5 mg / ml concentrate for solution for infusion
oxaliplatin
What Oxaliplatin Fresenius Kabi is and what it is used for
The active substance in oxaliplatin concentrate for solution for infusion is oxaliplatin.
Oxaliplatin Fresenius Kabi is used to treat colon cancer (treatment of stage III colon cancer after complete removal of the primary tumor or metastatic cancer of the colon and rectum). Oxaliplatin is used in combination with the cancer drugs 5-fluorouracil and folic acid.
Oxaliplatin Fresenius Kabi is an antineoplastic drug for cancer that contains platinum.
Oxaliplatin Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you are given Oxaliplatin Fresenius kabi
Do not use Oxaliplatin Fresenius Kabi if:
- you are allergic to oxaliplatin or any of the other ingredients of this medicine (listed in section 6).
- you breastfeed.
- you have already decreased the number of red or white blood cells .
- you already have tingling and numbness in your fingers and / or toes and have difficulty performing fine movements, such as pressing buttons.
- you have severe kidney problems.
Warnings and cautions
Talk to your doctor or pharmacist before using Oxaliplatin Fresenius Kabi
- if you have ever had an allergic reaction to medicines containing platinum, e.g. carboplatin and cisplatin. Allergic reactions may occur with infusion of oxaliplatin.
- if you have moderate or mild renal impairment.
- if you have any liver problems or get abnormal liver values during treatment.
- 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 or postpone your treatment or discontinue your oxaliplatin treatment.
- 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 or postpone your treatment with oxaliplatin.
- If you have unexplained respiratory problems such as coughing or difficulty breathing. Your doctor may discontinue oxaliplatin treatment.
- 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 have a decreased white blood cell count .
- 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 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 ) that 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 Fresenius Kabi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.
Pregnancy
- You should avoid getting pregnant when you are being treated with oxaliplatin and you must use an effective method of contraception. 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 tell your doctor immediately.
Breast-feeding
- You must not breast-feed while being treated with oxaliplatin.
Fertility
- Oxaliplatin may impair fertility and this effect may be permanent. Male patients should seek advice on the possibilities of preserving semen before treatment.
- Male patients are advised not to have children during treatment and for the following 6 months, and should use appropriate contraception during this time.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Treatment with oxaliplatin can lead to an increased risk of dizziness, nausea and vomiting, and other neurological symptoms that affect gait and balance. If this happens, do not drive or use machines. If you experience vision problems while using Oxaliplatin Fresenius Kabi, 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 attention. 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 give Oxaliplatin Fresenius Kabi
Oxaliplatin is for adults only.
For single use only.
Dosage
Dose one of oxaliplatin is based on body surface area. It is calculated according to your height and weight.
The usual dose for adults, including the elderly, is 85 mg / m 2 body surface area.
The dose you receive also depends on the results of blood tests and any side effects you have had with oxaliplatin before.
Method of administration and route of administration
- Oxaliplatin Fresenius Kabi is prescribed by a cancer treatment specialist.
- You will be treated by healthcare professionals, who will prepare an appropriate dose of oxaliplatin.
- Oxaliplatin Fresenius Kabi is given as a slow injection into a vein ( intravenous infusion ) for 2 to 6 hours.
- Oxaliplatin Fresenius Kabi is given concomitantly with folic acid and before infusion one of 5-fluorouracil.
Dosage interval
You will normally receive an infusion once every two weeks.
Treatment
time Your doctor decides how long the treatment should last. The treatment will last for a maximum of 6 months if you are treated after a tumor has been removed.
If you take more Oxaliplatin Fresenius Kabi than you should
Because this medicine is given by healthcare professionals, you are unlikely to get too little or too much. In case of overdose, you may experience more side effects. 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, nurse, or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any side effects, it is important that you tell your doctor before the next treatment.
Side effects that you may experience are described below.
Tell your doctor immediately if you notice any of the following :
- Symptoms of allergic or anaphylactic reaction with sudden signs such as rash, itching or hives on the skin, 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 be felt as if you are fainting). In most cases, these symptoms occur during infusion one or immediately afterwards, but delayed allergic reactions have also been observed several hours or 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
- Stomatitis / mucositis (sore lips or cold sores).
- Respiratory symptoms such as dry cough or mucus cough, difficulty breathing or rattling, shortness of breath and wheezing that can be symptoms of severe lung disease that can be fatal.
- A group of symptoms such as headache, altered mental ability, seizures and abnormal vision, from blurred vision to loss of vision (symptoms of reversible posterior eukoencephalopathy syndrome, an unusual neurological disease).
- Symptoms of stroke (sudden severe headache, confusion, difficulty seeing in one or both eyes, numbness or feeling of weakness in face, arm or leg, usually on one side, facial paralysis, difficulty walking, dizziness, balance difficulties and difficulty speaking.)
- 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 little or not at all (symptoms of hemolytic-uremic syndrome).
Other known side effects of oxaliplatin are:
Very common: may affect more than 1 user in 10
- Oxaliplatin can 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 can cause diarrhea, mild nausea and vomiting, but you will usually be given medicines to prevent nausea before and possibly after treatment.
- Oxaliplatin 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 one,
- Fever, stiffness ( tremor ), mild or severe fatigue, pain in the body,
- Weight changes, loss of appetite, changes in taste, constipation,
- Headache, back pain,
- Swelling of the nerves to the muscles, stiff 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 users
- 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 of 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 fatal (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
- 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 leading to reduction of all types of blood cells ( autoimmune pancytopenia)
- Severe blood infection 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 ( hemolytic anemia ), alone or together with a low platelet count and kidney disease that causes you to urinate little or nothing at all (symptoms of hemolytic uremic syndrome ) which can be fatal,
- Abnormal heart rhythm (long QT syndrome), which can be seen using electrocardiograms ( ECG ) and which can have a fatal outcome,
- Muscle pain and swelling, in combination with weakness, fever or reddish-brown urine (symptoms of muscle damage called rhabdomyolysis ) that 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 may be fatal;
- Decreased blood flow to the lining of the intestines (intestinal ischemia) which can be fatal,
- Risk of new cancer. One type of blood cancer, leukemia , has been reported in patients taking oxaliplatin in combination with other medicines. Talk to your doctor about the possible increased risk of this type of cancer when you are treated with oxaliplatin in combination with other medicines,
- Heart attack, angina (pain or discomfort in the chest)
- Inflammation of the esophagus (which causes pain and difficulty swallowing)
How to store Oxaliplatin Fresenius Kabi
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and carton after EXP or EXP. The expiration date is the last day of the specified month.
Keep the vial in the outer carton. Sensitive to light. Do not freeze. Do not store above 25 ° C.
Do not use this medicine if the solution is not clear and free of particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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.
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 other ingredients are water for injections.
What the medicine looks like and contents of the pack
This medicine is a concentrated solution for infusion. It is a clear colorless solution without visible particles.
Each vial contains 50 mg, 100 mg, or 200 mg of oxaliplatin. The concentrate is supplied in 10 ml, 20 ml and 40 ml type I clear glass vials with chlorobutyl elastomer stopper and aluminum flip-off cap (green (10 ml = 50 mg), blue (20 ml = 100 mg) and red (40 ml = 200 mg )). Each vial can be enclosed in shrink wrap and possibly packed in a plastic container.
The bottles are supplied individually in cardboard.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany