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.

LASTACAFT (NDA-022134)

(ALCAFTADINE)

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

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06/09/2020 (SUPPL-7)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions and/or revisions underlined)

The following adverse reactions have been identified during post-approval use of LASTACAFT®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

These reactions include eye discharge, eye swelling, erythema of eyelid, eyelid edema, lacrimation increased, vision blurred, hypersensitivity reactions including swelling of the face or allergic dermatitis, and somnolence

8 Use in Specific Populations

8.1 Pregnancy

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

Risk Summary

There are no adequate and well-controlled studies with LASTACAFT® in pregnant women to inform a drug associated risk. There are limited data with the use of alcaftadine eye drops in pregnant women.

In embryofetal studies in rats and rabbits, oral administration of alcaftadine during the period of organogenesis did not produce maternal or embryofetal toxicity at clinically relevant doses.

Advise pregnant women of a potential risk to the fetus and mother. LASTACAFT® should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus and mother. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies.

Data

Animal Data

In rats, oral administration of 5, 20 or 40 mg/kg/day alcaftadine during the period of organogenesis (gestational days 6 – 16) caused maternal lethality at doses of 40 mg/kg. The no observed adverse effect level (NOAEL) for maternal toxicity was 20 mg/kg/day (an exposure 230-times higher than that at the maximum recommended human ophthalmic dose [MRHOD], based on AUC). There were no adverse embryofetal effects up to a dose of 20 mg/kg.

In rabbits, oral administration of 10, 40 or 80 mg/kg/day alcaftadine during the period of organogenesis (gestational days 6 – 18) caused no maternal toxicity or adverse embryofetal effects up to a dose of 80 mg/kg/day (an exposure 8819-times higher than that at the MRHOD, based on AUC).

Daily oral doses of 20 and 30 mg/kg/day alcaftadine administered to rats from Day 6 of pregnancy until Day 20 postpartum produced lower pup weights in offspring. No adverse effects in dams or offspring were observed at doses up to 5 mg/kg/day (a dose 286 times higher than the MRHOD, on a mg/m2 basis).

8.2 Lactation

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

Risk Summary

There is no information regarding the presence of LASTACAFT® in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of LASTACAFT® to an infant during lactation. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for LASTACAFT®, and any potential adverse effects on the breastfed infant from LASTACAFT®.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Potential for Eye Injury and Sterility of Dropper Tip

To minimize eye injury and contamination of the dropper tip and solution, advise patients to not touch the eyelids or surrounding areas with the dropper tip, as this may contaminate the contents.

Concomitant Use with other Ophthalmic Products

If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.

Contact Lens Use

Advise patients not to wear a contact lens if their eye is red. LASTACAFT® should not be used to treat contact lens-related irritation. Advise patients remove contact lenses prior to instillation of LASTACAFT®. The preservative in LASTACAFT®, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of LASTACAFT®.