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MICAFUNGIN FOR is a brand name for Micafungin, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE........................................................................... 3 CONTRAINDICATIONS ................................................................................................ 4 WARNINGS AND PRECAUTIONS .............................................................................. 4…
Verbatim from this product's HC label. Tap a section to expand.
Micafungin for Injection is contraindicated in patients with hypersensitivity to micafungin, echinocandins or any component of this drug product (For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph).
WARNINGS AND PRECAUTIONS General Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock), Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported in patients receiving micafungin.
If these reactions occur, micafungin infusion should be discontinued and appropriate treatment administered (See ADVERSE REACTIONS). Carcinogenesis, 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.
Micafungin for Injection should not be used in higher than recommended doses and for prolonged duration because the potential risk of liver tumor formation cannot be fully excluded. 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 coloured patches/zones, multinucleated hepatocytes and altered hepatocellular foci after 1- or 3- month recovery periods, and adenomas were observed after a 20-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 for Injection 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Whole-life carcinogenicity studies of micafungin sodium 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 (See TOXICOLOGY).
Hepatic Laboratory abnormalities in liver function tests have been seen in healthy volunteers and patients treated with micafungin sodium. In some patients with serious underlying conditions who were receiving micafungin along with multiple concomitant medications, clinical hepatic Product Monograph Micafungin for Injection Page 5 of 37 abnormalities have occurred, and isolated cases of significant hepatic impairment, hepatitis, or worsening hepatic failure have been reported.
Patients with hepatic impairment or who develop abnormal liver function tests during Micafungin for Injection therapy should be monitored for evidence of worsening hepatic function and evaluated for the risk/benefit of continuing Micafungin for Injection therapy (See ADVERSE REACTIONS).
Renal Elevations in BUN and creatinine, and isolated cases of significant renal impairment or acute renal failure have been reported in patients who received micafungin sodium. 5% for fluconazole treated patients. Patients who develop abnormal renal function tests during Micafungin for Injection therapy should be monitored for evidence of worsening renal function (See ADVERSE REACTIONS).
Hematological Effects Acute intravascular hemolysis and hemoglobinuria were seen in a healthy volunteer during infusion of micafungin sodium (200 mg) and oral prednisolone (20 mg). This event was transient, and the subject did not develop significant anemia.
Isolated cases of significant hemolysis and hemolytic anemia have also been reported in patients treated with micafungin sodium. Patients who develop clinical or laboratory evidence of hemolysis or hemolytic anemia during Micafungin for Injection therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing Micafungin for Injection therapy (See ADVERSE REACTIONS).
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 (See TOXICOLOGY).
Special Populations Pregnant Women:
No adequate, well-controlled studies have been conducted in pregnant women. Micafungin for Injection should be used during pregnancy only if the benefits outweigh the potential risks. Micafungin sodium administration to pregnant rabbits (intravenous dosing on days 6 to 18 of gestation) resulted in visceral abnormalities and abortion at 32 mg/kg, a dose equivalent to about four times […]