Possible side effects

Like all medicines, Xalico can cause side effects, although not everybody gets them.

If you experience any side effect it is important that you inform your doctor before your next treatment.

You will find described below the side effects that you could experience.

 

Tell your doctor immediately if you notice any of the following:

• Symptoms of an allergic or anaphylactic reaction with sudden signs such as rash, itching or hives on the skin, difficulties in swallowing, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing, extreme tiredness (you may feel you are going to faint). In the majority of cases, these symptoms occurred during the infusion or immediately after but delayed allergic reactions have also been observed hours or even days after the infusion,
• Abnormal bruising, bleeding or signs of infection such as a sore throat and high temperature,
• Persistent or severe diarrhea or vomiting,
• Presence of blood or dark brown coffee-colored particles in your vomit,
• If you faint (lose consciousness) or have an irregular heartbeat while taking Xalico, tell your doctor immediately as this may be a sign of a serious heart condition,
• If you experience muscle pain and swelling, in combination with weakness, fever, or red brown urine, tell your doctor. These could be signs of muscle damage (rhabdomyolysis) and could lead to kidney problems or other complications,
• Stomatitis/mucositis (sore lips or mouth ulcers),
• Respiratory symptoms such as dry or wet cough, difficulties in breathing or crackles,
• Shortness of breath and, wheezing as these may be indications of a serious lung disease that may lead to death,
• A group of symptoms such as headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder),
• Stroke symptoms (including sudden severe headache, confusion, trouble seeing in one or both eyes, numbness or weakness of face, arm or leg usually on one side, face dropping, trouble walking, dizziness loss of balance and speech difficulty),
• Extreme tiredness with decreased number of red blood cells, and shortness of breath (hemolytic anemia), alone or combined with low platelet count, abnormal bruising (thrombocytopenia) and kidney disease where you pass little or no urine (symptoms of Hemolytic-uremic syndrome).

 

Other known side effects of Oxaliplatin are:

Very common (may affect more than 1 in 10 people):

 

Xalico can affect the nerves (peripheral neuropathy). You may feel a tingling and/or numbness in the fingers, toes, around the mouth or in the throat, which may sometimes occur in association with cramps.

These effects are often triggered by exposure to cold e.g. opening a refrigerator or holding a cold drink. You may also have difficulty in performing delicate tasks, such as buttoning clothes. Although in the majority of cases these symptoms resolve themselves completely, there is a possibility of persistent symptoms of peripheral sensory neuropathy after the end of the treatment. Some people have experienced a tingling, shock-like sensation passing down the arms or trunk when the neck is flexed.

• Xalico can sometimes cause an unpleasant sensation in the throat, in particular when swallowing, and give the sensation of shortness of breath. This sensation, if it happens, usually occurs during or within hours of the infusion and may be triggered by exposure to the cold. Although unpleasant, it will not last long and goes away without the need for any treatment.

Your doctor may decide to alter your treatment as a result.

• Xalico may cause diarrhea, mild nausea (feeling sick) and vomiting (being sick); however, medication to prevent the sickness is usually given to you by your doctor before treatment and may be continued after treatment.
• Xalico causes temporary reduction in the number of blood cells. The reduction of red cells may cause anemia (a reduction of red cells), abnormal bleeding or bruising (due to a reduction in platelets). The reduction in white blood cells may make you prone to infections.

Your doctor will take blood to check that you have sufficient blood cells before you start treatment and before each subsequent course.

• Sensation of discomfort close to or at the injection site during the infusion,
• Fever, rigors (tremors), mild or severe tiredness, body pain,
• Weight changes, loss or lack of appetite, taste disorders, constipation,
• Headache, back pain,
• Swelling of the nerves to your muscles, neck stiffness, abnormal tongue sensation possibly altering speech, stomatitis/ mucositis (sore lips or mouth ulcers),
• Stomach pain,
• Abnormal bleeding including nose bleeds,
• Coughing, difficulty in breathing,
• Allergic reactions, skin rash which may be red and itchy, mild hair loss (alopecia),
• Alteration in blood tests including those relating to abnormalities in liver function.

 

Common (may affect up to 1 in 10 people):

 

• Infection due to a reduction in white blood cells,
• Serious infection of the blood in addition to a reduction in white blood cells (neutropenic sepsis), which may be fatal,
• Reduction in white blood cells accompanied by fever > 38.3°C or a prolonged fever > 38°C for more than one hour (febrile neutropenia),
• Indigestion and heart burn, hiccups, flushing, dizziness,
• Increased sweating and nail disorders, flaking skin,
• Chest pain,
• Lung disorders and runny nose,
• Joint pain and bone pain,
• Pain on passing urine and changes in kidney function, changes of frequency of urination, dehydration,
• Blood in the urine/stools, swelling of the veins, clots in the lung,
• High blood pressure,
• Depression and insomnia,
• Conjunctivitis and visual problems,
• Decreased levels of calcium in the blood,
• Fall.

Uncommon (may affect up to 1 in 100 people):

 

• Serious infection of the blood (sepsis), which may be fatal,
• Blockage or swelling of the bowel,
• Nervousness.

 

Rare (may affect up to 1 in 1,000 people):

 

• Loss of hearing,
• Scarring and thickening in the lungs with difficulties in breathing, sometimes fatal (interstitial lung disease),
• Reversible short-term loss of vision,
• Unexpected bleeding or bruising due to widespread blood clots throughout the small blood vessels of the body (disseminated intravascular coagulation), which may be fatal.

Very rare (may affect up to 1 in 10,000 people):

 

• Presence of blood or dark brown coffee-colored particles in your vomit,
• Kidney disease where you pass little or no urine (symptoms of acute renal failure).
• Vascular disorders of the liver.

Not known (frequency cannot be estimated from the available data):

 

• Allergic vasculitis (inflammation of blood vessels),
• Auto-immune reaction leading to reduction of all blood cell lines (autoimmune pancytopenia) pancytopenia,
• Serious infection of the blood and low blood pressure (septic shock), which may be fatal,
• Convulsion (uncontrolled shaking of the body),
• Spasm of the throat causing difficulty in breathing,
• Extreme tiredness with decreased number of red blood cells, and shortness of breath (hemolytic anemia), alone or combined with low platelet count and kidney disease where you pass little or no urine (symptoms of Hemolytic-uremic syndrome), which may be fatal, have been reported,
• Abnormal heart rhythm (QT prolongation), that can be seen on electrocardiogram (ECG)which may be fatal,
• Heart attack (myocardial infarction), pain or uncomfortable feeling in the chest (angina pectoris),
• Inflammation of the lining of the esophagus – the tube that connects your mouth with your stomach – resulting in pain and swallowing difficulty (esophageal inflammation),
• Muscle pain and swelling, in combination with weakness, fever, or red-brown urine (symptoms of muscle damage called rhabdomyolysis), which may be fatal,
• Abdominal pain, nausea, bloody vomit or vomit that looks like “coffee grounds”, or dark colored/tarry stools (symptoms of gastrointestinal ulcer, with potential bleeding or perforation), which may be fatal,
• Decreased blood flow to the intestine/bowel (intestinal ischemia), which may be fatal,
• Risk of new cancers. Leukemia, a form of blood cancer, has been reported in patients after taking Oxaliplatin in combination with certain other medicines. Talk to your doctor about the potential for increased risk of this type of cancer when taking Oxaliplatin and certain other medicines.
• Non-cancerous abnormal liver nodules (focal nodular hyperplasia).

 

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.

By reporting side effects, you can help provide more information on the safety of this medicine.