5 mg / ml concentrate for solution for infusion
oxaliplatin
What Oxaliplatin Teva is and what it is used for
The active substance in Oxaliplatin Teva is oxaliplatin.
Oxaliplatin is used to treat colon cancer (treatment of stage III colon cancer after complete removal of the primary tumor or metastatic colon cancer). Oxaliplatin is used in combination with other anticancer medicines, called 5-fluorouracil and folic acid. Oxaliplatin Teva is a cytostatic (cancer drug) and contains platinum.
Oxaliplatin contained in Oxaliplatin Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Oxaliplatin Teva
You should not receive Oxaliplatin Teva:
- if you are allergic to oxaliplatin or any of the other ingredients of this medicine (listed in section 6)
- if you are breast-feeding (see also section “Pregnancy, breast-feeding and fertility”)
- if you have already reduced the number of red blood cells
- if you already have tingling and numbness in your fingers and / or toes and have difficulty performing movements that require precision, such as pressing buttons
- if you have severe kidney problems
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Oxaliplatin Teva
- if you have ever had an allergic reaction to platinum-containing medicines, e.g. carboplatin or cisplatin. Allergic reactions may occur during any oxaliplatin infusion
- if you have mild to moderate kidney problems
- if you have any liver problems or abnormal liver function test results
- if you have or have had heart problems , such as abnormal electrical signals called long QT syndrome, irregular heartbeat or previous family heart problems.
If you ever experience any of the following, tell your doctor immediately. Your doctor may need to treat you for these events. Your doctor may need to lower your dose of Oxaliplatin Teva or postpone your treatment or discontinue your treatment with Oxaliplatin Teva.
- If you get an unpleasant sensation in the throat, especially when swallowing, which gives a feeling of shortness of breath during treatment.
- If you get nerve problems in your hands and feet, such as numbness, tingling or decreased sensation.
- If you get headaches, altered mental ability, seizures and abnormal vision, from blurred vision to vision loss.
- If you feel sick or vomit.
- If you get severe diarrhea.
- If you get sore lips or sores in your mouth (mucositis / stomatitis).
- If you get diarrhea or a decreased number of white blood cells or platelets . Your doctor may reduce the dose of Oxaliplatin Teva or postpone your treatment with Oxaliplatin Teva.
- If you have unexplained respiratory problems such as coughing or difficulty breathing. Your doctor may stop you on taking Oxaliplatin Teva.
- If you develop extreme fatigue, shortness of breath or kidney disease where you urinate very little or not at all (symptoms of acute kidney failure ).
- If you get a fever (temperature above or equal to 38 ° C) or chills, which may be a sign of an infection . You may be at risk of getting an infection in the blood (blood poisoning).
- If you get a fever above 38 ° C. Your doctor may need to check if you also have a decreased number of white blood cells .
- If you get unexpected bleeding or bruising because it may be a sign of blood clots in the small blood vessels in your body (disseminated intravascular coagulation ).
- If you faint (lose consciousness) or have an irregular heartbeat while taking Oxaliplatin Teva as it may be a sign of a serious heart condition.
- If you get muscle pain and swelling, combined with weakness, fever or reddish-brown urine. It can be a sign of muscle damage ( rhabdomyolysis ) and can lead to kidney problems or other complications.
- If you experience abdominal pain, nausea, bloody vomiting or vomiting that looks like coffee grounds or dark-colored / tar-like stools, which may be a sign of a wound in the gastrointestinal tract with possible bleeding or holes.
- If you experience abdominal pain (stomach pain), bloody diarrhea and nausea and / or vomiting, which may be caused by a decrease in blood flow to the lining of the intestines (intestinal ischemia).
Other medicines and Oxaliplatin Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Pregnancy
- You should avoid becoming pregnant during treatment with oxaliplatin and you must use an effective contraceptive during treatment. Female patients should use appropriate contraception to prevent pregnancy during treatment and for 4 months after stopping treatment.
- If you are pregnant or planning to become pregnant, it is very important that you talk to your doctor about this before starting treatment.
- If you become pregnant during treatment, you must inform your doctor immediately.
Breast-feeding
- You must not breast-feed while being treated with oxaliplatin.
Fertility
- Oxaliplatin can cause infertility which can be permanent. Male patients should seek advice on freezing semen before starting treatment.
- Male patients are advised not to do anything with children during treatment and up to 6 months after stopping treatment and should use appropriate contraception during this period.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Treatment with oxaliplatin may increase the risk of dizziness, nausea, and vomiting as well as other neurological symptoms that affect gait and balance. About such side effects occur, do not drive or use machines. If you experience vision problems while using Oxaliplatin Teva, do not drive, operate machinery or perform hazardous activities.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to get Oxaliplatin Teva
Oxaliplatin Teva is for adults only.
For single use only.
Dosage
Dose an Oxaliplatin Teva based on your body surface area. It is calculated based on your height and weight. The recommended dose for adults including the elderly is 85 mg / m² body surface area. The dose you receive also depends on the results of blood tests and whether you have previously experienced side effects from Oxaliplatin Teva.
Method of administration and route of administration
- Oxaliplatin Teva is prescribed by a doctor who specializes in cancer treatment.
- You will be treated by healthcare professionals who prepare the estimated dose of Oxaliplatin Teva.
- Oxaliplatin Teva is given as a slow injection into a vein (an intravenous infusion ) for 2 to 6 hours.
- Oxaliplatin Teva is given concomitantly with folic acid and before infusion one of 5-fluorouracil.
Administration interval
You usually receive your infusion once every two weeks.
Treatment time
The treatment time is determined by your doctor. The treatment will last for a maximum of 6 months if you are treated after the tumor has been completely removed.
If you take more Oxaliplatin Teva than you should
Because this medicine is given by healthcare professionals, it is very unlikely that you will get too much or too little.
In case of overdose, the side effects may be aggravated. Your doctor may give you appropriate treatment for these side effects.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
If you forget to take Oxaliplatin Teva
The doctor will determine the time of each treatment session. If you think you have missed a dose, contact your doctor as soon as possible.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effects, talk to your doctor before taking this medicine.
Side effects that you may experience are described below.
Contact a doctor immediately if you get any of the following symptoms:
- 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 (it may feel like you fainting). In most cases, these symptoms occur during infusion or immediately after, but delayed allergic reactions have also been observed hours or even days after infusion one.
- Abnormal bruising, bleeding or signs of infection , such as sore throat and fever.
- Persistent or severe diarrhea or vomiting.
- Blood or dark brown coffee-colored grains in vomit.
- Sore lips or sores in the mouth (mucositis / stomatitis).
- Unexplained respiratory problems such as dry cough, difficulty breathing or wheezing.
- A group of symptoms such as headache, mental retardation, seizures and abnormal vision, from blurred vision to loss of vision (symptoms of reversible posterior leukoencephalopathy syndrome, an unusual neurological disease).
- Extreme fatigue with a decrease in red blood cells and shortness of breath ( hemolytic anemia ), alone or in combination with low platelet counts , abnormal bruising ( thrombocytopenia ) and kidney disease where you urinate very little or not at all (symptoms of hemolytic-uremic syndrome).
Other known side effects of Oxaliplatin Teva are:
Very common (may affect more than 1 user in 10):
- Oxaliplatin Teva may affect the nerves ( peripheral neuropathy ). You may experience tingling and / or numbness in the fingers, toes, around the mouth or in the throat, which can sometimes occur in connection with cramps.
- These effects are often triggered by exposure to cold, for example when you open the refrigerator or hold a cold drink. You may also find it difficult to perform fine motor movements, such as pushing buttons. Although these symptoms in most cases disappear completely on their own, there is a risk of persistent symptoms of peripheral sensory neuropathy after the end of treatment. Some have experienced a stinging, shock-like sensation along the arms or torso when bending at the neck.
- Oxaliplatin can in some cases cause an unpleasant sensation in the throat, especially when swallowing, which gives a feeling of shortness of breath. If that feeling occurs, it usually occurs during or within a few hours after infusion one, and it can be triggered by exposure to cold. Although the feeling is unpleasant, it is short-lived and passes without treatment. Your doctor may change your treatment because of this.
- Oxaliplatin Teva may cause diarrhea, mild nausea and vomiting, but you will usually be given medicines to prevent nausea before and after treatment.
- Oxaliplatin Teva causes a temporary decrease in the number of blood cells . The decrease in red blood cells can lead to anemia ( anemia ), abnormal bleeding or bruising (due to a decrease in the number of platelets ). The decrease in white blood cells can make you susceptible to infection . Your doctor will take blood samples to check that you have a sufficient number of blood cells before starting treatment and before each subsequent round of treatment.
- Feeling of discomfort near or at the injection site during infusion .
- Fever, stiffness ( tremor ), mild or pronounced fatigue, pain in the body.
- Weight changes, loss of appetite, changes in taste, constipation.
- Headache, back pain.
- Swelling of the nerves to the muscles, stiffness in the neck, abnormal sensation in the tongue that can affect speech, stomatitis / mucositis (sore lips or sores in the mouth).
- Stomach pain.
- Abnormal bleeding, including nosebleeds.
- Cough, difficulty breathing.
- Allergic reactions, skin rashes that may be red and itchy, mild hair loss ( alopecia ).
- Altered blood levels, including those associated with abnormal liver function.
Common (may affect up to 1 in 10 people):
- Infection caused by decreased white blood cell count .
- Serious infection in the blood in combination with decreased white blood cell count ( neutropenic sepsis ), which can be fatal,
- Decreased 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 and heartburn, hiccups, redness , dizziness.
- Increased sweating and nail diseases, flaky skin.
- Chest pain.
- Lung diseases and runny nose.
- Joint pain and skeletal pain.
- Pain when urinating and changes in kidney function, altered urination frequency, dehydration.
- Blood in the urine / feces, swelling of veins, blood clot in the lung.
- High blood pressure .
- Depression and insomnia.
- Conjunctivitis in the eye and vision problems.
- Decreased calcium levels in the blood.
- Fall accident
Uncommon (may affect up to 1 in 100 people):
- Serious infection in the blood (blood poisoning), which can be fatal.
- Blockage or swelling in the intestine.
- Nervousness.
Rare (may affect up to 1 in 1,000 people):
- Hearing loss.
- Scarring and thickening of the lungs with difficulty breathing, sometimes with fatal outcome (interstitial lung disease).
- Short-term vision loss.
- Unexpected bleeding or bruising due to extensive blood clots in the body’s small blood vessels (disseminated intravascular coagulation ), which can be fatal.
Very rare (may affect up to 1 in 10,000 people):
- Presence of blood or dark brown, coffee-colored grains in vomit.
- Kidney disease where you urinate little or nothing at all (symptoms of acute kidney failure ).
- Vascular diseases of the liver.
Has been reported (occurs in an unknown number of users):
- Allergic vasculitis (inflammation of blood vessels).
- Autoimmune reaction that leads to a decrease in all types of blood cells ( autoimmune pancytopenia).
- Severe infection in the blood and low blood pressure ( septic shock ), which can be fatal.
- Seizures (uncontrolled tremors in the body).
- Spasm is in the throat that causes difficulty breathing.
- Extreme fatigue with decreased red blood cell count and shortness of breath ( haemolytic anemia ), alone or with a low platelet count and kidney disease that causes you to urinate very little or nothing at all (symptoms of haemolytic uremic syndrome ), which can be fatal, have been reported .
- Abnormal heart rhythm (long QT syndrome), which can be seen using electrocardiograms ( ECG ) and which can be fatal.
- Muscle pain and swelling, in combination with weakness, fever or reddish-brown urine (symptoms of muscle damage called rhabdomyolysis ), which can be fatal.
- Abdominal pain, nausea, bloody vomiting or vomiting similar to coffee grounds or dark-colored, tar-like stools (signs of ulcers in the gastrointestinal tract with possible bleeding or holes), which can be fatal.
- Decreased blood flow to the lining of the intestines (intestinal ischemia), which can be fatal.
- Myocardial infarction, angina (pain or discomfort in the chest)
- Esophagitis ( inflammation of the esophagus – the tube that connects your mouth to your stomach – resulting in pain and difficulty swallowing),
- Post-treatment blood cancer (secondary leukemia ),
- Decreased number of all types of blood cells (pancytopenia),
- Disease or disorder affecting blood flow in the brain (ischemic and hemorrhagic cerebrovascular disease),
- Infection affecting the lungs ( pneumonia ) with possible difficulty breathing (bronchopneumonia), which can be fatal.
How to store Oxaliplatin Teva
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C. Keep the vial in the outer carton. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP”. respectively “EXP”. The expiration date is the last day of the specified month.
Oxaliplatin must not come into contact with eyes or skin. Tell your doctor or nurse immediately if any medicines should be spilled.
After completion of the infusion, the remaining Oxaliplatin Teva will be disposed of by your doctor or nurse.
Contents of the package and other information
Content declaration
- The active substance is oxaliplatin; 1 ml concentrate for solution for infusion contains 5 mg oxaliplatin.
- The other ingredients are lactose monohydrate and water for injections.
What the medicine looks like and contents of the pack
Oxaliplatin Teva is a clear, colorless, or almost colorless solution in a stained glass vial with a bromobutyl rubber stopper aluminum seal and polypropylene snap cap.
4 ml concentrate for solution for infusion contains 20 mg oxaliplatin.
10 ml concentrate for solution for infusion contains 50 mg oxaliplatin.
20 ml concentrate for solution for infusion contains 100 mg oxaliplatin.
40 ml concentrate for solution for infusion contains 200 mg oxaliplatin.
The vials are delivered in cartons, each containing a vial.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer:
Pharmachemie BV
Swensweg 5
2031 GA Haarlem, The Netherlands