Micafungin 100 mg/5mL Injection, Powder, Lyophilized, For Solution — NDC 71288-029-11 (Billing 71288-0029-11)
This is a package of Micafungin 100 mg/5mL Injection, Powder, Lyophilized, For Solution from Meitheal Pharmaceuticals Inc., marketed since Sep 2022 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 061686
- GCN: 97472
- GPI-14 (Medi-Span): 11500050102130
- HICL (First Databank): 032804
- AHFS class code: 08:14.16.00
- RxCUI (RxNorm): 861379
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Echinocandin Antifungal class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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 ↗- It treats serious Candida infections, such as those in the bloodstream or esophagus. It also helps prevent Candida infections in people having a stem cell transplant. It is not sho...
- It goes into a vein as an infusion over about an hour, once a day. A healthcare professional prepares and gives it. Your prescriber decides how long you need it.
- Diarrhea, nausea, vomiting, belly pain, fever and headache are the most common. Some people get low blood counts or vein irritation at the IV site. Tell your nurse if the site hurt...
- Get help right away for trouble breathing, facial swelling, or a severe rash, which can signal an allergic reaction. Also report dark or red urine, yellow skin or eyes, or changes...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $44.24 | $2,211.85 / 50 ml |
| Medicare drug plans payPart D · Q2 2026 | $22.33 | $1,116.42 / 50 ml |
| Medicare Part B allowsASP · J2248 | $0.180 / J2248 unit | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Sep 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 71288-0029-11 You're viewing this Main listing | 10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE | 2022-09-28 | — | Active |
| 71288-0029-12 71288-029-12 | 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE | 2024-11-01 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 95% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Micafungin 100 mg/5mL Injection, Powder, Lyophilized, For Solution?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Micafungin 100 mg 00143-9362-01 | Hikma | 1 vial | — | AP | FDA listed | — |
| Micafungin 100 mg/5mL 25021-0191-10 | Sagent | 1 vial | — | AP | FDA listed | — |
| Micafungin 20 mg/mL 42023-0230-10 | Par | 10 vials | — | — | Discontinued | — |
| Micafungin 100 mg 42658-0023-01 | Hisun | 1 vial | — | AP | FDA listed | — |
| Micafungin 100 mg 63323-0729-12 | Fresenius | 1 vial | — | AP | FDA listed | — |
| Micafungin 20 mg/mL 67184-0590-01 | Qilu | 1 vial | — | AP | FDA listed | — |
| Micafungin 20 mg/mL 68462-0772-01 | Glenmark | 1 vial | — | AP | FDA listed | — |
| Micafungin 20 mg/mL 70377-0076-91 | Biocon | 10 vials | — | AP | FDA listed | — |
| Micafungin 20 mg/mL 70710-1725-06 | Zydus | 10 vials | — | AP | FDA listed | — |
| Micafungin 20 mg/mL 70771-1684-06 | Zydus | 10 vials | — | AP | FDA listed | — |
| Micafungin 100 mg/5mLthis 71288-0029-11 | Meitheal | 10 vials | — | AP | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 )].
Micafungin for Injection is an echinocandin indicated in adult and pediatric patients for ( 1 ): Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older. Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older. Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT).
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 ) 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.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Recommended 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.
( 2.5 ) 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 . Table 1. Micafungin for Injection Dosage in Adult Patients * 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).
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
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 Candida 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.
2.4Directions for Reconstitution, Dilution, and Preparation 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.
Reconstitution 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 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 may be stored in the orig… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Micafungin for Injection is a sterile, white to off-white lyophilized powder or cake 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 ▾
4 CONTRAINDICATIONS Micafungin is contraindicated in persons with known hypersensitivity to micafungin, any component of micafungin, or other echinocandins. Micafungin is contraindicated in persons with known hypersensitivity to micafungin sodium, any component of micafungin, or other echinocandins. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Anaphylaxis and anaphylactoid reactions (including shock) have been observed. Discontinue micafungin 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.
( 2.5 , 5.5 )
5.1Hypersensitivity Reactions Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported in patients receiving micafungin. If these reactions occur, micafungin 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 (200 mg) and oral prednisolone (20 mg). Cases of significant hemolysis and hemolytic anemia have also been reported in patients treated with micafungin. 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 therapy.
5.3Hepatic Effects Laboratory abnormalities in liver function tests have been seen in healthy volunteers and patients treated with micafungin. In some patients with serious underlying conditions who were receiving micafungin 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 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. In fluconazole-controlled trials, the incidence of drug-related renal adverse reactions was 0.4% for micafungin-treated patients and 0.5% for fluconazole-treated patients. Patients who develop abnormal renal function tests during micafungin 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, including rash, pruritus, facial swelling, and vasodilatation. Slow the infusion rate if infusion reaction occurs [see Dosage and Administration ( 2.5 )]. Injection site reactions, including phlebitis and thrombophlebitis have been reported, at micafungin doses of 50 to 150 mg/day.
These reactions tended to occur more often in patients receiving micafungin via peripheral intravenous administration [see Dosage and Administration ( 2.5 ) and Adverse Reactions ( 6.1 )].
🤒 Adverse Reactions ▾
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 Meitheal Pharmaceuticals, Inc. at 1-844-824-8426 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 was assessed in 520 healthy volunteers and 3227 adult and pediatric patients who received single or multiple doses of micafungin across 46 clinical trials, including the invasive candidiasis, esophageal candidiasis and prophylaxis trials.
The doses of micafungin 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, 2497/2748 (91%) adult patients experienced at least one adverse reaction. Candidemia and Other Candida Infections In a randomized, double-blind trial for the treatment of candidemia and other Candida infections, adverse reactions occurred in 183/200 (92%) and 171/193 (89%) patients in the micafungin 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 treatment group, are shown in Table 3 . Table 3. Selected* Adverse Reactions in Adult Patients with Candidemia and Other Candida Infections 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).
Adverse Reactions by System Organ Class † Micafungin 100 mg n (%) Caspofungin § n (%) Number of Patients 200 193 Gastrointestinal 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) General Disorders/Administration Site Conditions 59 (30) 51 (26) Investigations 36 (18) 37 (19) Blood Alkaline Phosphatase Increased 11 (6) 8 (4) Cardiac Disorders 35 (18) 36 (19) Atrial Fibrillation 5 (3) 0 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 (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 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%). Esophageal Candidiasis In a randomized, double-blind study for treatment of esophageal candidiasis, a total of 202/260 (78%) patients who received micafungin 150 mg/day and 186/258 (72%) patients w… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
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 CYP3A4, CYP2C9 and CYP2C19 Inhibitors Co-administration of micafungin with cyclosporine, itraconazole, voriconazole and fluconazole did not alter the pharmacokinetics of micafungin. CYP2C19 and CYP3A4 Inducer Co-administration of micafungin with rifampin and ritonavir did not alter the pharmacokinetics of micafungin. Co-administration of Micafungin with Other Drugs Co-administration of micafungin with mycophenolate mofetil (MMF), amphotericin B, tacrolimus, prednisolone, sirolimus and nifedipine did not alter the pharmacokinetics of micafungin.
7.2Effect of Micafungin on Other Drugs CYP3A4 Substrates There was no effect of single or multiple doses of micafungin 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 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 Cmax were increased by 22% and 11%, respectively. Patients receiving sirolimus, nifedipine, and itraconazole in combination with micafungin 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 did not alter the pharmacokinetics of MMF.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy – Based on animal data, micafungin may cause fetal harm. Advise pregnant women of the risk to the fetus. ( 8.1 ) 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.
8.1Pregnancy Risk Summary Based on findings from animal studies, micafungin may cause fetal harm when administered to a pregnant woman (see Data ) . There is insufficient human data on the use of micafungin 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 fetal visceral abnormalities and abortion at 32 mg/kg, a dose equivalent to four times the recommended human 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, and any potential adverse effects on the breast-fed child from micafungin, or from the underlying maternal condition.
8.4Pediatric Use Pediatric Patients 4 Months of Age and Older The safety and effectiveness of micafungin 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 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 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses With Meningoencephalitis and/or Ocular Dissemination in Pediatric Patients Younger Than 4 Months of Age The safety and effectiveness of micafungin 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… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on findings from animal studies, micafungin may cause fetal harm when administered to a pregnant woman (see Data ) . There is insufficient human data on the use of micafungin 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 fetal visceral abnormalities and abortion at 32 mg/kg, a dose equivalent to four times the recommended human 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 ▾
8.4Pediatric Use Pediatric Patients 4 Months of Age and Older The safety and effectiveness of micafungin 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 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 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses With Meningoencephalitis and/or Ocular Dissemination in Pediatric Patients Younger Than 4 Months of Age The safety and effectiveness of micafungin 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. Treatment of Esophageal Candidiasis and Prophylaxis of Candida Infections in Patients Undergoing Hematopoietic Stem Cell Transplantation in Pediatric Patients Younger Than 4 Months of Age The safety and effectiveness of micafungin 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 ▾
8.5Geriatric Use A total of 418 subjects in clinical studies of micafungin 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 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 ▾
10 OVERDOSAGE Micafungin is highly protein bound and, therefore, is not dialyzable. No cases of micafungin 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 ▾
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 doses.
Steady-state pharmacokinetic parameters in relevant patient populations after repeated daily administration are presented in Table 7 . Table 7. Pharmacokinetic Parameters of Micafungin in Adult Patients * 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.
Population n Dose (mg) Pharmacokinetic Parameters (Mean ± Standard Deviation) C max (mcg/mL) AUC 0-24 * (mcg·h/mL) t ½ (h) Cl (mL/min/kg) Patients with IC † [Day 1] 20 100 5.7 ± 2.2 83 ± 51 14.5 ± 7.0 0.359 ± 0.179 [Steady-State] 20 100 10.1 ± 4.4 97 ± 29 13.4 ± 2.0 0.298 ± 0.115 HIV ‡ -Positive 20 50 4.1 ± 1.4 36 ± 9 14.9 ± 4.3 0.321 ± 0.098 Patients with EC § 20 100 8.0 ± 2.4 108 ± 31 13.8 ± 3.0 0.327 ± 0.093 [Day 1] 14 150 11.6 ± 3.1 151 ± 45 14.1 ± 2.6 0.340 ± 0.092 20 50 5.1 ± 1.0 54 ± 13 15.6 ± 2.8 0.300 ± 0.063 [Day 14 or 21] 20 100 10.1 ± 2.6 115 ± 25 16.9 ± 4.4 0.301 ± 0.086 14 150 16.4 ± 6.5 167 ± 40 15.2 ± 2.2 0.297 ± 0.081 HSCT ¶ Recipients [Day 7] per kg 8 10 8 3 4 6 21.1 ± 2.84 29.2 ± 6.2 38.4 ± 6.9 234 ± 34 339 ± 72 479 ± 157 14.0 ± 1.4 14.2 ± 3.2 14.9 ± 2.6 0.214 ± 0.031 0.204 ± 0.036 0.224 ± 0.064 8 8 60.8 ± 26.9 663 ± 212 17.2 ± 2.3 0.223 ± 0.081 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) * 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.
Body weight group N Dose* mg/kg C max.ss † (mcg/mL) AUC .ss † (mcg·h/mL) t½ ‡ (h) CL ‡ (mL/min/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 Specific Populations Adult Patients with Renal Impairment Micafungin does not require dose adjustment in patients with renal impairment. A single 1-hour infusion of 100 mg micafungin 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 was administered to 8 adult subjects with moderate hepatic impairment (Child-Pugh score 7 to 9) and 8 age-, gender-, an… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Micafungin is a member of the echinocandin class of antifungal agents [see Microbiology ( 12.4 )] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Micafungin for Injection is a white to off-white lyophilized powder or cake for reconstitution for intravenous infusion, and is supplied as follows: NDC Micafungin for Injection Package Factor 71288- 028 -11 50 mg equivalent of micafungin in a Single-Dose Vial wrapped with a light protective flap and sealed with a blue flip-off cap 10 vials per carton 71288- 029 -11 100 mg equivalent of micafungin in a Single-Dose Vial wrapped with a light protective flap and sealed with a red flip-off cap 10 vials per carton 71288- 028 -12 50 mg equivalent of micafungin in a Single-Dose Vial wrapped with a light protective flap and sealed with a blue flip-off cap 1 vial per carton 71288- 029 -12 100 mg equivalent of micafungin in a Single-Dose Vial wrapped with a light protective flap and sealed with a red flip-off cap 1 vial per carton Storage Unopened vials of lyophilized material must be stored at room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Store the reconstituted product at 20° to 25°C (68° to 77°F) [ see Dosage and Administration ( 2.4 )].
Store the diluted solution at 20° to 25°C (68° to 77°F) [ see Dosage and Administration ( 2.4 )]. Protect from light. Discard unused portion.
Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
📦 Storage and Handling ▾
Storage Unopened vials of lyophilized material must be stored at room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Store the reconstituted product at 20° to 25°C (68° to 77°F) [ see Dosage and Administration ( 2.4 )]. Store the diluted solution at 20° to 25°C (68° to 77°F) [ see Dosage and Administration ( 2.4 )]. Protect from light.
Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
📋 Description ▾
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) or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium), 200 mg lactose monohydrate, 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 )] . Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5-7.
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 to off-white lyophilized powder or cake that is freely soluble in water and practically insoluble in acetone. figure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Hypersensitivity Inform patients about the serious adverse effects of micafungin including hypersensitivity reactions e.g., anaphylaxis and anaphylactoid reactions including shock. Hepatic Inform patients about the serious adverse effects of micafungin 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 including hematological effects e.g., acute intravascular hemolysis, hemolytic anemia and hemoglobinuria.
Renal Inform patients about the serious adverse effects of micafungin 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 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, including over-the-counter medications. Brands listed are the trademarks of their respective owners. meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2024 Meitheal Pharmaceuticals Inc. Mfd. by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.
Nanjing, China 210061 Revised: July 2024 8K3AAM9-02
🧬 Pharmacokinetics ▾
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 doses.
Steady-state pharmacokinetic parameters in relevant patient populations after repeated daily administration are presented in Table 7 . Table 7. Pharmacokinetic Parameters of Micafungin in Adult Patients * 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.
Population n Dose (mg) Pharmacokinetic Parameters (Mean ± Standard Deviation) C max (mcg/mL) AUC 0-24 * (mcg·h/mL) t ½ (h) Cl (mL/min/kg) Patients with IC † [Day 1] 20 100 5.7 ± 2.2 83 ± 51 14.5 ± 7.0 0.359 ± 0.179 [Steady-State] 20 100 10.1 ± 4.4 97 ± 29 13.4 ± 2.0 0.298 ± 0.115 HIV ‡ -Positive 20 50 4.1 ± 1.4 36 ± 9 14.9 ± 4.3 0.321 ± 0.098 Patients with EC § 20 100 8.0 ± 2.4 108 ± 31 13.8 ± 3.0 0.327 ± 0.093 [Day 1] 14 150 11.6 ± 3.1 151 ± 45 14.1 ± 2.6 0.340 ± 0.092 20 50 5.1 ± 1.0 54 ± 13 15.6 ± 2.8 0.300 ± 0.063 [Day 14 or 21] 20 100 10.1 ± 2.6 115 ± 25 16.9 ± 4.4 0.301 ± 0.086 14 150 16.4 ± 6.5 167 ± 40 15.2 ± 2.2 0.297 ± 0.081 HSCT ¶ Recipients [Day 7] per kg 8 10 8 3 4 6 21.1 ± 2.84 29.2 ± 6.2 38.4 ± 6.9 234 ± 34 339 ± 72 479 ± 157 14.0 ± 1.4 14.2 ± 3.2 14.9 ± 2.6 0.214 ± 0.031 0.204 ± 0.036 0.224 ± 0.064 8 8 60.8 ± 26.9 663 ± 212 17.2 ± 2.3 0.223 ± 0.081 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) * 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.
Body weight group N Dose* mg/kg C max.ss † (mcg/mL) AUC .ss † (mcg·h/mL) t½ ‡ (h) CL ‡ (mL/min/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 Specific Populations Adult Patients with Renal Impairment Micafungin does not require dose adjustment in patients with renal impairment. A single 1-hour infusion of 100 mg micafungin 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 was administered to 8 adult subjects with moderate hepatic impairment (Child-Pugh score 7 to 9) and 8 age-, gender-, and weight-matched subjects with normal hepatic function. The C max and AUC values of micafungin were lower by approximately 22% in subjects with moderate hepatic impairment compared to normal subjects. This difference in micafungin exposure does not require dose adjustment of micafungin in patients with moderate hepatic impairment.
A single 1-hour infusion of 100 mg micafungin was administe… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
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 )] .
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Treatment of Candidemia and Other Candida Infections in Adult and Pediatric Patients 4 Months of Age and Older Two dose levels of micafungin were evaluated in a randomized, double-blind study to determine the efficacy and safety versus caspofungin in patients with invasive candidiasis and candidemia. Patients were randomized to receive once daily intravenous infusions (IV) of micafungin, either 100 mg/day or 150 mg/day or caspofungin (70 mg loading dose followed by 50 mg maintenance dose). Patients in both study arms were permitted to switch to oral fluconazole after at least 10 days of intravenous therapy, provided they were non-neutropenic, had improvement or resolution of clinical signs and symptoms, had a Candida isolate which was susceptible to fluconazole, and had documentation of 2 negative cultures drawn at least 24 hours apart.
Patients were stratified by APACHE II score (20 or less or greater than 20) and by geographic region. Patients with Candida endocarditis were excluded from this analysis. Outcome was assessed by overall treatment success based on clinical (complete resolution or improvement in attributable signs and symptoms and radiographic abnormalities of the Candida infection and no additional antifungal therapy) and mycological (eradication or presumed eradication) response at the end of IV therapy.
Deaths that occurred during IV study drug therapy were treated as failures. In this study, 111/578 (19.2%) of the patients had baseline APACHE II scores of greater than 20, and 50/578 (8.7%) were neutropenic at baseline (absolute neutrophil count less than 500 cells/mm 3 ). Outcome, relapse and mortality data are shown for the recommended dose of micafungin (100 mg/day) and caspofungin in Table 9 .
Table 9. Efficacy Analysis: Treatment Success in Patients in Study 03-0-192 with Candidemia and Other Candida Infections * 70 mg loading dose on day 1 followed by 50 mg/day thereafter (caspofungin). † All patients who received at least one dose of study medication and had documented invasive candidiasis or candidemia. Patients with Candida endocarditis were excluded from the analyses. ‡ A patient may have had greater than 1 organ of dissemination. § A patient may have had greater than 1 baseline infection species. ¶ All patients who had a culture-confirmed relapse or required systemic antifungal therapy in the post-treatment period for a suspected or proven Candida infection.
Also includes patients who died or were not assessed in follow-up. Micafungin 100 mg/day n (%) % treatment difference (95% CI) Caspofungin 70/50 mg/day* n (%) Treatment Success at End of IV Therapy † 135/191 (70.7) 7.4 (-2.0, 16.3) 119/188 (63.3) Success in Patients with Neutropenia at Baseline 14/22 (63.6) 5/11 (45.5) Success by Site of Infection Candidemia 116/163 (71.2) 103/161 (64) Abscess 4/5 (80) 5/9 (55.6) Acute Disseminated ‡ 6/13 (46.2) 5/9 (55.6) Endophthalmitis 1/3 1/1 Chorioretinitis 0/3 0 Skin 1/1 0 Kidney 2/2 1/1 Pancreas 1/1 0 Peritoneum 1/1 0 Lung/Skin 0/1 0 Lung/Spleen 0/1 0 Liver 0 0/2 Intraabdominal abscess 0 3/5 Chronic Disseminated 0/1 0 Peritonitis 4/6 (66.7) 2/5 (40) Success by Organism § C. albicans 57/81 (70.4) 45/73 (61.6) C. glabrata 16/23 (69.6) 19/31 (61.3) C. tropicalis 17/27 (63) 22/29 (75.9) C. parapsilosis 21/28 (75) 22/39 (56.4) C. krusei 5/8 (62.5) 2/3 (66.7) C. guilliermondii 1/2 0/1 C. lusitaniae 2/3 (66.7) 2/2 Relapse through 6 Weeks ¶ Overall Culture-confirmed relapse Required systemic antifungal therapy Died during follow-up Not assessed 49/135 (36.3) 5 11 17 16 44/119 (37) 4 5 16 19 Overall study mortality Mortality during IV therapy 58/200 (29) 28/200 (14) 51/193 (26.4) 27/193 (14) In two cases of ophthalmic involvement assessed as failures in the above table due to missing evaluation at the end of IV treatment with micafungin, therapeutic success was documented during protocol-defined oral fluconazole therapy.
14.2Treatment of Esophageal Candidiasis in Adult and Pediatric Patie… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Hepatic carcinomas and adenomas were observed in a 6-month intravenous toxicology study with an 18-month recovery period of micafungin sodium in rats designed to assess the reversibility of hepatocellular lesions. Rats administered micafungin sodium for 3 months at 32 mg/kg/day (corresponding to 8 times the highest recommended human dose [150 mg/day], based on AUC comparisons), exhibited colored patches/zones, multinucleated hepatocytes and altered hepatocellular foci after 1 or 3-month recovery periods, and adenomas were observed after a 21-month recovery period.
Rats administered micafungin sodium at the same dose for 6 months exhibited adenomas after a 12-month recovery period; after an 18-month recovery period, an increased incidence of adenomas was observed and, additionally, carcinomas were detected. A lower dose of micafungin sodium (equivalent to 5 times the human AUC) in the 6-month rat study resulted in a lower incidence of adenomas and carcinomas following 18 months recovery. The duration of micafungin dosing in these rat studies (3 or 6 months) exceeds the usual duration of micafungin dosing in patients, which is typically less than 1 month for treatment of esophageal candidiasis, but dosing may exceed 1 month for Candida prophylaxis.
Although the increase in carcinomas in the 6-month rat study did not reach statistical significance, the persistence of altered hepatocellular foci subsequent to micafungin dosing, and the presence of adenomas and carcinomas in the recovery periods suggest a causal relationship between micafungin sodium, altered hepatocellular foci, and hepatic neoplasms. Whole-life carcinogenicity studies of micafungin in animals have not been conducted, and it is not known whether the hepatic neoplasms observed in treated rats also occur in other species, or if there is a dose threshold for this effect.
Micafungin sodium was not mutagenic or clastogenic when evaluated in a standard battery of in vitro and in vivo tests (i.e., bacterial reversion - S. typhimurium, E. coli ; chromosomal aberration; intravenous mouse micronucleus). Male rats treated intravenously with micafungin sodium for 9 weeks showed vacuolation of the epididymal ductal epithelial cells at or above 10 mg/kg (about 0.6 times the recommended clinical dose for esophageal candidiasis, based on body surface area comparisons). Higher doses (about twice the recommended clinical dose, based on body surface area comparisons) resulted in higher epididymis weights and reduced numbers of sperm cells.
In a 39-week intravenous study in dogs, seminiferous tubular atrophy and decreased sperm in the epididymis were observed at 10 and 32 mg/kg, doses equal to about 2 and 7 times the recommended clinical dose, based on body surface area comparisons. There was no impairment of fertility in animal studies with micafungin sodium.
13.2Animal Toxicology and/or Pharmacology High doses of micafungin sodium (5 to 8 times the highest recommended human dose, based on AUC comparisons) have been associated with irreversible changes to the liver when administered for 3 or 6 months, and these changes may be indicative of pre-malignant processes [see Nonclinical Toxicology ( 13.1 )] .
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Hepatic carcinomas and adenomas were observed in a 6-month intravenous toxicology study with an 18-month recovery period of micafungin sodium in rats designed to assess the reversibility of hepatocellular lesions. Rats administered micafungin sodium for 3 months at 32 mg/kg/day (corresponding to 8 times the highest recommended human dose [150 mg/day], based on AUC comparisons), exhibited colored patches/zones, multinucleated hepatocytes and altered hepatocellular foci after 1 or 3-month recovery periods, and adenomas were observed after a 21-month recovery period.
Rats administered micafungin sodium at the same dose for 6 months exhibited adenomas after a 12-month recovery period; after an 18-month recovery period, an increased incidence of adenomas was observed and, additionally, carcinomas were detected. A lower dose of micafungin sodium (equivalent to 5 times the human AUC) in the 6-month rat study resulted in a lower incidence of adenomas and carcinomas following 18 months recovery. The duration of micafungin dosing in these rat studies (3 or 6 months) exceeds the usual duration of micafungin dosing in patients, which is typically less than 1 month for treatment of esophageal candidiasis, but dosing may exceed 1 month for Candida prophylaxis.
Although the increase in carcinomas in the 6-month rat study did not reach statistical significance, the persistence of altered hepatocellular foci subsequent to micafungin dosing, and the presence of adenomas and carcinomas in the recovery periods suggest a causal relationship between micafungin sodium, altered hepatocellular foci, and hepatic neoplasms. Whole-life carcinogenicity studies of micafungin in animals have not been conducted, and it is not known whether the hepatic neoplasms observed in treated rats also occur in other species, or if there is a dose threshold for this effect.
Micafungin sodium was not mutagenic or clastogenic when evaluated in a standard battery of in vitro and in vivo tests (i.e., bacterial reversion - S. typhimurium, E. coli ; chromosomal aberration; intravenous mouse micronucleus). Male rats treated intravenously with micafungin sodium for 9 weeks showed vacuolation of the epididymal ductal epithelial cells at or above 10 mg/kg (about 0.6 times the recommended clinical dose for esophageal candidiasis, based on body surface area comparisons). Higher doses (about twice the recommended clinical dose, based on body surface area comparisons) resulted in higher epididymis weights and reduced numbers of sperm cells.
In a 39-week intravenous study in dogs, seminiferous tubular atrophy and decreased sperm in the epididymis were observed at 10 and 32 mg/kg, doses equal to about 2 and 7 times the recommended clinical dose, based on body surface area comparisons. There was no impairment of fertility in animal studies with micafungin sodium.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL – Micafungin for Injection, 50 mg Container Label NDC 71288- 028 -10 Rx Only Micafungin for Injection 50 mg per vial After reconstitution each mL contains 10 mg micafungin. For Intravenous Infusion Only Single-Dose Vial Discard unused portion PRINCIPAL DISPLAY PANEL – Micafungin for Injection, 50 mg Container Label
PRINCIPAL DISPLAY PANEL – Micafungin for Injection, 50 mg Carton NDC 71288- 028 -11 Rx Only Micafungin for Injection 50 mg per vial For Intravenous Infusion Only 10 x 50 mg Single-Dose Vials Discard unused portion PRINCIPAL DISPLAY PANEL – Micafungin for Injection, 50 mg Carton
PRINCIPAL DISPLAY PANEL – Micafungin for Injection, 50 mg Single-Pack Carton NDC 71288- 028 -12 Rx Only Micafungin for Injection 50 mg per vial For Intravenous Infusion Only 1 x 50 mg Single-Dose Vial Discard unused portion PRINCIPAL DISPLAY PANEL – Micafungin for Injection, 50 mg Single-Pack Carton
PRINCIPAL DISPLAY PANEL – Micafungin for Injection, 100 mg Container Label NDC 71288- 029 -10 Rx Only Micafungin for Injection 100 mg per vial After reconstitution each mL contains 20 mg micafungin. For Intravenous Infusion Only Single-Dose Vial Discard unused portion PRINCIPAL DISPLAY PANEL – Micafungin for Injection, 100 mg Container Label
PRINCIPAL DISPLAY PANEL – Micafungin for Injection, 100 mg Carton NDC 71288- 029 -11 Rx Only Micafungin for Injection 100 mg per vial For Intravenous Infusion Only 10 x 100 mg Single-Dose Vials Discard unused portion PRINCIPAL DISPLAY PANEL – Micafungin for Injection, 100 mg Carton
PRINCIPAL DISPLAY PANEL – Micafungin for Injection, 100 mg Single-Pack Carton NDC 71288- 029 -12 Rx Only Micafungin for Injection 100 mg per vial For Intravenous Infusion Only 1 x 100 mg Single-Dose Vials Discard unused portion PRINCIPAL DISPLAY PANEL – Micafungin for Injection, 100 mg Single-Pack Carton
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