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.

FABHALTA (NDA-218276)

(IPTACOPAN HYDROCHLORIDE)

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

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07/16/2026 (SUPPL-7)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

. . .

Immunoglobulin A Nephropathy (IgAN)

The safety of FABHALTA was evaluated in APPLAUSE-IgAN, a randomized placebo-controlled, double-blind clinical study in adults with IgAN (eGFR greater than or equal to 20 mL/min/1.73 m2 at baseline).

The data below reflects FABHALTA exposure in 259 patients with IgAN (eGFR greater than or equal to 20 mL/min/1.73 m2 at baseline) with a median duration of 102 weeks (up to 107 weeks) in APPLAUSE-IgAN. Table 2 describes the adverse reactions that occurred in greater than or equal to 3 % of patients treated with FABHALTA and were greater than or equal to 2% higher in frequency than placebo. All of these adverse reactions were mild or moderate in severity.

Table 2: Adverse Reactions Reported in greater than or equal to 3% of Adult Patients with IgAN (eGFR greater than or equal to 20 mL/min/1.73 m2) Treated with FABHALTA and greater than or equal to 2% Higher in Frequency Than Placebo in APPLAUSE-IgAN

Extensive changes to table; please refer to label for complete information.

Serious infections caused by encapsulated bacteria reported in APPLAUSE-IgAN occurred in 3 patients (1.2%) on FABHALTA and none on placebo.

. . .

8 Use in Specific Populations

8.5 Geriatric Use

Additions and/or revisions underlined:

There were 29 PNH patients 65 years of age and older in APPLY-PNH and APPOINT-PNH [see Clinical Studies (14)]. Of the total number of FABHALTA-treated patients during the 24-week treatment period in these studies, 21 (20.6%) were 65 years of age and older, while 7 (6.9%) were 75 years of age and older. There were 14 IgAN patients 65 years of age and older in APPLAUSE-IgAN [see Clinical Studies (14)]. Of the total number of FABHALTA-treated patients, 5 (2.1%) were 65 years of age and older. Clinical studies of FABHALTA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients.

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 FABHALTA?

. . .

FABHALTA is only available through a program called the FABHALTA Risk Evaluation and Mitigation Strategy (REMS). Before you can take FABHALTA, your healthcare provider must:

enroll in the FABHALTA REMS program
counsel you about the risk of serious infections caused by certain bacteria
give you written information about the symptoms of serious infections
make sure that you are vaccinated against serious infections caused by encapsulated bacteria
make sure you receive antibiotics if you need to start FABHALTA right away and you are not up to date on your vaccinations
give you a Patient Safety Card about your risk of serious infections, as discussed above

. . .

What is FABHALTA?

FABHALTA is a prescription medicine used to:

treat adults with a disease called paroxysmal nocturnal hemoglobinuria (PNH).
slow kidney function decline in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN), who are at risk of their disease getting worse.

. . .

What are the possible side effects of FABHALTA?

FABHALTA may cause serious side effects, including:

. . .

The most common side effects of FABHALTA in adults include:

. . .

feeling dizzy

. . .

03/20/2025 (SUPPL-4)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

. . .

Immunoglobulin A Nephropathy (IgAN)

The safety of FABHALTA was evaluated in APPLAUSE-IgAN, a randomized placebo-controlled, double-blind clinical study in adults with IgAN (eGFR greater than or equal to 20 mL /min/1.73 m2 at baseline).

. . .

Complement 3 Glomerulopathy (C3G)

The safety of FABHALTA was evaluated in APPEAR-C3G, a randomized, placebo-controlled, double-blind trial in adult patients with native kidney C3G. No new adverse reactions were identified during the 6-month placebo-controlled period of APPEAR-C3G, in which 38 patients were treated with FABHALTA and 36 patients were treated with placebo. The most common adverse reactions that occurred in greater than or equal to 10% of patients treated with FABHALTA and were greater than or equal to 5% higher in frequency than placebo were nasopharyngitis (11% in FABHALTA, 3% placebo) and viral infections (29% in FABHALTA, 22% placebo), mainly respiratory infections. One patient (3%) on FABHALTA and none on placebo had a serious adverse reaction of pneumonia and bacteremia secondary to an encapsulated organism (S. pneumoniae).

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Risk Summary

Available data from clinical trials with FABHALTA use in pregnant women are insufficient to identify a drug- associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with untreated PNH, IgAN, or C3G in pregnancy (see Clinical Considerations). The use of FABHALTA in pregnant women or women planning to become pregnant may be considered following an assessment of the risks and benefits.

. . .

Clinical Considerations

. . .

C3G in pregnancy may be associated with adverse maternal outcomes, in particular preeclampsia and miscarriage, as well as adverse fetal outcomes including prematurity and low birth weight.

. . .

8.4 Pediatric Use

Additions and/or revisions underlined:

Safety and effectiveness in pediatric patients with PNH, IgAN, or C3G have not been established.

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

MEDICATION GUIDE

Additions and/or revisions underlined:

. . .

What is FABHALTA?

FABHALTA is a prescription medicine used to:

treat adults with a disease called paroxysmal nocturnal hemoglobinuria (PNH).
reduce levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN), who are at risk of their disease progressing quickly.
treat adults with a kidney disease called complement 3 glomerulopathy (C3G), to reduce levels of protein in the urine (proteinuria).

It is not known if FABHALTA is safe and effective in children with PNH, IgAN, or C3G.

. . .

03/26/2024 (SUPPL-2)

Approved Drug Label (PDF)

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 FABHALTA?

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

FABHALTA increases your chance of getting serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. These serious infections may quickly become life-threatening or fatal 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 FABHALTA.
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