Anidulafungin (Intravenous Route)

    Anidulafungin (Intravenous Route)

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    Description and Brand Names of Anidulafungin (Intravenous Route)

    US Brand Name

    1. Eraxis

    Descriptions

    Anidulafungin is an antifungal medicine. It is used to treat fungal infections in the blood, abdomen or stomach, and esophagus (part of your throat where food passes from the pharynx to the stomach).

    This medicine is to be given only by or under the direct supervision of a doctor.

    This product is available in the following dosage forms:

    • Powder for Solution

    Before Using Anidulafungin (Intravenous Route)

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of anidulafungin injection in children 16 years of age and younger. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of anidulafungin injection in the elderly.

    Pregnancy

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Allergies to other echinocandin antifungal drugs (e.g., caspofungin [Cancidas®], micafungin [Mycamine®]) – Should not be used in patients with this condition.
    • Liver problems – Use with caution. May make this condition worse.

    Proper Use of Anidulafungin (Intravenous Route)

    A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in a vein and given over 45 minutes to 3 hours, depending on your dose

    Precautions

    It is very important that your doctor check you closely while you are receiving this medicine. This is to make sure the medicine has worked properly. Blood tests may be needed to check for unwanted effects.

    Tell your doctor right away if you have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes.

    This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

    It is important to tell your doctor if you are pregnant, planning to become pregnant.

    Side Effects of Anidulafungin (Intravenous Route)

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor or nurse immediately if any of the following side effects occur:

    Less common

    1. Black, tarry stools
    2. chills
    3. cough
    4. decreased urine
    5. dry mouth
    6. fever
    7. increased thirst
    8. irregular heartbeat
    9. loss of appetite
    10. lower back or side pain
    11. mood or mental changes
    12. muscle pain or cramps
    13. nausea or vomiting
    14. numbness or tingling in the hands, feet or lips
    15. painful or difficult urination
    16. pale skin
    17. seizures
    18. shortness of breath
    19. sore throat
    20. sores, ulcers, or white spots on the lips or in the mouth
    21. unusual bleeding or bruising
    22. unusual tiredness or weakness

    Rare

    1. Abdominal or stomach pain
    2. back pain
    3. bleeding gums
    4. blood in the urine or stools
    5. bloody stools
    6. bluish color of skin
    7. blurred or loss of vision
    8. changes in skin color
    9. chest pain
    10. chest tightness
    11. clay-colored stools
    12. constipation
    13. dark urine
    14. depression
    15. diarrhea
    16. dizziness
    17. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    18. drowsiness
    19. extra heartbeats
    20. fainting
    21. fast heartbeat
    22. flushed, dry skin
    23. flushing
    24. fruit-like breath odor
    25. headache
    26. hives or welts
    27. incoherent speech
    28. increased hunger
    29. increased urination
    30. irregular fast heartbeat
    31. irritability
    32. itching
    33. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    34. light-colored stools
    35. metallic taste
    36. muscle spasms (tetany) or twitching
    37. muscle weakness
    38. nervousness
    39. pain, redness, or swelling in the arm or leg
    40. pain, tenderness, and swelling of foot or leg
    41. pinpoint red spots on the skin
    42. pounding in the ears
    43. redness of the skin
    44. restlessness
    45. skin rash
    46. slow heartbeat
    47. sore mouth or tongue
    48. sweating
    49. swelling of the feet or lower legs
    50. swollen glands
    51. trembling
    52. trouble breathing
    53. unexplained weight loss
    54. unpleasant breath odor
    55. unusually warm skin
    56. vomiting of blood
    57. weakness
    58. weight loss
    59. white patches in the mouth or throat or on the tongue
    60. white patches with diaper rash
    61. yellow eyes or skin

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Rare

    1. Acid or sour stomach
    2. belching
    3. bloating or swelling of the face, arms, hands, lower legs, or feet
    4. disturbed color perception
    5. double vision
    6. eye pain
    7. feeling of warmth
    8. feeling unusually cold
    9. halos around light
    10. indigestion
    11. loss of bowel control
    12. night blindness
    13. over bright appearance of lights
    14. rapid weight gain
    15. redness of the face, neck, arms, and occasionally, upper chest
    16. shivering
    17. stomach discomfort or upset
    18. tingling of the hands or feet
    19. tunnel vision
    20. unusual weight gain or loss
    21. upper stomach pain

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.