Abiraterone

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  • For more information, please download leaflet.

    • The brand name of your medication is XYBRONE ® and the generic name is Abiraterone acetate.
    • XYBRONE ® is anticancer product which blocks production of androgen in body. Androgen are male hormones and can cause tumor growth in prostate gland.
    • This medication is tablet in dosage of 250 mg packed in a bottle of 120 tablets.

    1 Why is XYBRONE® prescribed?

    XYBRONE® is used to metastatic prostate cancers which is untreatable with other medications or surgery. This drug is used in combination with Dexamethasone.

    2 How film coated tablet of XYBRONE® should be taken?

    • Take XYBRONE® according to your doctor’s order. Your doctor will talk to you about amount and interval of using tablets.
    • XYBRONE® is usually prescribed 4 tablets of 250mg per day. Most of the time prednisolone is prescribed twice a day.
    • Take XYBRONE® on an empty stomach and with water. No food should be eaten 2 hours before and 1 hour after taking tablets. Taking XYBRONE® with food can affect drug absorption which may lead to increase side effects.
    • Take tablets whole, do not crush or chew tablets.
    • During use of XYBRONE®, your blood pressure should be monitored. You may need blood test occasionally during treatment.
    • Do not stop taking your prescribed dose of Abiraterone acetate without physician’s order.
    • Store XYBRONE® at room temperature between (15-30 C). Keep away from light and moisture.
    • Consult your doctor or pharmacist about the safe way to throw out your medication.
    • If you have any more question about XYBRONE® talk to your doctor, pharmacist or other health care providers.

    3 What special precautions should you follow during your treatment with XYBRONE®?

    • If you have adrenal problems, talk with your doctor.
    • If you have heart disease, talk with your doctor.
    • If you have liver disease, talk with your doctor.
    • During using Xybrone®, have your blood checked and inform your doctor about the result.
    • Talk with your doctor about all medications (prescription, natural products, vitamins, OTC). This product may have interactions with them.
    • Never stop taking any medication like Xybrone® and prednisolone with our physicia’s order.
    • Women who are pregnant or planning to become pregnant should avoid touching or handling Xybrone® without gloves.
    • Men, who are using Xybrone® and have a pregnant partner or their partner may become pregnant, should use condom during and 3 weeks after treatment.

    4 What are some side effects that you need to call your doctor about right away?

    • If you see any sensitivity symptoms like any skin rash, hives, itching, redness, swelling, blisters, wheezing, difficulty in breathing or talking, roughness in voice, swelling in mouth, face, lips, tongue or throat;
    • Signs of infection. These include a fever of 38°C or higher, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, wound that will not heal, or anal itching or pain, sever dizziness or fainting;
    • Irregular heart beat;
    • Swelling in leg or feet or pain in feet
    • Urinary discomfort or pain during urination;
    • Increase in blood pressure with following signs: Sever headache, blurred vision, Palpitation in ears and neck, nose bleeding, anxiety, sever chest pain and difficulty in breathing
    • Increase in blood sugar with following signs: Feeling thirty, frequent urination, feeling hungry, dry mouth, fruity-smell breathing; feeling sleepy, dry skin, blurred vision and weight decrease;
    • Liver problems with following signs: nausea, pain in upper abdomen, itching, tiredness, loss of appetite, change in urine color (dark urine), change in stool color (clay color), yellowish skin and eyes;
    • Symptoms like: dizziness, irregular heartbeat, sever thirst, polyuria, feeling discomfort in legs or foot drop;
    • Signs of decrease in adrenal hormone levels like sever fatigue or muscle weakness, feeling dizzy, nausea, vomiting, diarrhea and weight decrease;
    • Sudden change in mood and logical thinking;
    • any chronic side effect;

    5 What is the storage condition of XYBRONE®?

    Store XYBRONE® away from light and moisture and at 15-30°C.

    Keep drugs out of reach of children.

    XYBRONE® should not be used after expiry date.

  • For more information, please download leaflet.

    • ABIRATERONE acetate, the active ingredient of XYBRONE® is the acetyl ester of abiraterone.
    • Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase).
    • Each XYBRONE® tablet contains 250 mg of ABIRATERONE acetate.

    1 INDICATIONS AND USAGE

    XYBRONE® (ABIRATERONE acetate) is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.

    2 DOSAGE AND ADMINISTRATION

    The recommended dose of ABIRATERONE acetate is 1,000 mg (four 250 mg tablets) administered orally once daily in combination with prednisolone 5 mg administered orally twice daily. ABIRATERONE acetate must be taken on an empty stomach. No food should be consumed for at least two hours before the dose of ABIRATERONE acetate is taken and for at least one hour after the dose of ABIRATERONE acetate is taken. The tablets should be swallowed whole with water. Do not crush or chew tablets.

    3 CONTRAINDICATIONS:

    3.1. Pregnancy

    ABIRATERONE acetate can cause fetal harm when administered to a pregnant woman. ABIRATERONE acetate is not indicated for use in women who are or may become pregnant. ABIRATERONE acetate is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss.

    4 USE IN SPECIAL POPULATIONS

      4.1. Pregnancy:

      Pregnancy Risk Factor: X

      ABIRATERONE acetate can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. While there are no adequate and well-controlled studies with ABIRATERONE acetate in pregnant women and ABIRATERONE acetate is not indicated for use in women, it is important to know that maternal use of a CYP17 inhibitor could affect development of the fetus. ABIRATERONE acetate is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss. Advice females of reproductive potential to avoid becoming pregnant during treatment with ABIRATERONE acetate.

      4.2. NURSING MOTHERS:

      Excretion in breast milk unknown/not recommended ABIRATERONE acetate is not indicated for use in women. It is not known if ABIRATERONE acetate is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from ABIRATERONE acetate, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.

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