NDC 42023-0229-10 — Micafungin 10 mg/mL

🆔 Identity & classification

FDA NDC (as labeled) 42023-229-10

Product NDC 42023-229

11-digit billing NDC 42023022910

NCPDP billing unit EA — each (per item)

RxCUI 861379, 861383

UNII IS1UP79R56

Application # NDA212156

SPL Set ID 70b3f044-95ca-4503-b669-ed39972592b6

Established class (EPC) Echinocandin Antifungal

Chemical class Lipopeptides

DEA schedule Non-controlled

Marketing category NDA

Marketing status Discontinued

FDA listing status Discontinued by firm (certified through Jul 2025)

Marketing start 2021-08-01

Route INTRAVENOUS

Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Substance MICAFUNGIN SODIUM

GPI-14 11500050102120

GPI class Micafungin Sodium

GCN Seq No 058872

GCN 24397

HICL code 032804

Ingredient (HICL) Micafungin Sodium

HIC1 code W

Therapeutic class — broad (HIC1) Anti-Infecting Agents

HIC2 code W3

Therapeutic class — intermediate (HIC2) Antimycotics

HIC3 code W3A

Therapeutic class — specific (HIC3) Antifungal Antibiotics

AHFS code 08:14.16.00

AHFS class Echinocandin Antifungals

FDB label name MICAFUNGIN 50 MG VIAL

FDB brand name Micafungin

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 42023-229-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 42023-0229-10. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Echinocandin Antifungal class.

Pharmacologic class Echinocandin Antifungal

Drug family (ATC) Other antimycotics for systemic use

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerPar Health USA, LLC

Application holderPH HEALTH LTD

FDA applicationNDA212156 (NDA)

Labeler code42023

First marketedAug 2021

Product typeHuman Prescription Drug

Portfolio210 products on file

🔎 All NDCs from Par Health USA, LLC

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name MICAFUNGIN 50 MG VIAL Ingredient Micafungin Sodium

📖 What it is MedlinePlus · NLM

Micafungin is used to treat certain fungal infections that have caused esophagitis ( infection of the throat), spread to the bloodstream, have caused abscesses (collection of pus in body tissue) or caused peritonitis (infection of the lining of the stomach) in adults and children. It is also used to prevent fungal infections in adults and children who have undergone a hematopoietic stem cell transplant (HSCT; procedure in which certain blood cells are removed from the body and then returned to the body). Micafungin is in a class of medications called echinocandins. It works by stopping the bui...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Micafungin only comes in an injectable form — there's no tablet or capsule version. It's given directly into your vein through an IV so it gets into your bloodstream quickly and at...
Why am I getting this medication through an IV instead of taking a pill?
That depends on which infection you have. For bloodstream or other invasive Candida infections, treatment typically lasted around 15 days on average in clinical trials, though it c...
How long will I need to be on micafungin?

📖 Read our full Micafungin guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Micafungin — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Micafungin (20 interactions) — ranked by severity →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$90.72	$9,072.00 / 100 ml
Medicare drug plans payPart D · Q2 2026	$22.33	$2,232.83 / 100 ml
Medicare Part B allowsASP · J2247	$0.219 / J2247 unit	—

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)42023-229-10

11-digit billing NDC42023-0229-10

Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)

HCPCS J-codeJ2247

DescriptorINJECTION, MICAFUNGIN SODIUM (PAR PHARM) NOT THEREAPEUTICALLY EQUIVALENT TO J2248, 1 MG

Billing units / pkg50 units

Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)

Where does this data come from?

The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Micafungin 50 mg 00143-9361-01	Hikma	1 vial	—	AP	FDA listed	—
Mycamine 10 mg/mL 00469-3250-10	Astellas	10 vials	—	—	FDA listed	—
Micafungin 50 mg/5mL 25021-0190-10	Sagent	1 vial	—	AP	FDA listed	—
Micafungin 10 mg/mLthis 42023-0229-10	Par	10 vials	—	—	Discontinued	—
Micafungin 50 mg 42658-0022-01	Hisun	1 vial	—	AP	FDA listed	—
Micafungin 50 mg 63323-0728-10	Fresenius	1 vial	—	AP	FDA listed	—
Micafungin 10 mg/mL 67184-0589-01	Qilu	1 vial	—	AP	FDA listed	—
Micafungin 10 mg/mL 68462-0771-01	Glenmark	1 vial	—	AP	FDA listed	—
Micafungin 10 mg/mL 70377-0075-91	Biocon	10 vials	—	AP	FDA listed	—
Micafungin 10 mg/mL 70710-1724-06	Zydus	10 vials	—	AP	FDA listed	—
Micafungin 10 mg/mL 70771-1683-06	Zydus	10 vials	—	AP	FDA listed	—
Micafungin 50 mg/5mL 71288-0028-11	Meitheal	10 vials	—	AP	FDA listed	—

About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2021

On the market since

Aug 2021

📍

2026

Currently FDA-listed

5 years listed

🔒

·

Generic approved (availability unconfirmed)

see note

🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 42023-0229-10, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

13

Units reimbursed last 4 qtrs

92

Gross reimbursed last 4 qtrs

$8.3K

Avg / prescription

$642.02

Avg / unit

$90.7200

Latest quarter Q4 2025

0Rx

Fee-for-service vs managed care ⓘ

100% FFS

Fee-for-service · 13 Rx Managed care · 0 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.20.2

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 California 0.2 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Micafungin — the program that covers self-administered drugs. 9 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Micafungin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$2.03M

Claims incl. refills

5.1K

Beneficiaries

1.6K

Spend / beneficiary

$1,280.10

Spend / claim

$399.51

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Micafungin — the ingredient across all brands.

Top reported reactions

Febrile Neutropenia552

Pyrexia535

Sepsis361

Pneumonia343

Death317

Diarrhoea303

Neutropenia287

Age at onset

Neonate36

Infant57

Child201

Adolescent115

Adult584

Elderly285

Reporter sex

Male · 60%

Female · 39%

Unknown · 0%

Serious outcomes

Hospitalization3,747

Death2,797

Life-threatening1,445

Disabling155

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
42023-0229-10 You're viewing this	10 VIAL, SINGLE-DOSE in 1 CARTON (42023-229-10) / 10 mL in 1 VIAL, SINGLE-DOSE	2021-08-01	Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	✓ Available
Medicaid utilization (CMS SDUD)	✓ Available

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

What does the discontinued status mean for this NDC?

The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 42023-229-10, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 42023-0229-10, written without dashes as 42023022910. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 42023-0229-10, the first segment (42023) is the labeler code FDA assigned to Par Health USA, LLC; the middle segment (0229) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) identifies this exact package size and type. Together they name one specific package of one specific product.

Who lists this product with the FDA?

Par Health USA, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

Does this product have a billing J-code?

Yes — this NDC cross-references HCPCS code J2247 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Micafungin for Injection is indicated for: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies ( 14.1 ) and Use in Specific Populations ( 8.4 )] . Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies ( 14.2 )] . Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies ( 14.3 )] .

Limitations of Use Micafungin for Injection has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida . The efficacy of Micafungin for Injection against infections caused by fungi other than Candida has not been established. Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Mycamine ® (micafungin for injection).

However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Micafungin for Injection is an echinocandin indicated in adult and pediatric patients for: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older. ( 1 ) Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older.

( 1 ) Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT). ( 1 ) Limitations of Use Micafungin for injection has not been adequately studied in patients with endocarditis, osteomyelitis or meningoencephalitis due to Candida . ( 1 ) The efficacy of Micafungin for Injection against infections caused by fungi other than Candida has not been established.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION R eco m m e nd e d Dosage Administered by Indication, Weight and Age ( 2.1 , 2.2 , 8.4 ) Adult Pediatric Patients 4 Months and Older 30 kg or less Pediatric Patients 4 Months and Older greater than 30 kg Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses 100 mg daily 2 mg/kg/day (maximum 100 mg daily) Treatment of Esophageal Candidiasis 150 mg daily 3 mg/kg/day 2.5 mg/kg/day (maximum 150 mg daily) Prophylaxis of Candida Infections in HSCT Recipients 50 mg daily 1 mg/kg/day (maximum 50 mg daily) Infuse over 1 hour.

( 2.4 ) See full prescribing information for intravenous (IV) preparation and administration instructions. ( 2 )

2.1Dosage for Adults The recommended dosage for adult patients based on indications are shown in Table 1. T able 1. Micafungin for Injection Dosage in Adult Patients Indication Recommended Reconstituted Dose Once Daily Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses* 100 mg Treatment of Esophageal Candidiasis ‡ 150 mg Prophylaxis of Candida Infections in HSCT Recipients § 50 mg * In patients treated successfully for candidemia and other Candida infections, the mean duration of treatment was 15 days (range 10 to 47 days). ‡ In patients treated successfully for esophageal candidiasis, the mean duration of treatment was 15 days (range 10 to 30 days). § In hematopoietic stem cell transplant (HSCT) recipients who experienced success of prophylactic therapy, the mean duration of prophylaxis was 19 days (range 6 to 51 days).

2.2Dosage for Pediatric Patients 4 Months and Older The recommended dosage for pediatric patients 4 months of age and older based on indication and weight are shown in Table 2. Table 2. Micafungin for Injection Dosage in Pediatric Patients (4 Months of Age and Older) Indication Dosage for Pediatric Patients 4 Months of Age and Older 30 kg or less Greater than 30 kg Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses 2 mg/kg once daily (maximum daily dose 100 mg) Treatment of Esophageal Candidiasis 3 mg/kg once daily 2.5 mg/kg once daily (maximum daily dose 150 mg) Prophylaxis of C andida Infections in HSCT Recipients 1 mg/kg once daily (maximum daily dose 50 mg) Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Mycamine ® (micafungin for injection).

However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

2.3Directions for Reconstitution, Dilution, Preparation and Storage Do not mix or co-infuse Micafungin for Injection with other medications. Micafungin for injection has been shown to precipitate when mixed directly with a number of other commonly used medications. Please read this entire section carefully before beginning reconstitution.

R econstitution Reconstitute Micafungin for Injection vials by aseptically adding 5 mL of one of the following compatible solutions: 0.9% Sodium Chloride Injection, USP (without a bacteriostatic agent) 5% Dextrose Injection, USP To minimize excessive foaming, gently dissolve the micafungin for injection powder by swirling the vial. Do not vigorously shake the vial . Visually inspect the vial for particulate matter.

Micafungin for Injection 50 mg vial : after reconstitution each mL contains 10 mg of micafungin. Micafungin for Injection 100 mg vial : after reconstitution each mL contains 20 mg of micafungin. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not use material if there is any evidence of precipitation or foreign matter. Aseptic technique must be strictly observed in all handling since no preservative or bacteriostatic agent is present in Micafungin for Injection or in the materials specified for reconstitution and dilution. The reconstituted product should be protected from light and…

💊 Dosage Forms and Strengths 47 words ▾

3 DOSAGE FORMS AND STRENGTHS Micafungin for Injection is a sterile, white lyophilized powder for reconstitution for intravenous infusion available as: 50 mg single-dose vial 100 mg single-dose vial For injection: 50 mg single-dose vial. ( 3 ) For injection: 100 mg single-dose vial. ( 3 )

⛔ Contraindications 48 words ▾

4 CONTRAINDICATIONS Micafungin for Injection is contraindicated in persons with known hypersensitivity to micafungin, any component of Micafungin for Injection, or other echinocandins. Micafungin for Injection is contraindicated in persons with known hypersensitivity to micafungin sodium, any component of Micafungin for Injection, or other echinocandins. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Anaphylaxis and anaphylactoid reactions (including shock) have been observed. Discontinue Micafungin for Injection and administer appropriate treatment. ( 5.1) Hematological Effects: Isolated cases of acute intravascular hemolysis, hemolytic anemia and hemoglobinuria have been reported.

Monitor rate of hemolysis. Discontinue if severe. ( 5.2) Hepatic Effects: Abnormalities in liver tests; isolated cases of hepatic impairment, hepatitis, and hepatic failure have been observed.

Monitor hepatic function. Discontinue if severe dysfunction occurs. ( 5.3 ) Renal Effects: Elevations in BUN and creatinine; isolated cases of renal impairment or acute renal failure have been reported.

Monitor renal function. ( 5.4 ) Infusion and Injection Site Reactions can occur including rash, pruritus, facial swelling, and vasodilatation. Monitor infusion closely, slow infusion rate if necessary.

( 2.4 , 5.5 )

5.1Hypersensitivity Reactions Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported in patients receiving micafungin for injection. If these reactions occur, Micafungin for Injection infusion should be discontinued, and appropriate treatment administered.

5.2Hematological Effects Acute intravascular hemolysis and hemoglobinuria was seen in a healthy volunteer during infusion of micafungin for injection (200 mg) and oral prednisolone (20 mg). Cases of significant hemolysis and hemolytic anemia have also been reported in patients treated with micafungin for injection. Patients who develop clinical or laboratory evidence of hemolysis or hemolytic anemia during micafungin therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing Micafungin for Injection therapy.

5.3Hepatic Effects Laboratory abnormalities in liver function tests have been seen in healthy volunteers and patients treated with micafungin for injection. In some patients with serious underlying conditions who were receiving micafungin for injection along with multiple concomitant medications, clinical hepatic abnormalities have occurred, and isolated cases of significant hepatic impairment, hepatitis, and hepatic failure have been reported. Patients who develop abnormal liver function tests during micafungin therapy should be monitored for evidence of worsening hepatic function and evaluated for the risk/benefit of continuing Micafungin for Injection therapy.

5.4Renal Effects Elevations in BUN and creatinine, and isolated cases of significant renal impairment or acute renal failure have been reported in patients who received micafungin for injection. In fluconazole-controlled trials, the incidence of drug-related renal adverse reactions was 0.4% for micafungin for injection-treated patients and 0.5% for fluconazole-treated patients. Patients who develop abnormal renal function tests during Micafungin for Injection therapy should be monitored for evidence of worsening renal function.

5.5Infusion and Injection Site Reactions Possible histamine-mediated symptoms have been reported with micafungin for injection, including rash, pruritus, facial swelling, and vasodilatation. Slow the infusion rate if infusion reaction occurs [see Dosage and Administration ( 2.4 )] . Injection site reactions, including phlebitis and thrombophlebitis have been reported, at micafungin for injection doses of 50 to 150 mg/day.

These reactions tended to occur more often in patients receiving micafungin for injection via peripheral intravenous administration [see Dosage and Administration ( 2.4 ) and Adverse Reactions ( 6.1 )] .

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hematological Effects [see Warnings and Precautions ( 5.2 )] Hepatic Effects [see Warnings and Precautions ( 5.3 )] Renal Effects [see Warnings and Precautions ( 5.4 )] Infusion and Injection Site Reactions [see Warnings and Precautions ( 5.5 )] Most common adverse reactions across adult and pediatric clinical trials for all indications include diarrhea, nausea, vomiting, abdominal pain, pyrexia, thrombocytopenia, neutropenia, and headache.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of micafungin cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. The overall safety of micafungin for injection was assessed in 520 healthy volunteers and 3227 adult and pediatric patients who received single or multiple doses of micafungin for injection across 46 clinical trials, including the invasive candidiasis, esophageal candidiasis, and prophylaxis trials.

The doses of micafungin for injection administered included doses above and below the recommended doses [see Dosage and Administration ( 2.1 , 2.2 )] and ranged from 0.75 mg/kg to 10 mg/kg in pediatric patients and 12.5 mg to 150 mg/day or greater in adults. Clinical Trials Experience in Adults In clinical trials with micafungin for injection, 2497/2748 (91%) adult patients experienced at least one adverse reaction. C andidemia and Other Candida Infections In a randomized, double-blind trial for treatment of candidemia and other Candida infections, adverse reactions occurred in 183/200 (92%) and 171/193 (89%) patients in the micafungin for injection 100 mg/day and caspofungin (70 mg loading dose followed by 50 mg/day dose) treatment groups, respectively.

Selected adverse reactions occurring in 5% or more of the patients and more frequently in the micafungin for injection treatment group, are shown in Table 3. T able 3. Selected* Adverse Reactions in Adult Patients with Candidemia and Other Candida Infections Adverse Reactions by System Organ Class † Micafungin for Injection 100 mg n (%) C aspofungin § n (%) N umber of Patients 200 193 G astrointestinal Disorders 81 (41) 76 (39) Diarrhea 15 (8) 14 (7) Vomiting 18 (9) 16 (8) Metabolism and Nutrition Disorders 77 (39) 73 (38) Hypoglycemia 12 (6) 9 (5) Hyperkalemia 10 (5) 5 (3) G eneral Disorders/Administration Site Conditions 59 (30) 51 (26) I nvestigations 36 (18) 37 (19) Blood Alkaline Phosphatase Increased 11 (6) 8 (4) C ardiac Disorders 35 (18) 36 (19) Atrial Fibrillation 5 (3) 0 Patient base: all randomized patients who received at least 1 dose of trial drug. * During IV treatment + 3 days † Within a system organ class, patients may experience more than 1 adverse reaction. § 70 mg loading dose on day 1 followed by 50 mg/day thereafter (caspofungin) In a second, supportive, randomized, double-blind trial for the treatment of candidemia and other Candida infections, adverse reactions occurred in 245/264 (93%) and 250/265 (94%) adult and pediatric patients in the micafungin for injection (100 mg/day) and amphotericin B liposome (3 mg/kg/day) treatment groups, respectively.

In this trial, the following adverse reactions were reported in patients at least 16 years of age in the micafungin for injection and amphotericin B liposome treatment groups, respectively: nausea (10% vs. 8%); diarrhea (11% vs. 11%), vomiting (13% vs.

9%), abnormal liver tests (4% vs. 3%); increased aspartate aminotransferase (3% vs. 2%), and increased blood alkaline phosphatase (3% vs.

2%). E s ophageal Candidiasis In a randomized, double-blind study for treatment of esophageal candidi…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Monitor for sirolimus, itraconazole or nifedipine toxicity, and dosage of sirolimus, itraconazole or nifedipine should be reduced, if necessary. ( 7 )

7.1Effect of Other Drugs on Micafungin for Injection CYP3A4, CYP2C9 and CYP2C19 Inhibitors Co-administration of micafungin for injection with cyclosporine, itraconazole, voriconazole and fluconazole did not alter the pharmacokinetics of micafungin. CYP2C19 and CYP3A4 Inducer Co-administration of micafungin for injection with rifampin and ritonavir did not alter the pharmacokinetics of micafungin. Co-administration of Micafungin with Other Drugs Co-administration of micafungin for injection with mycophenolate mofetil (MMF), amphotericin B, tacrolimus, prednisolone, sirolimus and nifedipine did not alter the pharmacokinetics of micafungin for injection.

7.2Effect of Micafungin for Injection on Other Drugs CYP3A4 Substrates There was no effect of single or multiple doses of micafungin for injection on cyclosporine, tacrolimus, prednisolone, voriconazole and fluconazole pharmacokinetics. Sirolimus AUC was increased by 21% with no effect on C max in the presence of steady-state micafungin for injection compared with sirolimus alone. Nifedipine AUC and C max were increased by 18% and 42%, respectively, in the presence of steady-state micafungin compared with nifedipine alone.

Itraconazole AUC and C max were increased by 22% and 11%, respectively. Patients receiving sirolimus, nifedipine, and itraconazole in combination with Micafungin for Injection should be monitored for sirolimus, nifedipine, and itraconazole toxicity and the sirolimus, nifedipine, and itraconazole dosage should be reduced if necessary. UDP-Glycosyltransferase Substrate Co-administration of mycophenolate mofetil (MMF) with micafungin for injection did not alter the pharmacokinetics of MMF.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, Micafungin for Injection may cause fetal harm. Advise pregnant women of the risk to the fetus. ( 8.1 )

8.1Pregnancy Risk Summary Based on findings from animal studies, Micafungin for Injection may cause fetal harm when administered to a pregnant woman (see Data) . There is insufficient human data on the use of micafungin for injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, intravenous administration of micafungin sodium to pregnant rabbits during organogenesis at doses four times the maximum recommended human dose resulted in visceral abnormalities and increased abortion (see Data) .

Advise pregnant women of the risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal data In an embryo-fetal toxicity study in pregnant rabbits, intravenous administration of micafungin sodium during organogenesis (days 6 to 18 of gestation) resulted in visceral abnormalities and abortion at 32 mg/kg, a dose equivalent to about four times the recommended dose based on body surface area comparisons. Visceral abnormalities included abnormal lobation of the lung, levocardia, retrocaval ureter, anomalous right subclavian artery, and dilatation of the ureter.

8.2Lactation Risk Summary There are no data on the presence of micafungin in human milk, the effects on the breast-fed infant or the effects on milk production. Micafungin was present in the milk of lactating rats following intravenous administration. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Micafungin for Injection, and any potential adverse effects on the breast-fed child from Micafungin for Injection, or from the underlying maternal condition.

8.4Pediatric Use Pediatric Patients 4 Months of Age and Older The safety and effectiveness of micafungin for injection for the treatment of esophageal candidiasis, candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and for prophylaxis of Candida infections in patients undergoing HSCT have been established in pediatric patients 4 months of age and older. Use of micafungin for injection for these indications and in this age group is supported by evidence from adequate and well-controlled studies in adult and pediatric patients with additional pharmacokinetic and safety data in pediatric patients 4 months of age and older [see Indications and Usage ( 1 ), Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14 )].

Pediatric Patients Younger than 4 Months of Age The safety and effectiveness of micafungin for injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age. In a rabbit model of hematogenous Candida meningoencephalitis (HCME) with Candida albicans (minimum inhibitory concentration of 0.125 mcg/mL), a decrease in mean fungal burden in central nervous system (CNS) compartments assessed as the average of combined fungal burden in the cerebrum, cerebellum, and spinal cord relative to untreated controls, was observed with increasing micafungin dosages administered once daily for 7 days.

In this rabbit model, micafungin concentrations could not be reliably detected in cerebrospinal fluid (CSF). Due to limitations of the study design, the clinical significance of a decreased CNS fungal burden in the rabbit H…

🤰 Pregnancy 219 words ▾

8.1Pregnancy Risk Summary Based on findings from animal studies, Micafungin for Injection may cause fetal harm when administered to a pregnant woman (see Data) . There is insufficient human data on the use of micafungin for injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, intravenous administration of micafungin sodium to pregnant rabbits during organogenesis at doses four times the maximum recommended human dose resulted in visceral abnormalities and increased abortion (see Data) .

Advise pregnant women of the risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal data In an embryo-fetal toxicity study in pregnant rabbits, intravenous administration of micafungin sodium during organogenesis (days 6 to 18 of gestation) resulted in visceral abnormalities and abortion at 32 mg/kg, a dose equivalent to about four times the recommended dose based on body surface area comparisons. Visceral abnormalities included abnormal lobation of the lung, levocardia, retrocaval ureter, anomalous right subclavian artery, and dilatation of the ureter.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Pediatric Patients 4 Months of Age and Older The safety and effectiveness of micafungin for injection for the treatment of esophageal candidiasis, candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and for prophylaxis of Candida infections in patients undergoing HSCT have been established in pediatric patients 4 months of age and older. Use of micafungin for injection for these indications and in this age group is supported by evidence from adequate and well-controlled studies in adult and pediatric patients with additional pharmacokinetic and safety data in pediatric patients 4 months of age and older [see Indications and Usage ( 1 ), Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14 )].

Pediatric Patients Younger than 4 Months of Age The safety and effectiveness of micafungin for injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age. In a rabbit model of hematogenous Candida meningoencephalitis (HCME) with Candida albicans (minimum inhibitory concentration of 0.125 mcg/mL), a decrease in mean fungal burden in central nervous system (CNS) compartments assessed as the average of combined fungal burden in the cerebrum, cerebellum, and spinal cord relative to untreated controls, was observed with increasing micafungin dosages administered once daily for 7 days.

In this rabbit model, micafungin concentrations could not be reliably detected in cerebrospinal fluid (CSF). Due to limitations of the study design, the clinical significance of a decreased CNS fungal burden in the rabbit HCME model is uncertain. The safety and effectiveness of micafungin for injection in pediatric patients younger than 4 months of age have not been established for the: Treatment of esophageal candidiasis Prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Mycamine ® (micafungin for injection).

However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information .

🧓 Geriatric Use 124 words ▾

8.5Geriatric Use A total of 418 subjects in clinical studies of micafungin for injection were 65 years of age and older, and 124 subjects were 75 years of age and older. No overall differences in safety and effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

The exposure and disposition of a 50 mg micafungin for injection dose administered as a single 1-hour infusion to 10 healthy subjects aged 66 to 78 years were not significantly different from those in 10 healthy subjects aged 20 to 24 years. No dose adjustment is necessary for the elderly.

🆘 Overdosage 120 words ▾

10 OVERDOSAGE Micafungin for injection is highly protein bound and, therefore, is not dialyzable. No cases of micafungin for injection overdosage have been reported. Repeated daily doses up to 8 mg/kg (maximum total dose of 896 mg) in adult patients, up to 6 mg/kg in pediatric patients 4 months of age and older, and up to 10 mg/kg in pediatric patients younger than 4 months of age have been administered in clinical trials with no reported dose-limiting toxicity [see Adverse Reactions ( 6.1 )] .

Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Mycamine ® (micafungin for injection). However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Micafungin is a member of the echinocandin class of antifungal agents [see Microbiology ( 12.4 )] .

12.2Pharmacodynamics The pharmacodynamics of micafungin related to hematogenous Candida meningoencephalitis are described in other sections of the prescribing information [see Use in Specific Populations ( 8.4 ) and Microbiology ( 12.4 )] .

12.3Pharmacokinetics Adults The pharmacokinetics of micafungin were determined in healthy subjects, hematopoietic stem cell transplant recipients, and patients with esophageal candidiasis up to a maximum daily dose of 8 mg/kg body weight. The relationship of area under the concentration-time curve (AUC) to micafungin dose was linear over the daily dose range of 50 mg to 150 mg and 3 mg/kg to 8 mg/kg body weight. Typically, 85% of the steady-state concentration is achieved after three daily micafungin for injection doses.

Steady-state pharmacokinetic parameters in relevant patient populations after repeated daily administration are presented in Table 7. T able 7. Pharmacokinetic Parameters of Micafungin in Adult Patients P opulation n D ose (m g ) P harmacokinetic Parameters ( Mean ± Standard Deviation) C m a x (m c g/mL) AUC 0-24* (m c g·h/mL) t 1/2 ( h) Cl (m L/ m i n/kg) Patients with IC † [Day 1] [Steady State] 20 20 100 100 5.7±2.2 10.1±4.4 83±51 97±29 14.5±7.0 13.4±2.0 0.359 ±0.179 0.298 ±0.115 HIV ‡ - Positive Patients with EC § [Day 1] [Day 14 or 21] 20 20 14 20 20 14 50 100 150 50 100 150 4.1±1.4 8.0±2.4 11.6±3.1 5.1±1.0 10.1±2.6 16.4±6.5 36±9 108±31 151±45 54±13 115±25 167±40 14.9±4.3 13.8±3.0 14.1±2.6 15.6±2.8 16.9±4.4 15.2±2.2 0.321 ±0.098 0.327 ±0.093 0.340 ±0.092 0.300±0.063 0.301±0.086 0.297±0.081 HSCT ¶ Recipients [Day 7] 8 10 8 8 per kg 3 4 6 8 21.1±2.84 29.2±6.2 38.4±6.9 60.8±26.9 234±34 339±72 479±157 663±212 14.0±1.4 14.2±3.2 14.9±2.6 17.2±2.3 0.214±0.031 0.204±0.036 0.224±0.064 0.223±0.081 * AUC 0-infinity is presented for day 1; AUC 0-24 is presented for steady state. † candidemia or other Candida infections. ‡ human immunodeficiency virus. § esophageal candidiasis. ¶ hematopoietic stem cell transplant.

Pediatric Patients 4 months of age and older Micafungin pharmacokinetics in 229 pediatric patients 4 months through 16 years of age were characterized using population pharmacokinetics. Micafungin exposure was dose proportional across the dose and age range studied. Table 8.

Summary (Mean +/- Standard Deviation) of Micafungin Pharmacokinetics in Pediatric Patients 4 Months of Age and Older (Steady-State) B ody weight group N D ose* m g/kg C m a x .ss † (m c g/mL) AUC .ss † (m c g·h /mL) t 1/2 ‡ ( h) CL ‡ (m L/ m i n/kg) 30 kg or less 149 1.0 7.1 +/- 4.7 55 +/- 16 12.5 +/- 4.6 0.328 +/- 0.091 2.0 14.2 +/- 9.3 109 +/- 31 3.0 21.3 +/- 14.0 164 +/- 47 Greater than 30 kg 80 1.0 8.7 +/- 5.6 67 +/- 17 13.6 +/- 8.8 0.241 +/- 0.061 2.0 17.5 +/- 11.2 134 +/- 33 2.5 23.0 +/- 14.5 176 +/- 42 * Or the equivalent if receiving the adult dose (50, 100, or 150 mg). † Derived from simulations from the population PK model. ‡ Derived from the population PK model.

Specific Populations Adult Patients with Renal Impairment Micafungin for injection does not require dose adjustment in patients with renal impairment. A single 1-hour infusion of 100 mg micafungin for injection was administered to 9 adult subjects with severe renal impairment (creatinine clearance less than 30 mL/min) and to 9 age-, gender-, and weight-matched subjects with normal renal function (creatinine clearance greater than 80 mL/min). The maximum concentration (C max ) and AUC were not significantly altered by severe renal impairment.

Since micafungin is highly protein bound, it is not dialyzable. Supplementary dosing should not be required following hemodialysis. Adult Patients with Hepatic Impairment A single 1-hour infusion of 100 mg micafungin for injection was administered to 8 adult subjects with moderate hepatic impairment (Child-Pugh score 7 to 9) and 8 age-, gender-,…

🧬 Mechanism of Action 21 words ▾

12.1Mechanism of Action Micafungin is a member of the echinocandin class of antifungal agents [see Microbiology ( 12.4 )] .

📦 How Supplied / Storage and Handling 114 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Micafungin for Injection is supplied as a sterile, white lyophilized powder for reconstitution for intravenous infusion, and is available in the following packaging configurations: NDC 42023-229-10: 50 mg single-dose vials supplied in packages of 10 NDC 42023-230-10: 100 mg single-dose vials supplied in packages of 10 The vial stopper is not manufactured with natural rubber latex. Storage Store Micafungin for Injection, for intravenous use at room temperature, 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].

Store the reconstituted product at 25°C (77°F) [see Dosage and Administration ( 2.3 )]. Store the diluted solution at 25°C (77°F) [see Dosage and Administration ( 2.3 )]. Protect from light.

📋 Description ~1 min read ▾

11 DESCRIPTION Micafungin for injection is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1, 3-beta-D-glucan, an integral component of the fungal cell wall.

Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg micafungin sodium) and 200 mg sucrose or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium) and 400 mg sucrose, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for injection must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration ( 2.3 )] . Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 4.5 to 7.0.

Micafungin sodium is chemically designated as: Pneumocandin A0,1-[(4 R ,5 R )-4,5-dihydroxy- N 2 -[4-[5-[4-(pentyloxy)phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4 S )-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of micafungin sodium is: The empirical/molecular formula is C 56 H 70 N 9 NaO 23 S and the formula weight is 1292.26. Micafungin sodium is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane.

Micafungin sodium structural formula

💬 Information for Patients 177 words ▾

17 PATIENT COUNSELING INFORMATION Hypersensitivity Inform patients about the serious adverse effects of Micafungin for Injection including hypersensitivity reactions e.g., anaphylaxis and anaphylactoid reactions including shock. Hepatic Inform patients about the serious adverse effects of Micafungin for Injection including hepatic effects e.g., abnormal liver tests, hepatic impairment, hepatitis or worsening hepatic failure. Hematologic Inform patients about the serious adverse effects of Micafungin for Injection including hematological effects e.g., acute intravascular hemolysis, hemolytic anemia and hemoglobinuria.

Renal Inform patients about the serious adverse effects of Micafungin for Injection including renal effects e.g., elevations in BUN and creatinine, renal impairment or acute renal failure. Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk of Micafungin for Injection to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy.

Concomitant Medications Instruct patients to inform their healthcare provider of any other medications they are currently taking with Micafungin for Injection, including over-the-counter medications. Manufactured for: Endo USA Malvern, PA 19355 © 2024 Endo, Inc. or one of its affiliates. R07/2024

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

atrial fibrillation: An irregular, often fast heart rhythm coming from the heart's upper chambers, which can raise the risk of blood clots.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

bacteriostatic: Describes a medicine that stops bacteria from multiplying so the body's own defenses can clear them.

BUN: Blood urea nitrogen, a waste product measured in a blood test that helps show how well the kidneys are working.

candidiasis: An infection caused by a yeast called Candida, which can affect the mouth, throat, skin, or other areas.

Child-Pugh: A scoring system doctors use to grade how severe long-term liver disease is, often to help set the right medicine dose.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

CYP2C19: A liver enzyme that breaks down certain medicines, such as some stomach-acid drugs and drugs that help prevent blood clots.

CYP2C9: A liver enzyme that breaks down certain medicines, including some blood thinners and anti-inflammatory drugs.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose-limiting toxicity: A side effect severe enough that it prevents giving a higher dose of a medicine.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

embryo-fetal toxicity: Harm to a developing baby in the womb, such as birth defects, slowed growth, or loss of the pregnancy.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemolysis: The breaking apart of red blood cells, which can lower the number of cells available to carry oxygen.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperkalemia: A higher-than-normal level of potassium, an important mineral, in the blood.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inducer: A substance that speeds up an enzyme, which can lower the levels of drugs that enzyme breaks down.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

infusion reaction: Symptoms such as fever, chills, rash, or trouble breathing that happen while or shortly after a medicine is given through a vein.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

loading dose: A larger dose given at the start to quickly build the medicine up to an effective level in the body.

lyophilized: Freeze-dried into a powder that is mixed with liquid before it is given.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

pruritus: Itching of the skin.

pyrexia: A raised body temperature; a fever.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

reconstitution: Mixing a powdered medicine with a liquid to prepare it for use, following the label's directions.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

single-dose vial: A small container holding one dose of medicine, meant to be used once and then thrown away.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Micafungin NDCsSame ingredient 🏭 All Par labeler NDCsLabeler code 42023 📚 All Echinocandin Antifungal NDCsDrug class 🧾 J2247 billing & NDC crosswalkJ-code 📖 Read the Micafungin drug informationUses, warnings & side effects

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Caspofungin Acetate 00006-3822-10 Anidulafungin 00049-0114-28 Nystatin 00093-0983-01 Griseofulvin Ultramicrosize 00115-1724-01 Micafungin In 0.9 % Sodium Chl 00338-9051-12 Amphotericin B Liposome 00469-3051-30 Griseofulvin, Microsize 00472-0013-04 Amphotericin B 39822-1055-05 Amphotericin B Lipid Complex 57665-0101-41 Rezafungin Acetate 70842-0240-01 Ibrexafungerp Citrate 75788-0115-04

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Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

Micafungin 10 mg/mL Injection, Powder, Lyophilized, For Solution

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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

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12 CLINICAL PHARMACOLOGY

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