Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

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.

ENJAYMO (BLA-761164)

(SUTIMLIMAB-JOME)

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

Download Data

Expand all

02/08/2024 (SUPPL-4)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Serious Infections Including Those Caused by Encapsulated Bacteria

Additions and/or revisions underlined:

ENJAYMO, a proximal classical complement C1s inhibitor, increases a patient’s susceptibility to serious infections, including those caused by encapsulated bacteria e.g. Neisseria meningitidis (any serogroup, including non-groupable strains), Streptococcus pneumoniae, and Haemophilus influenzae type B.

…

Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors.

…

Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of ENJAYMO, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the chronic duration of therapy with ENJAYMO. Note that, ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent ENJAYMO therapy is indicated in a patient who is not up to date on their vaccines administer vaccine(s) as soon as possible.

Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Serious Infections Including Those Caused by Encapsulated Bacteria

Advise patients of the risk of serious infection. Inform patients of the need to complete or update their vaccinations against encapsulated bacteria at least 2 weeks prior to receiving the first dose of ENJAYMO. If urgent ENJAYMO therapy is indicated in a patient who is not up to date on their vaccines administer vaccine(s) as soon as possible. Inform the patient that they are required to be revaccinated according to current ACIP recommendations for encapsulated bacteria while on ENJAYMO therapy [see Warnings and Precautions (5.1)].

Inform patients that vaccination may not prevent serious infection and strongly advise the patient to seek immediate medical attention if signs or symptoms of serious infection occur. These signs and symptoms include the following:

fever with or without shivers or the chills
fever and a rash
fever with chest pain and cough
fever with breathlessness/fast breathing
fever with high heart rate
headache with nausea or vomiting
headache and a fever
headache with a stiff neck or stiff back
confusion
body aches with flu-like symptoms
clammy skin

eyes sensitive to light

MEDICATION GUIDE

Additions and/or revisions underlined:

What is the most important information I should know about ENJAYMO?

ENJAYMO is a medicine that affects your immune system. ENJAYMO may lower the ability of your immune system to fight infections.

ENJAYMO increases your chance of getting serious infections including those caused by encapsulated bacteria, including Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type B. These serious infections may quickly become life-threatening or cause death if not recognized and treated early.

You must complete or be up to date with the vaccines against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before your first dose of ENJAYMO.
If your healthcare provider decides that urgent treatment with ENJAYMO is needed, you should receive vaccinations as soon as possible.
If you have been vaccinated against these bacteria in the past, you might need additional vaccines before starting ENJAYMO. Your healthcare provider will decide if you need additional vaccines.
Vaccines do not prevent all infections caused by encapsulated bacteria. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious infection:

fever with or without shivers or chills
fever and a rash
fever with chest pain and cough
fever with breathlessness or fast breathing
fever with high heart rate
headache with nausea or vomiting
headache and fever
headache with stiff neck or stiff back
confusion
body aches with flu-like symptoms
clammy skin

eyes sensitive to light

For more information about side effects, see “What are the possible side effects of ENJAYMO?”

…

01/25/2023 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Serious Infections

Additions and/or revisions underlined:

…

Serious infections (bacterial and viral) were reported in 15% (10/66) of patients receiving ENJAYMO from the two phase 3 studies. These infections included urinary tract infection with sepsis, respiratory tract infection, pneumonia, otomastoiditis, and skin infections. One patient (1.5%) died due to klebsiella pneumonia.

…

5.2 Infusion-Related Reactions

Additions and/or revisions underlined:

ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients [see Contraindications (4)]. Administration of ENJAYMO may result in infusion-related reactions. In the two phase 3 studies, 19 of 66 (29%) patients treated with ENJAYMO experienced infusion-related reactions (e.g., shortness of breath, rapid heartbeat, nausea, flushing, headache, hypotension, chest discomfort, pruritus, rash, injection site reaction, and dizziness) were reported in patients from the two clinical studies. One patient permanently discontinued ENJAYMO due to an infusion-related reaction.

…

5.3 Risk of Autoimmune Disease

Additions and/or revisions underlined:

Based on its mechanism of action, ENJAYMO may potentially increase the risk for developing autoimmune diseases such as systemic lupus erythematosus (SLE). Development of systemic lupus erythematosus (SLE) has been associated with inherited classical complement deficiency. Patients with SLE or autoimmune disease with positive anti-nuclear antibody were excluded from clinical trials with ENJAYMO. In clinical trials, 3/66 (4.5%) patients developed a relapse or worsening of preexisting autoimmune disease. Monitor patients being treated with ENJAYMO for signs and symptoms and manage medically.

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes; please refer to label

8 Use in Specific Populations

8.5 Geriatric Use

Additions and/or revisions underlined:

Of the 66 patients with CAD in clinical studies of ENJAYMO, 65% were 65 years of age and over, including 27% who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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

MEDICATION GUIDE

Extensive changes; please refer to label