems.

 

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:

• acetyl salicylic acid and non-steroidal anti-inflammatories (NSAIDs) such as ibuprofen or naproxen
• blood thinners such as warfarin, heparin or other medicines for blood clots
• Supplements that may increase your risk of bleeding such as fish oil, vitamin E or flaxseed.

 

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:

• medicines called antibiotics to treat bacterial infections – clarithromycin, telithromycin, ciprofloxacin, erythromycin or rifampicin
• medicines for fungal infections – posaconazole, ketoconazole, itraconazole, fluconazole or voriconazole
• medicines for HIV infection – ritonavir, cobicistat, indinavir, nelfinavir, saquinavir, amprenavir, atazanavir, or fosamprenavir
• medicines to prevent nausea and vomiting associated with chemotherapy – aprepitant
• medicines for depression – nefazodone
• medicines called kinase inhibitors for treatment of other cancers – crizotinib or imatinib
• medicines called calcium channel blockers for high blood pressure or chest pain – diltiazem or verapamil
• medicines called statins to treat high cholesterol – rosuvastatin
• heart medicines/anti-arrhythmic – amiodarone or dronedarone
• medicines to prevent seizures or to treat epilepsy, or medicines to treat a painful condition of the face called trigeminal neuralgia – carbamazepine or phenytoin.

 

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.

 

• Tell your doctor immediately if you become pregnant.
• Do not breast-feed while you are taking this medicine.

 

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’.