Fasenra

Q: Who makes Fasenra?

Fasenra is listed by 1 labeler in the FDA NDC directory, including AstraZeneca Pharmaceuticals LP.

Q: Has Fasenra been recalled?

The FDA enforcement database lists 1 recall for Fasenra, most recently D-0028-2026 (class ii): Lack of Assurance of Sterility:

Benralizumab · Injection, Solution · Subcutaneous

Prescription (Rx) Interleukin-5 Receptor alpha-directed Cytolytic Antibody 1 recall

Uses

1 INDICATIONS AND USAGE FASENRA is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for:
• add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. ( 1.1 )
• treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). ( 1.2 )
• treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause. ( 1.3 ) Limitations of Use : Not for relief of acute bronchospasm or status asthmaticus. (1.1) 1.1 Asthma FASENRA is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. Limitations of Use:
• FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus. 1.2 Eosinophilic Granulomatosis with Polyangiitis FASENRA is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). 1.3 Hypereosinophilic Syndrome FASENRA is indicated for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause.

Dosage and administration

Administer by subcutaneous injection. ( 2.4 ) Asthma Adult and Pediatric Patients 12 Years of Age and Older:
• Recommended dosage is 30 mg every 4 weeks for first 3 doses followed by once every 8 weeks thereafter. ( 2.1 ) Pediatric Patients 6 Years to 11 Years of Age:
• Weighing Less Than 35 kg : the recommended dosage is 10 mg every 4 weeks for first 3 doses followed by once every 8 weeks thereafter. ( 2.1 )
• Weighing 35 kg or More : the recommended dosage is 30 mg every 4 weeks for first 3 doses followed by once every 8 weeks thereafter. ( 2.1 ) EGPA and HES
• Recommended dosage is 30 mg every 4 weeks. ( 2.2 , 2.3 ) See full prescribing information for administration instructions of FASENRA prefilled syringe and FASENRA PEN. ( 2.4 , 2.5 , 2.6 ) 2.1 Recommended Dosage for Asthma Adult and Pediatric Patients 12 Years of Age and Older The recommended dosage of FASENRA is 30 mg (one injection) administered subcutaneously every 4 weeks for the first 3 doses, and then every 8 weeks thereafter. Pediatric Patients 6 to 11 Years of Age The recommended dosage of FASENRA for pediatric patients 6 to 11 years of age is based on body weight as provided in Table 1 . Table 1. Recommended Dosage of FASENRA in Pediatric Patients 6 to 11 Years of Age with Asthma Body weight Recommended Dosage Less than 35 kg 10 mg (one injection) administered subcutaneously every 4 weeks for the first 3 doses, and then every 8 weeks thereafter. 35 kg or more 30 mg (one injection) administered subcutaneously every 4 weeks for the first 3 doses, and then every 8 weeks thereafter. 2.2 Recommended Dosage for EGPA The recommended dosage of FASENRA is 30 mg (one injection) administered subcutaneously once every 4 weeks. 2.3 Recommended Dosage for HES The recommended dosage of FASENRA is 30 mg (one injection) administered subcutaneously once every 4 weeks. 2.4 General Administration Instructions FASENRA is for subcutaneous use only. FASENRA is intended for use under the guidance of a healthcare provider. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended [see Warnings and Precautions (5.1) ] . Administer FASENRA into the thigh or abdomen. The upper arm can also be used if a healthcare provider or caregiver administers the injection. Prior to administration, warm FASENRA by leaving carton at room temperature up to 77°F (25°C) for about 30 minutes. Visually inspect FASENRA for particulate matter and discoloration prior to administration. FASENRA is clear to opalescent, colorless to slightly yellow, and may contain a few translucent or white to off-white particles. Do not use FASENRA if the liquid is cloudy, discolored, or if it contains large particles or foreign particulate matter. Prefilled Syringe The prefilled syringe is for administration by a healthcare provider. Autoinjector (FASENRA PEN®) FASENRA PEN is intended for administration by patients/caregivers. Patients/caregivers may inject after proper training in subcutaneous injection technique, and after the healthcare provider determines it is appropriate. In asthma patients aged 6 to 11 years weighing 35 kg or more, FASENRA PEN should only be administered by a caregiver or healthcare provider. 2.5 Instructions for Administration of FASENRA Prefilled Syringe (Healthcare Providers) Figure 1 FASENRA Prefilled Syringes Prefilled Syringe Components To prepare FASENRA prefilled syringe for subcutaneous administration, carefully read and adhere to these instructions for use. FASENRA is available in a 10 mg and a 30 mg prefilled syringe. Check the labels on the FASENRA carton and prefilled syringe to ensure the correct 10 mg or 30 mg product is being used ( Figure 1 ). Refer to Figure 1 to identify the prefilled syringe components for use in the administration steps. Do not touch the needle guard activation clips to prevent premature activation of the needle safety guard. 1 Grasp the syringe body, not the plunger, to remove prefilled syringe from the tray. Check the expiration date on the syringe. The syringe may contain small air bubbles; this is normal. Do not expel the air bubbles prior to administration. 2 Do not remove needle cover until ready to inject. Hold the syringe body and remove the needle cover by pulling straight off. Do not hold the plunger or plunger head while removing the needle cover or the plunger may move. If the prefilled syringe is damaged or contaminated (for example, dropped without needle cover in place), discard and use a new prefilled syringe. 3 Gently pinch the skin and insert the needle at the recommended injection site (i.e., upper arm, thigh, or abdomen). 4 Inject all of the medication by pushing in the plunger all the way until the plunger head is completely between the needle guard activation clips. This is necessary to activate the needle guard. 5 After injection, maintain pressure on the plunger head and remove the needle from the skin. Release pressure on the plunger head to allow the needle guard to cover the needle. Do not re-cap the prefilled syringe. 6 Discard the used syringe into a sharps container. figure_1_saphnelo figure_2_saphnelo Step 2 needle cover image Step 3 Step 4 Step 5 2.6 Instructions for Administration of FASENRA PEN Refer to the FASENRA PEN ‘Instructions for Use’ for more detailed instructions on the preparation and administration of FASENRA PEN [see Instructions for Use] . A patient may self-inject or the patient’s caregiver may administer FASENRA PEN subcutaneously after the healthcare provider determines it is appropriate. In patients aged 6 to 11 years weighing 35 kg or more, FASENRA PEN should only be administered by a caregiver or healthcare provider.

Dosage forms and strengths

Injection: clear to opalescent, colorless to slightly yellow solution and may contain a few translucent or white to off‑white particles available as:
• 10 mg/0.5 mL solution in a single-dose prefilled syringe.
• 30 mg/mL solution in a single-dose prefilled syringe.
• 30 mg/mL solution in a single-dose autoinjector FASENRA PEN. Injection:
• 10 mg/0.5 mL solution in a single-dose prefilled syringe. ( 3 )
• 30 mg/mL solution in a single-dose prefilled syringe. (3)
• 30 mg/mL solution in a single-dose autoinjector FASENRA PEN. (3)

Contraindications

4 CONTRAINDICATIONS FASENRA is contraindicated in patients who have known hypersensitivity to benralizumab or any of its excipients [see Warnings and Precautions (5.1) ] . Known hypersensitivity to benralizumab or excipients. (4)

Warnings and precautions

• Hypersensitivity reactions: Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. Discontinue in the event of a hypersensitivity reaction. (5.1)
• Reduction in Corticosteroid Dosage: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Decrease corticosteroids gradually, if appropriate. (5.3)
• Parasitic (Helminth) Infection: Treat patients with pre-existing helminth infections before therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until the parasitic infection resolves. (5.4) 5.1 Hypersensitivity Reactions Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred following administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, FASENRA should be discontinued [see Contraindications (4) ] . 5.2 Acute Asthma Symptoms or Deteriorating Disease FASENRA should not be used to treat acute asthma symptoms or acute exacerbations. Do not use FASENRA to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with FASENRA. 5.3 Reduction of Corticosteroid Dosage Do not discontinue systemic or inhaled corticosteroids (ICS) abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. 5.4 Parasitic (Helminth) Infection Eosinophils may be involved in the immunological response to some helminth infections. Patients with known helminth infections were excluded from participation in clinical trials. It is unknown if FASENRA will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If patients become infected while receiving treatment with FASENRA and do not respond to anti-helminth treatment, discontinue treatment with FASENRA until infection resolves.

Side effects

The following adverse reactions are described in greater detail in other sections:
• Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence greater than or equal to 5%):
• Asthma: headache and pharyngitis. ( 6.1 )
• EGPA: headache. ( 6.1 )
• HES: headache, hypersensitivity reactions, and influenza-like illness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult and Pediatric Patients 12 Years of Age and Older with Asthma Across three clinical trials (SIROCCO, CALIMA, and ZONDA) for asthma, 1,808 patients received at least 1 dose of FASENRA [see Clinical Studies (14.1) ] . The data described below reflect exposure to FASENRA in 1,663 patients, including 1,556 exposed for at least 24 weeks and 1,387 exposed for at least 48 weeks. The safety exposure for FASENRA is derived from two Phase 3 placebo-controlled trials (SIROCCO and CALIMA) from 48 weeks duration [FASENRA every 4 weeks (n=841), FASENRA every 4 weeks for 3 doses, then every 8 weeks (n=822), and placebo (n=847)]. While a dosing regimen of FASENRA every 4 weeks was included in clinical trials, FASENRA administered every 4 weeks for 3 doses, then every 8 weeks thereafter is the recommended dose [ see Dosage and Administration (2.1) ] . The population studied was 12 to 75 years of age, of which 64% were female and 79% were White. Adverse reactions that occurred at greater than or equal to 3% incidence are shown in Table 2 . Table 2. Adverse Reactions with FASENRA with Greater than or Equal to 3% Incidence in Patients with Asthma (SIROCCO and CALIMA) Adverse Reactions FASENRA (N=822) % Placebo (N=847) % Headache 8 6 Pyrexia 3 2 Pharyngitis Pharyngitis was defined by the following terms: ‘Pharyngitis’, ‘Pharyngitis bacterial’, ‘Viral pharyngitis’, ‘Pharyngitis streptococcal’. 5 3 Hypersensitivity reactions Hypersensitivity Reactions were defined by the following terms: ‘Urticaria’, ‘Urticaria papular’, and ‘Rash’ [see Warnings and Precautions (5.1) ] . 3 3 28-Week Trial Adverse reactions from ZONDA with 28 weeks of treatment with FASENRA (n=73) or placebo (n=75) in which the incidence was more common in FASENRA than placebo include headache (8.2% compared to 5.3%, respectively) and pyrexia (2.7% compared to 1.3%, respectively) [see Clinical Studies (14.1) ] . The frequencies for the remaining adverse reactions with FASENRA were similar to placebo. Injection Site Reactions in Patients with Asthma In SIROCCO and CALIMA, the FASENRA 30 mg prefilled syringe was administered at the recommended dosage and injection site reactions (e.g., pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients treated with placebo. Pediatric Patients 6 to 11 Years of Age with Asthma The safety data for FASENRA is based on a 48-week, open-label, parallel group, pharmacokinetic and pharmacodynamic trial (TATE) of 28 pediatric patients aged 6 to 11 years with severe asthma, and with an eosinophilic phenotype [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.2 , 12.3) ] . Patients received subcutaneous dose of 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) ] . No new safety signals were observed in these patients. 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. 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 (≥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%). 6.2 Postmarketing Experience 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.

Use in specific populations

8.1 Pregnancy Risk Summary The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. In a prenatal and postnatal development study conducted in cynomolgus monkeys, there was no evidence of fetal harm with IV administration of benralizumab throughout pregnancy at doses that produced exposures up to approximately 310 times the exposure at the maximum recommended human dose (MRHD) of 30 mg subcutaneously (see Data) . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. Data Animal Data In a prenatal and postnatal development study, pregnant cynomolgus monkeys received benralizumab from beginning on GD20 to GD22 (dependent on pregnancy determination), on GD35, once every 14 days thereafter throughout the gestation period and 1-month postpartum (maximum 14 doses) at doses that produced exposures up to approximately 310 times that achieved with the MRHD (on an AUC basis with maternal IV doses up to 30 mg/kg once every 2 weeks). Benralizumab did not elicit adverse effects on fetal or neonatal growth (including immune function) up to 6.5 months after birth. There was no evidence of treatment-related external, visceral, or skeletal malformations. Benralizumab was not teratogenic in cynomolgus monkeys. Benralizumab crossed the placenta in cynomolgus monkeys. Benralizumab concentrations were approximately equal in mothers and infants on postpartum day 7, but were lower in infants at later time points. Eosinophil counts were suppressed in infant monkeys with gradual recovery by 6 months postpartum; however, recovery of eosinophil counts was not observed for one infant monkey during this period. 8.2 Lactation Risk Summary There is no information regarding the presence of benralizumab in human or animal milk, and the effects of benralizumab on the breast fed infant and on milk production are not known. However, benralizumab is a humanized monoclonal antibody (IgG1/κ-class), and immunoglobulin G (IgG) is present in human milk in small amounts. If benralizumab is transferred into human milk, the effects of local exposure in the gastrointestinal tract and potential limited systemic exposure in the infant to benralizumab are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for benralizumab and any potential adverse effects on the breast-fed child from benralizumab or from the underlying maternal condition. 8.4 Pediatric Use Asthma The safety and effectiveness of FASENRA for add-on maintenance treatment of patients with severe asthma and with an eosinophilic phenotype have been established in pediatric patients 6 years and older. Use of FASENRA for this indication is supported by evidence from the following: 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 FEV 1 <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.

Pregnancy

Pediatric use

8.4 Pediatric Use Asthma The safety and effectiveness of FASENRA for add-on maintenance treatment of patients with severe asthma and with an eosinophilic phenotype have been established in pediatric patients 6 years and older. Use of FASENRA for this indication is supported by evidence from the following: 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 FEV 1 <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 <35 kg) and subcutaneous dose of 30 mg (patients ≥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. The safety and effectiveness in patients younger than 6 years of age have not been established. EGPA The safety and effectiveness of FASENRA in patients with EGPA younger than 18 years of age have not been established. 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.

Geriatric use

8.5 Geriatric Use Asthma Of the total number of patients in asthma clinical trials of benralizumab, 13% (n=320) were 65 and over, while 0.4% (n=9) were 75 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. 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.

Overdosage

There is no specific treatment for an overdosage with benralizumab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

Description

Benralizumab is a humanized monoclonal antibody (IgG1/κ-class) selective for interleukin-5 receptor alpha subunit (IL-5Rα). Benralizumab is produced in Chinese hamster ovary cells by recombinant DNA technology. Benralizumab has a molecular weight of approximately 150 kDa. FASENRA (benralizumab) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for subcutaneous injection. Since benralizumab is a protein, a few translucent or white to off-white particles may be present in the solution. Each 10 mg single-dose prefilled syringe delivers 0.5 mL containing 10 mg benralizumab, L-histidine (0.7 mg); L-histidine hydrochloride monohydrate (1.2 mg); polysorbate 20 (0.03 mg); α,α‑trehalose dihydrate (47 mg); and Water for Injection, USP, at pH of 5.5 – 6.5. The single-dose prefilled syringe contains a 1 mL glass syringe with a staked 29-gauge ½ inch stainless steel needle. Each 30 mg single-dose prefilled syringe or single-dose autoinjector delivers 1 mL containing 30 mg benralizumab, L-histidine (1.4 mg); L-histidine hydrochloride monohydrate (2.3 mg); polysorbate 20 (0.06 mg); α,α‑trehalose dihydrate (95 mg); and Water for Injection, USP, at pH of 5.5 – 6.5. The single-dose prefilled syringe or single-dose autoinjector contains a 1 mL glass syringe with a staked 29-gauge ½ inch stainless steel needle.

Mechanism of action

12.1 Mechanism of Action Benralizumab is a humanized afucosylated, monoclonal antibody (IgG1, kappa) that directly binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with a dissociation constant of 11 pM. The IL-5 receptor is expressed on the surface of eosinophils and basophils. In an in vitro setting, the absence of fucose in the Fc domain of benralizumab facilitates binding (45.5 nM) to FcɣRIII receptors on immune effector cells, such as natural killer (NK) cells, leading to apoptosis of eosinophils and basophils through antibody-dependent cell-mediated cytotoxicity (ADCC). Inflammation is an important component in the pathogenesis of asthma, EGPA, and HES. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in inflammation. Benralizumab, by binding to the IL-5Rα chain, reduces eosinophils through ADCC; however, the mechanism of benralizumab action in asthma, EGPA, and HES has not been definitively established.

How supplied

How Supplied FASENRA (benralizumab) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution and may contain a few translucent or white to off-white particles, for subcutaneous injection supplied as a single-dose prefilled syringe or single-dose autoinjector. The prefilled syringe (including stopper and cap) and autoinjector are not made with natural rubber latex. FASENRA is available as: Single-Dose Prefilled Syringe
• Carton contains one 10 mg/0.5 mL single-dose prefilled syringe with a gray plunger rod: NDC 0310-1745-01
• Carton contains one 30 mg/mL single-dose prefilled syringe with a blue plunger rod: NDC 0310-1730-30 Single-Dose Autoinjector FASENRA PEN
• Carton contains one 30 mg/mL single-dose autoinjector: NDC 0310-1830-30 Storage and Handling Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. If needed, the prefilled syringe and autoinjector may be stored at room temperature up to 77°F (25°C) for a maximum of 14 days in the original carton to protect from light. Once removed from the refrigerator and brought to room temperature (up to 77°F [25°C]), the prefilled syringe and autoinjector must be used within 14 days or discarded. Do not freeze. Do not shake. Do not expose to heat.

Patient information

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. Administration Instructions Instruct 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 [see Instructions for Use]. 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 [see Warnings and Precautions (5.1) ]. 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 [see Warnings and Precautions (5.2) ] . 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 [see Warnings and Precautions (5.3) ] . Manufactured by AstraZeneca AB Södertälje, Sweden SE-15185 US License No. 2059 Distributed by AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 FASENRA is a registered trademark of the AstraZeneca group of companies. ©AstraZeneca 2026

Label text from the FDA structured product label by AstraZeneca Pharmaceuticals LP (revised May 13, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Benralizumab in 3 products

Fasenra NDC products (3)

NDC	Strength & form	Labeler	Type
0310-1730	Benralizumab 30 mg/mL Injection, Solution	AstraZeneca Pharmaceuticals LP	BLA
0310-1745	Benralizumab 10 mg/.5mL Injection, Solution	AstraZeneca Pharmaceuticals LP	BLA
0310-1830	Benralizumab 30 mg/mL Injection, Solution	AstraZeneca Pharmaceuticals LP	BLA

Fasenra recalls

D-0028-2026 Oct 22, 2025 · Class II · Ongoing
Lack of Assurance of Sterility:

Frequently asked questions

What is Fasenra used for?

What are the side effects of Fasenra?

Who makes Fasenra?

Fasenra is listed by 1 labeler in the FDA NDC directory, including AstraZeneca Pharmaceuticals LP.

Has Fasenra been recalled?

The FDA enforcement database lists 1 recall for Fasenra, most recently D-0028-2026 (class ii): Lack of Assurance of Sterility: