Eraxis

DRUG DESCRIPTION

ERAXIS (anidulafungin) 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-?-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]-L-ornithine]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 (anidulafungin) 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 (11.2mg), 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:

ERAXIS™ (anidulafungin) Structural Formula Illustration

Prior to administration, ERAXIS (anidulafungin) 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).

What are the possible side effects of anidulafungin (Eraxis)?

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

Call your doctor at once if you have any of these serious side effects:

  • feeling light-headed or faint; or
  • confusion, weakness, dry mouth, or muscle tenderness.

Less serious side effects may include:

  • hot flashes;
  • diarrhea or constipation;
  • nausea, vomiting, stomach pain; or
  • ...

Read All Potential Side Effects and See Pictures of Eraxis »

What are the precautions when taking anidulafungin (Eraxis)?

Before using anidulafungin, tell your doctor or pharmacist if you are allergic to it; or to other echinocandins (e.g., caspofungin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Eraxis »


Eraxis Consumer (continued)

SIDE EFFECTS: Flushing, dizziness, diarrhea, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: swelling/pain at injection site, shortness of breath, dark urine, severe stomach/abdominal pain, yellowing eyes/skin, persistent nausea/vomiting, muscle weakness/spasm, vision changes, pain/redness/swelling of arms or legs, new signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, fast/slow/irregular heartbeat, seizures, increased urination/thirst, mental/mood changes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using anidulafungin, tell your doctor or pharmacist if you are allergic to it; or to other echinocandins (e.g., caspofungin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.


Eraxis Patient Information Including Side Effects

Brand Names: Eraxis

Generic Name: anidulafungin (injection) (Pronunciation: a nid yoo luh FUN jin)

  • What is anidulafungin (Eraxis)?
  • What are the possible side effects of anidulafungin (Eraxis)?
  • What is the most important information I should know about anidulafungin (Eraxis)?
  • What should I discuss with my health care provider before using anidulafungin (Eraxis)?
  • How is anidulafungin given (Eraxis)?
  • What happens if I miss a dose (Eraxis)?
  • What happens if I overdose (Eraxis)?
  • What should I avoid while using anidulafungin (Eraxis)?
  • What other drugs will affect anidulafungin (Eraxis)?
  • Where can I get more information?

What is anidulafungin (Eraxis)?

Anidulafungin is an antifungal antibiotic. It helps your body fight infection caused by a fungus.

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

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

What are the possible side effects of anidulafungin (Eraxis)?

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

Call your doctor at once if you have any of these serious side effects:

  • feeling light-headed or faint; or
  • confusion, weakness, dry mouth, or muscle tenderness.

Less serious side effects may include:

  • hot flashes;
  • diarrhea or constipation;
  • nausea, vomiting, stomach pain; or
  • headache.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about anidulafungin (Eraxis)?

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor.

Before using this medication, tell your doctor if you have liver disease.

There may be other drugs that can affect anidulafungin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Stop using this medication and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

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