Vexfan 6 mg

    Vexfan 6 mg

    S4

    API: Busulfan | Company: Eurolab

    1. What VEXFAN is and what it is used for

    What VEXFAN is
    VEXFAN contains the active substance ‘busulfan’, which belongs to a group of medicines called alkylating agents. VEXFAN destroys the original bone marrow before the transplant.

    What VEXFAN is used for
    VEXFAN is used in adults as a treatment prior to transplantation in combination with cyclophosphamide (used in adults to suppress the immune system). You will receive this preparative medicine before receiving a transplant of either bone marrow or haematopoietic progenitor cell.

    2. What you need to know before you use VEXFAN

    VEXFAN should not be administered to you
    • if you are hypersensitive (allergic) to busulfan or any of the other ingredients of VEXFAN (listed in section 6).
    • if you are pregnant or think you may be pregnant.
    • there is no experience of use of VEXFAN in children.
    • Liver failure.

    Warnings and Precautions

    VEXFAN is a potent cytotoxic medicine that results in profound decrease of blood cells. At the recommended dose, this is the desired effect. Therefore, careful monitoring will be performed, including frequent blood tests. It is possible that use of VEXFAN may increase the risk of suffering another malignancy or type of cancer in the future.

    Tell your doctor or healthcare professional before being given the injection:
    − if you have a liver, kidney, heart or lung problem.
    − if you have a history of seizures, head injury or receiving any potentially epileptic medicine.
    − if you have a prior history of chest or lung radiation.
    − If you plan to father children, as VEXFAN can cause infertility. It is advised not to father a child during and up to 6 months after treatment and to seek advice on preserving sperm prior to treatment because of the possibility of irreversible infertility due to therapy with VEXFAN.

    3. How to use VEXFAN

    Do not share medicines prescribed for you with any other person. Always use VEXFAN exactly as your doctor has told you. Check with your doctor if you are not sure.

    The dose of VEXFAN will be calculated according to your body weight.

    VEXFAN in combination with cyclophosphamide:
    − The recommended dose of VEXFAN is 0,8 mg/kg
    − Each infusion will last 2 hours
    − VEXFAN will be administered every 6 hours during 4 consecutive days, for a total of 16 doses prior to transplant.

    You will not be expected to give yourself VEXFAN. It will be given to you by a person who is qualified to do so. VEXFAN is administered by a qualified health care professional as a central intravenous infusion, after dilution of the individual vial.

    Medicines to be taken before you receive VEXFAN:
    Before receiving VEXFAN, you will be medicated with
    − anticonvulsive medicines to prevent seizures (phenytoin or benzodiazepines) and
    − anti-nausea medicines to prevent vomiting.

    If you use more VEXFAN than you should
    In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

    You will be closely monitored, and vigorous supportive measures taken as medically indicated. Symptoms of an overdose of busulfan includes tiredness, weakness, headache, shortness of breath, rapid heart rate, cold hands or feet, pale skin, bleeding problems. Overdose, due to exposure to the excipient Dimethylacetamide (DMA), may include symptoms of a rash, stomach pain, nausea and vomiting, tiredness, dark-coloured urine, light-coloured bowel movements, yellow skin and eyes, loss of appetite. Any central nervous system effects, that include confusion, abnormal thinking, anxiety, agitation, sleep disturbances, drowsiness.

    4. Possible side effects

    VEXFAN can have side effects. Not all side effects reported for VEXFAN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VEXFAN, please consult your doctor, pharmacist or other healthcare professional for advice.

    If any of the following happens, stop taking VEXFAN and tell your doctor immediately or go to the casualty department at your nearest hospital:
    • Graft-versus host disease (GVHD) - symptoms include mouth ulcers, abdominal pain and rash, as it is a major cause of death.
    • Pneumonia that can be fatal - symptoms include coughing, phlegm, fever, chills and difficulty breathing.
    • Hepatic Veno Occlusive Disease (HVOD), a potentially life-threatening condition where small veins in the liver are obstructed. Signs and symptoms include weight gain, yellowing of the skin and eyes, dark coloured urine and an increase in liver size.
    • Life-threatening acute respiratory distress syndrome. Symptoms include shortness of breath, rapid breathing, blue skin, coughing, muscle weakness.
    • Encephalopathy - symptoms include declining ability to reason and concentrate, memory loss, personality change, seizures and twitching.
    • Cerebral haemorrhage (a brain bleed). Symptoms may include numbness or weakness in part of the face, difficulty speaking or walking, decreased level of consciousness.
    • Respiratory failure (condition in which your blood doesn’t pass enough oxygen into your blood).
    • Alveolar haemorrhage, a life-threatening disorder that causes bleeding in the respiratory tract.

    These are all very serious side effects. If you have them, you may have had a serious reaction to VEXFAN. 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:
    • Yellowed skin and eyes, stomach pain and swelling, nausea, vomiting, tiredness, dark-coloured urine. All can be signs of liver complications.
    • A fall in the number of white blood cells (the cells that fight infection), platelets (the cells that help the blood to clot, which may lead to bleeding disorders) and red blood cells (anaemia leading to tiredness and weakness).
    • Hives, rash, fever, itching, wheezing or breathing problems, as you may experience an allergic reaction.
    • Dysrythmia (irregular heartbeat).

    5. How to store VEXFAN

    • Store all medicines out of reach of children.
    • Store at 2 - 8 °C under refrigerated conditions. Keep in the outer carton until required for use.
    Storage after Dilution: VEXFAN, when diluted under aseptic conditions in 0,9 % Sodium Chloride Injection, USP or 5 % Dextrose Injection, USP is stable at room temperature (25 °C) for up to 8 hours, but the infusion must be completed within that timeframe. VEXFAN, when diluted under aseptic conditions in 0,9 % Sodium Chloride Injection, USP is stable at refrigerated conditions (2 °C - 8 °C) for up to 12 hours, but the infusion must be completed within that timeframe. Although chemical and physical stability of the reconstituted solution has been demonstrated, from a microbiological point of view, VEXFAN should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
    • Do not use after the expiry date stated on the label / carton/ bottle.
    • Do not use VEXFAN if you notice any visible signs of deterioration.
    • Return all unused medicine to your pharmacist.
    • Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

    Shelf-life 24 months

    Important Disclaimer

    The Vexfan 6 mg professional information leaflet below is the property of Eurolab 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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