Description and Brand Names

Información sobre medicamentos proporcionada por: IBM Micromedex

US Brand Name

  1. Eraxis

Descriptions


Anidulafungin is an antifungal medicine. It is used to treat fungal infections including candidemia (fungal infection in the blood), candida peritonitis and abscess (fungal infection in the stomach), esophageal candidiasis (fungal infection in the esophagus), and other fungal infections (including infections in 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

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 younger than 1 month of age with candidemia or candida peritonitis and abscess. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of anidulafungin injection in children with esophageal candidiasis. 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. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

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 (eg, caspofungin [Cancidas®], micafungin [Mycamine®])—Should not be used in patients with this condition.
  • Fructose intolerance (rare hereditary problem)—Should not be used in patients with this condition.
  • Liver disease—Use with caution. May make this condition worse.

Proper Use

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. This medicine is given slowly, so the needle will have to remain in place for 45 minutes to 3 hours.

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.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause a serious type of allergic reaction called anaphylaxis, which 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.

This medicine contains polysorbate 80, which can increase the risk for polysorbate toxicity in low-birth weight infants. Talk with your doctor if you have any concerns about this.

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

Side Effects

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
  14. numbness or tingling in the hands, feet or lips
  15. painful or difficult urination
  16. pale skin
  17. seizures
  18. sore throat
  19. sores, ulcers, or white spots on the lips or in the mouth
  20. trouble breathing
  21. unusual bleeding or bruising
  22. unusual tiredness or weakness
  23. vomiting

Rare

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

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.