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.

EPYSQLI (BLA-761340)

(ECULIZUMAB-AAGH)

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

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11/15/2024 (SUPPL-3)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trial Experience

Newly added information:

Generalized Myasthenia Gravis (gMG)

In a 26-week placebo-controlled trial evaluating the effect of eculizumab for the treatment of gMG (gMG Study 1), 62 patients received eculizumab at the recommended dosage regimen and 63 patients received placebo [see Clinical Studies (14.3)]. Patients were 19 to 79 years of age, and 66% were female. Table 8 displays the most common adverse reactions from gMG Study 1 that occurred in > or =5% of eculizumab-treated patients and at a greater frequency than on placebo.

The most common adverse reactions (> or =10%) that occurred in eculizumab-treated patients in the long-term extension to gMG Study 1, Study ECU-MG-302, and that are not included in Table 8 were headache (26%), nasopharyngitis (24%), diarrhea (15%), arthralgia (12%), upper respiratory tract infection (11%), and nausea (10%).

Table 8: Adverse Reactions Reported in 5% or More of Eculizumab-Treated Patients in gMG Study 1 and at a Greater Frequency than in Placebo-Treated Patients added; please refer to label

6.2 Postmarketing Experience

Additions and revisions underlined:

The following adverse reactions have been identified during post-approval use of eculizumab products. 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 eculizumab products exposure.

Adverse Reactions from Postmarketing Spontaneous Reports

Fatal or serious infections: Neisseria gonorrhoeae, Neisseria meningitidis, Neisseria sicca/subflava, Neisseria spp unspecified.
Cases of cholestatic or mixed pattern liver injury with increased serum liver enzymes and bilirubin levels have been reported in adult and pediatric patients with aHUS who were treated with eculizumab products. These events occurred within 3 to 27 days after starting treatment. The median time to resolution (or return to baseline) was approximately 3 weeks.

7 Drug Interactions

7.1 Plasmapheresis, Plasma Exchange, or Fresh Frozen Plasma Infusion

Newly added subsection:

Concomitant use of eculizumab products with plasma exchange (PE), plasmapheresis (PP) or fresh frozen plasma infusion (PE/PI) treatment can reduce serum eculizumab product concentrations and requires a supplemental dose of EPYSQLI [see Dosage and Administration (2.5)].

7.2 Neonatal Fc Receptor Blockers

Newly added subsection:

Concomitant use of eculizumab products with neonatal Fc receptor (FcRn) blockers may lower systemic exposures and reduce effectiveness of eculizumab products. Closely monitor for reduced effectiveness of EPYSQLI.

8 Use in Specific Populations

8.4 Pediatric Use

Additions and revisions underlined:

Safety and effectiveness of EPYSQLI for the treatment of PNH or gMG in pediatric patients have not been established.

. . .

8.5 Geriatric Use

Additions and revisions underlined:

Fifty-one patients 65 years of age or older (15 with PNH, 4 with aHUS, 26 with gMG, and 6 with another indication) were treated with eculizumab in clinical trials in the approved indications. Although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.

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

Medication Guide

Additions and revisions underlined:

What is EPYSQLI?

EPYSQLI is a prescription medicine used to treat:

people with paroxysmal nocturnal hemoglobinuria (PNH).
people with atypical hemolytic uremic syndrome (aHUS).
EPYSQLI is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC- HUS).
adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive.

It is not known if EPYSQLI is safe and effective in children with PNH or gMG.

The most common side effects in people with gMG treated with EPYSQLI include:

muscle and joint (musculoskeletal) pain