Anidulafungin

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy, sweaty, or if you have chest tightness or trouble breathing.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• trouble breathing;
• pain or burning when you urinate;
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or
• low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Common side effects may include:

• upset stomach, nausea, vomiting, diarrhea;
• fever;
• headache; or
• anemia.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

ERAXIS for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains anidulafungin. ERAXIS (anidulafungin) is a semi-synthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans. Anidulafungin is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls.

ERAXIS (anidulafungin) is 1-[(4R,5R)-4,5-dihydroxy-N2-[[4"-(pentyloxy)[1,1’:4’,1"-terphenyl]-4-yl]carbonyl]-Lornithine]echinocandin B. Anidulafungin is a white to off-white powder that is practically insoluble in water and slightly soluble in ethanol. In addition to the active ingredient, anidulafungin, ERAXIS for Injection contains the following inactive ingredients:

50 mg/vial -fructose (50 mg), mannitol (250 mg), polysorbate 80 (125 mg), tartaric acid (5.6 mg), and sodium hydroxide and/or hydrochloric acid for pH adjustment.

100 mg/vial -fructose (100 mg), mannitol (500 mg), polysorbate 80 (250 mg), tartaric acid (11.2 mg), and sodium hydroxide and/or hydrochloric acid for pH adjustment.

The empirical formula of anidulafungin is C58H73N7O17 and the formula weight is 1140.3.

The structural formula is:

Prior to administration, ERAXIS for Injection requires reconstitution with sterile Water for Injection and subsequent dilution with either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline).

DO NOT dilute with other solutions or co-infuse with other medications or electrolytes [see DOSAGE AND ADMINISTRATION].

Included as part of the "PRECAUTIONS" Section

Anidulafungin may be found in some form under the following brand names:

• Eraxis

Anidulafungin is an antifungal medication that fights infections caused by fungus.

Anidulafungin treats candida (yeast) infections in the blood, or in the stomach or esophagus.

Anidulafungin may also be used for purposes not listed in this medication guide.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
• Chest pain or pressure.
• Coughing up blood.
• Trouble passing urine.
• Pain when passing urine.
• Very bad dizziness or passing out.
• Fever or chills.
• Sore throat.
• Flushing.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Very bad headache.
• Shortness of breath.
• Swelling in the arms or legs.

>10%:

Cardiovascular: Hypotension (15%), hypertension (12%), peripheral edema (11%)

Central nervous system: Insomnia (15%)

Endocrine & metabolic: Hypokalemia (≤25%), hypomagnesemia (12%)

Gastrointestinal: Nausea (7% to 24%), diarrhea (9% to 18%), vomiting (7% to 18%)

Genitourinary: Urinary tract infection (15%)

Hepatic: Increased serum alkaline phosphatase (12%)

Infection: Bacteremia (18%)

Respiratory: Dyspnea (12%)

Miscellaneous: Fever (9% to 18%)

2% to 10%:

Cardiovascular: Deep vein thrombosis (10%), chest pain (5%)

Central nervous system: Confusion (8%), headache (8%), depression (6%)

Dermatologic: Decubitus ulcer (5%)

Endocrine & metabolic: Hypoglycemia (7%), dehydration (6%), hyperglycemia (6%), hyperkalemia (6%)

Gastrointestinal: Constipation (8%), dyspepsia (7%), abdominal pain (6%), oral candidiasis (5%)

Hematologic & oncologic: Anemia (8% to 9%), leukocytosis (5% to 8%), thrombocythemia (6%)

Hepatic: Increased serum transaminases (≤5%)

Infection: Sepsis (7%)

Neuromuscular & skeletal: Back pain (5%)

Renal: Increased serum creatinine (5%)

Respiratory: Pleural effusion (10%), cough (7%), pneumonia (6%), respiratory distress (6%)

<2% (Limited to important or life-threatening): Anaphylactic shock, anaphylaxis, angioedema, atrial fibrillation, blood coagulation disorder, blurred vision, cholestasis, clostridium infection, ECG abnormality (including ECG changes – prolonged Q-T interval), hepatic insufficiency, hepatic necrosis, hepatitis, increased amylase, infusion related reaction, prolonged prothrombin time, right bundle branch block, seizure, sinus arrhythmia, thrombocytopenia, thrombophlebitis, ventricular premature contractions

Liver function tests

Adverse effects were observed in animal reproduction studies. Other agents are currently preferred for the treatment of Candida infections in pregnant women (IDSA [Pappas 2016]).

Your pharmacist can provide more information about anidulafungin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Initial dose: 100 mg IV on Day 1
Maintenance dose: 50 mg IV once a day thereafter

Duration: Treatment should be given for a minimum of 14 days and for at least 7 days following resolution of symptoms. Treatment duration should be based on the patient's clinical response. If the patient is infected with HIV, suppressive antifungal therapy may be considered after a course of treatment to minimize the risk of relapse.

No adjustment recommended.

Clinically significant hepatic abnormalities have occurred in some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with anidulafungin. Patients who develop abnormal liver function tests during anidulafungin therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing anidulafungin therapy.

Anaphylactic reactions (including shock) were reported with anidulafungin. If these reactions occur, anidulafungin should be discontinued and appropriate treatment administered.

Safety and effectiveness have not been established in pediatric patients 16 years of age or younger.

The rate of infusion should not exceed 1.1 mg/minute.