Oxaliplatin Key Injection

    Oxaliplatin Key Injection

    S4

    API: Oxaliplatin | Company: Key Oncologics

    1. What OXALIPLATIN KEY is and what it is used for

    What OXALIPLATIN KEY is:
    Oxaliplatin belongs to the group of medicines called antineoplastics. This medicine interferes with the growth of cancer cells to eventually destroy the cancer cells and is used in combination with other anticancer medicines.

    What it is used for:
    • Treatment of advanced large bowel (colon) or back passage (rectum) cancer;
    • Additional treatment of large bowel (colon) cancer.

    2. What you need to know before you are given OXALIPLATIN KEY

    OXALIPLATIN KEY should not be administered to you:
    • if you are hypersensitive (allergic) to oxaliplatin or any of the other ingredients of oxaliplatin key (listed in section 6);
    • if you suffer from severe kidney disease;
    • if you are pregnant or breastfeeding;
    • if you suffer from bone marrow failure or suppression;
    • if you already have tingling and numbness in the fingers and/or toes, and have difficulty performing delicate tasks, such as buttoning clothes. You may be suffering from a disease that damages the nerves, called peripheral sensory neuropathy;
    • if you already have reduced number of blood cells (white blood cells and/or platelets);
    • if you have damage to the lungs.

    Warnings and precautions

    Tell your doctor or healthcare provider before being given the infusion:
    • if you have a history of allergic reactions to any other platinum containing medicines, such as carboplatin, cisplatin etc.;
    • if you have moderate kidney disease;
    • if you have nerve damage (neuropathy);
    • if you have any liver problems or disease;
    • if your blood cell counts are too low after previous treatment. Your doctor will perform tests to check that you have sufficient blood cells before treatment;
    • if you are pregnant, breastfeeding or planning a pregnancy. It is not recommended that you become pregnant during treatment with OXALIPLATIN KEY and you must use an effective method of contraception. Potentially fertile patients should take appropriate contraceptive measures during and after stopping therapy, continuing for 4 months in women and 6 months in men;
    • OXALIPLATIN KEY may have an antifertility effect, which may be irreversible. Male patients are therefore advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment;
    • if you have or had heart disorders such as an abnormal electrical signal called prolongation of the QT interval, an irregular heartbeat, or a family history of heart problems. Don’t have immunisations with live vaccines while you’re having treatment. Ask your doctor or pharmacist how long you should avoid live vaccinations. You can have other vaccines, but they might not give you as much protection as usual.

    3. How to receive OXALIPLATIN KEY

    Do not share medicines prescribed for you with any other person.
    OXALIPLATIN KEY should only be used in specialised departments of oncology and administered under the supervision of an experienced oncologist.
    The usual dose is:
    FOR ADULTS ONLY:
    • OXALIPLATIN KEY will be administered intravenously by your doctor or under his supervision.
    • Your doctor will determine the exact dosage that you will need. The dosage may vary according to the type of cancer that you have.
    • The recommended dose is administered intravenously over 2 to 6 hours and usually repeated every two weeks.
    • Your doctor will tell you how long your treatment with OXALIPLATIN KEY will last.
    • If you have the impression that the effect of OXALIPLATIN KEY is too strong or too weak, tell your doctor or pharmacist.
    • You will not be expected to give yourself OXALIPLATIN KEY. It will be given to you by a person who is qualified to do so.

    4. Possible side effects

    OXALIPLATIN KEY can have side effects.
    Not all side effects reported for OXALIPLATIN KEY are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking OXALIPLATIN KEY, please consult your healthcare provider for advice.
    If any of the following happens, stop receiving OXALIPLATIN KEY and tell your doctor immediately or go to the casualty department at your nearest hospital:
    • swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
    • rash or itching,
    • fainting,
    • 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),
    • pain in the chest or upper back, difficulty breathing and coughing up blood (symptoms of clots in the lungs),
    • unexpected bleeding or bruising due to widespread blood clots throughout the small blood vessels of the body (disseminated intravascular coagulation), which may be fatal. Blood clots, usually in the leg, which can cause pain, swelling or redness,
    • headache, altered mental functioning, seizures (fits) and abnormal vision from blurriness to vision loss (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder),
    • scarring and thickening in the lungs with difficulties in breathing, sometimes fatal (interstitial lung disease),
    • serious infection of the blood and low blood pressure (septic shock), which may be fatal,
    • kidney disease where you pass little or no urine (symptoms of Haemolytic-uraemic syndrome),
    • 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),
    • abnormal heart rhythm (QT prolongation), that can be seen on electrocardiogram (ECG), which may be fatal,
    • pneumonia (serious lung infection) 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,
    • muscle pain and swelling, in combination with weakness, fever, or red-brown urine (symptoms of muscle damage called rhabdomyolysis), which may be fatal.

    These are all very serious side effects. If you have them, you may have had a serious allergic reaction to OXALIPLATIN KEY. You may need urgent medical attention or hospitalisation.
    Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
    • abnormal bruising, bleeding or signs of infection such as a sore throat and high temperature,
    • persistent or severe diarrhoea or vomiting,
    • sore lips or mouth ulcers (stomatitis/mucositis),
    • unexplained symptoms affecting your breathing system, such as non-productive cough, breathing difficulties,
    • effects on the nerves (peripheral sensory 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. This side effect is 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,
    • some people have experienced a tingling shock-like sensation passing down the arms or trunk when the neck is flexed,
    • OXALIPLATIN KEY 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,
    • decreased number of red blood cells, which may make the skin pale, and cause weakness or breathlessness. Your doctor will take blood to check that you have sufficient blood cells before you start treatment and before each subsequent course,
    • blood abnormality (lack of platelets) caused by an allergic reaction associated with bruises and abnormal bleeding (immunoallergic thrombocytopenia),
    These are all serious side effects. You may need urgent medical attention.

    5. How to store OXALIPLATIN KEY

    Store all medicines out of reach of children.
    Store at or below 25 ° C.
    Store in the original package/container.
    Keep the container in the outer carton.
    Protect from light.
    Do not store in a bathroom.
    Do not use after the expiry date stated on the label/carto/bottle.
    Return all unused medicine to your pharmacist.
    Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

    Important Disclaimer

    The Oxaliplatin Key Injection professional information leaflet below is the property of Key Oncologics and is provided on Somayeza exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Somayeza serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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