Oxaliplatin 5 mg/ml concentrate for solution for infusion

Oxaliplatin 5 mg/ml concentrate for solution for infusion

oxaliplatin

The active ingredient of Oxaliplatin SUN is oxaliplatin

Oxaliplatin is used to treat cancer of the large bowel (treatment of stage III colon cancer after complete resection of primary tumour, metastatic cancer of colon and rectum).

Oxaliplatin is used in combination with other anticancer agents called 5-fluorouracil and folinic acid.

Oxaliplatin is an anti-cancer drug that inhibits tumour growth and contains a platinum.

Oxaliplatin may only be given to adults.

For single use only.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine 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.

Most serious side effects

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

• Symptoms of an allergic or anaphylactic reaction with sudden signs such as skin rash, itching or hives, difficulty swallowing, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing, extreme tiredness (you may feel as if you are about to faint). In most cases, these symptoms occurred during or immediately after the infusion, but delayed allergic reactions have also been observed hours or even days after the infusion.
• Abnormal bruising, bleeding or signs of infection such as sore throat or fever,
• Persistent or severe diarrhea or nausea,
• Presence of blood or dark-brown coffee-coloured particles in your vomit,
• Stomatitis/mucositis (sore lips or ulcers in the mouth),
• Respiratory symptoms such as dry cough or cough with sputum, difficulty breathing or crackles, shortness of breath and wheezing, as these may be indicators of serious lung disease that may lead to death,
• A group of symptoms such as headache, altered mental function, seizures and visual disturbances, from blurred vision to loss of vision (these are the manifestations of a so-called reversible posterior leukoencephalopathy syndrome, a rare neurological disorder),
• Symptoms of a stroke (including sudden severe headache, confusion, visual disturbances in one or both eyes, numbness or weakness in the face, arm or leg, usually occurring on one side, face drooping, trouble walking, dizziness, loss of balance and speech difficulty),
• Extreme fatigue with decreased number red blood cell and shortness of breath (hemolytic anemia), alone or in combination with a low platelet count, abnormal bruising (thrombocytopenia), and kidney disease in which you excrete little or no urine (symptoms of hemolytic uremic syndrome).

Other known side effects

Very common: may affect more than 1 in 10 people

• Oxaliplatin 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.
• Oxaliplatin 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.
• Oxaliplatin may cause diarrhoea, mild nausea (feeling sick) and vomiting (being sick); your doctor will therefore give you medication to prevent this, which is usually given to you before treatment. You can continue to take the medication until after the treatment.
  Oxaliplatin causes temporary reduction in the number of blood cells. The reduction of red cells may cause anaemia (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 at the site of administration during the infusion,
• Fever, rigors (tremors, mild to severe tiredness, body pain,
• Weight changes, loss of appetite, taste disorders, constipation,
• Headaches, back pain,
• Swelling of the nerves to your muscles, neck stiffness, abnormal sensation in the tongue which may affect the ability to speak, inflammation of the mouth or other mucous membranes (sore lips or mouth ulcers).
• Stomach pain,
• Abnormal bleeding including nose bleeds,
• Cough, difficulty in breathing,
• Allergic reactions, skin rash which may be accompanied by redness and itching, mild hair loss (alopecia),

Changes in blood tests, including those relating to abnormalities in liver function.

Common: may affect up to 1 in 10 people

• Infections caused by the reduction in white blood cells,
• Serious blood infection associated with a reduction in the number of white blood cells (neutropenic sepsis), which may be fatal.
• Reduction in white blood cell count, accompanied by fever above 38.3 °C or prolonged fever above 38 °C for more than one hour (febrile neutropenia),
• Indigestion, heartburn, hiccups, flushing dizziness,
• Increased sweating and nail disorders, flaking skin
• Chest pain,
• Lung diseases and rhinitis (runny nose),
• Joint pain, bone pain,
• Pain when urinating and changes in kidney function, changes in the frequency of urination, dehydration,
• Bloody urine, blood in the stool, swelling of the veins, clots in the lung (pulmonary embolism),
• High blood pressure,
• Depression, insomnia,
• Conjunctivitis, visual problems,
• Reduced calcium levels 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

• Hearing loss,
• Scarring and thickening in the lungs with breathing difficulties, which can sometimes be fatal (interstitial lung disease),
• Temporary and reversible short-term loss of vision,
• Unexpected bleeding or bruising due to extensive blood clots in the small blood vessels of the body (disseminated intravascular coagulation), which can be fatal

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

• Appearance of blood or dark coffee-brown particles in your vomit,
• A kidney disease in which you excrete little or no urine (symptoms of acute kidney failure),
• Vascular disorders of the liver.

Not known: frequency cannot be estimated from the available data

• Allergic vasculitis (inflammation of the blood vessels),
• Autoimmune reaction that leads to the reduction of all blood cell lines (autoimmune pancytopenia), pancytopenia,
• Serious blood infection and low blood pressure (septic shock), which can be fatal,
• Seizures (uncontrolled shaking movements of the body),
• Spasm of the throat causing difficulty in breathing (laryngospasm),
• Extreme fatigue with reduced red blood cell count and shortness of breath (hemolytic anemia), alone or in combination with a low platelet count and kidney disease in which you excrete little or no urine (symptoms of hemolytic uremic syndrome). This has been reported to be fatal.
• Abnormal heart rhythm (QT prolongation), which can be seen on the electrocardiogram (ECG) and can be fatal,
• Myocardial infarction (heart attack), angina pectoris (pain or uncomfortable feeling in the chest).
• Muscle pain and swelling combined with weakness, fever or reddish-brown urine (symptoms of muscle damage called rhabdomyolysis), which can be fatal,
• Abdominal pain, nausea, bloody or coffee grounds-like vomiting or dark stools (tarry stools) (symptoms of a gastrointestinal ulcer with possible bleeding or perforation), which can be fatal,
• Oesophagitis (inflammation of the lining of the oesophagus -the tube that connect your mouth with your stomach -causing pain and difficulty swallowing).
• Decreased blood flow to the intestine/bowel (intestinal ischemia), which can be fatal,
• Risk of new cancer. Leukaemia, a form of blood cancer, has been reported in patients after being treated with Oxaliplatin SUN in combination with certain other medicines. Talk to your doctor about the possibility of an increased risk of this cancer if you are treated with Oxaliplatin SUN and certain other medicines.
• Benign abnormal nodules in the liver (focal nodular hyperplasia).

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

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.

This medicine is authorised in the Member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany Oxaliplatin SUN 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung

France Oxaliplatine SUN 5 mg/ml solution à diluer pour perfusion

Italy Oxaliplatino SUN 5 mg/ml concentrato per soluzione per infusione

Spain Oxaliplatino SUN 5 mg/ml concentrado para solución para perfusión EFG

The Netherlands Oxaliplatine SUN 5 mg/ml concentraat voor oplossing voor infusie

Norway Oksaliplatin SUN 5 mg/ml konsentrat til infusjonsvæske, oppløsning

United Kingdom (Northern Ireland) Oxaliplatin 5 mg/ml concentrate for solution for infusion