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Prescribing information

FASENRA® (benralizumab) AIMS TOWARDS ZERO

Fasenra® is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists1,2

Patients

40 - 60% of severe asthma patients have eosinophilic airway inflammation3

Patients with severe asthma may benefit from a referral to a specialist severe asthma centre and access to FASENRA treatment4

Uncontrolled despite maximum doses of ICS/LABA treatment5

Systemic
corticosteroids5,6

Elevated blood
eosinophil levels5,6

Frequent Severe Exacerbations

Commonly adult onset5,6

Chronic rhinosinusitis with nasal polyposis5,6


Mode of Action

FASENRA demonstrates near complete depletion of eosinophils by actively targeting eosinophils in the blood and sputum 1,2,7-9


OCS

OCS use in Severe Asthma

Up to 60% of patients with severe asthma use oral corticosteroid (OCS) therapy on a regular basis11,12

While corticosteroids play a role in the management of asthma by controlling symptoms and exacerbations, long-term use of high doses is associated with systemic side effects such as:

  • Type II Diabetes
  • Cardiovascular Disease
  • Depression
  • Hypertension13,14

Hear from Professor Andrew Menzies Gow

FASENRA aims towards ZERO need for OCS15

In patients with severe eosinophilic asthma who are OCS-dependent

62%

OF ELIGIBLE* PATIENTS ON FASENRA REDUCED THEIR

OCS USE TO ZERO

(N=598)
(95% CI, 58.18 – 66.11)

BASELINE OCS: 32.3% 5 MG/DAY;
42.8% >5 TO ≤10 MG/DAY; 24.9% >10 MG/DAY

74%

OF PATIENTS HAD

ZERO EXACERBATIONS

(N=598)
VS 15.6 AT BASELINE
during OCS reduction phase

* Patients with average daily dose equivalent to ≥5 mg of prednisolone for the last 3 months before study entry

Patients with severe eosinophilic asthma is defined as patients with asthma requiring high-dosage inhaled corticosteroids (ICS) and longacting 2-agonists (LABA) for 6 months plus OCS (5 mg prednisone or equivalent) for 3 months and blood eosinophil counts 150 cells/μL at baseline or 300 cells/μL in the previous 12 months were enrolled

PONENTE: Patients must have blood eosinophil counts ≥150 cells/μL at enrolment or ≥300 cells/μL in the 12 months before enrolment and average daily dose equivalent to ≥5 mg of prednisone for the last 3 months before study entry. The two primary endpoints are whether patients achieve 100% reduction in daily OCS use and whether patients achieve 100% reduction in daily OCS or achieve OCS dosage ≤5 mg·day, if adrenal insufficiency prevented further reduction, both sustained over ≥4 weeks without worsening of asthma.


Exacerbations

FASENRA aims towards ZERO exacerbations16

In SIROCCO & CALIMA: Fasenra significantly reduced AER* rates vs placebo (primary end point),17,18 65.2 and 60.3% of patients had zero exacerbations during the clinical study vs 49.4 and 49.2% for placebo respectively.19

74%

OF PATIENTS HAD

ZERO EXACERBATIONS

IN YEAR 2
OF TRATMENT
(SECONDARY END POINT)

BORA: Patients from predecessor trials SIROCCO and CALIMA who continued on Q8W dosing during the 56-week evaluation period.†16

FASENRA® Q8W/Q8W group (n=339)

87%

OF PATIENTS HAD

ZERO EXACERBATIONS

IN YEAR 5 OF TREATMENT WITH NO NEW SAFETY SIGNALS
(SECONDARY END POINT)

MELTEMI: Patients in a ≥16-to <40-week window participating in the predecessor trial BORA enrolled in a 3-year open-label extension continuing on Q8W.†‡20

FASENRA® Q8W/Q8W group (n=45)§

†All analyses were descriptive. This study was not powered to test any null hypothesis.

‡As in predecessor studies, exacerbations were evaluated among patients with blood eosinophils ≥300 cells/µL receiving high dose inhaled corticosteroid at baseline. Of patients initiating Q8W dosing at baseline (n = 159), 14.5% (n = 23) were on treatment for ≥5 years.

§Not all patients who entered treatment year 5 completed the year (Total number of patient follow-up Years 25.5).

*Annual Exacerbation Rates.


Tolerability

Approximately 83,600 patients treated with FASENRA® worldwide21

Fasenra’s safety tolerability profile has been studies in an extensive respiratory phase III programme 12,16–18

The most commonly reported adverse reactions were headache and pharyngitis.* Anaphylactic reactions have been reported.1,2

SYSTEM ORGAN CLASS ADVERSE REACTION FREQUENCY
Infections and infestations Pharyngitis** Common
Immune system disorders Hypersensitivity reactions Anaphylactic reaction Common
Not known
Nervous system disorders Headache Common
General disorders and administration site conditions Pyrexia
Injection site reactions
Common

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.1,2

*The frequency of common adverse events is defined as ≥1/100 to <1/101; **Pharyngitis was defined by the following grouped preferred terms: ‘Pharyngitis’, ‘Pharyngitis bacterial’ , ‘Viral pharyngitis’ and ‘Pharyngitis stretococcocal’; †Hypersensitivity reactions were defined by the following grouped preferred terms: ‘urticaria’, ‘papular urticaria’ and ‘rash’.

Warnings and precautions

For additional information please refer to Summaries of Product Characteristics1,2

This medicine is subject to additional monitoring. This will allow quick identification of new saftey information. You can help by reporting any side effects you may get. See the Yellow Card Scheme at www.mhra.gov.uk/yellowcard for how to report side effects. Side effects can also be reported to AstraZeneca by visiting https://contactazmedical.astrazenenca.com or by calling 0800 783 0033.

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