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.

FASENRA (BLA-761070)

(BENRALIZUMAB)

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

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05/13/2026 (SUPPL-23)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

. . .

Adult and Pediatric Patients 12 Years of Age and Older with HES

The safety of FASENRA is based on 67 adult and pediatric patients aged 12 years and older with HES who received at least 1 dose of FASENRA 30 mg administered subcutaneously every 4 weeks in a randomized, placebo-controlled, multicenter study of 24 weeks duration (NATRON) [see Clinical Studies (14.3)]. The most common adverse reactions (greater than or equal to 5% and more common than placebo) with FASENRA in NATRON were headache in 11 patients (16%), hypersensitivity reactions (including urticaria, urticaria papular, rash) in 6 patients (9%), and influenza-like illness in 4 patients (6%).

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

. . .

Pediatric Patients 12 to 17 Years of Age

Use of FASENRA in pediatric patients 12 to 17 years of age with severe asthma and with an eosinophilic phenotype is supported by evidence from SIROCCO (n=53) and CALIMA (n=55) that enrolled 108 pediatric patients aged 12 to 17 years (mean age 14 years, 42% female, White 82%, Asian 2%, Black or African American 4%) with asthma. Of these patients, 46 received placebo, 40 received 30 mg of FASENRA every 4 weeks for 3 doses, followed by every 8 weeks thereafter, and 22 received 30 mg of FASENRA every 4 weeks. Patients were required to weigh 40 kg or more and to have a history of 2 or more asthma exacerbations requiring oral or systemic corticosteroid treatment in the past 12 months and reduced lung function at baseline (pre-bronchodilator FEV1 less than 90%) despite regular treatment with medium or high dose ICS and LABA with or without OCS or other controller therapy [see Clinical Studies (14)]. The pharmacokinetics of benralizumab in pediatric patients 12 to 17 years of age were consistent with adults based on population pharmacokinetic analysis and the reduction in blood eosinophil counts was similar to that observed in adults following the same FASENRA treatment. The adverse reaction profile in pediatric patients was generally similar to the overall population in the clinical trials [see Adverse Reactions (6.1)].

Pediatric Patients 6 to 11 Years of Age

Use of FASENRA in pediatric patients aged 6 to 11 years with severe asthma and with an eosinophilic phenotype is supported by evidence from adequate and well-controlled trials in adults and pediatric patients aged 12 to 17 years with additional pharmacokinetic, pharmacodynamic, and safety data in pediatric patients aged 6 to 11 years. The effectiveness of FASENRA in pediatric patients 6 to 11 years of age is extrapolated from efficacy in three clinical trials (SIROCCO, CALIMA, and ZONDA) [see Clinical Studies (14)] with support from pharmacokinetic analysis and pharmacodynamic response in pediatric patients aged 6 to 11 years compared to adults and pediatric patients aged 12 to 17 years. TATE is a 48-week, open-label, pharmacokinetic and pharmacodynamic trial that was conducted in 28 patients aged 6 to 11 years (mean age 9 years; 6-8 years, n=11; 9-11 years, n=17; 32% female, White 29%, Asian 32%, Black or African American 29%) with severe asthma and with an eosinophilic phenotype.

. . .

Based upon the pharmacokinetic data from TATE, a subcutaneous dose of 10 mg (patients less than 35 kg) and subcutaneous dose of 30 mg (patients greater than or equal to 35 kg) of benralizumab administered every 4 weeks for the first 3 doses, then every 8 weeks thereafter in patients aged 6 to 11 years was determined to have similar or higher exposure, respectively, to adults and pediatric patients aged 12 to 17 years administered a subcutaneous dose of 30 mg with the same dosing regimen [see Clinical Pharmacology (12.3)]. The pharmacodynamic response observed in TATE for pediatric patients aged 6 to 11 years was similar to that observed in adults and pediatric patients aged 12 to 17 years [see Clinical Pharmacology (12.2)]. No new safety signals were observed from TATE and safety for the higher drug exposure is supported by safety data from SIROCCO and CALIMA in adults and pediatric patients aged 12 to 17 years, and ZONDA in adults, who received 30 mg of FASENRA every 4 weeks for 1 year.

. . .

HES

The safety and effectiveness of FASENRA have been established in the age groups 12 years and older. Use of FASENRA in this age group is supported by evidence from an adequate and well-controlled trial of FASENRA in adults and pediatric patients aged 12 years and older in which pediatric patients received FASENRA (n=3) or placebo (n=1) every 4 weeks for 24 weeks.

The safety and effectiveness of FASENRA in patients with HES younger than 12 years of age have not been established.

8.5 Geriatric Use

Additions and/or revisions underlined:

. . .

EGPA and HES

Clinical studies of FASENRA for EGPA and HES did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Of the 70 patients with EGPA exposed to FASENRA, a total of 13 (19%) were 65 years or older. Of the 67 patients with HES exposed to FASENRA, a total of 15 (22%) were 65 years or older.

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

PATIENT INFORMATION

Additions and/or revisions underlined:

What is FASENRA?

FASENRA is a prescription medicine used:
- with other asthma medicines for the maintenance treatment of severe asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. FASENRA helps prevent severe asthma attacks (exacerbations) and may improve your breathing.
  - FASENRA is not used to treat sudden breathing problems.
  - Tell your healthcare provider if your asthma does not get better or if it gets worse after you start treatment with FASENRA.
- to treat adults with eosinophilic granulomatosis with polyangiitis (EGPA).
- to treat adults and children 12 years of age and older with hypereosinophilic syndrome (HES). FASENRA helps reduce symptoms and prevent flares.
FASENRA reduces blood eosinophils. Eosinophils are a type of white blood cell that may contribute to your condition.
It is not known if FASENRA is safe and effective in:
children with asthma younger than 6 years of age.
children with EGPA younger than 18 years of age.
children with HES younger than 12 years of age.

. . .

FASENRA is injected under your skin (subcutaneously):
- one time every 4 weeks for the first 3 doses and then every 8 weeks, for asthma.
- one time every 4 weeks for EGPA and HES.
  . . .
In children with asthma aged 6 to 11 years, FASENRA should only be given by a caregiver or healthcare provider.
. . .

If you use or give too much FASENRA, call the Poison Help Line at 1-800-222-1222.

. . .

The most common side effects of FASENRA in:

adults and children with asthma include headache and sore throat.
adults with EGPA include headache.
adults and children with HES include headache, allergic reactions, and flu-like symptoms. These are not all the possible side effects of FASENRA.

. . .

Store FASENRA in the original carton to protect from light.

. . .

09/17/2024 (SUPPL-21)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Newly added information:

Adult Patients with EGPA

The safety of FASENRA is based on 70 adult patients who received at least 1 dose of FASENRA 30 mg administered subcutaneously every 4 weeks in an active-controlled study of 52 weeks duration (MANDARA) [see Clinical Studies (14.2)]. The incidence of adverse reactions were consistent to those reported in asthma, with the exception of headache, which occurred in 17% of FASENRA-treated patients with EGPA. No new adverse reactions were identified.

8 Use in Specific Populations

8.4 Pediatric Use

Newly added information:

The safety and effectiveness of FASENRA in patients with EGPA younger than 18 years of age have not been established.

8.5 Geriatric Use

Newly added information:

EGPA

Of the 70 patients with EGPA exposed to FASENRA, a total of 13 (19%) were 65 years or older. Clinical studies of FASENRA for EGPA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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

Patient Information

Additions and revisions underlined:

. . .

FASENRA is a prescription medicine used:

with other asthma medicines for the maintenance treatment of asthma in people 6 years and older whose asthma is not controlled with their current asthma medicines. FASENRA helps prevent severe asthma attacks (exacerbations) and may improve your breathing.
to treat people 18 years and older with eosinophilic granulomatosis with polyangiitis (EGPA).

FASENRA reduces blood eosinophils. Eosinophils are a type of white blood cell that may contribute to your condition.
FASENRA is not used to treat sudden breathing problems.
Tell your healthcare provider if your asthma does not get better or if it gets worse after you start treatment with FASENRA.
It is not known if FASENRA is safe and effective in children with asthma under 6 years of age. It is not known if FASENRA is safe and effective in children with EGPA under 18 years of age.
. . .

FASENRA is injected under your skin (subcutaneously):
- one time every 4 weeks for the first 3 doses and then every 8 weeks, for asthma.
- one time every 4 weeks for EGPA.

04/05/2024 (SUPPL-20)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Pediatric Patients Aged 6 to 11 Years

The safety data for FASENRA is based upon a 48-week, open-label, parallel group, pharmacokinetic and pharmacodynamic study of 28 patients with severe eosinophilic asthma aged 6 to 11 years old. Patients received 10 mg (for those weighing less than 35 kg) or 30 mg (for those weighing 35 kg or more) of FASENRA administered every 4 weeks for the first 3 doses, then every 8 weeks thereafter [see Dosage and Administration (2.1)]. The safety profile for patients aged 6 to 11 years was similar to that observed in patients 12 years and older.

…

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

Use of FASENRA in adolescents is supported by evidence from 108 adolescents aged 12 to 17 years with asthma enrolled in the Phase 3 exacerbation trials (Trial 1: n=53, Trial 2: n=55). Of these, 46 received placebo, 40 received FASENRA every 4 weeks for 3 doses, followed by every 8 weeks thereafter, and 22 received FASENRA every 4 weeks.

…

Use of FASENRA in pediatric patients aged 6 to 11 years with severe eosinophilic asthma is supported by evidence from adequate and well-controlled trials in adults and adolescents with additional pharmacokinetic, pharmacodynamic, and safety data in children aged 6 to 11 years. A single, open-label clinical trial (NCT04159519) was conducted in 28 children aged 6 to 11 years (mean age: 8.8 years, 32% female) with severe asthma. Based upon the pharmacokinetic data from this trial, a dose of 10 mg (patients <35 kg) and 30 mg (patients greater than or equal to 35 kg) administered subcutaneous every 4 weeks for the first 3 doses, then every 8 weeks thereafter in children aged 6 to 11 years was determined to have similar exposure to adults and adolescents administered a dose of 30 mg subcutaneous [see Clinical Pharmacology (12.3)].

The effectiveness of FASENRA in pediatric patients is extrapolated from efficacy in Trials 1, 2 and 3 with support from pharmacokinetic analysis showing similar drug exposure levels in children aged 6 to 11 years compared to adults and adolescents, at the recommended doses respectively [see Clinical Pharmacology (12.3)]. The safety profile and pharmacodynamic response observed in this trial for children aged 6 to 11 years were similar to that seen in adults and adolescents [see Adverse Reactions (6.1), Clinical Pharmacology (12.2)].

The safety and efficacy in patients younger than 6 years of age have not been established.

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

PATIENT INFORMATION

Additions and/or revisions underlined:

What is FASENRA?

FASENRA is a prescription medicine used with other asthma medicines for the maintenance treatment of asthma in people 6 years and older whose asthma is not controlled with their current asthma medicines. FASENRA helps prevent severe asthma attacks (exacerbations) and may improve your breathing. Medicines such as FASENRA reduce blood eosinophils. Eosinophils are a type of white blood cell that may contribute to your asthma.

…

How will I use FASENRA?

…

In people aged 6 to 11 years, FASENRA should only be given by a caregiver or healthcare provider.
…

10/03/2019 (SUPPL-5)

Approved Drug Label (PDF)

6 Adverse Reactions

6.3 Postmarketing Experience

(newly added subsection)

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during post approval use of FASENRA. 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 drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to FASENRA or a combination of these factors.

Immune System Disorders: Hypersensitivity reactions, including anaphylaxis.

8 Use in Specific Populations

8.1 Pregnancy

(additions and/or revisions are underlined)

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FASENRA during pregnancy. Healthcare providers can enroll patients or encourage patients to enroll themselves by calling 1-877-311-8972 or visiting mothertobaby.org/Fasenra.

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

PATIENT COUNSELING INFORMATION

(additions and/or revisions are underlined)

Advise the patients and/or caregivers to read the FDA-approved patient labeling (Patient Information and Instructions for Use for FASENRA PEN) before the patient starts using FASENRA and each time the prescription is renewed as there may be new information they need to know.

Provide proper training to patients and/or caregivers on proper subcutaneous injection technique using the FASENRA PEN, including aseptic technique, and the preparation and administration of FASENRA PEN prior to use. Advise patients to follow sharps disposal recommendations.

Hypersensitivity Reactions

Inform patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occurred within hours of FASENRA administration, but in some instances had a delayed onset (i.e., days). Instruct patients to contact their healthcare provider if they experience symptoms of an allergic reaction.

Not for Acute Symptoms or Deteriorating Disease

Inform patients that FASENRA does not treat acute asthma symptoms or acute exacerbations. Inform patients to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with FASENRA.

Reduction of Corticosteroid Dosage

Inform patients to not discontinue systemic or inhaled corticosteroids except under the direct supervision of a physician. Inform patients that reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Pregnancy Exposure Registry

Inform women there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FASENRA during pregnancy and that they can enroll in the Pregnancy Exposure Registry by calling 1-877-311-8972 or by visiting mothertobaby.org/Fasenra.

PATIENT INFORMATION

(extensive revisions; please refer to labeling for complete information)