Anidulafungin

What is Anidulafungin?

• Anidulafungin (Eraxis) is an echinocandin antifungal used for the treatment of Candidemia and other forms of Candida infections and Esophageal candidiasis.

Anidulafungin structure

Anidulafungin

What are the uses of this medicine?

Anidulafungin (Eraxis) used for the treatment of the following infections:

• Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older).
• Esophageal candidiasis in adults.

Limitations of use:

• Anidulafungin (Eraxis) has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida or in sufficient numbers of neutropenic patients.
• Anidulafungin (Eraxis) is associated with high relapse rates in esophageal candidiasis.

How does this medicine work?

• Anidulafungin is an anti-fungal drug.
• Anidulafungin is a semi-synthetic echinocandin with antifungal activity.
• Anidulafungin inhibits glucan synthase, an enzyme present in fungal, but not mammalian cells.
• This results in inhibition of the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall.

Who Should Not Use this medicine ?

This medicine have cannot be used in patients with:

• with known hypersensitivity to anidulafungin, any component of Eraxis, or other echinocandins.
• with known or suspected Hereditary Fructose Intolerance (HFI).

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• Cyclosporine
• Voriconazole
• Tacrolimus
• Rifampin
• Amphotericin B Liposome for Injection

Is this medicine FDA approved?

• Three echinocandins are available for use: caspofungin (kas" poe fun' jin), micafungin (mye" ka fun' jin) and anidulafungin (ay nid" ue la fun' jin).
• Caspofungin was approved for use in the United States in 2001, micafungin in 2005 and anidulafungin in 2006.

How should this medicine be used?

Recommended dosage: Recommended Dosage in Adults: Candidemia and other Candida infections:

• The recommended dose is a single 200 mg loading dose of Eraxis on Day 1, followed by a 100 mg once daily maintenance dose thereafter.
• Duration of treatment should be based on the patient's clinical response.
• In general, antifungal therapy should continue for at least 14 days after the last positive culture.

Esophageal Candidiasis:

• The recommended dose is a single 100 mg loading dose of Eraxis on Day 1, followed by a 50 mg once daily maintenance dose thereafter. Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms.

Recommended Dosage in Pediatric Patients (1 Month of Age and Older): Candidemia and other Candida infections:

• The recommended dose is a single loading dose of 3 mg/kg (not to exceed 200 mg) of Eraxis on Day 1, followed by a once daily maintenance dose of 1.5 mg/kg (not to exceed 100 mg) of Eraxis thereafter.
• Overall antifungal treatment should continue for at least 14 days after the last positive culture.

Administration:

• Anidulafungin (Eraxis) comes as injection.
• Eraxis for Injection must be reconstituted with sterile Water for Injection and subsequently diluted only with 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline), prior to administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter or discoloration is identified, discard the solution.
• The rate of infusion should not exceed 1.1 mg/minute [equivalent to 1.4 mL/minute or 84 mL/hour when reconstituted and diluted per instructions].

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 50 mg, and 100 mg as a lyophilized powder in a single-dose vial for reconstitution

This medicine is available in fallowing brand namesː

• Eraxis

What side effects can this medication cause?

The most common side effects of this medicine include: In Adults: Candidemia and other forms of Candida infections:

• hypokalemia, nausea, diarrhea, vomiting, pyrexia, insomnia, hypotension.

Esophageal candidiasis:

• diarrhea, pyrexia, anemia, headache, vomiting, nausea, dyspepsia, oral candidiasis, and hypokalemia.

In Pediatric Patients (1 month and older): Candidemia and other forms of Candida infections:

• diarrhea, vomiting, pyrexia, abdominal pain, anemia, thrombocytopenia, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) increased, hypoglycemia, epistaxis, and rash.

The most serious adverse reactions may include:

• Hepatic Adverse Reactions
• Anaphylactic and Hypersensitivity Reactions

What special precautions should I follow?

• Laboratory abnormalities in liver tests have been seen in healthy volunteers and pediatric patients treated with Eraxis. Patients who develop abnormal liver tests during Eraxis therapy should be monitored for evidence of worsening hepatic tests and evaluated for risk/benefit of continuing Eraxis therapy.
• Anaphylactic reactions, including shock were reported with the use of Eraxis. Risk of infusion-related adverse reactions, possibly histamine-mediated, including rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension; to reduce occurrence, do not exceed a rate of infusion of 1.1 mg/minute.
• Eraxis contains polysorbate 80, an inactive ingredient. Thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension, and metabolic acidosis have been reported in low-birth weight infants receiving high doses of polysorbate. Eraxis is not approved in pediatric patients younger than 1 month of age.
• Eraxis contains fructose. Risk of metabolic crisis with life-threatening hypoglycemia, hypophosphatemia, lactic acidosis, and hepatic failure. Obtain history of HFI symptoms in pediatric patients before Eraxis administration.
• Advise pregnant women and females of reproductive potential of the potential risk of Eraxis to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy.
• Eraxis can cause transient and asymptomatic serum aminotransferase elevations, and individual instances of acute liver injury have been observed during therapy with these agents, but none has been definitely shown to cause clinically apparent acute drug induced liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• transaminase elevations

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Anidulafungin is not dialyzable.

Can this medicine be used in pregnancy?

• Based on findings from animal studies, Eraxis can cause fetal harm when administered to a pregnant woman.
• There are no available human data on the use of Eraxis in pregnant women to inform a drug-associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Eraxis in patients younger than 1 month of age with candidemia/invasive candidiasis has not been established.
• The safety and effectiveness of Eraxis in pediatric patients with esophageal candidiasis has not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• ANIDULAFUNGIN

Inactive ingredients:

• FRUCTOSE
• MANNITOL
• POLYSORBATE 80
• TARTARIC ACID
• SODIUM HYDROXIDE
• HYDROCHLORIC ACID

Who manufactures and distributes this medicine?

Distributed by:

• Roerig
• Division of Pfizer Inc

What should I know about storage and disposal of this medication?

• Eraxis (unreconstituted) vials should be stored in a refrigerator at 2°C – 8°C (36°F – 46°F).
• Do not freeze.
• Excursions for 96 hours up to 25°C (77°F) are permitted, and the vial can be returned to storage at 2°C – 8°C (36°F – 46°F).
• Eraxis reconstituted solution can be stored at up to 25°C (77°F) for up to 24 hours.
• Eraxis infusion solution can be stored at temperatures up to 25°C (77°F) for up to 48 hours.
• Do not freeze.

• Dailymed label info on Anidulafungin
• FDA Anidulafungin

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