Pronunciation:

ay-nid-ue-la-FUN-jin

Brand Names:

• Eraxis

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antifungal

Pharmacologic—

Glucan Synthesis Inhibitor

Chemical—

Echinocandin

Uses of This Medicine:

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.

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:

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Levoketoconazole
• Methotrexate

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 of This Medicine:

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 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.

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 of This Medicine:

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

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

numbness or tingling in the hands, feet or lips

painful or difficult urination

pale skin

seizures

sore throat

sores, ulcers, or white spots on the lips or in the mouth

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Rare

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 or tightness

clay-colored stools

constipation

dark urine

depression

diarrhea

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

extra heartbeats

fainting

fast heartbeat

flushed, dry skin

flushing

fruit-like breath odor

headache

hives or welts

incoherent speech

increased hunger

increased urination

irregular fast heartbeat

irritability

itching

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

nervousness

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

restlessness

skin rash

slow heartbeat

sore mouth or tongue

stomach pain

sweating

swelling of the feet or lower legs

swollen glands

trembling

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:

Rare

Acid or sour stomach

belching

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

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 or upset

tingling of the hands or feet

tunnel vision

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.