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Anidulafungin (Intravenous Route)

US Brand Names

Description

Anidulafungin is an antifungal. It is used to help the body overcome serious fungus infections. This medicine is available only with your doctor's prescription.

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of anidulafungin in children with use in other age groups.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

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 (Caspofungin [e.g., Cancidas], Micafungin [e.g., Mycamine])—You should not use anidulafungin.

• Liver problems—This medicine may cause liver problems to become worse.

Proper Use

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • Adults—At first, the dose is 200 milligrams (mg) injected into a vein. After that, the dose is 100 mg a day injected into a vein. For a fungal infection of the esophagus, the first dose is 100 mg and after that the dose is 50 mg a day.
  • Children—Use and dose must be determined by your doctor.

Precautions

It is important that you adhere to your doctor's treatment plan for you.

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 immediately if any of the following side effects occur:

• Black, tarry stools
• Chills
• Cough
• Decreased urine
• Dry mouth
• Fever
• Increased thirst
• Irregular heartbeat
• Loss of appetite
• Lower back or side pain
• Mood or mental changes
• Muscle pain or cramps
• Nausea or vomiting
• Numbness or tingling in hands, feet or lips
• Painful or difficult urination
• Pale skin
• Seizures
• Shortness of breath
• Sore throat
• Sores, ulcers, or white spots on lips or in mouth
• Unusual bleeding or bruising
• Unusual tiredness or weakness

• Abdominal or stomach pain
• Back pain
• Bleeding gums
• Blood in urine or stools
• Bloody stools
• Bluish color of skin
• Blurred or loss of vision
• Changes in skin color
• Chest pain
• Chest tightness
• Clay-colored stools
• Confusion
• Constipation
• Dark urine
• Depression
• Diarrhea
• Dizziness
• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• Drowsiness
• Extra heartbeats
• Fainting
• Fast heartbeat
• Fatigue
• Flushed, dry skin
• Flushing
• Fruit-like breath odor
• Headache
• High blood pressure
• Hives or welts
• Incoherent speech
• Increased hunger
• Increased urination
• Infection of blood
• Irregular fast heartbeat
• Irritability
• Itching
• Large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• Light-colored stools
• Metallic taste
• Muscle spasms (tetany) or twitching
• Muscle weakness
• Nervousness
• Pain, redness or swelling in arm or leg
• Pain, tenderness, and swelling of foot or leg
• Palpitations
• Pinpoint red spots on skin
• Pounding in the ears
• Redness of skin
• Restlessness
• Skin rash
• Slow heartbeat
• Sore mouth or tongue
• Sweating
• Swelling of feet or lower legs
• Swollen glands
• Trembling
• Trouble breathing
• Unexplained weight loss
• Unpleasant breath odor
• Unusually warm skin
• Vomiting of blood
• Weakness
• Weight loss
• White patches in the mouth or throat or on the tongue
• White patches with diaper rash
• 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:

• Acid or sour stomach
• Belching
• Bloating or swelling of face, arms, hands, lower legs, or feet
• Disturbed color perception
• Double vision
• Eye pain
• Feeling of warmth
• Feeling unusually cold
• Halos around light
• Hot flushes
• Indigestion
• Loss of bowel control
• Night blindness
• Over bright appearance of lights
• Rapid weight gain
• Redness of the face, neck, arms and occasionally, upper chest
• Shivering
• Stomach discomfort, upset, or pain
• Tingling of hands or feet
• Tunnel vision
• Unusual weight gain or loss
• 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.

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