FASENRA STUDIES
Continue Reading About FASENRA in Severe Eosinophilic Asthma
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Important Information for the Healthcare Professional
This study discusses some information about FASENRA® (benralizumab) that is not contained in FDA-approved Prescribing Information. AstraZeneca manufactures and markets FASENRA and is the sponsor of and provided funding for this study. Some authors may have a financial interest in either FASENRA or AstraZeneca and/or may have received compensation from AstraZeneca in connection with this study or other engagements. AstraZeneca recommends use of FASENRA only in accordance with its approved Prescribing Information. Prescription drugs used outside of an approved indication may not be eligible for reimbursement by third-party payers, including Medicare or Medicaid.
In connection with the discussions contained in the reprint, please note:
- The study assessed a benralizumab 30-mg Q4W arm. This is not an approved dose
- Pooled analyses were not part of the general testing strategy, therefore all comparator results of FASENRA vs placebo use nominal P values and no formal statistical significance can be inferred
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Important Information for the Healthcare Professional
Please note: AstraZeneca does not control, review, or endorse third-party content and is not responsible for the content you are about to access. We provide links to external websites as a convenience and for educational purposes only.
Would you like to continue to an external link?
You are about to leave FASENRAStudies.com
Important Information for the Healthcare Professional
This study discusses some information about FASENRA® (benralizumab) that is not contained in FDA-approved Prescribing Information. AstraZeneca manufactures and markets FASENRA and is the sponsor of and provided funding for this study. Some authors may have a financial interest in either FASENRA or AstraZeneca and/or may have received compensation from AstraZeneca in connection with this study or other engagements. AstraZeneca recommends use of FASENRA only in accordance with its approved Prescribing Information. Prescription drugs used outside of an approved indication may not be eligible for reimbursement by third-party payers, including Medicare or Medicaid.
In connection with the discussions contained in the reprint, please note:
- The study evaluated FASENRA's treatment effect using an open-label, single-arm study design and did not include a control group to adjust for potential changes not due to treatment
- Patients did not undergo an oral corticosteroid dosage-optimization phase and prednisolone levels were only assessed at baseline in patients who switched from another oral corticosteroid and were not assessed during the study duration
- This study was conducted in an adult population, and the results cannot be extrapolated to children and adolescents
You are about to leave FASENRAStudies.com
Important Information for the Healthcare Professional
This study discusses some information about FASENRA® (benralizumab) that is not contained in FDA-approved Prescribing Information. AstraZeneca manufactures and markets FASENRA and is the sponsor of and provided funding for this study. Some authors may have a financial interest in either FASENRA or AstraZeneca and/or may have received compensation from AstraZeneca in connection with this study or other engagements. AstraZeneca recommends use of FASENRA only in accordance with its approved Prescribing Information. Prescription drugs used outside of an approved indication may not be eligible for reimbursement by third-party payers, including Medicare or Medicaid.
In connection with the discussions contained in the reprint, please note:
- The study evaluated FASENRA's treatment effect using an open-label, single-arm study design and did not include a control group to adjust for potential changes not due to treatment
- Patients did not undergo an oral corticosteroid dosage-optimization phase and prednisolone levels were only assessed at baseline in patients who switched from another oral corticosteroid and were not assessed during the study duration
- This study was conducted in an adult population, and the results cannot be extrapolated to children and adolescents
You are about to leave FASENRAStudies.com
Important Information for the Healthcare Professional
This study discusses some information about FASENRA® (benralizumab) that is not contained in FDA-approved Prescribing Information. AstraZeneca manufactures and markets FASENRA and is the sponsor of and provided funding for this study. Some authors may have a financial interest in either FASENRA or AstraZeneca and/or may have received compensation from AstraZeneca in connection with this study or other engagements. AstraZeneca recommends use of FASENRA only in accordance with its approved Prescribing Information. Prescription drugs used outside of an approved indication may not be eligible for reimbursement by third-party payers, including Medicare or Medicaid.
In connection with the discussions contained in the reprint, please note:
- The study assessed a benralizumab 30-mg Q4W arm. This is not an approved dose
- There was no control arm, and there was potential selection bias
- Patients who did not experience benefits with their asthma treatment may have been more likely to discontinue the study vs those who did experience benefits and, similarly, patients who experienced certain serious adverse events in predecessor studies were not eligible to enter MELTEMI, both of which could contribute to selection bias
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Known hypersensitivity to benralizumab or excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days). Discontinue in the event of a hypersensitivity reaction.
Acute Asthma Symptoms or Deteriorating Disease
FASENRA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.
Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids 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.
Parasitic (Helminth) Infection
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 FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until infection resolves.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 5%):
- Asthma: headache, pharyngitis
- EGPA: headache
- HES: headache, hypersensitivity reactions, influenza-like illness
Injection site reactions (eg, 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 in asthma exacerbation studies.
USE IN SPECIFIC POPULATIONS
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.
INDICATIONS
FASENRA is indicated for:
- the add-on maintenance treatment of patients with severe asthma aged 6 years and older and with an eosinophilic phenotype. FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus
- the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA)
- the treatment of adult and adolescent patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause
Please read full Prescribing Information, including Patient Information.
