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.

BIMZELX (BLA-761151)

(BIMEKIZUMAB-BKZX)

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

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11/19/2024 (SUPPL-10)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Suicidal Ideation and Behavior

Additions and/or revisions underlined:

An increased incidence of new onset or worsening suicidal ideation and behavior was observed in subjects treated with BIMZELX. A causal association between treatment with BIMZELX and increased risk of suicidal ideation and behavior has not been definitively established.

Suicidal ideation and behavior were prospectively monitored using the Columbia Suicide Severity Rating Scale (C-SSRS) in clinical trials. The C-SSRS is an interview-based instrument used to monitor for the presence and severity of suicidal ideation (ranging from “none” to “active suicidal ideation with specific plan and intent”) and behaviors (rating the injury and potential lethality of self-injury, if present).

Plaque Psoriasis

During the two 16-week, placebo-controlled periods of Trials Ps-1 and Ps-2, higher rates of suicidal ideation as assessed by C-SSRS were reported in BIMZELX-treated subjects than in subjects receiving placebo. Pooled analysis of C-SSRS data indicated that 12/670 (1.8%) BIMZELX-treated subjects and 1/169 (0.6%) subjects receiving placebo reported passive suicidal ideation with an estimated relative risk of 3.0 (95% confidence interval: 0.39, 22.74). Subjects without a prior history of SI/B treated with BIMZELX also reported a higher rate of new onset suicidal ideation on the C-SSRS than subjects receiving placebo (1.3% vs 0.6%). During the open-label extension trial, one completed suicide was reported in a BIMZELX-treated subject [see Adverse Reactions (6.1)].

…

Hidradenitis Suppurativa

During the two 16-week, placebo-controlled periods of Trials HS-1 and HS-2, higher rates of suicidal ideation as assessed by C-SSRS were reported in BIMZELX-treated subjects than in subjects receiving placebo. Based on a pooled analysis of the first 16 weeks of the placebo controlled clinical trials, 16/861 subjects in the BIMZELX group (1.9 %) reported suicidal ideation on the C-SSRS compared to 1/146 subjects in the placebo group (0.7%) with an estimated relative risk of 2.70 (95% confidence interval: 0.36, 20.12). Subjects without a prior history of SI/B treated with BIMZELX also reported a higher rate of new-onset suicidal ideation on the C-SSRS than subjects treated with placebo (0.9% vs. 0%). [see Adverse Reactions 6.1].

Consider the potential risks and benefits before prescribing BIMZELX to patients with a history of severe depression or suicidal ideation or behavior. Advise patients, their caregivers, and families to monitor for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct patients to promptly seek medical attention or call the National Suicide and Crisis Lifeline at 988 [see Patient Counseling Information (17)]. Refer BIMZELX-treated patients with new or worsening symptoms of depression or suicidal ideation and/or behavior to a mental health professional, as appropriate. Re-evaluate the risks and benefits of continuing treatment with BIMZELX if such events occur.

5.2 Infections

Additions and/or revisions underlined:

BIMZELX may increase the risk of infections, including serious infections.

…

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes; please refer to label for complete information

8 Use in Specific Populations

8.5 Geriatric Use

Additions and/or revisions underlined:

Of the 1,789 subjects with plaque psoriasis that were exposed to BIMZELX, a total of 153 subjects were 65 years of age or older, and 18 subjects were 75 years of age or older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, clinical trials in PSO did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects.

Of the 1,197 subjects with PsA that were exposed to BIMZELX, a total of 148 were 65 years of age and older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, clinical trials in PsA did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects.

Of the 244 subjects with nr-axSpA that were exposed to BIMZELX, a total of 6 were 65 years of age and older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, the clinical trial in nr-axSpA did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects.

Of the 330 subjects with AS that were exposed to BIMZELX, a total of 11 were 65 years of age and older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, the clinical trial in AS did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects.

Of the 995 subjects with hidradenitis suppurativa that were exposed to BIMZELX, a total of 18 were 65 years of age and older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, clinical trials in HS did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects.

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

MEDICATION GUIDE

Additions and/or revisions underlined:

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

BIMZELX is a medicine that affects your immune system. BIMZELX may increase your risk of having serious side effects, including:

Suicidal thoughts and behavior. New or worsening suicidal thoughts and behavior have happened in some people treated with BIMZELX. Get medical help right away or call the National Suicide and Crisis Lifeline at 988 if you, your caregiver or your family member notice in you any of the following symptoms:

…

Infections. BIMZELX is a medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections, including serious infections.

…

What is BIMZELX?

BIMZELX is a prescription medicine used to treat:

adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet light alone or with pills (phototherapy).
adults with active psoriatic arthritis.
adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.
adults with active ankylosing spondylitis.
adults with moderate to severe hidradenitis suppurativa.

…

The most common side effects of BIMZELX in people treated for Psoriasis and Hidradenitis Suppurativa include:

…

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Immunizations

Advise patients to avoid vaccination with live vaccines during BIMZELX treatment. Instruct patients to inform their healthcare practitioner that they are taking BIMZELX prior to a potential vaccination [see Warnings and Precautions (5.6)].

Pregnancy

Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in patients exposed to BIMZELX during pregnancy [see Use in Specific Populations (8.1)].

10/11/2024 (SUPPL-9)

Approved Drug Label (PDF)

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

If two separate 160 mg injections are used to achieve the recommended dose, instruct patients or caregivers to administer each injection subcutaneously at a different anatomic location [see Dosage and Administration (2.7)].

MEDICATION GUIDE

Additions and/or revisions underlined:

…

How should I use BIMZELX?

See the detailed “Instructions for Use” that comes with your BIMZELX for information on how to prepare and inject a dose of BIMZELX, and how to properly throw away (dispose of) used BIMZELX autoinjectors and prefilled syringes.

Use BIMZELX exactly as prescribed by your healthcare provider.
Before self-injecting with BIMZELX prefilled autoinjector or prefilled syringe, your healthcare provider should show you how to inject BIMZELX.
BIMZELX is given as an injection under the skin (subcutaneous injection) by you or a caregiver.
If you miss your BIMZELX dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. Call your healthcare provider if you are not sure what to do.
…

09/20/2024 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Suicidal Ideation and Behavior

Additions and revisions underlined:

During the placebo-controlled periods of Trials Ps-1 and Ps-2, higher rates of suicidal ideation as assessed by C-SSRS were reported in BIMZELX treated subjects than in placebo treated subjects. A causal association between treatment with BIMZELX and increased risk of suicidal ideation and behavior has not been established.

Plaque Psoriasis

Pooled analysis of C-SSRS data from two 16-week, placebo-controlled clinical trials indicated that 12/670

(1.8%) BIMZELX-treated subjects and 1/169 (0.6%) placebo-treated subjects reported passive suicidal ideation with an estimated relative risk of 3.0 (95% confidence interval: 0.39, 22.74). Subjects without a prior history of SI/B treated with BIMZELX also reported a higher rate of new-onset suicidal ideation on the C-SSRS than subjects treated with placebo (1.3% vs. 0.6%). During the open-label extension trial, one completed suicide was reported in a BIMZELX-treated subject. [see Adverse Reactions (6.1)].

Psoriatic Arthritis

Pooled analysis of C-SSRS data from the two 16-week, placebo-controlled periods of Trials PsA-1 and PsA-2 indicated that 2/698 (0.3%) BIMZELX-treated subjects and 3/413 (0.7%) placebo-treated subjects reported passive suicidal ideation with an estimated relative risk of 0.35 (95% confidence interval: 0.05, 2.29) [see Adverse Reactions (6.1)].

Non-Radiographic Axial Spondyloarthritis

Analysis of C-SSRS data from a 16-week, placebo-controlled period of Trial nr-axSpA-1 indicated that no subjects, being treated either with BIMZELX or placebo, reported suicidal ideation [see Adverse Reactions (6.1)].

Ankylosing Spondylitis

Analysis of C-SSRS data from a 16-week, placebo-controlled period of Trial AS-1 indicated that no subjects, being treated either with BIMZELX or placebo, reported suicidal ideation [see Adverse Reactions (6.1)].

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes; please refer to label

7 Drug Interactions

Newly added information:

Population pharmacokinetic (PK) data analyses indicated that the clearance of BIMZELX was not impacted by concomitant administration of cDMARDs including methotrexate, or by prior exposure to biologics.

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

Medication Guide

Additions and revisions underlined:

BIMZELX is a prescription medicine used to treat:

• adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy)

or treatment using ultraviolet light alone or with pills (phototherapy).

• adults with active psoriatic arthritis.

• adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

• adults with active ankylosing spondylitis.

. . .

The most common side effects of BIMZELX in people treated for psoriatic arthritis include:

• upper respiratory tract infections

• headache

• urinary tract infection

• oral thrush or infections in the mouth

• diarrhea

The most common side effects of BIMZELX in people treated for non-radiographic axial spondyloarthritis

include:

• upper respiratory tract infections

• headache

• cough

• joint pain

• tonsilitis

• urinary tract infection

• oral thrush or infections in the mouth

• diarrhea

• feeling tired

• muscle aches

• liver enzyme increase

The most common side effects of BIMZELX in people treated for ankylosing spondylitis include:

• upper respiratory tract infections

• headache

• pain at injection site

• vaginal yeast infections

• oral thrush or infections in the mouth

• diarrhea

• rash

PATIENT COUNSELING INFORMATION

Additions and revisions underlined:

For plaque psoriasis, instruct patients or caregivers to administer two 160 mg single-dose syringes or two 160 mg single-dose autoinjectors to achieve the 320 mg dose of BIMZELX [see Dosage and Administration (2.7)].