Anidulafungin

Name: Anidulafungin

Administration

IV Preparation

Aseptically reconstitute each 50 mg vial with 15 mL supplied diluent to obtain a 3.33 mg/mL solution

Administer within 24 hr post-reconstitution

Dilute further by transferring aseptically in a bag or bottle containing D5W or 0.9% NaCl to provide an infusion solution of 0.5 mg/mL

Discard if particulate matter or discoloration appears

IV Administration

IV infusion rate: Not to exceed 1.1 mg/min

Do not give as IV bolus

Storage

Unopened vials: Store at 25°C (77°F)

Reconstituted vials and diluted solutions: May store at 25° (77°F) for up to 24 hr

Do not freeze

Overdose

During clinical trials a single 400 mg dose of ERAXIS was inadvertently administered as a loading dose. No clinical adverse events were reported. In a study of 10 healthy subjects administered a loading dose of 260 mg followed by 130 mg daily, ERAXIS was generally well tolerated; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (≤3 x ULN) [see WARNINGS AND PRECAUTIONS].

Anidulafungin is not dialyzable.

The maximum non-lethal dose of anidulafungin in rats was 50 mg/kg, a dose which is equivalent to 10 times the recommended daily dose for esophageal candidiasis (50 mg/day) or equivalent to 5 times the recommended daily dose for candidemia and other Candida infections (100 mg/day), based on relative body surface area comparisons.

Anidulafungin Interactions

This is not a complete list of Anidulafungindrug interactions. Ask your doctor or pharmacist for more information.

Anidulafungin Dosage

Take anidulafungin exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Anidulafungin dose your doctor recommends will be based on the following (use any or all that apply):

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your weight
  • your height
  • your age
  • your gender

Anidulafungin is available in the following doses:

  • Anidulafungin 100 Mg Intravenous Powder For Injection
  • Anidulafungin 50 Mg Intravenous Powder For Injection

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What should I discuss with my health care provider before using anidulafungin?

You should not use this medicine if you are allergic to anidulafungin, caspofungin (Cancidas), micafungin (Mycamine), or similar antifungal medicines.

To make sure you can safely use anidulafungin, tell your doctor if you have liver disease.

FDA pregnancy category C. It is not known whether anidulafungin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether anidulafungin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is anidulafungin given?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Anidulafungin is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Anidulafungin is a powder medicine that must be mixed with a liquid (diluent) before using it. You will then need to dilute this mixture into a solution with another liquid in an IV bag. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Anidulafungin is sometimes given for up to 14 days after lab tests show that the infection has cleared. Use this medicine for the full prescribed length of time. Anidulafungin will not treat a viral infection such as the flu or a common cold.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Store the dry powder medicine in a refrigerator. Do not freeze.

After you mix the powder and diluent, you may store this mixture at room temperature for up to 24 hours before further diluting it. The final diluted solution may be stored at room temperature for up to 48 hours.

You may also store the diluted solution in a freezer for at least 72 hours before using it.

Do not use anidulafungin diluted solution if it has changed colors or has particles in it. Call your pharmacist for new medication.

Anidulafungin Dosage and Administration

Administration

IV Administration

Administer by slow IV infusion.1 Do not administer by rapid IV injection.1

Do not admix or infuse concomitantly with other drugs.1

Must be reconstituted and diluted prior to administration.1 Use strict aseptic technique since the drug contains no preservatives.1

Reconstitution

Reconstitute 50- or 100-mg vials of lyophilized anidulafungin with 15 or 30 mL, respectively, of sterile water for injection to provide a solution containing 3.33 mg/mL.1

Dilution

Dilute total contents of the required number of reconstituted vials in 50, 100, or 200 mL of 5% dextrose injection or 0.9% sodium chloride injection as directed to provide an IV infusion solution containing 0.77 mg/mL.1 (See Table.)

Instructions for Diluting Reconstituted Vials of Anidulafungin1

Anidulafungin Dose Indicated

Number of Reconstituted Vials Required

Required Volume of Diluent (5% Dextrose Injection or 0.9% Sodium Chloride Injection)

Total Infusion Volume of 0.77-mg/mL Solution

Minimum Duration of Infusion (minutes)

50 mg

One 50-mg vial

50 mL

65 mL

45

100 mg

Two 50-mg vials or one 100-mg vial

100 mL

130 mL

90

200 mg

Four 50-mg vials or two 100-mg vials

200 mL

260 mL

180

Rate of Administration

Administer by IV infusion at a rate not exceeding 1.1 mg/minute (1.4 mL/minute).1 More rapid infusion may increase risk of histamine-mediated reactions.1 (See Histamine-mediated Reactions under Cautions.)

Dosage

Pediatric Patients

General Pediatric Dosage† IV

AAP recommends a loading dose of 1.5–3 mg/kg, followed by 0.75–1.5 mg/kg once daily.292

Candidemia and Other Invasive Candida Infections IV

HIV-infected children ≥2 years of age†: Some experts recommend an initial loading dose of 3 mg/kg on day 1, followed by 1.5 mg/kg once daily.441

IDSA recommends that antifungal treatment for candidemia (without persistent fungemia or metastatic complications) be continued for 2 weeks after documented clearance of Candida from the bloodstream, resolution of candidemia symptoms, and resolution of neutropenia.425

Esophageal Candidiasis IV

HIV-infected children ≥2 years of age†: Some experts recommend an initial loading dose of 3 mg/kg on day 1, followed by 1.5 mg/kg (up to 100 mg) once daily.441

HIV-infected adolescents†: A single 100-mg loading dose on day 1, followed by 50 mg once daily.440

IDSA and others recommend that antifungal treatment for esophageal candidiasis be continued for 14–21 days.425 440

Adults

Candidemia and Other Invasive Candida Infections IV

A single 200-mg loading dose on day 1, followed by 100 mg once daily.1 425

IDSA states consider a transition from the echinocandin to fluconazole (usually within 5–7 days) in patients who are clinically stable, have isolates susceptible to fluconazole (e.g., C. albicans), and have negative repeat blood cultures after initial antifungal treatment.425

Duration of treatment is based on clinical response.1 Manufacturer recommends anidulafungin be continued for at least 14 days after last positive culture.1 IDSA recommend that antifungal treatment for candidemia (without persistent fungemia or metastatic complications) be continued for 2 weeks after documented clearance of Candida from the bloodstream and resolution of candidemia symptoms and neutropenia.425

Osteoarticular infections†: IDSA recommends 100 mg once daily.425 After ≥2 weeks, can switch to fluconazole.425

Endocarditis† (native or prosthetic valve) or implantable cardiac device infections†: IDSA recommends 200 mg once daily.425 If infection caused by fluconazole-susceptible Candida, can switch to fluconazole after patient stabilized and Candida has been cleared from bloodstream.425

Esophageal Candidiasis IV

A single 100-mg loading dose on day 1, followed by 50 mg once daily is recommended by the manufacturer.1

IDSA recommends 200 mg once daily if anidulafungin used for treatment of esophageal candidiasis, including fluconazole-refractory disease (see Esophageal Candidiasis under Uses).425

HIV-infected adults: A single 100-mg loading dose on day 1, followed by 50 mg once daily.440

Duration of treatment is based on clinical response.1 Manufacturer recommends a minimum of 14 days and at least 7 days following resolution of symptoms.1 IDSA and others recommend that antifungal treatment be continued for 14–21 days.425 440

Oropharyngeal Candidiasis† IV

IDSA recommends a single 200-mg loading dose on day 1, followed by 100 mg once daily for 7–14 days.425

Candida auris Infections IV

CDC recommends a single 200-mg loading dose on day 1, followed by 100 mg once daily.510

Aspergillosis† IV

Some experts recommend a single 200-mg loading dose, followed by 100 mg daily.440

Duration of treatment is based on severity of patient's underlying disease, recovery from immunosuppression, and clinical response.423 440 IDSA recommends that treatment of invasive pulmonary aspergillosis be continued for at least 6–12 weeks.423

Special Populations

Hepatic Impairment

Mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, or C): Dosage adjustments not necessary.1

Renal Impairment

Mild, moderate, or severe renal impairment: Dosage adjustments not necessary.1

Not dialyzable;1 may administer without regard to dialysis timing.1 2 4 5 7 11

Geriatric Patients

Adults ≥65 years of age: Dosage adjustments not necessary.1 7 11

Cautions for Anidulafungin

Contraindications

  • Known hypersensitivity to anidulafungin, other echinocandin antifungals (e.g., caspofungin, micafungin), or any ingredient in the formulation.1

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactic reactions, including anaphylactic shock, reported in patients receiving anidulafungin.1 If such reactions occur, discontinue the drug and administer appropriate treatment.1

Possible histamine-mediated symptoms (e.g., rash, urticaria, flushing, pruritus, dyspnea, hypotension).1 6 12 Reported infrequently when infusion rate does not exceed 1.1 mg/minute.1

Infusion-related adverse reactions (e.g., rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, hypotension) reported and possibly may be histamine-mediated reactions.1 6 12 To reduce occurrence of such reactions, do not exceed infusion rate of 1.1 mg/minute.1

Hepatic Effects

Abnormal liver function test results reported.1 Clinically important hepatic dysfunction, hepatitis, or worsening hepatic failure reported in patients with serious underlying conditions receiving multiple drugs concomitantly; causal relationship not established.1

If abnormal liver function test results occur, monitor for evidence of worsening hepatic function and evaluate benefits versus risks of continuing anidulafungin therapy.1

Selection and Use of Antifungals

Obtain specimens for fungal culture and other relevant laboratory studies (e.g., histopathology) prior to initiation of therapy.1 Therapy may be started pending results; adjust therapy as needed when results available.1

Specific Populations

Pregnancy

Category B.1

No adequate and well-controlled studies in pregnant women;1 use during pregnancy only if clearly needed.1

In rats, crosses the placenta, is detected in fetal plasma, and has been associated with incomplete ossification of several bones.1

Lactation

Distributed into milk in rats; not known whether distributed into human milk.1

Use with caution in nursing women.1

Pediatric Use

Safety and efficacy not established in pediatric patients ≤16 years of age.1

Has been used in a limited number of neutropenic children 2–17 years of age† without unusual adverse effects.18

Although data limited, some experts state anidulafungin can be considered for first-line treatment of invasive candidiasis or for alternative treatment of esophageal candidiasis in HIV-infected children 2–17 years of age†.441

Geriatric Use

No overall differences in efficacy or safety were observed between adults ≥65 years of age and younger adults, but possibility that some older patients may have increased sensitivity to the drug cannot be ruled out.1

Hepatic Impairment

Mild, moderate or severe hepatic impairment (Child-Pugh class A, B, or C): No clinically important effects on pharmacokinetics;1 dosage adjustments not necessary.1

Renal Impairment

Mild, moderate, or severe renal impairment: No clinically important effects on pharmacokinetics;1 dosage adjustments not necessary.1

Common Adverse Effects

GI effects (nausea,1 3 5 6 8 diarrhea,1 vomiting1 , dyspepsia1 ), phlebitis/thrombophlebitis,3 5 6 hypokalemia,1 8 12 increased ALT,3 increased alkaline phosphatase,1 increased γ-glutamyltransferase (GGT, γ-glutamyl transpeptidase, GGPT),3 7 12 pyrexia,1 headache,1 3 5 6 8 rash,1 3 insomnia,1 anemia,1 neutropenia.3 5 6

What are some things I need to know or do while I take Anidulafungin?

  • Tell all of your health care providers that you take anidulafungin. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

What are some other side effects of Anidulafungin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Upset stomach or throwing up.
  • Loose stools (diarrhea).
  • Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Use Labeled Indications

Treatment of candidemia and other forms of Candida infections (including those of intra-abdominal, peritoneal, and esophageal locus)

Contraindications

Hypersensitivity to anidulafungin, other echinocandins, or any component of the formulation

Dosing Geriatric

Refer to adult dosing.

What is the most important information i should know about anidulafungin (eraxis)?

You should not use this medication if you are allergic to anidulafungin, caspofungin (Cancidas), micafungin (Mycamine), or similar antifungal medicines.

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

There may be other drugs that can interact with anidulafungin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Anidulafungin will not treat a viral infection such as the common cold or flu.

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