Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

MYCAMINE (NDA-021506)

(MICAFUNGIN SODIUM)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

Download Data

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12/20/2019 (SUPPL-23)

Approved Drug Label (PDF)

6 Adverse Reactions

(Additions and/or revisions underlined)

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Hypersensitivity Reactions

• Hematological Effects

• Hepatic Effects

• Renal Effects

• Infusion and Injection Site Reactions

6.1 Clinical Trials Experience

(Extensive changes; please refer to label)

7 Drug Interactions

7.1 Effect of Other Drugs on MYCAMINE

(Additions and/or revisions underlined)

CYP3A4, CYP2C9 and CYP2C19 Inhibitors

Co-administration of MYCAMINE with cyclosporine, itraconazole, voriconazole and fluconazole did not alter the pharmacokinetics of MYCAMINE.

CYP2C19 and CYP3A4 Inducer

Co-administration of MYCAMINE with rifampin and ritonavir did not alter the pharmacokinetics of MYCAMINE.

Co-administration of MYCAMINE with Other Drugs

Co-administration of MYCAMINE with mycophenolate mofetil (MMF), amphotericin B, tacrolimus, prednisolone, sirolimus and nifedipine did not alter the pharmacokinetics of MYCAMINE.

7.2 Effect of MYCAMINE on Other Drugs

(Additions and/or revisions underlined)

CYP3A4 Substrates

There was no effect of single or multiple doses of MYCAMINE on cyclosporine, tacrolimus, prednisolone, voriconazole and fluconazole pharmacokinetics.

Sirolimus AUC was increased by 21% with no effect on Cmax in the presence of steady-state MYCAMINE compared with sirolimus alone. Nifedipine AUC and Cmax were increased by 18% and 42%, respectively, in the presence of steady-state MYCAMINE compared with nifedipine alone. Itraconazole AUC and Cmax were increased by 22% and 11%, respectively. Patients receiving sirolimus, nifedipine, and itraconazole in combination with MYCAMINE 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 MYCAMINE did not alter the pharmacokinetics of MMF.

8 Use in Specific Populations

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR) conversion; additions and/or revisions underlined)

Risk Summary

Based on findings from animal studies, MYCAMINE may cause fetal harm when administered to a pregnant woman. There is insufficient human data on the use of MYCAMINE 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. 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.

8.2 Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) conversion; additions and/or revisions underlined)

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 MYCAMINE, and any potential adverse effects on the breast-fed child from MYCAMINE, or from the underlying maternal condition.

8.4 Pediatric Use

(Extensive changes; please refer to label)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Hypersensitivity

Inform patients about the serious adverse effects of MYCAMINE including hypersensitivity reactions e.g., anaphylaxis and anaphylactoid reactions including shock.

Hepatic

Inform patients about the serious adverse effects of MYCAMINE including hepatic effects e.g., abnormal liver tests, hepatic impairment, hepatitis or worsening hepatic failure.

Hematologic

Inform patients about the serious adverse effects of MYCAMINE including hematological effects e.g., acute intravascular hemolysis, hemolytic anemia and hemoglobinuria.

Renal

Inform patients about the serious adverse effects of MYCAMINE 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 MYCAMINE 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 MYCAMINE, including over-the -counter medications.