micafungin in sodium chloride 0.9%
Micafungin in Sodium Chloride 0.9% (Micafungin Sodium) is an echinocandin antifungal used to treat Candidemia.
Micafungin Sodium · by Baxter Hlthcare
Available as a generic: Micafungin Sodium
Key facts
- Active ingredient
- Micafungin Sodium
- Drug class
- Echinocandin Antifungal
- Form
- Injectable
- Strength
- Micafungin Sodium EQ 100MG BASE/100ML (EQ 1MG BASE/ML) · Micafungin Sodium EQ 150MG BASE/150ML (EQ 1MG BASE/ML) · Micafungin Sodium EQ 50MG BASE/50ML (EQ 1MG BASE/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- candidemia
- Manufacturer
- Baxter Hlthcare
- FDA application
- NDA216142
What is Micafungin in Sodium Chloride 0.9%?
From the FDA label:Micafungin in Sodium Chloride Injection is a premixed, iso-osmotic, sterile, nonpyrogenic solution for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin). Micafungin in Sodium Chloride Injection is supplied as a refrigerated 50 mL, 100 mL, or 150 mL single-dose GALAXY container in the following presentations: 50 mg/50 mL (1 mg/mL): containing 50 mg of micafungin (equivalent to 50.87 mg of micafungin sodium); 36 mg citric acid, anhydrous; 450 mg sodium chloride; 92 mg sodium citrate dihydrate; 100 mg/100 mL (1 mg/mL): containing 100 mg of micafungin (equivalent to 101.73 mg of micafungin sodium); 72 mg citric acid, anhydrous; 900 mg sodium chloride; 184 mg sodium citrate dihydrate; 150 mg/150 mL (1 mg/mL): containing 150 mg of micafungin (equivalent to 152.60 mg of micafungin sodium); 108 mg citric acid, anhydrous; 1350 mg sodium chloride; 276 mg sodium citrate dihydrate. • Each 50 mg/50 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 200 mg of sodium. • Each 100 mg/100 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 400 mg of sodium. • Each 150 mg/150 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 600 mg of sodium. The premixed solution is clear and colorless, with a pH range of 4.5 to 5.1. Micafungin sodium is chemically designated…
How to use
If a dose of Micafungin in Sodium Chloride Injection is required that does not equal 50 mg, 100 mg, or 150 mg, this product is not recommended for use and an alternative formulation of micafungin should be considered. Recommended Dosage Administered by Indication, Weight and Age ( 2.1 , 2.2 , 2.3 , 2.4 , 8.4 ) Adult Pediatric Patients 4 Months and Older 30 kg or less Pediatric Patients 4 Months and Older greater than 30 kg Pediatric Patients Younger than 4 Months of Age Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses 100 mg daily 2 mg/kg/day (maximum 100 mg daily) See below Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without Meningoencephalitis and/or Ocular Dissemination See above See above 4 mg/kg/day Treatment of Esophageal Candidiasis 150 mg daily 3 mg/kg/day 2.5 mg/kg/day (maximum 150 mg daily) Not approved Prophylaxis of Candida Infections in HSCT Recipients 50 mg daily 1 mg/kg/day (maximum 50 mg daily) Not approved • Infuse over 1 hour. ( 2.6 ) • See Full Prescribing Information for intravenous (IV) directions for preparation for administration instructions. ( 2.5 , 2.6 ) 2.1 Important Administration Instructions If a dose of Micafungin in Sodium Chloride Injection is required that does not equal 50 mg, 100 mg, or 150 mg, this product is not recommended for use and an alternative…
Side effects
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) ] • High Sodium Load [ see Warnings and Precautions (5.6) ] • 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 ) • In pediatric patients younger than 4 months of age, the following additional common adverse reactions were reported at an incidence rate of ≥15%: hypokalemia, acidosis, sepsis, anemia, and oxygen saturation decreased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of micafungin for injection 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…
Warnings
Important safety information
Hypersensitivity Reactions: Anaphylaxis and anaphylactoid reactions (including shock) have been observed. Discontinue Micafungin in Sodium Chloride 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. ( 2.5 , 5.5 ) • High Sodium Load: Each 50, 100, and 150 mL Galaxy container contains 200, 400, and 600 mg of sodium, respectively. Avoid use in patients with congestive heart failure, elderly patients, and patients requiring restricted sodium intake. ( 5.6 , 8.5 ) 5.1 Hypersensitivity 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 in Sodium Chloride Injection infusion should be discontinued and appropriate treatment administered. 5.2 Hematological 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 in Sodium Chloride Injection therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing Micafungin in Sodium Chloride Injection therapy. 5.3 Hepatic 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 in Sodium Chloride Injection therapy should be monitored for evidence of worsening hepatic function and evaluated for the risk/benefit of continuing Micafungin in Sodium Chloride Injection therapy. 5.4 Renal 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 in Sodium Chloride Injection therapy should be monitored for evidence of worsening renal function. 5.5 Infusion 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 (2.6) ]. 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 Adverse Reactions (6.1) ]. 5.6 High Sodium Load Each 50 mg/50 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 200 mg of sodium, each 100 mg/100 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 400 mg of sodium, and each 150 mg/150 mL Galaxy container of Micafungin in Sodium Chloride Injection contains 600 mg of sodium. Avoid use of Micafungin in Sodium Chloride Injection in patients with congestive heart failure, elderly patients, and patients requiring restricted sodium intake.
Who should not take Micafungin in Sodium Chloride 0.9%
Micafungin in Sodium Chloride Injection is contraindicated in persons with known hypersensitivity to micafungin, any component of Micafungin in Sodium Chloride Injection, or other echinocandins. Micafungin in Sodium Chloride Injection is contraindicated in persons with known hypersensitivity to micafungin sodium, any component of Micafungin in Sodium Chloride Injection, or other echinocandins. ( 4 )
Overdose — what happens if you take too much
Micafungin 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 15 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) and Use in Specific Populations (8.4) ].
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Monitor for sirolimus, itraconazole or nifedipine toxicity, and dosage of sirolimus, itraconazole or nifedipine should be reduced, if necessary. ( 7 ) 7.1 Effect of Other Drugs on Micafungin in Sodium Chloride Injection CYP3A4, CYP2C9 and CYP2C19 Inhibitors Co-administration of Micafungin in Sodium Chloride Injection with cyclosporine, itraconazole, voriconazole and fluconazole did not alter the pharmacokinetics of micafungin. CYP2C19 and CYP3A4 Inducer Co-administration of Micafungin in Sodium Chloride Injection with rifampin and ritonavir did not alter the pharmacokinetics of micafungin. Co-administration of Micafungin in Sodium Chloride Injection with Other Drugs Co-administration of Micafungin in Sodium Chloride Injection with mycophenolate mofetil (MMF), amphotericin B, tacrolimus, prednisolone, sirolimus and nifedipine did not alter the pharmacokinetics of micafungin. 7.2 Effect of Micafungin in Sodium Chloride 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 for injection 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.
Drug class
May treat (source: NIH RxClass)
See how Micafungin in Sodium Chloride 0.9% ranks — best-rated echinocandin antifungal for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Micafungin in Sodium Chloride 0.9% treat?
- Micafungin in Sodium Chloride 0.9% (Micafungin Sodium) may be used to treat candidemia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Micafungin in Sodium Chloride 0.9%?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Micafungin in Sodium Chloride 0.9%. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Micafungin in Sodium Chloride 0.9%?
- Micafungin in Sodium Chloride 0.9% is marketed by Baxter Hlthcare. You can see Baxter Hlthcare's full profile, rating, and other products on pharmaranks.
- Is Micafungin in Sodium Chloride 0.9% a brand-name or generic drug?
- Micafungin in Sodium Chloride 0.9% is a brand-name product with the active ingredient Micafungin Sodium. Lower-cost generic equivalents containing Micafungin Sodium are available — ask your pharmacist.
- Is Micafungin in Sodium Chloride 0.9% available over the counter?
- No. Micafungin in Sodium Chloride 0.9% is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Micafungin in Sodium Chloride 0.9% come in?
- Micafungin in Sodium Chloride 0.9% is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Micafungin in Sodium Chloride 0.9%?
- Micafungin in Sodium Chloride 0.9% is classified as echinocandin antifungal, per the FDA's Established Pharmacologic Class.
- Is Micafungin in Sodium Chloride 0.9% FDA-registered?
- Micafungin in Sodium Chloride 0.9% is on record with the U.S. FDA under application number NDA216142. You can verify this on its official FDA label.
- Is Micafungin in Sodium Chloride 0.9% safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Micafungin in Sodium Chloride 0.9%. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Micafungin in Sodium Chloride 0.9%?
- Micafungin in Sodium Chloride 0.9%'s side effects are taken directly from its FDA label. From the label: 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… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
Compare Micafungin in Sodium Chloride 0.9% head-to-head
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
micafungin in sodium chloride 0.9%
New