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.

SAPHNELO (BLA-761123)

(ANIFROLUMAB-FNIA)

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

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08/07/2024 (SUPPL-5)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Newly added subsection:

The following adverse reaction has been identified during post-approval use of SAPHNELO. Because the 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 drug exposure.

Arthralgia

12/01/2023 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Serious Infections

Additions and/or revisions underlined:

Serious and sometimes fatal infections (including COVID-19) have occurred in patients receiving immunosuppressive agents, including SAPHNELO. Overall, the incidence of serious infections in controlled trials was similar in patients receiving SAPHNELO compared with placebo, whereas fatal infections occurred more frequently in patients receiving SAPHNELO [see Adverse Reactions (6.1)].

In controlled trials, SAPHNELO increased the risk of respiratory infections and herpes zoster (disseminated herpes zoster events have been reported) [see Adverse Reactions (6.1)].

Consider the benefit and risk of administering SAPHNELO in patients with a chronic infection, a history of recurrent infections, or known risk factors for infection. Avoid initiating treatment with SAPHNELO in patients with any clinically significant active infection until the infection resolves or is adequately treated. Instruct patients to seek medical advice if signs or symptoms of clinically significant infection occur. If a patient develops an infection, or is not responding to standard anti-infective therapy, monitor the patient closely and consider interrupting SAPHNELO therapy until the infection resolves.

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Long-term Safety

Patients who completed Trials 2 and 3 (Phase III feeder trials) were eligible to continue on treatment in a randomized, double-blind, placebo-controlled ong-term extension (LTE) study, for an additional 3 years. The long-term safety of SAPHNELO was assessed in 257 patients who received anifrolumab-fnia 300 mg and 112 patients who received placebo in both a feeder trial and the LTE. Of these, 177 patients who received SAPHNELO (68.9%) and 52 patients who received placebo (46.4%) completed a total of 4 years on treatment. The overall long-term safety profile of SAPHNELO was consistent with Trials 1, 2 and 3.

Specific Adverse Reactions

Infections

In the 52-week controlled-clinical trials, infections were reported in a greater proportion of patients while on treatment with SAPHNELO compared to placebo (69.7% [320/459] versus 55.4% [258/466]), corresponding to exposure-adjusted incidence rates (EAIR) of 141.8 and 99.9 per 100 patient years (PY), respectively.

Serious Infections

In the 52-week controlled-clinical trials, the incidence of serious infections while on treatment was 4.8% (22/459) in patients treated with SAPHNELO compared with 5.6% (26/466) in patients receiving placebo, corresponding to EAIR of5.4 and 6.6 per 100 PY, respectively. The most frequent serious infection was pneumonia.

In the 52-week controlled-clinical trials, fatal infections occurred in 0.4% of patients receiving SAPHNELO and 0.2% of the patients receiving placebo.

During the LTE study, the most common serious infections were COVID-19 and pneumonia.

Herpes Zoster

In the 52-week controlled-clinical trials, the incidence of herpes zoster in patients while on treatment with SAPHNELO was 6.1% (28/459) and 1.3% (6/466) in patients on placebo, corresponding to EAIRs of 6.9 and 1.5 per 100 PY, respectively. Cases with multidermatomal involvement and disseminated presentation have been reported. Of the 28 SAPHNELO-treated patients with herpes zoster, 2 experienced disseminated disease requiring hospitalization compared to none among patients who received placebo.

Hypersensitivity Reactions Including Anaphylaxis

During the SLE development program, there was one report of an anaphylactic reaction in a patient who received 150 mg anifrolumab-fnia, and 4 reports of angioedema after 300 mg. In general, the hypersensitivity reactions were predominantly mild or moderate in intensity and did not lead to discontinuation of SAPHNELO.

In the 52-week controlled-clinical trials, hypersensitivity reactions occurred in 2.8% (13/459) of patients while on treatment with SAPHNELO and 0.6% (3/466) of patients on placebo, corresponding to EAIR of 3.2 and 0.7 per 100 PY, respectively. Serious hypersensitivity reactions were reported for 0.6% (3/459) of patients receiving SAPHNELO, including angioedema (n=2).

Infusion-related Reactions

Infusion-related reactions were mild to moderate in intensity; the most common symptoms were headache, nausea, vomiting, fatigue, and dizziness.

In the 52-week controlled-clinical trials, the incidence of infusion-related reactions while on treatment was 9.4% (43/459) in patients while on treatment with SAPHNELO and 7.1% (33/466) in patients on placebo, corresponding to EAIRs of11.1 and 8.7 per 100 PY, respectively.

Malignancies In 52-week controlled-clinical trials, malignancies (excluding non-melanoma skin cancers) were observed in 0.7% (3/459) and 0.6% (3/466) of patients receiving SAPHNELO and placebo, corresponding to EAIR of 0.7 and 0.7 per 100 PY, respectively. Malignant neoplasm (including non-melanoma skin cancers) was reported for 1.3% (6/459) patients receiving SAPHNELO, compared to 0.6% (3/466) patients receiving placebo (EAIR: 1.3 and 0.7 per 100 PY, respectively). The malignancies that were reported in more than one patient treated with SAPHNELO included breast cancer and squamous cell carcinoma.

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

MEDICATION GUIDE

Additions and/or revisions underlined:

…

What are the possible side effects of SAPHNELO? SAPHNELO may cause serious side effects, including:

Serious Infections. SAPHNELO can lower the ability of your immune system to fight infections. You may be at a
higher risk of developing respiratory infections, and shingles (herpes zoster) during treatment with SAPHNELO. Infections (including COVID-19) could be serious, leading to hospitalization or death. Tell your healthcare provider right away if you have any of the following symptoms of an infection:

…