Dosing & Uses
Dosage Forms & Strengths
powder for injection
- 50mg/vial
- 100mg/vial
Treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses
100 mg/day IV infusion x10-47 days (mean 15 days)
Treatment of Esophageal Candidiasis
150 mg/day IV infusion x10-30 days (mean 15 days)
Prophylaxis of Candida Infections in HSCT Recipients
50 mg/day IV infusion x6-51 days (mean 19 days)
Candida auris (Off-label)
Based on the limited data, an echinocandin drug (eg, anidulafungin, caspofungin, micafungin) is recommended by the CDC as initial therapy for treatment of C auris infections
100 mg IV qDay
Dosing Considerations
Limitations of use
- Has not been adequately studied in patients with endocarditis, osteomyelitis, and meningoencephalitis due to Candida
- Efficacy against infections caused by fungi other than Candida has not been established
Dosage Forms & Strengths
powder for injection
- 50mg/vial
- 100mg/vial
Candida Infections
Age 4 months or older
Indicated for candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and prophylaxis of Candida infections in hematopoietic stem cell transplants (HSCT) recipients
-
Treatment of Candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses
- 2 mg/kg IV qDay; not to exceed 100 mg/day
-
Treatment of esophageal candidiasis
- ≤30 kg: 3 mg/kg IV qDay
- >30 kg: 2.5 mg/kg IV qDay; not to exceed 150 mg/day
-
Prophylaxis of Candida infections in HSCT recipients
- 1 mg/kg IV qDay; not to exceed 50 mg/day
Age younger than 4 months
- Indicated for treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination
- 4 mg/kg IV qDay
Dosing Considerations
Limitations of use
- Safety and effectiveness have not been established for treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients aged <4 months as a higher dose may be needed
- Has not been adequately studied in patients with endocarditis, osteomyelitis, and meningoencephalitis due to Candida
- Efficacy against infections caused by fungi other than Candida has not been established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (2)
- lonafarnib
micafungin will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.
- Saccharomyces boulardii
micafungin decreases effects of Saccharomyces boulardii by unspecified interaction mechanism. Avoid or Use Alternate Drug. Systemic or oral antifungals may decrease activity of probiotic.
Monitor Closely (16)
- atogepant
micafungin will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- avapritinib
micafungin will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- axitinib
micafungin increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- dichlorphenamide
dichlorphenamide and micafungin both decrease serum potassium. Use Caution/Monitor.
- finerenone
micafungin will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.
- flibanserin
micafungin will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.
- isavuconazonium sulfate
micafungin will increase the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ivacaftor
micafungin increases levels of ivacaftor by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor when coadministered with weak CYP3A4 inhibitors .
- lemborexant
micafungin will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.
- lomitapide
micafungin increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lomitapide dose should not exceed 30 mg/day.
- midazolam intranasal
micafungin will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.
- nifedipine
micafungin increases levels of nifedipine by unspecified interaction mechanism. Use Caution/Monitor.
- sirolimus
micafungin increases levels of sirolimus by unspecified interaction mechanism. Use Caution/Monitor.
- tazemetostat
micafungin will increase the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tinidazole
micafungin will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- voclosporin
voclosporin, micafungin. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.
Minor (2)
- ruxolitinib
micafungin will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- ruxolitinib topical
micafungin will increase the level or effect of ruxolitinib topical by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
Adverse Effects
1-10%
Abd pain
Anemia
Headache
Diarrhea
Increased LFTs
Leukopenia
Nausea
Neutropenia
Phlebitis
Pruritus
Pyrexia
Rash
Rigors
Thrombocytopenia
Vomiting
Facial swelling
Vasodilation
<1%
Delirium
Dizziness
Somnolence
Postmarketing Reports
Blood and lymphatic system disorders: white blood cell count decreased, hemolytic anemia, disseminated intravascular coagulation
Hepatobiliary disorders: hyperbilirubinemia, hepatic function abnormal, hepatic disorder, hepatocellular damage
Renal and urinary disorders: acute renal failure and renal impairment
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis
Vascular disorders: shock
Warnings
Contraindications
Hypersensitivity
Cautions
NOT for IV bolus
No data on effectiveness against fungi other than Candida
Anaphylaxis and anaphylactoid reactions (including shock) reported; discontinue therapy and administer appropriate treatment
Isolated cases of acute intravascular hemolysis, hemolytic anemia and hemoglobinuria reported; patients who develop clinical or laboratory evidence of hemolysis or hemolytic anemia during therapy should be monitored closely for evidence of worsening of these conditions and evaluated for risk/benefit of continuing therapy
Abnormalities in liver function tests; isolated cases of hepatic impairment, hepatitis, and hepatic failure reported; in some patients with serious underlying conditions receiving therapy along with multiple concomitant medications, clinical hepatic abnormalities have occurred, and isolated cases of significant hepatic impairment, hepatitis, and hepatic failure reported; patients who develop abnormal liver function tests during therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing therapy
Elevations in BUN and creatinine; isolated cases of renal impairment or acute renal failure reported; patients who develop abnormal renal function tests during therapy should be monitored for evidence of worsening renal function
Infusion and injection site reactions
- Possible histamine-mediated symptoms reported. including rash, pruritus, facial swelling, and vasodilation; slow infusion rate if reactions occur
- Injection site reactions, including phlebitis and thrombophlebitis reported; these reactions occur more often when administered via peripheral IV
Pregnancy & Lactation
Pregnancy
Based on findings from animal studies, may cause fetal harm when administered to pregnant women
Human data are insufficient on use in pregnant women to inform a drug-associated risk of adverse developmental outcomes
Animal studies
- In an embryo-fetal toxicity study in pregnant rabbits, IV administration during organogenesis resulted in fetal visceral abnormalities and abortion at 32 mg/kg, a dose equivalent to 4x 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
Lactation
Data are not available regarding the presence of micafungin in human milk, effects on breastfed infants, or effects on milk production
Micafungin was present in the milk of lactating rats following IV administration; when a drug is present in animal milk, it is likely that the drug will be present in human milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Semisynthetic lipopeptide (echinocandin class), inhibits fungal cell wall synthesis
Pharmacokinetics
Protein Bound: >99%
Metabolism: Hepatic to catechol & methoxy forms
Half-life: 5.6-11hr (preterm infants); 12.5 +/- 4.6 hr (4 months to 16 years < 30 kg); 13.6 +/- 8.8 hr (4 months to 16 years > 30 kg); 11-21 hr (adults)
Excretion: Feces (71%), urine (<1%)
Dialyzable: No
Administration
IV Preparation
Aseptically add 5 mL 0.9% NaCl to vial to obtain 10 mg/mL (50 mg vial) or 20 mg/mL (100 mg vial)
Gently swirl to mix, do not shake vigorously or vortex
Dilute further by adding reconstituted solution to 100 mL of 0.9% NaCl or D5W
Dilution preparation
Diluted solution should be protected from light; not necessary to cover infusion drip chamber or tubing
Adult patients
- Add appropriate volume of reconstituted drug into 100 mL of 0.9% sodium chloride injection, USP or 100 mL of 5% dextrose injection, USP.
- Appropriately label the bag
Pediatric Patients
- Calculate total dose in milligrams (mg) by multiplying recommended pediatric dose (mg/kg) for their respective indication and the weight of the patient in kilograms (kg)
- To calculate volume (mL) of drug needed, divide calculated dose (mg) from step 1 by final concentration of selected reconstituted vial(s) (either 10 mg/mL for the 50 mg vial or 20 mg/mL for the 100 mg vial)
- Withdraw calculated volume (mL) of drug needed from selected concentration and size of reconstituted vial(s) used in Step 2 (ensure selected concentration and vial size used to calculate dose is also used to prepare infusion)
- Add the withdrawn volume of drug (step 3) to a 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP intravenous infusion bag or syringe; ensure final concentration of solution is between 0.5 mg/mL to 4 mg/mL
- To decrease risk of infusion reactions, concentrations above 1.5 mg/mL should be administered via central catheter
- Appropriately label infusion bag or syringe; for concentrations above 1.5 mg/mL, if required, label to specifically warn to administer the solution via central catheter
- The diluted infusion bag should be protected from light and may be stored for up to 24 hours at room temperature, 25°C (77°F)
IV Administration
Flush existing infusion line with 0.9% NaCl before administration
Infuse IV over 1 hr
Storage
Reconstituted vial or diluted solution: May be stored at controlled room temperature for up to 24 hr
Protect from light
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| micafungin intravenous - | 100 mg vial |  | |
| micafungin intravenous - | 50 mg vial |  | |
| micafungin intravenous - | 100 mg vial |  | |
| micafungin intravenous - | 50 mg vial |  | |
| Mycamine intravenous - | 50 mg vial |  | |
| Mycamine intravenous - | 100 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
micafungin intravenous
MICAFUNGIN - INJECTION
(MYE-ka-FUN-jin)
COMMON BRAND NAME(S): Mycamine
USES: This medication is used to treat a variety of fungal infections. It is also used to prevent fungal infections in patients who are having a stem cell transplant. Micafungin belongs to a class of drugs known as echinocandins. It works by stopping the growth of fungi.
HOW TO USE: This medication is given by injection into a vein as directed by your doctor, usually once a day over 1 hour. The dosage and length of treatment are based on your medical condition and response to treatment. In children, the dosage is also based on weight.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.Learn how to store and discard medical supplies safely.Infusion reactions may happen while you are receiving the drug. Tell your doctor right away if you have symptoms such as flushing or dizziness.Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition does not get better or if it gets worse.
SIDE EFFECTS: Swelling/redness/irritation at the injection site, nausea/vomiting, diarrhea, headache, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, dark urine, stomach/abdominal pain, yellowing eyes/skin), signs of kidney problems (such as change in the amount of urine), unusual tiredness, shortness of breath, signs of infection (such as fever, chills), easy bleeding/bruising, mental/mood changes (such as anxiety), fast/irregular heartbeat.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using micafungin, tell your doctor or pharmacist if you are allergic to it; or to other echinocandin antifungal drugs (such as anidulafungin, caspofungin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as liver/kidney function, complete blood count) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2021. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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