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.

ANTHIM (BLA-125509)

(OBILTOXAXIMAB)

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

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11/29/2019 (SUPPL-15)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion)

Risk Summary

There are no data on the use of ANTHIM in pregnant women to inform on drug-associated risk. There are adverse effects on maternal and fetal outcomes associated with anthrax in pregnancy (see Clinical Considerations). In pregnant rabbits, intravenous administration of obiltoxaximab during organogenesis was not associated with adverse developmental outcomes at up to 0.62 times the human systemic exposure at the maximum recommended adult dose (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population 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.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk:

Limited data in the form of case reports of anthrax infection in pregnant women indicate that maternal infection is associated with a high risk of maternal, fetal, and neonatal deaths, particularly in the absence of treatment.

Data

Animal Data:

A study was conducted in pregnant, healthy, New Zealand White rabbits administered intravenous obiltoxaximab at dose levels of 16 or 32 mg/kg during organogenesis on Gestation Days 6, 10, 13 and 17. No maternal toxicity or adverse developmental outcomes were observed at the highest tested dose, 32 mg/kg. In those rabbits, mean maternal maximum plasma concentration (Cmax = 1180 mcg/mL) and mean maternal AUCinf

(3220 mcg•day/mL) were approximately 3 times and 0.62 times the respective values for Cmax and AUC reported in clinical trial subjects at the maximum recommended adult dose of 16 mg/kg.

8.2 Lactation

(PLLR conversion)

Risk Summary

There is no information available on the presence of obiltoxaximab in human milk, the effects on the breastfed child, or the effects on milk production. Maternal IgG is known to be present in human milk. Therefore, the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for ANTHIM and any potential adverse effects on the breastfed child from ANTHIM or from the underlying maternal condition.