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.

NIMBEX (NDA-020551)

(CISATRACURIUM BESYLATE)

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

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10/14/2022 (SUPPL-28)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion; additions and revisions underlined

Risk Summary

The 10 mL NIMBEX multiple-dose vials contain the preservative benzyl alcohol. Therefore, if NIMBEX is needed during pregnancy, consider using a benzyl alcohol-free formulation (i.e., 5 mL and 20 mL NIMBEX single-dose vials). Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see Contraindications (4), Warnings and Precautions (5.2), and Use in Specific Populations (8.4)].

There are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies conducted in rats administered cisatracurium besylate during organogenesis (Gestational Day 6 to 15) found no evidence of fetal harm at 0.8 times (ventilated rats) the exposure from a human starting IV bolus dose of 0.2 mg/kg (see Data).

The estimated background risk for major birth defects and miscarriage in the indicated population is unknown.

. . .

Data

Animal Data

(0.5 and 1 mg/kg; equivalent to 0.4- and 0.8-times, respectively, the exposure in humans following a bolus dose of 0.2 mg/kg IV based on mg/m2 comparison). Neither of these studies revealed maternal or fetal toxicity or malformations.

8.2 Lactation

PLLR conversion

Newly added information:

Risk Summary

The 10 mL NIMBEX multiple-dose vials contains the preservative benzyl alcohol. Therefore, if NIMBEX is needed during lactation, consider using a benzyl alcohol-free formulation (i.e., 5 mL and 20 mL NIMBEX single-dose vials). Because benzyl alcohol is rapidly metabolized by a lactating woman, benzyl alcohol exposure in the breastfed infant is unlikely. However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see Contraindications (4), Warnings and Precautions (5.2) and Use in Specific Populations (8.4)].

There are no data on the presence of cisatracurium besylate in human milk, the effects on the breastfed child, or the effects on milk production.

8.9 Patients with Hemiparesis or Paraparesis

Additions and revisions underlined:

Patients with hemiparesis or paraparesis may demonstrate resistance to nondepolarizing neuromuscular blocking agents in the affected limbs. To avoid inaccurate dosing, perform neuromuscular monitoring on a non-paretic limb.

07/27/2018 (SUPPL-26)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Risk of Death Due to Medication Errors

(Newly Added Subsection)

Administration of NIMBEX results in paralysis, which may lead to respiratory arrest and death, a progression that may be more likely to occur in a patient for whom it is not intended. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. If another healthcare provider is administering the product, ensure that the intended dose is clearly labeled and communicated.

07/26/2018 (SUPPL-20)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions are underlined)

NIMBEX is contraindicated in patients with known hypersensitivity to cisatracurium. Severe anaphylactic reactions to NIMBEX have been reported.

The use of 10 mL NIMBEX multiple-dose vials is contraindicated for use in pediatric patients less than 1 month of age and low birth-weight infants because the formulation contains benzyl alcohol.