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    XARELTO STARTER PACK

    RIVAROXABAN ORAL (XARELTO)

    BOXED WARNINGS: (A) DISCONTINUING XARELTO IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION INCREASES RISK OF STROKE, (B) SPINAL/EPIDURAL HEMATOMA
    See full prescribing information for complete boxed warning

    A. DISCONTINUING XARELTO IN PATIENTS WITH
    NONVALVULAR ATRIAL FIBRILLATION Discontinuing XARELTO places patients at an increased risk of thrombotic events. If anticoagulation with XARELTO must be discontinued for a reason other than pathological bleeding, consider administering another anticoagulant

    B. SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas have occurred in patients treated with XARELTO who are receiving neuraxial anesthesia or undergoing spinal
    puncture. These hematomas may result in long-term or permanent paralysis
    Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary
    Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis
    -----------------------------------Contraindications------------------------------------
    • Hypersensitivity to XARELTO
    • Active major bleeding

    -----------------------------Warnings and Precautions-----------------------------
    • Risk of bleeding: XARELTO can cause serious and fatal bleeding. Promptly evaluate signs and symptoms of blood loss.
    • Pregnancy related hemorrhage: Use XARELTO with caution in pregnant women due to the potential for obstetric hemorrhage and/or emergent delivery. Promptly evaluate signs and symptoms of blood loss.
    • Patients with Prosthetic Heart Valves - The safety and efficacy of Xarelto have not been studied in patients with prosthetic heart valves. Therefore, use of Xarelto is not recommended in these patients.

    BEFORE USING THIS MEDICINE: Tell your doctor: TOP
    If you are PREGNANT; If you are BREAST FEEDING.
    Tell your doctor if you are having any of the following conditions: TOP
    BLEEDING PROBLEMS; KIDNEY DISEASE; MAJOR SURGERY.
    * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding.
    * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use.
    HOW MEDICINE IS ADMINISTERED? TOP
    Use this medicine exactly as directed on the label, unless instructed differently by your doctor
    * Take WITH the evening meal unless instructed differently by your physician.
    * DO NOT skip doses or discontinue unless directed by your doctor.
    WARNINGS/PRECAUTIONS: TOP
    * Notify doctor if there are symptoms that suggest BLEEDING, such as black tarry stools or "coffee ground" vomit.
    * Because of INTERACTIONS, report the use of any other prescription or nonprescription medicines, including natural/herbal remedies, to your doctor.
    * Inform doctor or dentist that you are taking this medicine BEFORE HAVING ANY KIND OF SURGERY including dental surgery or medical procedure.
    * Notify doctor if you are pregnant, if pregnancy is suspected, or if you intend to become pregnant.
    * Notify your doctor if you are a nursing mother before breast-feeding your baby.
    * Inform your doctor if you have KIDNEY DISEASE; monitoring of renal function and/or dose adjustment may be necessary.
    Other Common Side Effects: TOP
    Unusual bleeding or bruising; Nausea; Diarrhea; Severe skin itching with patches; Mouth ulcers; Skin inflammation; Baldness; Headache; Indigestion; Stomach discomfort or pain; Gastro-esophageal reflux.
    Other Common Side Effects:
    If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY.
    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
    This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients.



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