Anidulafungin (Intravenous route)
- Powder for Solution
Glucan Synthesis Inhibitor
Uses of This Medicine:
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.
Before Using This Medicine:
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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of anidulafungin injection in the elderly.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
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.
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 This Medicine:
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 While Using This Medicine:
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 This Medicine:
- Less common
- Black, tarry stools
- decreased urine
- dry mouth
- 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 the hands, feet or lips
- painful or difficult urination
- pale skin
- shortness of breath
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- Abdominal or stomach pain
- back pain
- bleeding gums
- blood in the 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
- dark urine
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- extra heartbeats
- fast heartbeat
- flushed, dry skin
- fruit-like breath odor
- hives or welts
- incoherent speech
- increased hunger
- increased urination
- irregular fast heartbeat
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- metallic taste
- muscle spasms (tetany) or twitching
- muscle weakness
- pain, redness, or swelling in the arm or leg
- pain, tenderness, and swelling of foot or leg
- pinpoint red spots on the skin
- pounding in the ears
- redness of the skin
- skin rash
- slow heartbeat
- sore mouth or tongue
- swelling of the feet or lower legs
- swollen glands
- trouble breathing
- unexplained weight loss
- unpleasant breath odor
- unusually warm skin
- vomiting of blood
- weight loss
- white patches in the mouth or throat or on the tongue
- white patches with diaper rash
- yellow eyes or skin
- Acid or sour stomach
- bloating or swelling of the face, arms, hands, lower legs, or feet
- disturbed color perception
- double vision
- eye pain
- feeling of warmth
- feeling unusually cold
- halos around light
- loss of bowel control
- night blindness
- over bright appearance of lights
- rapid weight gain
- redness of the face, neck, arms, and occasionally, upper chest
- stomach discomfort or upset
- tingling of the hands or feet
- tunnel vision
- unusual weight gain or loss
- upper stomach pain
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:
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:
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.
Last Updated: 9/4/2017