Oxaliplatin 5 mg/ml concentrate for solution for infusion

oxaliplatin

Oxaliplatin is an anticancer drug that contains platinum.

Oxaliplatin is used to treat metastatic (advanced) cancer of the colon (large bowel) or rectum (back passage), or as additional treatment following surgery to remove a tumour (growth) in the colon. It is used in combination with other anticancer agents, 5-fluorouracil and folinic acid.

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.

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:

Very common: may affect more than 1 in 10 people

• allergies/allergic reactions, occurring mainly during infusion, sometimes fatal
• stomatitis / mucositis (sore lips or mouth ulcers)
• low platelet count, abnormal bruising (thrombocytopenia). Your doctor will take blood to check that you have sufficient blood cells before you start treatment and before each subsequent course.
• unexplained respiratory symptoms such as dry cough, difficulties in breathing or crackles.

Common: may affect up to 1 in 10 people

• 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)
• 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.
• pain in the chest or upper back, difficulty breathing and coughing up blood (symptoms of clots in the lungs).

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
• difficulty in hearing, vertigo, ringing in ears.

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

• unexpected bleeding or bruising due to widespread blood clots throughout the small blood vessels of the body (disseminated intravascular coagulation), which may be fatal
• abnormal bruising, bleeding or signs of infection such as a sore throat and high temperature
• persistent or severe diarrhoea or vomiting
• reversible short-term loss of vision
• 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)
• extreme tiredness with decreased number of red blood cells, and shortness of breath (haemolytic anaemia), alone or combined with low platelet count, abnormal bruising (thrombocytopenia) and kidney disease where you pass little or no urine (symptoms of Haemolytic-uraemic syndrome)
• scarring and thickening in the lungs with difficulties in breathing, sometimes fatal (interstitial lung disease)
• pain in upper abdomen and pain associated with nausea and vomiting.

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

• kidney disease where you pass little or no urine (symptoms of acute renal failure)
• vascular disorders of the liver (symptoms include abdominal pain and swelling, weight gain and tissue swelling of the feet, ankles or other parts of the body).

Not known: frequency cannot be estimated from the available data

• serious infection of the blood and low blood pressure (septic shock), which may be fatal
• abnormal heart rhythm (QT prolongation), that can be seen on electrocardiogram (ECG), which may be fatal
• 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-coloured/tarry stools (symptoms of gastrointestinal ulcer, with potential bleeding or perforation), which may be fatal
• decreased blood flow to the intestine/bowel (intestinal ischaemia), which may be fatal
• spasm of the throat causing difficulty in breathing
• auto-immune reaction leading to reduction of all blood cell lines (autoimmune pancytopenia) (symptoms include easy bleeding, easy bruising, shortness of breath, extreme lethargy and weakness, and an increased risk of infection due to the immune compromised state)
• 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 drooping, trouble walking, dizziness, loss of balance and speech difficulty)
• pneumonia (serious lung infection) which may be fatal
• Non-cancerous abnormal liver nodules (focal nodular hyperplasia).

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 disappear 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); however medication to prevent the sickness is usually given before treatment and may be continued after 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 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
• abnormal tongue sensation possibly altering speech
• stomach pain
• abnormal bleeding including nose bleeds
• allergic reactions, skin rash including red and itchy skin, mild hair loss (alopecia)
• alteration in blood tests including those relating to abnormalities on liver function.

Common: may affect up to 1 in 10 people

• indigestion and heart burn, hiccups, flushing and 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
• high blood pressure
• depression and sleeplessness (insomnia)
• conjunctivitis and visual problems
• decreased levels of calcium in the blood
• swelling of the nerves to the muscles, neck stiffness
• fall.

Uncommon: may affect up to 1 in 100 people

• nervousness.

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

• loss of hearing.

Not known: frequency cannot be estimated from the available data

• allergic vasculitis (inflammation of blood vessels)
• convulsion (uncontrolled shaking of the body)
• myocardial infarction (heart attack), angina pectoris (pain or uncomfortable feeling in the chest)
• oesophageal inflammation (inflammation of the lining of the oesophagus - the tube that connects your mouth with your stomach- resulting in pain and swallowing difficulty)
• risk of new cancers. Leukemia, a form of blood cancer, has been reported in patients after taking oxaliplatin concentrate for solution for infusion in combination with certain other medicines. Talk to your doctor about the potential for increased risk of this type of cancer when you are given Oxaliplatin 5 mg/ml concentrate for solution for infusion and certain other medicines.

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