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.

LUCENTIS (BLA-125156)

(RANIBIZUMAB)

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

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02/15/2024 (SUPPL-128)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Retinal Vasculitis with or without Occlusion

Newly added subsection:

Retinal vasculitis with or without occlusion, typically in the presence of preexisting intraocular inflammation or post-treatment with other intravitreal agents, have been reported with the use of LUCENTIS. Discontinue treatment with LUCENTIS in patients who develop these events. Patients should be instructed to report any change in vision without delay [see Patient Counseling Information (17)].

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise patients that in the days following LUCENTIS administration, patients are at risk of developing endophthalmitis and retinal vasculitis with or without occlusion. If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise the patient to seek immediate care from an ophthalmologist [see Warnings and Precautions (5.1, 5.5)].

04/15/2017 (SUPPL-114)

Approved Drug Label (PDF)

5 Warnings and Precautions

(Additions and/or revisions are underlined)

5.4 Fatal Events in Patients with Diabetic Macular Edema and Diabetic Retinopathy at Baseline

6 Adverse Reactions

6.2 Clinical Studies Experience

(Additions and/or revisions are underlined)

Safety data observed in 224 patients with mCNV, as well as Studies AMD-4 and D-3, were consistent with these results...

01/05/2017 (SUPPL-111)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Clinical Studies Experience

Additions and/or revisions underlined:

…Safety data observed in Study AMD-4 and in 224 patients with mCNV were consistent with these results …

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Risk Summary

There are no adequate and well-controlled studies of LUCENTIS administration in pregnant women.

Administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses 13-times the predicted human exposure (based on maximal serum trough levels [Cmax]) after a single eye treatment at the recommended clinical dose. No skeletal abnormalities were observed at serum trough levels equivalent to the predicted human exposure after a single eye treatment at the recommended clinical dose.

Animal reproduction studies are not always predictive of human response, and it is not known whether ranibizumab can cause fetal harm when administered to a pregnant woman. Based on the anti-VEGF mechanism of action for ranibizumab, treatment with LUCENTIS may pose a risk to human embryofetal development.

Data

Animal Data

An embryo-fetal developmental toxicity study was performed on pregnant cynomolgus monkeys ….

8.2 Lactation

Additions and/or revisions underlined:

Risk Summary

There are no data available on the presence of ranibizumab in human milk, the effects of ranibizumab on the breastfed infant or the effects of ranibizumab on milk production/excretion.

Because many drugs are excreted in human milk …

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LUCENTIS and any potential adverse effects on the breastfed child from ranibizumab.

8.3 Females and Males of Reproductive Potential

Additions and/or revisions underlined:

Infertility

No studies on the effects of ranibizumab on fertility have been conducted. and it is not known whether ranibizumab can affect reproduction capacity. Based on the anti-VEGF mechanism of action for ranibizumab, treatment with LUCENTIS may pose a risk to reproductive capacity.

8.5 Geriatric Use

Additions and/or revisions underlined:

In the clinical studies, approximately 76% (2449 of 3227) of patients randomized to treatment with LUCENTIS were ? 65 years of age and approximately 51% (1644 of 3227) were ? 75 years of age …